Clinical Benefits

Clinical benefits are intended outcomes derived from the device's performance characteristics. Each benefit is supported by multiple performance claims.

7GH The device improves accuracy of HCPs during the diagnosis of dermatological conditions. This has a positive impact on patient management and outcomes related to diagnosis and monitoring of patients.

Estimated Magnitude of Benefit

  • 89.29% Top-3 accuracy:
    • 7V9 89.29%. Study: IDEI_2023 (Multiple conditions). User Group: Dermatologists.
  • 89.29% Top-5 accuracy:
    • 1S5 89.29%. Study: IDEI_2023 (Multiple conditions). User Group: Dermatologists.
  • 84.22% Top-5 accuracy:
    • EYP 84.22%. Study: MC_EVCDAO_2019 (Multiple conditions). User Group: Dermatologists.
  • 80.00% Specificity. Weighted average across the following studies:
    • H3D 75.83%. Study: BI_2024 (Multiple conditions). User Group: Primary care practitioners.
    • 0QF 75.83%. Study: BI_2024 (Multiple conditions). User Group: Primary care practitioners.
    • QX8 89.91%. Study: PH_2024 (Multiple conditions). User Group: Primary care practitioners.
    • VCN 89.91%. Study: PH_2024 (Multiple conditions). User Group: Primary care practitioners.
    • FBJ 84.15%. Study: SAN_2024 (Multiple conditions). User Group: Primary care practitioners.
    • N2E 84.15%. Study: SAN_2024 (Multiple conditions). User Group: Primary care practitioners.
  • 78.31% Specificity. Weighted average across the following studies:
    • 0ZD 75.83%. Study: BI_2024 (Multiple conditions). User Group: Dermatologists, Primary care practitioners.
    • MJY 75.83%. Study: BI_2024 (Multiple conditions). User Group: Dermatologists, Primary care practitioners.
    • FEH 86.84%. Study: SAN_2024 (Multiple conditions). User Group: Dermatologists, Primary care practitioners.
    • VFV 86.84%. Study: SAN_2024 (Multiple conditions). User Group: Dermatologists, Primary care practitioners.
  • 77.05% Specificity. Weighted average across the following studies:
    • 9MI 73.08%. Study: BI_2024 (Multiple conditions). User Group: Dermatologists.
    • NLW 73.08%. Study: BI_2024 (Multiple conditions). User Group: Dermatologists.
    • B4N 90.72%. Study: SAN_2024 (Multiple conditions). User Group: Dermatologists.
    • YIO 90.72%. Study: SAN_2024 (Multiple conditions). User Group: Dermatologists.
  • 75.69% Top-3 accuracy:
    • 6R7 75.69%. Study: MC_EVCDAO_2019 (Multiple conditions). User Group: Dermatologists.
  • 75.60% Top-1 accuracy. Weighted average across the following studies:
    • GU0 65.65%. Study: BI_2024 (Multiple conditions). User Group: Dermatologists.
    • 47J 65.65%. Study: BI_2024 (Multiple conditions). User Group: Dermatologists.
    • LXJ 82.14%. Study: IDEI_2023 (Multiple conditions). User Group: Dermatologists.
    • 8V3 86.93%. Study: SAN_2024 (Multiple conditions). User Group: Dermatologists.
    • UC7 86.93%. Study: SAN_2024 (Multiple conditions). User Group: Dermatologists.
  • 74.33% Sensitivity. Weighted average across the following studies:
    • 37G 71.04%. Study: BI_2024 (Multiple conditions). User Group: Primary care practitioners.
    • 19H 71.04%. Study: BI_2024 (Multiple conditions). User Group: Primary care practitioners.
    • HUG 83.15%. Study: PH_2024 (Multiple conditions). User Group: Primary care practitioners.
    • JZ1 83.15%. Study: PH_2024 (Multiple conditions). User Group: Primary care practitioners.
    • KPM 76.53%. Study: SAN_2024 (Multiple conditions). User Group: Primary care practitioners.
    • 2W5 76.53%. Study: SAN_2024 (Multiple conditions). User Group: Primary care practitioners.
  • 74.17% Sensitivity. Weighted average across the following studies:
    • A76 71.01%. Study: BI_2024 (Multiple conditions). User Group: Dermatologists.
    • CUC 71.01%. Study: BI_2024 (Multiple conditions). User Group: Dermatologists.
    • Q5G 85.08%. Study: SAN_2024 (Multiple conditions). User Group: Dermatologists.
    • 3GH 85.08%. Study: SAN_2024 (Multiple conditions). User Group: Dermatologists.
  • 73.20% Sensitivity. Weighted average across the following studies:
    • 5IT 71.04%. Study: BI_2024 (Multiple conditions). User Group: Dermatologists, Primary care practitioners.
    • ASM 71.04%. Study: BI_2024 (Multiple conditions). User Group: Dermatologists, Primary care practitioners.
