Search Results

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.

Ask a specific question about this device