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

  • 86.93% Top-1 accuracy. Weighted average across the following studies:
    • 8V3 86.93%. Study: SAN_2024 (Multiple conditions). User Group: Dermatologists.
    • UC7 86.93%. Study: SAN_2024 (Multiple conditions). User Group: Dermatologists.
  • 79.87% Specificity. Weighted average across the following studies:
    • 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.
  • 77.70% Specificity. Weighted average across the following studies:
    • 0QF 75.83%. Study: BI_2024 (Multiple conditions). User Group: Primary care practitioners.
    • N2E 84.15%. Study: SAN_2024 (Multiple conditions). User Group: Primary care practitioners.
  • 77.05% Specificity. Weighted average across the following studies:
    • NLW 73.08%. Study: BI_2024 (Multiple conditions). User Group: Dermatologists.
    • YIO 90.72%. Study: SAN_2024 (Multiple conditions). User Group: Dermatologists.
  • 74.17% Sensitivity. Weighted average across the following studies:
    • CUC 71.01%. Study: BI_2024 (Multiple conditions). User Group: Dermatologists.
    • 3GH 85.08%. Study: SAN_2024 (Multiple conditions). User Group: Dermatologists.
  • 72.27% Sensitivity. Weighted average across the following studies:
    • 19H 71.04%. Study: BI_2024 (Multiple conditions). User Group: Primary care practitioners.
    • 2W5 76.53%. Study: SAN_2024 (Multiple conditions). User Group: Primary care practitioners.
  • 63.84% Top-1 accuracy. Weighted average across the following studies:
    • 6FT 8.30%. Study: BI_2024 (Multiple conditions). User Group: Dermatologists.
    • 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.
    • O0B 10.50%. Study: SAN_2024 (Multiple conditions). User Group: Dermatologists.
  • 63.06% Top-1 accuracy:
    • 9D7 63.06%. Study: BI_2024 (Multiple conditions). User Group: Dermatologists, Primary care practitioners.
  • 57.90% Sensitivity. Weighted average across the following studies:
    • 02A 18.43%. Study: BI_2024 (Multiple conditions). User Group: Dermatologists, Primary care practitioners.
    • 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.
  • 53.45% Top-1 accuracy. Weighted average across the following studies:
    • O4L 17.00%. Study: BI_2024 (Multiple conditions). User Group: Primary care practitioners.
    • 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.
    • 6KX 18.15%. Study: PH_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.
    • AR8 27.00%. Study: SAN_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.
  • 53.38% Specificity. Weighted average across the following studies:
    • 0H6 19.38%. Study: BI_2024 (Multiple conditions). User Group: Primary care practitioners.
    • H3D 75.83%. Study: BI_2024 (Multiple conditions). User Group: Primary care practitioners.
    • VEF 11.90%. Study: PH_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.
    • 9YX 29.80%. Study: SAN_2024 (Multiple conditions). User Group: Primary care practitioners.
    • FBJ 84.15%. Study: SAN_2024 (Multiple conditions). User Group: Primary care practitioners.
  • 49.76% Sensitivity. Weighted average across the following studies:
    • 81T 18.43%. Study: BI_2024 (Multiple conditions). User Group: Primary care practitioners.
    • 37G 71.04%. Study: BI_2024 (Multiple conditions). User Group: Primary care practitioners.
    • 09O 14.60%. Study: PH_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.
    • 7YC 24.95%. Study: SAN_2024 (Multiple conditions). User Group: Primary care practitioners.
    • KPM 76.53%. Study: SAN_2024 (Multiple conditions). User Group: Primary care practitioners.
  • 47.20% Top-1 accuracy. Weighted average across the following studies:
    • MRT 15.12%. 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.
    • 61I 20.00%. Study: SAN_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.
  • 45.42% Specificity. Weighted average across the following studies:
    • X70 19.38%. Study: BI_2024 (Multiple conditions). User Group: Dermatologists, Primary care practitioners.
    • 0ZD 75.83%. 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.
  • 43.58% Specificity. Weighted average across the following studies:
    • R9C 10.61%. Study: BI_2024 (Multiple conditions). User Group: Dermatologists.
    • 9MI 73.08%. Study: BI_2024 (Multiple conditions). User Group: Dermatologists.
    • N50 8.37%. Study: SAN_2024 (Multiple conditions). User Group: Dermatologists.
    • B4N 90.72%. Study: SAN_2024 (Multiple conditions). User Group: Dermatologists.
  • 42.37% Sensitivity. Weighted average across the following studies:
    • W8N 9.37%. Study: BI_2024 (Multiple conditions). User Group: Dermatologists.
    • A76 71.01%. Study: BI_2024 (Multiple conditions). User Group: Dermatologists.
    • BHO 14.70%. Study: SAN_2024 (Multiple conditions). User Group: Dermatologists.
    • Q5G 85.08%. Study: SAN_2024 (Multiple conditions). User Group: Dermatologists.
  • 28.03% Sensitivity:
    • A84 28.03%. Study: SAN_2024 (Multiple conditions). User Group: Dermatologists, Primary care practitioners.

Means of Measure

Top-1 accuracySensitivitySpecificity

Associated Performance Claims

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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

  • 500.00% Reduction in the number of days:
    • UGS 5 days. Study: DAO_Derivation_O_2022 (Multiple conditions). User Group: Primary care practitioners.
  • 84.37% Reduction in the number of days:
    • KPQ 84.37%. Study: DAO_Derivation_O_2022 (Multiple conditions). User Group: Primary care practitioners.
  • 84.33% :
    • 8MV 100.00%. Study: SAN_2024 (Multiple conditions). User Group: Dermatologists.
  • 56.96% Reduction in the number of days:
    • 1M1 56.00%. Study: DAO_Derivation_O_2022 (Multiple conditions). User Group: Primary care practitioners.
  • 55.11% Increase in patients that can be managed remotely:
    • WL4 55.11%. Study: SAN_2024 (Multiple conditions). User Group: Dermatologists.

