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The Serenity Pro PSF™ System is an accessory for a compatible leqally marketed Laser or Intense Pulse Light System for use in hair removal. Its handpiece produces a negative pressure over the skin surface, just prior to the administration of the treatment beam through it.

The Serenity Pro PSF™ System is a device which has the ability to produce a vacuum at a level of 400-700 mbar. Suction can be delivered through its handpiece, which has a sapphire window at its distal end, to be positioned over the skin for laser or IPL treatment. When the PSF system is activated, the negative pressure results in the flattening of the skin of the treatment site. During the time duration of suction, the treatment beam of the laser or IPL is administered through the sapphire window of the handpiece, which is transparent and thermally conductive. The resultant tight mechanical contact produced by the PSF expels blood from the treatment site which enhances the light penetration of the laser or IPL in tissue as well as the removal of its heat from the skin. This can reduce the possibility of post treatment ervthema.

I am sorry, but the provided text does not contain information about acceptance criteria or a study proving device performance in the format requested. The document is a 510(k) summary for the Serenity Pro PSF™ System, which describes the device, its intended use, and its substantial equivalence to a predicate device for FDA clearance. It does not detail specific performance metrics, clinical study design, or results in the way you've outlined.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment based on the provided text.

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The Serenity PSF™ (Pneumatic Skin Flattening) System is an accessory for a compatible legally marketed Laser or Intense Pulse Light System for use in hair removal. Its handpiece produces a negative pressure over the skin surface, just prior to the administration of the treatment beam through it.

The Serenity PSF™ (Pneumatic Skin Flattening) System is a device which has the ability to produce a vacuum at a level of 200-700 mmHg. Suction can be delivered through its handpiece, which has a sapphire window at its distal end, to be positioned over the skin for laser or IPL treatment. When the PFS system is activated, the negative pressure results in the flattening of the skin of the treatment site. During the time duration of suction, the treatment beam of the laser or IPL is administered through the sapphire window of the handpiece, which is transparent and thermally conductive. The resultant tight mechanical contact produced by the PSF expels blood from the treatment site which enhances the light penetration of the laser or IPL in tissue as well as the removal of its heat from the skin. This can reduce the possibility of post treatment erythema.

This 510(k) summary (K062589) describes the Serenity PSF™ (Pneumatic Skin Flattening) System, an accessory to compatible laser or Intense Pulsed Light (IPL) systems for hair removal. The document focuses on establishing substantial equivalence to a predicate device and does not contain detailed information about specific acceptance criteria or a comprehensive study demonstrating direct performance against such criteria.

Therefore, the requested information cannot be fully extracted from the provided text. However, based on the context of a 510(k) submission, we can infer some general aspects and state what is not present:

Missing Information:
The provided document does not include:

• A table of acceptance criteria and reported device performance.
• Sample sizes used for test sets.
• Data provenance (country of origin, retrospective/prospective).
• Number and qualifications of experts for ground truth.
• Adjudication method for the test set.
• Results from a multi-reader multi-case (MRMC) comparative effectiveness study, nor an effect size for human reader improvement with AI.
• Details on a standalone (algorithm only) performance study.
• The type of ground truth used (e.g., pathology, outcomes data).
• Sample size for the training set.
• How ground truth for the training set was established.

Analysis based on available information:

The document is a 510(k) summary, which aims to demonstrate that a new device is substantially equivalent to a legally marketed predicate device. This process typically focuses on comparing technological characteristics, intended use, and safety/effectiveness rather than presenting a performance study against predefined acceptance criteria for a novel algorithm's accuracy or efficacy.

Here's an attempt to answer the questions based on the limited information, primarily noting what is not provided:

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

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

• Sample Size for Test Set: Not specified in the provided document.
• Data Provenance: Not specified in the provided document.

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)

• Not specified. This document does not describe a study involving expert-established ground truth for a test set.

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

• Not specified. There is no mention of a test set requiring adjudication in this document.

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. The device is a pneumatic accessory for laser/IPL therapy, not an AI-assisted diagnostic or interpretative system. Therefore, an MRMC study comparing human readers with/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

• No. This device is a physical accessory, not an algorithm, so a standalone algorithm performance study is not applicable.

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

• Not applicable in the context of an algorithm's "ground truth." The document describes the physical and functional aspects of the device in relation to its intended use (skin flattening, enhanced light penetration, reduced erythema for hair removal). Performance is gauged by these physical effects and the established safety of similar predicate devices.

8. The sample size for the training set

• Not applicable. As a physical device accessory, there is no "training set" in the sense of machine learning.

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

• Not applicable, as there is no training set for an algorithm. The "ground truth" for the device's claims would be based on engineering specifications, physical testing, and potentially clinical observation of its effects (skin flattening, blood expulsion, etc.) in a clinical setting, but these details are not provided beyond the functional description.

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