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          • ChatGPT-5 Pro Investigation
          • Clinical Benefits
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  • Clinical Benefits

Clinical Benefits

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

7GH Clinical Benefit​

Intended Clinical Benefit​

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.

Means of Measure​

  • top-1 accuracy
  • sensitivity
  • specificity

Estimated Magnitude of Benefit​

  • top-1 accuracy: 15.12% (Study: BI_2024, Indications: Multiple conditions)
  • top-1 accuracy: 63.06% (Study: BI_2024, Indications: Multiple conditions)
  • top-1 accuracy: 63.06% (Study: BI_2024, Indications: Multiple conditions)
  • sensitivity: 18.43% (Study: BI_2024, Indications: Multiple conditions)
  • sensitivity: 71.04% (Study: BI_2024, Indications: Multiple conditions)
  • sensitivity: 71.04% (Study: BI_2024, Indications: Multiple conditions)
  • specificity: 19.38% (Study: BI_2024, Indications: Multiple conditions)
  • specificity: 75.83% (Study: BI_2024, Indications: Multiple conditions)
  • specificity: 75.83% (Study: BI_2024, Indications: Multiple conditions)
  • top-1 accuracy: 17.00% (Study: BI_2024, Indications: Multiple conditions)
  • top-1 accuracy: 61.71% (Study: BI_2024, Indications: Multiple conditions)
  • top-1 accuracy: 61.71% (Study: BI_2024, Indications: Multiple conditions)
  • sensitivity: 18.43% (Study: BI_2024, Indications: Multiple conditions)
  • sensitivity: 71.04% (Study: BI_2024, Indications: Multiple conditions)
  • sensitivity: 71.04% (Study: BI_2024, Indications: Multiple conditions)
  • specificity: 19.38% (Study: BI_2024, Indications: Multiple conditions)
  • specificity: 75.83% (Study: BI_2024, Indications: Multiple conditions)
  • specificity: 75.83% (Study: BI_2024, Indications: Multiple conditions)
  • top-1 accuracy: 8.30% (Study: BI_2024, Indications: Multiple conditions)
  • top-1 accuracy: 65.65% (Study: BI_2024, Indications: Multiple conditions)
  • top-1 accuracy: 65.65% (Study: BI_2024, Indications: Multiple conditions)
  • sensitivity: 9.37% (Study: BI_2024, Indications: Multiple conditions)
  • sensitivity: 71.01% (Study: BI_2024, Indications: Multiple conditions)
  • sensitivity: 71.01% (Study: BI_2024, Indications: Multiple conditions)
  • specificity: 10.61% (Study: BI_2024, Indications: Multiple conditions)
  • specificity: 73.08% (Study: BI_2024, Indications: Multiple conditions)
  • specificity: 73.08% (Study: BI_2024, Indications: Multiple conditions)
  • top-1 accuracy: 82.14% (Study: IDEI_2023, Indications: Multiple conditions)
  • top-1 accuracy: 18.15% (Study: PH_2024, Indications: Multiple conditions)
  • top-1 accuracy: 81.85% (Study: PH_2024, Indications: Multiple conditions)
  • top-1 accuracy: 81.85% (Study: PH_2024, Indications: Multiple conditions)
  • sensitivity: 14.60% (Study: PH_2024, Indications: Multiple conditions)
  • sensitivity: 83.15% (Study: PH_2024, Indications: Multiple conditions)
  • sensitivity: 83.15% (Study: PH_2024, Indications: Multiple conditions)
  • specificity: 11.90% (Study: PH_2024, Indications: Multiple conditions)
  • specificity: 89.91% (Study: PH_2024, Indications: Multiple conditions)
  • specificity: 89.91% (Study: PH_2024, Indications: Multiple conditions)
  • top-1 accuracy: 20.00% (Study: SAN_2024, Indications: Multiple conditions)
  • top-1 accuracy: 88.78% (Study: SAN_2024, Indications: Multiple conditions)
  • top-1 accuracy: 88.78% (Study: SAN_2024, Indications: Multiple conditions)
  • sensitivity: 28.03% (Study: SAN_2024, Indications: Multiple conditions)
  • sensitivity: 80.64% (Study: SAN_2024, Indications: Multiple conditions)
  • sensitivity: 80.64% (Study: SAN_2024, Indications: Multiple conditions)
  • specificity: 30.39% (Study: SAN_2024, Indications: Multiple conditions)
  • specificity: 86.84% (Study: SAN_2024, Indications: Multiple conditions)
  • specificity: 86.84% (Study: SAN_2024, Indications: Multiple conditions)
  • top-1 accuracy: 27.00% (Study: SAN_2024, Indications: Multiple conditions)
  • top-1 accuracy: 89.92% (Study: SAN_2024, Indications: Multiple conditions)
  • top-1 accuracy: 89.92% (Study: SAN_2024, Indications: Multiple conditions)
  • sensitivity: 24.95% (Study: SAN_2024, Indications: Multiple conditions)
  • sensitivity: 76.53% (Study: SAN_2024, Indications: Multiple conditions)
  • sensitivity: 76.53% (Study: SAN_2024, Indications: Multiple conditions)
  • specificity: 29.80% (Study: SAN_2024, Indications: Multiple conditions)
  • specificity: 84.15% (Study: SAN_2024, Indications: Multiple conditions)
  • specificity: 84.15% (Study: SAN_2024, Indications: Multiple conditions)
  • top-1 accuracy: 10.50% (Study: SAN_2024, Indications: Multiple conditions)
  • top-1 accuracy: 86.93% (Study: SAN_2024, Indications: Multiple conditions)
  • top-1 accuracy: 86.93% (Study: SAN_2024, Indications: Multiple conditions)
  • sensitivity: 14.70% (Study: SAN_2024, Indications: Multiple conditions)
  • sensitivity: 85.08% (Study: SAN_2024, Indications: Multiple conditions)
  • sensitivity: 85.08% (Study: SAN_2024, Indications: Multiple conditions)
  • specificity: 8.37% (Study: SAN_2024, Indications: Multiple conditions)
  • specificity: 90.72% (Study: SAN_2024, Indications: Multiple conditions)
  • specificity: 90.72% (Study: SAN_2024, Indications: Multiple conditions)