    • 5UM 80.64%. Study: SAN_2024 (Multiple conditions). User Group: Dermatologists, Primary care practitioners.
    • S2C 80.64%. Study: SAN_2024 (Multiple conditions). User Group: Dermatologists, Primary care practitioners.
  • 70.66% Top-1 accuracy. Weighted average across the following studies:
    • GZS 61.71%. Study: BI_2024 (Multiple conditions). User Group: Primary care practitioners.
    • 31Q 61.71%. Study: BI_2024 (Multiple conditions). User Group: Primary care practitioners.
    • CZR 81.85%. Study: PH_2024 (Multiple conditions). User Group: Primary care practitioners.
    • F16 81.85%. Study: PH_2024 (Multiple conditions). User Group: Primary care practitioners.
    • 5XF 89.92%. Study: SAN_2024 (Multiple conditions). User Group: Primary care practitioners.
    • R7X 89.92%. Study: SAN_2024 (Multiple conditions). User Group: Primary care practitioners.
  • 70.56% Top-1 accuracy. Weighted average across the following studies:
    • KW3 78.57%. Study: IDEI_2023 (Multiple conditions). User Group: Dermatologists.
    • WGP 55.00%. Study: MC_EVCDAO_2019 (Multiple conditions). User Group: Dermatologists.
  • 68.84% Top-1 accuracy. Weighted average across the following studies:
    • 9D7 63.06%. Study: BI_2024 (Multiple conditions). User Group: Dermatologists, Primary care practitioners.
    • ZKC 63.06%. Study: BI_2024 (Multiple conditions). User Group: Dermatologists, Primary care practitioners.
    • YJC 88.78%. Study: SAN_2024 (Multiple conditions). User Group: Dermatologists, Primary care practitioners.
    • ME3 88.78%. Study: SAN_2024 (Multiple conditions). User Group: Dermatologists, Primary care practitioners.
  • 21.86% Specificity. Weighted average across the following studies:
    • X70 19.38%. Study: BI_2024 (Multiple conditions). User Group: Dermatologists, Primary care practitioners.
    • ZGT 30.39%. Study: SAN_2024 (Multiple conditions). User Group: Dermatologists, Primary care practitioners.
  • 20.59% Sensitivity. Weighted average across the following studies:
    • 02A 18.43%. Study: BI_2024 (Multiple conditions). User Group: Dermatologists, Primary care practitioners.
    • A84 28.03%. Study: SAN_2024 (Multiple conditions). User Group: Dermatologists, Primary care practitioners.
  • 19.87% Specificity. Weighted average across the following studies:
    • 0H6 19.38%. Study: BI_2024 (Multiple conditions). User Group: Primary care practitioners.
    • VEF 11.90%. Study: PH_2024 (Multiple conditions). User Group: Primary care practitioners.
    • 9YX 29.80%. Study: SAN_2024 (Multiple conditions). User Group: Primary care practitioners.
  • 19.04% Top-1 accuracy. Weighted average across the following studies:
    • O4L 17.00%. Study: BI_2024 (Multiple conditions). User Group: Primary care practitioners.
    • 6KX 18.15%. Study: PH_2024 (Multiple conditions). User Group: Primary care practitioners.
    • AR8 27.00%. Study: SAN_2024 (Multiple conditions). User Group: Primary care practitioners.
  • 18.90% Sensitivity. Weighted average across the following studies:
    • 81T 18.43%. Study: BI_2024 (Multiple conditions). User Group: Primary care practitioners.
    • 09O 14.60%. Study: PH_2024 (Multiple conditions). User Group: Primary care practitioners.
    • 7YC 24.95%. Study: SAN_2024 (Multiple conditions). User Group: Primary care practitioners.
  • 16.22% Top-1 accuracy. Weighted average across the following studies:
    • MRT 15.12%. Study: BI_2024 (Multiple conditions). User Group: Dermatologists, Primary care practitioners.
    • 61I 20.00%. Study: SAN_2024 (Multiple conditions). User Group: Dermatologists, Primary care practitioners.
  • 10.57% Sensitivity. Weighted average across the following studies:
    • W8N 9.37%. Study: BI_2024 (Multiple conditions). User Group: Dermatologists.
    • BHO 14.70%. Study: SAN_2024 (Multiple conditions). User Group: Dermatologists.
  • 10.11% Specificity. Weighted average across the following studies:
    • R9C 10.61%. Study: BI_2024 (Multiple conditions). User Group: Dermatologists.
    • N50 8.37%. Study: SAN_2024 (Multiple conditions). User Group: Dermatologists.
  • 8.79% Top-1 accuracy. Weighted average across the following studies:
    • 6FT 8.30%. Study: BI_2024 (Multiple conditions). User Group: Dermatologists.
    • O0B 10.50%. Study: SAN_2024 (Multiple conditions). User Group: Dermatologists.

