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The ProLite Pulsed Light System is indicated for use to remove unwanted hair in all skin types according to the Fitzpatrick Scale.

The ProLite Pulsed Light System delivers pulsed light at a wavelength beginning at a wavelength of 600 nm. The device consists of three interconnected sections: The cabinet which houses the internal cooling system, power sypply and microcontroller, the umbilical to the handpiece, and the handpiece, which houses the waveguide

This document describes the ProLite Pulsed Light System for hair removal. However, it does not contain acceptance criteria in the typical sense for a medical device study leading to performance metrics for the device itself. Instead, it focuses on demonstrating substantial equivalence to a predicate device.

Here's an analysis of the provided text in relation to your request:

1. A table of acceptance criteria and the reported device performance

The document does not provide specific quantitative acceptance criteria (e.g., "90% hair reduction after X treatments") or detailed device performance metrics (e.g., "average hair reduction of Y%").

Instead, the "Performance Data" section states: "Clinical studies were conducted to provide assurance that difference in the specifications of the ProLite Pulsed Light System and the predicate device for hair removal did not result in different performance during use." And the "Results of Clinical Study" section states: "Observation in the clinical study were recorded prior to Results of Clinical Study: treatment and at 3-6 months after treatment. There was no scarring in any subject. The study demonstrated that selective photothermolysis targeting melanin in the human hair follicle is an effective tool for hair removal."

The "Conclusion" then states: "The ProLite Pulsed Light System is substantially equivalent to other existing pulsed light systems in commercial distribution for removal of hair in Dermatology and Plastic Surgery."

Therefore, the implicit acceptance criterion is that the ProLite Pulsed Light System performs similarly to the legally marketed predicate device (EpiLight/Photoderm HR System, K974536) in terms of efficacy for hair removal and safety (no scarring). The documented performance is that the study "demonstrated that selective photothermolysis targeting melanin in the human hair follicle is an effective tool for hair removal" and that there was "no scarring in any subject."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: The document does not explicitly state the sample size of subjects in the clinical study. It only refers to "any subject" in the results, implying a group of individuals participated.
• Data Provenance: Not specified. The applicant is from Sweden, but the location of the clinical study is not mentioned.
• Retrospective or Prospective: Not specified, but clinical studies are generally prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the document. The evaluation of hair removal and scarring would typically involve medical professionals, but their number and qualifications are not mentioned.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information 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

This document describes a medical device, not an AI software. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable and not mentioned.

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

This is a physical pulsed light system, not an algorithm. Therefore, "standalone" performance in the context of an algorithm is not applicable and not mentioned. The device's performance is inherently "standalone" in that it performs the therapeutic action.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" or primary endpoints for this type of device would typically be observed hair reduction and absence of adverse events (like scarring). The document states "Observations in the clinical study were recorded prior to treatment and at 3-6 months after treatment." This implies clinical observation and outcomes data were used.

8. The sample size for the training set

This is a physical device, not a machine learning model, so there is no training set in the context of AI.

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

As there is no training set for an AI model, this is not applicable.

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