Associated Performance Claims​

MRT, 9D7, ZKC, 02A, 5IT, ASM, X70, 0ZD, MJY, O4L, GZS, 31Q, 81T, 37G, 19H, 0H6, H3D, 0QF, 6FT, GU0, 47J, W8N, A76, CUC, R9C, 9MI, NLW, LXJ, 6KX, CZR, F16, 09O, HUG, JZ1, VEF, VCN, QX8, 61I, YIO, YJC, ME3, A84, 5UM, S2C, ZGT, FEH, VFV, B4N, N50, 3GH, Q5G, BHO, UC7, 8V3, O0B, N2E, FBJ, 9YX, AR8, 5XF, 2W5, KPM, 7YC, R7X

3KX Clinical Benefit​

Intended Clinical Benefit​

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.

Means of Measure​

  • reduction in the number of days
  • increase in patients that can be managed remotely

Estimated Magnitude of Benefit​

  • reduction in the number of days: 84.37% (Study: DAO_Derivation_O_2022, Indications: Multiple conditions)
  • reduction in the number of days: 56.00% (Study: DAO_Derivation_O_2022, Indications: Multiple conditions)
  • reduction in the number of days: 5 days (Study: DAO_Derivation_O_2022, Indications: Multiple conditions)
  • increase in patients that can be managed remotely: 55.11% (Study: SAN_2024, Indications: Multiple conditions)
  • ****: 100.00% (Study: SAN_2024, Indications: Multiple conditions)

Associated Performance Claims​

KPQ, 1M1, UGS, WL4, 8MV

8PL Clinical Benefit​

Intended Clinical Benefit​

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.

Means of Measure​

  • adequacy of referrals
  • sensitivity
  • specificity
  • adequacy of referrals during in-person care

Estimated Magnitude of Benefit​

  • adequacy of referrals: 38.00% (Study: DAO_Derivation_O_2022, Indications: Multiple conditions)
  • sensitivity: 74.00% (Study: DAO_Derivation_O_2022, Indications: Multiple conditions)
  • sensitivity: 74.00% (Study: DAO_Derivation_O_2022, Indications: Multiple conditions)
  • specificity: 67.00% (Study: DAO_Derivation_O_2022, Indications: Multiple conditions)
  • specificity: 67.00% (Study: DAO_Derivation_O_2022, Indications: Multiple conditions)
  • adequacy of referrals during in-person care: 78.60% (Study: DAO_Derivation_O_2022, Indications: Multiple conditions)
  • adequacy of referrals during in-person care: 67.60% (Study: DAO_Derivation_O_2022, Indications: Multiple conditions)

Associated Performance Claims​

D62, CST, 6H0, H4U, 04D, DCH, DZC

1QF Clinical Benefit​

Intended Clinical Benefit​

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.

