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The Soprano Titanium diode laser module is intended for use in dermatology procedures requiring coagulation. The indications for use for the Soprano Trio diode laser module include: The Super Hair Removal (SHR) Mode is intended for temporary hair reduction. The Soprano Trio diode laser module HR mode is intended for use in dermatology procedures requiring coagulation. The indications for use for the Soprano Trio diode include: Benign vascular and vascular dependent lesions.

810nm Applicator: The Hair Removal (HR) and Super Hair Removal (SHR) Mode are intended for permanent reduction in hair regrowth defined as a long term, stable reduction in the number of hairs re-growing when measured at 6,9 and 12 months after the completion of a treatment regimen. Use on all skin types (Fitzpatrick I-VI), including tanned skin.(HR, and SHR Modes)

755nm applicator: The Hair Removal (HR) and Super Hair Removal (SHR) Mode are intended for permanent reduction in hair regrowth defined as a long term, stable reduction in the number of hairs re-growing when measured at 6,9 and 12 months after the completion of a treatment regimen. Use on all skin types (Fitzpatrick I-VI), including tanned skin.(HR, SHR Modes)

NIR Applicator: The Alma Lasers NIR Modules intended use is to emit energy in the near infrared (NIR) spectrum to provide topical heating. The indications for use for NIR Modules are: Elevating the tissue temperature for the temporary relief of minor muscle pain and stiffness, The temporary relief of minor joint pain associated with arthritis, The temporary increase in local circulation where applied, and The relaxation of muscles; may also help muscle spasms, minor sprains and strains, and minor muscular back pain.

The Alma Lasers Soprano Titanium Laser System consists of: System console (contains the laser diodes, the system software, power supply, and various other electronic and mechanical parts), Operator control panel with touch-screen technology (GUI), Trio applicator with 1064 nm, 810 nm and 755 nm wavelengths applied simultaneously, 810 nm applicator, 755 nm applicator, Small NIR applicator, Footswitch and other laser safety accessories.

The provided text describes the acceptance criteria and a human clinical study performed for the Soprano Titanium device.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Sample Size (Test Set): 30 healthy subjects.
• Data Provenance: The study was a multi-center, prospective, open-label, single-arm human clinical study conducted in the US at two sites.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Number of Experts: 3 blinded evaluators.
• Qualifications of Experts: Not explicitly stated in the document. They were described simply as "blinded evaluators" who physically counted hairs and assessed results.

4. Adjudication method for the test set

• Adjudication Method: Not explicitly detailed beyond stating that "three blinded evaluators assessed the results compared to the baseline for each treatment area." The document reports an "average reduction" based on these evaluations, suggesting a consensus or averaging approach, but the specific adjudication method (e.g., majority vote, independent assessment with average, etc.) is not provided.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• No, an MRMC comparative effectiveness study was not done. This study was a human clinical trial evaluating the device's efficacy for hair removal, not an AI-assisted diagnostic or interpretive study comparing human reader performance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• No, this was a device efficacy study, not an algorithm-only performance study. The "algorithm" here refers to the laser treatment protocol, and the performance was measured by its effect on human subjects, not by an automated algorithm's output.

7. The type of ground truth used

• Type of Ground Truth: Expert assessment of directly observed outcomes. The ground truth for hair reduction was established by "physically counted" hairs and "assessed" results by "three blinded evaluators" compared to baseline.

8. The sample size for the training set

• Training Set Sample Size: Not applicable/not provided. This was a clinical study on a medical device, not a machine learning model requiring a separate training set. The "protocol was reviewed by the FDA in Q181225 prior to its use," suggesting a pre-defined treatment protocol rather than an algorithm developed from a training dataset.

9. How the ground truth for the training set was established

• Ground Truth for Training Set: Not applicable. As explained above, this was a clinical efficacy study, not an AI model development study with a training set and corresponding ground truth. The device and its operating parameters would have been developed and refined through engineering and earlier testing, leading to the protocol used in this specific clinical trial.

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