Means of Measure

Top-1 accuracySensitivitySpecificityTop-3 accuracyTop-5 accuracy

Associated Performance Claims

MRT9D7ZKC02A5ITASMX700ZDMJYO4LGZS31Q81T37G19H0H6H3D0QF6FTGU047JW8NA76CUCR9C9MINLWLXJKW37V91S5WGP6R7EYP6KXCZRF1609OHUGJZ1VEFQX8VCN61IYJCME3A845UMS2CZGTFEHVFVAR85XFR7X7YCKPM2W59YXFBJN2EO0B8V3UC7BHOQ5G3GHN50B4NYIO

3KX The device reduces waiting times for skin-related medical consultations by providing healthcare providers with additional relevant clinical information. This has a positive impact on patient management and outcomes related to the diagnosis and monitoring of patients.

Estimated Magnitude of Benefit

  • 213.46% Reduction in the number of days. Weighted average across the following studies:
    • KPQ 84.37%. Study: DAO_Derivation_O_2022 (Multiple conditions). User Group: Primary care practitioners.
    • 1M1 56.00%. Study: DAO_Derivation_O_2022 (Multiple conditions). User Group: Primary care practitioners.
    • UGS 5 days. Study: DAO_Derivation_O_2022 (Multiple conditions). User Group: Primary care practitioners.
  • 100.00% Expert consensus:
    • 8MV 100.00%. Study: SAN_2024 (Multiple conditions). User Group: Dermatologists.
  • 74.99% Expert consensus. Weighted average across the following studies:
    • ZGP 50.00%. Study: COVIDX_EVCDAO_2022 (Multiple conditions). User Group: Dermatologists.
    • RND 100.00%. Study: COVIDX_EVCDAO_2022 (Multiple conditions). User Group: Dermatologists.
    • 3BD 67.00%. Study: COVIDX_EVCDAO_2022 (Multiple conditions). User Group: Dermatologists.
    • NVT 76.67%. Study: COVIDX_EVCDAO_2022 (Multiple conditions). User Group: Dermatologists.
    • VCT 80.00%. Study: DAO_Derivación_PH_2022 (Multiple conditions). User Group: Dermatologists.
    • LYP 87.00%. Study: SAN_2024 (Multiple conditions). User Group: Dermatologists.
  • 60.70% Reduction in the number of days:
    • IP4 60.70%. Study: PH_2024 (Multiple conditions). User Group: Primary care practitioners.
  • 56.00% Increase in patients that can be managed remotely:
    • WL4 56.00%. Study: SAN_2024 (Multiple conditions). User Group: Dermatologists.
  • 49.00% Increase in patients that can be managed remotely:
    • WOI 49.00%. Study: PH_2024 (Multiple conditions). User Group: Primary care practitioners.
  • 42.00% Reduction in the number of days:
    • V2J 42.00%. Study: SAN_2024 (Multiple conditions). User Group: Dermatologists.

Means of Measure

Expert consensusReduction in the number of daysIncrease in patients that can be managed remotely

Associated Performance Claims

ZGPRND3BDNVTVCTKPQ1M1UGSIP4WOIV2JWL4LYP8MV

8PL The device improves the precision of HCPs during the referral. This has a positive impact on patient management, increases the adequacy of referrals and positively impacts outcomes related to diagnosis and monitoring of patients.

