(134 days)
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:
| Characteristic | Acceptance Criteria (Implied by Predicate Devices) | Reported Device Performance (MCL 31 Dermablate) |
|---|---|---|
| Intended Use | Similar to predicate devices | Coagulation, vaporization, ablation or cutting of soft tissue (skin) in various medical fields (matching predicate K101306 and expanding on K081541 due to larger spot size). |
| Laser medium | Er:YAG | Er:YAG |
| Wavelength | 2940 nm | 2940 nm |
| Interaction with skin | Ablation, Coagulation | Ablation, Coagulation |
| Energy, max. | Similar range to predicate (1.5 - 3.0 J) | 2.5 J |
| Power, max. | Similar range to predicate (12 - 20 W) | 20 W |
| Frequency, max. | Similar range to predicate (20 - 50 Hz) | 20 Hz |
| Spot size | Similar range to predicate (1-12 mm) | 1-12 mm |
| Fluence, max. | Similar range to predicate (100 - 250 J/cm^2) | 250 J/cm^2 |
| Pulsewidth | Similar range to predicate (100 - 1500 µs) | 100 - 1000 µs |
| Safety Standards | Adherence to recognized medical device standards | Tested according to ISO 14971, DIN EN 60601-1, DIN EN 60601-1-2, DIN EN 60601-1-6, DIN EN 60601-2-22, DIN EN 60825-1, DIN EN 62304. |
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.
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.