Means of Measure​

  • area under the ROC curve
  • sensitivity
  • specificity
  • positive predictive value
  • negative predictive value
  • negative positive value

Estimated Magnitude of Benefit​

  • area under the ROC curve (AUC): 84.20% (Study: DAO_Derivación_PH_2022, Indications: Multiple malignant conditions)
  • area under the ROC curve (AUC): 82.00% (Study: DAO_Derivation_O_2022, Indications: Multiple malignant conditions)
  • sensitivity: 57.14% (Study: DAO_Derivation_O_2022, Indications: Multiple malignant conditions)
  • specificity: 93.53% (Study: DAO_Derivation_O_2022, Indications: Multiple malignant conditions)
  • positive predictive value (PPV): 42.00% (Study: DAO_Derivation_O_2022, Indications: Multiple malignant conditions)
  • negative predictive value (NPV): 96.00% (Study: DAO_Derivation_O_2022, Indications: Multiple malignant conditions)
  • area under the ROC curve (AUC): 97.00% (Study: IDEI_2023, Indications: Multiple malignant conditions)
  • sensitivity: 87.50% (Study: IDEI_2023, Indications: Multiple malignant conditions)
  • specificity: 97.06% (Study: IDEI_2023, Indications: Multiple malignant conditions)
  • positive predictive value (PPV): 87.50% (Study: IDEI_2023, Indications: Multiple malignant conditions)
  • negative positive value (NPV): 97.06% (Study: IDEI_2023, Indications: Multiple malignant conditions)
  • area under the ROC curve (AUC): 85.00% (Study: MC_EVCDAO_2019, Indications: Melanoma)
  • area under the ROC curve (AUC): 89.83% (Study: MC_EVCDAO_2019, Indications: Multiple malignant conditions)
  • sensitivity: 81.00% (Study: MC_EVCDAO_2019, Indications: Multiple malignant conditions)
  • specificity: 86.00% (Study: MC_EVCDAO_2019, Indications: Multiple malignant conditions)
  • positive predictive value (PPV): 92.47% (Study: MC_EVCDAO_2019, Indications: Multiple malignant conditions)
  • negative positive value (NPV): 67.89% (Study: MC_EVCDAO_2019, Indications: Multiple malignant conditions)

Associated Performance Claims​

EAC, DX7, FIQ, 6U1, 9OD, LU4, R9P, 0L2, 7ZI, GS5, 6EP, PZD, V2U, BRI, VFY, 9G4, Z96

9VW Clinical Benefit​

Intended Clinical Benefit​

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.

Means of Measure​

  • top-1 accuracy
  • sensitivity
  • specificity

Estimated Magnitude of Benefit​

  • top-1 accuracy: 26.77% (Study: BI_2024, Indications: Rare diseases)
  • top-1 accuracy: 57.88% (Study: BI_2024, Indications: Rare diseases)
  • sensitivity: 25.56% (Study: BI_2024, Indications: Rare diseases)
  • sensitivity: 46.59% (Study: BI_2024, Indications: Rare diseases)
  • specificity: 23.50% (Study: BI_2024, Indications: Rare diseases)
  • specificity: 62.19% (Study: BI_2024, Indications: Rare diseases)
  • top-1 accuracy: 32.10% (Study: BI_2024, Indications: Rare diseases)
  • top-1 accuracy: 56.44% (Study: BI_2024, Indications: Rare diseases)
  • sensitivity: 25.21% (Study: BI_2024, Indications: Rare diseases)
  • sensitivity: 44.55% (Study: BI_2024, Indications: Rare diseases)
  • specificity: 24.73% (Study: BI_2024, Indications: Rare diseases)
  • specificity: 61.36% (Study: BI_2024, Indications: Rare diseases)
  • top-1 accuracy: 12.97% (Study: BI_2024, Indications: Rare diseases)
  • top-1 accuracy: 61.11% (Study: BI_2024, Indications: Rare diseases)
  • sensitivity: 16.44% (Study: BI_2024, Indications: Rare diseases)
  • sensitivity: 52.33% (Study: BI_2024, Indications: Rare diseases)
  • specificity: 15.41% (Study: BI_2024, Indications: Rare diseases)
  • specificity: 71.08% (Study: BI_2024, Indications: Rare diseases)
  • top-1 accuracy: 16.66% (Study: PH_2024, Indications: Rare diseases, Pustular psoriasis)
  • top-1 accuracy: 22.22% (Study: PH_2024, Indications: Rare diseases, Pustular psoriasis)
  • sensitivity: 22.22% (Study: PH_2024, Indications: Rare diseases, Pustular psoriasis)
  • sensitivity: 44.44% (Study: PH_2024, Indications: Rare diseases, Pustular psoriasis)
  • specificity: 51.85% (Study: PH_2024, Indications: Rare diseases, Pustular psoriasis)
  • specificity: 74.07% (Study: PH_2024, Indications: Rare diseases, Pustular psoriasis)