Estimated Magnitude of Benefit

  • 74.00% Sensitivity. Weighted average across the following studies:
    • CST 74.00%. Study: DAO_Derivation_O_2022 (Multiple conditions). User Group: Primary care practitioners.
    • 6H0 74.00%. Study: DAO_Derivation_O_2022 (Multiple conditions). User Group: Primary care practitioners.
  • 73.10% Adequacy of referrals during in-person care. Weighted average across the following studies:
    • DCH 78.60%. Study: DAO_Derivation_O_2022 (Multiple conditions). User Group: Primary care practitioners.
    • DZC 67.60%. Study: DAO_Derivation_O_2022 (Multiple conditions). User Group: Primary care practitioners.
  • 67.00% Specificity. Weighted average across the following studies:
    • H4U 67.00%. Study: DAO_Derivation_O_2022 (Multiple conditions). User Group: Primary care practitioners.
    • 04D 67.00%. Study: DAO_Derivation_O_2022 (Multiple conditions). User Group: Primary care practitioners.
  • 38.00% :
    • D62 38.00%. Study: DAO_Derivation_O_2022 (Multiple conditions). User Group: Primary care practitioners.
  • 7.00% Increase in the adequacy of referrals:
    • 8H5 7.00%. Study: DAO_Derivación_PH_2022 (Multiple conditions). User Group: Dermatologists.

Means of Measure

Increase in the adequacy of referralsSensitivitySpecificityAdequacy of referrals during in-person care

Associated Performance Claims

8H5D62CST6H0H4U04DDCHDZC

1QF The device improves accuracy of HCPs during the diagnosis of lesions suspicious for skin cancer. This has a positive impact on patient management and outcomes related to diagnosis and monitoring of patients, such as reducing the need for invasive procedures.

Estimated Magnitude of Benefit

  • 97.06% Specificity:
    • 6EP 97.06%. Study: IDEI_2023 (Multiple malignant conditions). User Group: Dermatologists.
  • 97.06% Negative predictive value(NPV):
    • V2U 97.06%. Study: IDEI_2023 (Multiple malignant conditions). User Group: Dermatologists.
  • 96.00% Negative predictive value(NPV):
    • 7ZI 96.00%. Study: DAO_Derivation_O_2022 (Multiple malignant conditions). User Group: Primary care practitioners.
  • 93.53% Specificity:
    • R9P 93.53%. Study: DAO_Derivation_O_2022 (Multiple malignant conditions). User Group: Primary care practitioners.
  • 93.00% Sensitivity:
    • ZM8 93.00%. Study: MC_EVCDAO_2019 (Melanoma). User Group: Dermatologists.
  • 92.47% Positive predictive value(PPV):
    • 9G4 92.47%. Study: MC_EVCDAO_2019 (Multiple malignant conditions). User Group: Dermatologists.
  • 91.99% Area under the ROC curve(AUC). Weighted average across the following studies:
    • EAC 84.20%. Study: DAO_Derivación_PH_2022 (Multiple malignant conditions). User Group: Dermatologists.
    • FIQ 97.00%. Study: IDEI_2023 (Multiple malignant conditions). User Group: Dermatologists.
  • 89.83% Area under the ROC curve(AUC):
    • 9OD 89.83%. Study: MC_EVCDAO_2019 (Multiple malignant conditions). User Group: Dermatologists.
  • 87.50% Sensitivity:
    • GS5 87.50%. Study: IDEI_2023 (Multiple malignant conditions). User Group: Dermatologists.
  • 87.50% Positive predictive value(PPV):
    • PZD 87.50%. Study: IDEI_2023 (Multiple malignant conditions). User Group: Dermatologists.
  • 86.00% Specificity:
    • VFY 86.00%. Study: MC_EVCDAO_2019 (Multiple malignant conditions). User Group: Dermatologists.
  • 85.00% Area under the ROC curve(AUC):
    • 6U1 85.00%. Study: MC_EVCDAO_2019 (Melanoma). User Group: Dermatologists.
  • 82.00% Area under the ROC curve(AUC):
    • DX7 82.00%. Study: DAO_Derivation_O_2022 (Multiple malignant conditions). User Group: Primary care practitioners.
  • 81.00% Top-1 accuracy:
    • JFM 81.00%. Study: MC_EVCDAO_2019 (Melanoma). User Group: Dermatologists.
  • 81.00% Sensitivity:
    • BRI 81.00%. Study: MC_EVCDAO_2019 (Multiple malignant conditions). User Group: Dermatologists.
  • 80.00% Specificity:
    • 4JY 80.00%. Study: MC_EVCDAO_2019 (Melanoma). User Group: Dermatologists.
  • 67.89% Negative predictive value(NPV):
    • Z96 67.89%. Study: MC_EVCDAO_2019 (Multiple malignant conditions). User Group: Dermatologists.
  • 57.14% Sensitivity:
    • LU4 57.14%. Study: DAO_Derivation_O_2022 (Multiple malignant conditions). User Group: Primary care practitioners.
  • 42.00% Positive predictive value(PPV):
    • 0L2 42.00%. Study: DAO_Derivation_O_2022 (Multiple malignant conditions). User Group: Primary care practitioners.

