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The MCL 31 Dermablate System with its accessories is indicated for coagulation, vaporization, ablation, or cutting of soft tissue (skin) in Dermatology, Plastic Surgery, Oral Surgery, ENT, Gynecology, General Surgery, Podiatry, and Ophthalmology (skin around the eyes).
The MCL 31 Dermablate System, when used with its micro beam handpieces, is intended for use in Dermatological procedures and Skin resurfacing procedures.

The MCL 31 Dermablate System is a pulsed Er:YAG laser emitting a wavelength of 2940 nm. The system comprises a main console unit, detachable handpieces, and a footswitch. The MCL 31 Dermablate System can be operated with micro beam and non-micro beam handpieces. The system incorporates a suction unit for the safe removal of laser plume. The laser is fired with a foot-operated switch (footswitch).

The provided text is a 510(k) summary for the MCL 31 Dermablate System, a pulsed Er:YAG laser. It details the device's technical characteristics, intended use, and compares it to legally marketed predicate devices. However, this document primarily focuses on demonstrating substantial equivalence to predicate devices through technical specifications and compliance with various safety and performance standards. It does not present a study with specific acceptance criteria related to a device's diagnostic or therapeutic performance, nor does it report on a device's performance metrics like sensitivity, specificity, or AUC.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving device performance as such a study is not part of this 510(k) summary. This type of submission relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than conducting new clinical performance studies to establish new performance metrics.

Specifically, the document does not contain:

1. A table of acceptance criteria and reported device performance.
2. Information on sample sizes, data provenance, or ground truth for test sets.
3. Details on the number or qualifications of experts for ground truth establishment.
4. Adjudication methods.
5. Results of a multi-reader multi-case (MRMC) comparative effectiveness study.
6. Information on a standalone algorithm performance study.
7. The type of ground truth used (e.g., pathology, outcomes data).
8. Sample size for the training set.
9. How ground truth for the training set was established.

The "Nonclinical Performance Data" section lists various engineering and biocompatibility standards the device complied with, such as:

• EN 60601-1 (Medical electrical equipment - Part 1: General requirements for basic safety and essential performance)
• IEC 60601-1-2 (Electromagnetic compatibility)
• IEC 60601-2-22 (Particular requirements for laser equipment)
• EN/IEC 60825-1 (Safety of laser products)
• IEC 62304 (Medical Device Software - Software life cycle processes)
• ISO 14971 (Risk management)
• EN/ISO 10993-1, -5, -10, -23 (Biocompatibility testing for cytotoxicity, sensitivity, and irritation)

These are standards that the device must meet for safety and basic performance, not metrics measuring its effectiveness in treating patients or its diagnostic accuracy. The compliance with these standards is considered sufficient for substantial equivalence in this context, aligning with the "General controls provisions of the Act" mentioned in the FDA letter.

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Coagulation, vaporization, ablation or cutting of soft tissue (skin) in Dermatology, Plastic Surgery, Oral Surgery, ENT, Gynecology, General Surgery, Podiatry and Ophthalmology (skin around the eyes).

The MCL 31 Dermablate is a pulsed Er:YAG laser emitting a wavelength of 2940 nm. The system comprises a main console unit, a handpiece and is triggered by means of a footswitch. The MCL 31 is operated with a handpiece of larger spotsize. The system incorporates a suction unit for the safe removal of laser plume.

This document is a 510(k) summary for the MCL 31 Dermablate laser system. It does not describe a study to prove the device meets specific acceptance criteria in the context of AI/ML device performance. Instead, it demonstrates substantial equivalence to predicate devices through technical characteristics and adherence to recognized standards.

Therefore, most of the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment (which are typically relevant for AI/ML device evaluations) are not applicable to this document.

However, I can extract the relevant information regarding performance and testing that is available:

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

The document does not explicitly state "acceptance criteria" in the traditional sense of a performance study with numerical targets for metrics like sensitivity, specificity, etc. Instead, acceptance is implied by demonstrating substantial equivalence to predicate devices, focusing on:

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

Not applicable. This is a non-clinical submission based on comparison to predicate devices and adherence to standards. No "test set" of clinical data for AI/ML performance is mentioned.

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 applicable. No ground truth establishment for a test set of clinical data is mentioned.

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

Not applicable. No test set requiring expert adjudication is mentioned.

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

Not applicable. This is a laser surgical instrument, not an AI/ML diagnostic or assistive device.

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

Not applicable. This is a physical medical device (laser system), not an algorithm.

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

Not applicable. The basis for safety and effectiveness is substantial equivalence to legally marketed predicate devices and compliance with recognized standards, not a specific ground truth for a performance study.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI/ML algorithm requiring a training set.

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

Not applicable.

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