Associated Performance Claims​

DII, KOQ, NK7, DR7, 0I1, WAM, 8PG, ERK, JBB, DIK, 99Y, 8QZ, 4KO, S03, TG6, OR5, Q2D, MM8, I7Y, Z90, 6YW, REV, 5W2, CH0

5RB Clinical Benefit​

Intended Clinical Benefit​

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.

Means of Measure​

  • inter-observer intraclass correlation coefficient
  • inter-class coefficient correlation variability
  • correlation
  • unweighted Kappa

Estimated Magnitude of Benefit​

  • inter-observer intraclass correlation coefficient (ICC): 72.70% (Study: AIHS4 2025, Indications: Hidradenitis supurativa)
  • inter-class coefficient correlation variability (ICC): 10.00% (Study: AIHS4 2025, Indications: Hidradenitis supurativa)
  • ** (CUS)**: 80.00% (Study: COVIDX_EVCDAO_2022, Indications: Multiple conditions)
  • correlation: 77.00% (Study: IDEI_2023, Indications: Androgenetic alopecia)
  • unweighted Kappa: 73.97% (Study: IDEI_2023, Indications: Androgenetic alopecia)
  • correlation: 47.00% (Study: IDEI_2023, Indications: Androgenetic alopecia)
  • unweighted Kappa: 32.97% (Study: IDEI_2023, Indications: Androgenetic alopecia)
  • correlation: 53.00% (Study: IDEI_2023, Indications: Androgenetic alopecia)

Associated Performance Claims​

LL5, SDP, JWQ, A1Q, 284, 3OB, 7TS, 3OA

0ZC Clinical Benefit​

Intended Clinical Benefit​

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.

Means of Measure​

  • adequacy of referrals during remote care
  • increase in patients that can be managed remotely

Estimated Magnitude of Benefit​

  • ****: 100.00% (Study: COVIDX_EVCDAO_2022, Indications: Multiple conditions)
  • adequacy of referrals during remote care: 33.00% (Study: DAO_Derivation_O_2022, Indications: Multiple conditions)
  • adequacy of referrals during remote care: 67.00% (Study: DAO_Derivation_O_2022, Indications: Multiple conditions)
  • increase in patients that can be managed remotely: 49.00% (Study: PH_2024, Indications: Multiple conditions)
  • increase in patients that can be managed remotely: 55.11% (Study: SAN_2024, Indications: Multiple conditions)

Associated Performance Claims​

LHF, 4BO, WL4, WOI, P30

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  • 7GH Clinical Benefit
    • Intended Clinical Benefit
    • Means of Measure
    • Estimated Magnitude of Benefit
    • Associated Performance Claims
  • 3KX Clinical Benefit
    • Intended Clinical Benefit
    • Means of Measure
    • Estimated Magnitude of Benefit
    • Associated Performance Claims
  • 8PL Clinical Benefit
    • Intended Clinical Benefit
    • Means of Measure
    • Estimated Magnitude of Benefit
    • Associated Performance Claims
  • 1QF Clinical Benefit
    • Intended Clinical Benefit
    • Means of Measure
    • Estimated Magnitude of Benefit
    • Associated Performance Claims
  • 9VW Clinical Benefit
    • Intended Clinical Benefit
    • Means of Measure
    • Estimated Magnitude of Benefit
    • Associated Performance Claims
  • 5RB Clinical Benefit
    • Intended Clinical Benefit
    • Means of Measure
    • Estimated Magnitude of Benefit
    • Associated Performance Claims
  • 0ZC Clinical Benefit
    • Intended Clinical Benefit
    • Means of Measure
    • Estimated Magnitude of Benefit
    • Associated Performance Claims
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