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TRIA is an over-the-counter device intended for adjunctive use with shaving for hair removal sustained with periodic treatments. TRIA is also intended for permanent reduction in hair regrowth defined as a long-term, stable reduction in hair counts following a treatment regime.

TRIA is a semiconductor diode laser system that delivers infrared light at a wavelength of nominally 800 nm.

1. Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly list a table of acceptance criteria with corresponding performance metrics like sensitivity, specificity, or AUC. Instead, it focuses on demonstrating safety and efficacy for its intended use. The performance is described in terms of achieving "hair removal sustained with periodic treatments" and "permanent reduction in hair regrowth."

However, based on the narrative, the implicit acceptance criteria are that the device effectively performs these functions, and the reported performance indicates that this was demonstrated through clinical trials.

The specific "acceptance criteria" are not detailed in a quantitative manner but are centered around the clinical outcomes of hair removal and permanent reduction in hair regrowth.

2. Sample Size Used for the Test Set and Data Provenance:

The document explicitly states that "Clinical trials have been conducted to demonstrate the safety and efficacy of TRIA." However, it does not provide details on the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective nature).

3. Number of Experts Used to Establish Ground Truth and Qualifications:

The document does not specify the number of experts used to establish ground truth or their qualifications. Given the nature of the device (hair removal), ground truth might have been established through objective measurements (e.g., hair count, photographic evaluation) and/or patient self-assessment, rather than solely by expert consensus in the traditional sense of diagnostic imaging.

4. Adjudication Method for the Test Set:

The document does not mention any adjudication method (e.g., 2+1, 3+1) for establishing ground truth in the test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study evaluating the improvement of human readers with AI assistance. This is expected given that the TRIA device is a consumer- direct treatment device, not an AI diagnostic tool.

6. Standalone Performance Study:

The document describes "Clinical trials" that "demonstrate the safety and efficacy of TRIA." This implies a standalone performance study of the device itself (algorithm only, in the context of the device's function) without human adjudication in the loop during the treatment phase. The trials focused on the device's direct effect on hair reduction.

7. Type of Ground Truth Used:

The document states that clinical trials demonstrated "hair removal sustained with periodic treatments" and "permanent reduction in hair regrowth." While not explicitly defined, the ground truth would likely involve:

• Objective Measurements: Such as hair count comparisons before and after treatment, potentially using standardized photography.
• Patient Diaries/Self-Assessment: To track sustained hair removal and satisfaction.
• Clinical Assessments by Investigators: Assessing the visible reduction in hair.

8. Sample Size for the Training Set:

The document does not provide any information regarding a training set sample size. This is consistent with the device being a laser hair removal system, where "training a model" in the AI sense is not applicable. The development would involve engineering and physical testing, followed by clinical trials to validate the device's performance, not the feeding of data into an AI algorithm for learning.

9. How Ground Truth for the Training Set Was Established:

As there is no mention of a "training set" in the context of an AI algorithm, the question of how its ground truth was established is not applicable. The "ground truth" in the development of the TRIA device would relate to the physical and biological principles of laser hair removal, established through scientific understanding and prior research, rather than a data-driven training process.

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