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

Here's an analysis of the provided text regarding the acceptance criteria and study information for the ASCLEPION-MEDITEC AG Laser System BeautyStar 532:

Based on the provided 510(k) summary, no performance data or study information is included. The submission explicitly states:

"Performance data: None. The specifications and intended uses of the laser system BeautyStar 532 are the same as or very similar to those of claimed predicate devices. Because of this, performance data were not required."

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and study details. This device gained clearance based on substantial equivalence to predicate devices, meaning it was deemed as safe and effective as pre-existing devices without new clinical performance data being required.

Here's a breakdown of what can be extracted and why the other details are absent:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (e.g., Sensitivity, Specificity, Accuracy, Safety endpoints)	Reported Device Performance (e.g., % (95% CI))
N/A - No performance data was required or submitted.	N/A - No performance data was required or submitted.

Explanation: The documentation explicitly states "Performance data: None." and that performance data was not required due to substantial equivalence to predicate devices. Therefore, there are no reported acceptance criteria or corresponding device performance metrics from a study in this submission.

2. Sample size used for the test set and the data provenance:

Sample size: Not applicable, as no dedicated performance study was conducted.
Data provenance: Not applicable.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Number of experts: Not applicable.
Qualifications of experts: Not applicable.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Adjudication method: Not applicable.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and 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. The device is a laser system, not an AI-powered diagnostic tool, and its clearance was based on substantial equivalence, not new performance data.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

No, a standalone (algorithm only) performance study was not done. This is a physical laser device, not an algorithm, and its clearance was based on substantial equivalence, not new performance data.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Not applicable, as no dedicated performance study was conducted requiring ground truth.

8. The sample size for the training set:

Not applicable, as this is a physical medical device (laser system) and not an AI/ML algorithm that would typically have a "training set."

9. How the ground truth for the training set was established:

Not applicable, for the same reasons as point 8.

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.