Means of Measure

Reduction in the number of daysIncrease in patients that can be managed remotely

Associated Performance Claims

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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.

Means of Measure

SensitivitySpecificityAdequacy of referrals during in-person care

Associated Performance Claims

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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

  • 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.
  • 93.30% Specificity. Weighted average across the following studies:
    • 6EP 97.06%. Study: IDEI_2023 (Multiple malignant conditions). User Group: Dermatologists.
    • VFY 86.00%. Study: MC_EVCDAO_2019 (Multiple malignant conditions). User Group: Dermatologists.
  • 91.48% 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.
    • 9OD 89.83%. Study: MC_EVCDAO_2019 (Multiple malignant conditions). User Group: Dermatologists.
  • 89.19% Positive predictive value(PPV). Weighted average across the following studies:
    • PZD 87.50%. Study: IDEI_2023 (Multiple malignant conditions). User Group: Dermatologists.
    • 9G4 92.47%. Study: MC_EVCDAO_2019 (Multiple malignant conditions). User Group: Dermatologists.
  • 87.15% Negative predictive value(NPV). Weighted average across the following studies:
    • V2U 97.06%. Study: IDEI_2023 (Multiple malignant conditions). User Group: Dermatologists.
    • Z96 67.89%. Study: MC_EVCDAO_2019 (Multiple malignant conditions). User Group: Dermatologists.
  • 85.29% Sensitivity. Weighted average across the following studies:
    • GS5 87.50%. Study: IDEI_2023 (Multiple malignant conditions). User Group: Dermatologists.
    • BRI 81.00%. 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.
  • 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 value

Associated Performance Claims

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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

  • 74.07% Specificity:
    • CH0 74.07%. Study: PH_2024 (Rare diseases, Pustular psoriasis). User Group: Primary care practitioners.
  • 71.08% Specificity:
    • MM8 71.08%. Study: BI_2024 (Rare diseases). User Group: Dermatologists.
  • 62.19% Specificity:
    • WAM 62.19%. Study: BI_2024 (Rare diseases). User Group: Dermatologists, Primary care practitioners.
  • 61.36% Specificity:
    • 8QZ 61.36%. Study: BI_2024 (Rare diseases). User Group: Primary care practitioners.
  • 52.33% Sensitivity:
    • OR5 52.33%. Study: BI_2024 (Rare diseases). User Group: Dermatologists.
  • 51.85% Specificity:
    • 5W2 51.85%. Study: PH_2024 (Rare diseases, Pustular psoriasis). User Group: Primary care practitioners.
  • 46.59% Sensitivity:
    • DR7 46.59%. Study: BI_2024 (Rare diseases). User Group: Dermatologists, Primary care practitioners.
  • 44.55% Sensitivity:
    • DIK 44.55%. Study: BI_2024 (Rare diseases). User Group: Primary care practitioners.
  • 44.44% Sensitivity:
    • REV 44.44%. Study: PH_2024 (Rare diseases, Pustular psoriasis). User Group: Primary care practitioners.
  • 44.27% Top-1 accuracy. Weighted average across the following studies:
    • JBB 32.10%. Study: BI_2024 (Rare diseases). User Group: Primary care practitioners.
    • ERK 56.44%. Study: BI_2024 (Rare diseases). User Group: Primary care practitioners.
  • 42.32% Top-1 accuracy. Weighted average across the following studies:
    • DII 26.77%. Study: BI_2024 (Rare diseases). User Group: Dermatologists, Primary care practitioners.
    • KOQ 57.88%. Study: BI_2024 (Rare diseases). User Group: Dermatologists, Primary care practitioners.
  • 37.04% Top-1 accuracy. Weighted average across the following studies:
    • 4KO 12.97%. Study: BI_2024 (Rare diseases). User Group: Dermatologists.
    • S03 61.11%. Study: BI_2024 (Rare diseases). User Group: Dermatologists.
  • 25.56% Sensitivity:
    • NK7 25.56%. Study: BI_2024 (Rare diseases). User Group: Dermatologists, Primary care practitioners.
  • 25.21% Sensitivity:
    • 8PG 25.21%. Study: BI_2024 (Rare diseases). User Group: Primary care practitioners.
  • 24.73% Specificity:
    • 99Y 24.73%. Study: BI_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.
  • 22.22% Sensitivity:
    • 6YW 22.22%. Study: PH_2024 (Rare diseases, Pustular psoriasis). User Group: Primary care practitioners.
  • 19.44% Top-1 accuracy. Weighted average across the following studies:
    • I7Y 16.66%. Study: PH_2024 (Rare diseases, Pustular psoriasis). User Group: Primary care practitioners.
    • Z90 22.22%. Study: PH_2024 (Rare diseases, Pustular psoriasis). User Group: 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.

Means of Measure

Top-1 accuracySensitivitySpecificity

Associated Performance Claims

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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

  • 84.33% (CUS):
    • 3OA 80.00%. 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 variabilityCorrelationUnweighted Kappa

Associated Performance Claims

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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

  • 84.33% :
    • P30 100.00%. Study: COVIDX_EVCDAO_2022 (Multiple conditions). User Group: Dermatologists.
  • 55.11% Increase in patients that can be managed remotely:
    • WL4 55.11%. 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

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Check out the Performance Claims.