Means of Measure

Area under the ROC curveSensitivitySpecificityPositive predictive valueNegative predictive valueTop-1 accuracy

Associated Performance Claims

EACDX7LU4R9P0L27ZIFIQGS56EPPZDV2U6U1JFMZM84JY9ODBRIVFY9G4Z96

9VW The device improves accuracy of HCPs during the diagnosis of rare diseases. This has a positive impact on patient management and outcomes related to diagnosis and monitoring of patients, especially those suffering from rare diseases.

Estimated Magnitude of Benefit

  • 71.08% Specificity:
    • MM8 71.08%. Study: BI_2024 (Rare diseases). User Group: Dermatologists.
  • 64.29% Specificity. Weighted average across the following studies:
    • 8QZ 61.36%. Study: BI_2024 (Rare diseases). User Group: Primary care practitioners.
    • CH0 74.07%. Study: PH_2024 (Rare diseases). User Group: Primary care practitioners.
  • 62.19% Specificity:
    • WAM 62.19%. Study: BI_2024 (Rare diseases). User Group: Dermatologists, Primary care practitioners.
  • 61.11% Top-1 accuracy:
    • S03 61.11%. Study: BI_2024 (Rare diseases). User Group: Dermatologists.
  • 57.88% Top-1 accuracy:
    • KOQ 57.88%. Study: BI_2024 (Rare diseases). User Group: Dermatologists, Primary care practitioners.
  • 52.33% Sensitivity:
    • OR5 52.33%. Study: BI_2024 (Rare diseases). User Group: Dermatologists.
  • 48.54% Top-1 accuracy. Weighted average across the following studies:
    • ERK 56.44%. Study: BI_2024 (Rare diseases). User Group: Primary care practitioners.
    • Z90 22.22%. Study: PH_2024 (Rare diseases). User Group: Primary care practitioners.
  • 46.59% Sensitivity:
    • DR7 46.59%. Study: BI_2024 (Rare diseases). User Group: Dermatologists, Primary care practitioners.
  • 44.52% Sensitivity. Weighted average across the following studies:
    • DIK 44.55%. Study: BI_2024 (Rare diseases). User Group: Primary care practitioners.
    • REV 44.44%. Study: PH_2024 (Rare diseases). User Group: Primary care practitioners.
  • 30.99% Specificity. Weighted average across the following studies:
    • 99Y 24.73%. Study: BI_2024 (Rare diseases). User Group: Primary care practitioners.
    • 5W2 51.85%. Study: PH_2024 (Rare diseases). User Group: Primary care practitioners.
  • 28.54% Top-1 accuracy. Weighted average across the following studies:
    • JBB 32.10%. Study: BI_2024 (Rare diseases). User Group: Primary care practitioners.
    • I7Y 16.66%. Study: PH_2024 (Rare diseases). User Group: Primary care practitioners.
  • 26.77% Top-1 accuracy:
    • DII 26.77%. Study: BI_2024 (Rare diseases). User Group: Dermatologists, Primary care practitioners.
  • 25.56% Sensitivity:
    • NK7 25.56%. Study: BI_2024 (Rare diseases). User Group: Dermatologists, Primary care practitioners.
  • 24.52% Sensitivity. Weighted average across the following studies:
    • 8PG 25.21%. Study: BI_2024 (Rare diseases). User Group: Primary care practitioners.
    • 6YW 22.22%. Study: PH_2024 (Rare diseases). User Group: Primary care practitioners.
  • 23.50% Specificity:
    • 0I1 23.50%. Study: BI_2024 (Rare diseases). User Group: Dermatologists, Primary care practitioners.
  • 16.44% Sensitivity:
    • TG6 16.44%. Study: BI_2024 (Rare diseases). User Group: Dermatologists.
  • 15.41% Specificity:
    • Q2D 15.41%. Study: BI_2024 (Rare diseases). User Group: Dermatologists.
  • 12.97% Top-1 accuracy:
    • 4KO 12.97%. Study: BI_2024 (Rare diseases). User Group: Dermatologists.

