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Dermablate System with its accessories is indicated for coagulation, or cutting of soft tissue (skin) in Dermatology, Plastic Surgery, Oral Surgery, ENT, Gynecology, General Surgery, Podiatry, and Ophthalmology (skin around the eyes).

Dermablate System, when used with its micro beam handpieces, is intended for use in Dermatological procedures and Skin resurfacing procedures.

Dermablate 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 device 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).

This document, a 510(k) Premarket Notification summary for the Dermablate laser system, primarily focuses on demonstrating substantial equivalence to predicate devices rather than presenting a detailed study proving the device meets specific performance acceptance criteria. Therefore, most of the requested information (acceptance criteria table, sample sizes, ground truth details, MRMC study, standalone performance) cannot be extracted directly from this document.

The document outlines that "Dermablate passed all the required testing and is in compliance with all applicable sections of the abovementioned performance standards," which implies that the device did meet acceptance criteria related to these standards, but the specific performance results or acceptance thresholds are not detailed.

Here's an analysis of the information available:

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

The document does not provide a table of specific acceptance criteria (e.g., target energy output with an allowable deviation) and the device's reported performance against these criteria. Instead, it lists harmonized standards that the device passed. Compliance with these standards is the reported performance in this context, demonstrating that the device meets safety and electromagnetic compatibility requirements, among others.

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

This information is not provided in the document. The testing described (performance testing, software V&V, biocompatibility) typically involves engineering tests, hardware verification, and software validation rather than patient-level clinical studies with test sets in the context of AI/diagnostic devices.

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 applicable/provided. The Dermablate is a laser surgical instrument, and its performance evaluation documented here revolves around technical and safety specifications rather than diagnostic accuracy established by expert consensus on a test set.

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

This information is not applicable/provided. As explained in point 3, the evaluation of this device does not involve expert adjudication of a test set in the way a diagnostic AI would.

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

An MRMC comparative effectiveness study is not applicable here. The Dermablate is a therapeutic laser device, not a diagnostic AI system designed to assist human readers.

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

This concept is not applicable to a therapeutic laser device. The device's function is direct treatment, not an algorithmic standalone performance for diagnosis or image analysis.

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

The document does not detail "ground truth" in the context of clinical outcomes or diagnostic accuracy. For a laser device, "ground truth" would relate to its physical output parameters (wavelength, energy, fluence, etc.) matching specifications, and its safety compliance with international standards. The document states that the device "passed all the required testing and is in compliance with all applicable sections of the above-mentioned performance standards," implying that these standards' requirements serve as the "ground truth" for technical and safety performance.

8. The sample size for the training set

This information is not applicable/provided. The Dermablate is not an AI/machine learning device that requires a training set.

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

This information is not applicable/provided. As above, the device does not use a training set.

Summary of available information regarding compliance and efficacy (as per the document):

The document focuses on demonstrating substantial equivalence of the modified Dermablate device (increased max pulse energy to 3J and addition of a "DeepSpot" microbeam handpiece) to its predicate devices (MCL 31 Dermablate and Erise). The "study" proving the device meets acceptance criteria is implied through its successful passage of various harmonized standard tests and software verifications and validations.

The key statement is: "Based on the nature of the changes implemented, the device underwent and successfully passed performance testing and software verifications and validation according to the relevant standards." and "Dermablate passed all the required testing and is in compliance will all applicable sections of the abovementioned performance standards."

The listed standards that the device passed are:

• IEC 60601-1-6:2010/AMD1:2013: Medical electrical equipment Part 1: General requirements for safety and essential performance
• IEC 60601-1-2:2015: Medical electrical equipment – Part 1-2: General requirements for safety and essential performance – Collateral standard: Electromagnetic compatibility – Requirements and tests
• IEC 62304: Medical Device Software – Software life cycle processes
• IEC 62366-1:2015: Medical devices – Application of usability engineering to medical devices
• IEC 60601-2-22:2019: Medical electrical equipment – Part 2: Particular requirements for the safety of diagnostic and therapeutic laser equipment
• IEC 60825-1:2014: Safety of laser products - Part 1: Equipment classification, and requirement
• ISO 14971: Medical devices - Application of risk management to medical devices
• FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (for software V&V)
• EN/ISO 10993-1: Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
• ISO 10993-5: Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
• ISO 10993-10: Biological evaluation of medical devices - Part 10 Tests for irritation and skin sensitization
• ISO 10993-23: Biological evaluation of medical devices - Part 23 Tests for irritation

The "acceptance criteria" are compliance with these standards, and the "reported device performance" is that it did comply. The document does not elaborate on the specific test results or the criteria defined within each standard that the device had to meet (e.g., maximum electromagnetic emissions or specific laser output tolerances).

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