FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

The provided document is a 510(k) summary for a medical laser device (Medlite™ Q-Switched Nd:YAG Laser / Medlite™ IV Q-Switched Nd:YAG Laser) and does not contain information about an AI/ML powered device or software. Therefore, most of the requested information regarding acceptance criteria and a study proving an AI device meets those criteria cannot be extracted.

The document indicates that the device's substantial equivalence was established by comparison to a predicate device (ThermoLase LT-100 Nd:YAG Laser Hair Removal System, K950019). The "Clinical Performance Data" section states "Authorization provided to access data in K950019." This implies that the clinical data from the predicate device was used to support the safety and effectiveness of the new device, rather than new clinical trials specifically for the Medlite laser.

Below is an attempt to answer the questions based only on the provided text, highlighting what is missing due to the nature of the document.

Acceptance Criteria and Device Performance for Continuum Biomedical's Medlite™ Q-Switched Nd:YAG Laser

This document pertains to a traditional medical device (laser system) and therefore does not include detailed acceptance criteria or a study design typical for an AI/ML-powered device. The regulatory submission relies on substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance
This information is not present in the provided 510(k) summary. For a traditional medical device like a laser, acceptance criteria would typically involve engineering specifications, safety standards compliance, and potentially clinical outcomes shown to be equivalent to a predicate device. The performance is assessed by comparison to the predicate.

Acceptance Criteria (e.g., Performance Threshold)	Reported Device Performance
Not specified for this device type in the document.	Not specified in this format.
(Implied: Equivalent efficacy and safety for hair removal/lightening as the predicate device K950019)	(Implied: Achieves removal or lightening of unwanted hair with comparable outcomes to K950019)

2. Sample size used for the test set and the data provenance
Not applicable/not provided for a standalone AI/ML device study. The clinical performance data relies on the predicate device (K950019). The document states, "Clinical Performance Data: Authorization provided to access data in K950019." This implies that the data from the predicate device's studies were referenced. The specific sample size, country of origin, or retrospective/prospective nature of that predicate data is not detailed here.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable/not provided. This concept (ground truth established by experts for a test set) is specific to AI/ML model evaluation. For this laser device, clinical efficacy against unwanted hair would likely have been assessed by clinicians or through patient outcomes in the predicate study.

4. Adjudication method for the test set
Not applicable/not provided. This refers to resolving disagreements among experts for ground truth establishment in AI/ML studies.

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
No, an MRMC comparative effectiveness study was not done, as this is not an AI-assisted device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable, as this is not an AI algorithm.

7. The type of ground truth used
Not applicable for an AI device. For the laser device's intended use, the "ground truth" for efficacy would likely be direct observation of hair removal/lightening by clinicians or patient self-reporting, as established in the predicate device's clinical data.

8. The sample size for the training set
Not applicable, as this is not an AI/ML device that requires a training set.

9. How the ground truth for the training set was established
Not applicable, as this is not an AI/ML device.

Summary

Regulation Number and Section

§ 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.