Means of Measure

Top-1 accuracySensitivitySpecificity

Associated Performance Claims

DIIKOQNK7DR70I1WAMJBBERK8PGDIK99Y8QZ4KOS03TG6OR5Q2DMM8I7YZ906YWREV5W2CH0

5RB The device measures the degree of involvement of disease objectively, quantitatively, and reproducibly. This increases the precision of healthcare providers during the monitoring of patients. This has a positive impact on patient management and outcomes related to the monitoring of patients and treatment.

Estimated Magnitude of Benefit

  • 81.50% Expert consensus(CUS). Weighted average across the following studies:
    • 3OA 80.00%. Study: COVIDX_EVCDAO_2022 (Multiple conditions). User Group: Dermatologists.
    • EZ1 83.00%. Study: COVIDX_EVCDAO_2022 (Multiple conditions). User Group: Dermatologists.
  • 72.70% Inter-observer intraclass correlation coefficient(ICC):
    • LL5 72.70%. Study: AIHS4 2025 (Hidradenitis supurativa). User Group: Dermatologists.
  • 59.00% Correlation. Weighted average across the following studies:
    • JWQ 77.00%. Study: IDEI_2023 (Androgenetic alopecia). User Group: Dermatologists.
    • 284 47.00%. Study: IDEI_2023 (Androgenetic alopecia). User Group: Dermatologists.
    • 7TS 53.00%. Study: IDEI_2023 (Androgenetic alopecia). User Group: Dermatologists.
  • 53.47% Unweighted Kappa. Weighted average across the following studies:
    • A1Q 73.97%. Study: IDEI_2023 (Androgenetic alopecia). User Group: Dermatologists.
    • 3OB 32.97%. Study: IDEI_2023 (Androgenetic alopecia). User Group: Dermatologists.
  • 10.00% Inter-class coefficient correlation variability(ICC):
    • SDP 10.00%. Study: AIHS4 2025 (Hidradenitis supurativa). User Group: Dermatologists.

Means of Measure

Inter-observer intraclass correlation coefficientInter-class coefficient correlation variabilityExpert consensusCorrelationUnweighted Kappa

Associated Performance Claims

LL5SDP3OAEZ1JWQA1Q2843OB7TS

0ZC The device improves accuracy of HCPs during the remote diagnosis of skin conditions and the precision of HCPs during the remote referral. This has a positive impact on patient management and outcomes related to diagnosis and monitoring of patients, especially during remote care.

Estimated Magnitude of Benefit

  • 100.00% :
    • P30 100.00%. Study: COVIDX_EVCDAO_2022 (Multiple conditions). User Group: Dermatologists.
  • 56.00% Increase in patients that can be managed remotely:
    • WL4 56.00%. Study: SAN_2024 (Multiple conditions). User Group: Dermatologists.
  • 50.00% Adequacy of referrals during remote care. Weighted average across the following studies:
    • LHF 33.00%. Study: DAO_Derivation_O_2022 (Multiple conditions). User Group: Primary care practitioners.
    • 4BO 67.00%. Study: DAO_Derivation_O_2022 (Multiple conditions). User Group: Primary care practitioners.
  • 49.00% Increase in patients that can be managed remotely:
    • WOI 49.00%. Study: PH_2024 (Multiple conditions). User Group: Primary care practitioners.

Means of Measure

Adequacy of referrals during remote careIncrease in patients that can be managed remotely

Associated Performance Claims

P30LHF4BOWOIWL4
Check out the Performance Claims.