(90 days)
The International Biophysics Corporation Laser Peel system is intended for coagulation, vaporization, ablation, or cutting of soft tissue (skin) in dermatology, plastic surgery (including aesthetic surgery), oral surgery, and ophthalmology.
The International Biophysics Corporation Laser Peel System is an Er:YAG laser producing emission at a wavelength of 2940 nm. The laser consist of two interconnected sections: The cabinet which houses the power supply, the cooling system and the electronics, and; the umbilical cables and the hand piece, which houses the laser.
The provided text is a 510(K) Summary for the International Biophysics Corporation Laser Peel System. This document is a premarket notification to the FDA, demonstrating substantial equivalence to previously marketed devices. It is not a study that proves device performance against acceptance criteria in the manner typically understood for clinical trials or AI/software evaluations.
Therefore, many of the requested categories are not applicable to this type of regulatory submission. The document explicitly states "None Required" for both nonclinical and clinical performance data.
Here's a breakdown based on the provided text, highlighting what is (and isn't) present:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not applicable. This document is a 510(k) summary demonstrating substantial equivalence for a medical device (laser system), not a study against specific performance acceptance criteria. | Not applicable. The document states "None Required" for both nonclinical and clinical performance data, as its purpose is to show substantial equivalence to predicate devices, not novel performance metrics. |
2. Sample size used for the test set and the data provenance
Not applicable. No test set or related data provenance is mentioned as this is a 510(k) summary for a physical medical device, not a data-driven AI/software product requiring a test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No test set or ground truth establishment by experts is mentioned.
4. Adjudication method for the test set
Not applicable. No test set or adjudication method 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. No MRMC study was done. This device is a laser system, not an AI or imaging diagnostic tool that would involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a laser system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. Ground truth is not relevant for this type of regulatory submission. The submission relies on demonstrating substantial equivalence to predicate devices, not on validating performance against a ground truth.
8. The sample size for the training set
Not applicable. This device is a physical laser system, not a machine learning model, so there is no training set.
9. How the ground truth for the training set was established
Not applicable. As there is no training set, there is no ground truth for a training set to be established.
§ 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.