(27 days)
Intended for coagulation, vaporization, ablation or cutting of soft tissue (skin) in dermatology, plastic surgery (including aesthetic surgery), oral surgery, and ophthalmology (skin around the eyes).
The smoke evacuator integrated into the handpiece is intended to remove aerosol, a by-product of laser treatment.
MCL 30 Dermablate Er: Y AG Laser System is an Er: Y AG laser system, having an articulated arm and handpiece. It is a laser with a wavelength of approximately 2.94 um. Laser emission activation is by foot switch. Overall weight of the laser is 85 kg, and the size is 970x360x650 cm (HxWxD). Electrical requirement is 230 VAC, 16A, 50-60 Hz, single phase. Smoke evacuation is provided by the evacuator integrated into the handpiece that removes the aerosol, a by-product of laser treatment.
The provided text is a 510(k) summary for the MCL 30 Dermablate Er:YAG Laser System. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study that proves the device meets specific acceptance criteria with quantifiable performance metrics.
Therefore, many of the requested details about acceptance criteria, study design, and performance metrics are not available in the provided text.
Here's a breakdown of what can be extracted and what information is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated as quantifiable criteria. | Not explicitly stated as quantifiable performance metrics. |
| Implicit Acceptance Criteria: Substantial equivalence to the DermaStar Er:YAG Laser System. | Reported Equivalence: Same principle of operation, same wavelength (approx. 2.94 um), and essentially the same power range as the predicate device. |
| Implicit Acceptance Criteria: Safe and effective for intended use. | Reported Conclusion: "The MCL 30 Dermablate Er: Y AG Laser System is another safe and effective device for coagulation, vaporization, ablation or cutting of soft tissue (skin) in dermatology, plastic surgery (including aesthetic surgery), oral surgery, and ophthalmology (skin around the eyes)." |
Regarding the Study (or lack thereof):
The document explicitly states:
- Nonclinical Performance Data: none
- Clinical Performance Data: none
This means there was no specific study conducted and reported in this 510(k) submission to establish acceptance criteria or demonstrate performance directly through testing. The approval is based on substantial equivalence to a legally marketed predicate device.
Given the above, the following information is not applicable or not provided by the document:
2. Sample size used for the test set and the data provenance: Not applicable, as no dedicated test set or clinical/non-clinical performance data was presented.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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 device is a laser system, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an algorithm-based device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as no specific performance study with ground truth was reported.
8. The sample size for the training set: Not applicable, as this is not a machine learning/AI device.
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.