CYNOSURE PHOTOGENICA ER LASER by CYNOSURE, INC.

Typical applications include dermatology, plastic surgery, urology, gastrocnterology, neurosurgery, gynecology, arthroscopy, general surgery. ENT and ophthalmology.

Device Description

The PhotoGenica Er Laser consists of three interconnected sections: the power supply, the water cooling system and the optical bench. At 20 pulses per second and a pulse energy of 2 Joules, the average power from the laser is 20 watts.

AI/ML Overview

This document pertains to a 510(k) premarket notification for a medical laser system, specifically the PhotoGenica Er Laser by Cynosure, Inc. The core of this submission is to demonstrate substantial equivalence to a predicate device, not to establish new safety and efficacy criteria through clinical trials. As such, the information you've requested regarding acceptance criteria and performance studies for a new device's clinical performance, ground truth, and expert evaluation is largely not applicable in this context.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria: For a 510(k) submission seeking substantial equivalence, the "acceptance criteria" are not typically performance metrics demonstrating new clinical safety and efficacy. Instead, the acceptance criteria are met by demonstrating the new device is as safe and effective as a legally marketed predicate device. This is achieved by showing:
- Same intended use.
- Same technological characteristics, or if different, that the differences do not raise new questions of safety and effectiveness and that performance data (non-clinical or clinical) demonstrate the device is as safe and effective as the predicate.
Reported Device Performance:
Since this is a 510(k) for substantial equivalence, clinical performance data demonstrating novel safety and efficacy was not provided and not required. The submission explicitly states "Nonclinical Performance Data: none" and "Clinical Performance Data: none." The device's performance is assumed to be substantially equivalent to the predicate.

Acceptance Criteria (for 510(k) Substantial Equivalence)	Reported Device Performance (as demonstrated for 510(k))
Same Intended Use as Predicate Device	Yes, stated Intended Use for PhotoGenica Er Laser is "Skin resurfacing and for the incision, excision, ablation or vaporization of soft bodily tissues," which is implied to be the same as the predicate Continuum Biomedical CB Erbium / 2.94™ Er:YAG Laser.
Same Technological Characteristics as Predicate Device	The PhotoGenica Er Laser is compared to the predicate in terms of "treatment wavelength, pulse duration, pulse energy, and biological effects," implying substantial similarity.
Differences in Technology Do Not Raise New Questions of Safety and Effectiveness	Explicitly stated: "The PhotoGenica Er Laser is substantially equivalent to the Continuum Biomedical CB Erbium / 2.94™ Er:YAG Laser in terms of treatment wavelength, pulse duration, pulse energy, and biological effects."
Performance Data (if technological differences exist)	None provided; the submission relies on the substantial equivalence of technological characteristics and intended use, rather than new performance data.

Regarding the other points you've asked for, they are largely not applicable to this 510(k) submission:

2. Sample Size Used for the Test Set and the Data Provenance

Not Applicable. No test set was used for a de novo clinical study in this 510(k). The submission relies on the established safety and efficacy of the predicate device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

Not Applicable. No new ground truth was established by experts for a test set for this 510(k).

4. Adjudication Method for the Test Set

Not Applicable. No test set existed that required adjudication.

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 or interpretation tool. No MRMC study was conducted.

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

Not Applicable. This is a physical medical device (a laser), not an algorithm or AI system.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc)

Not Applicable. No new ground truth was established or used for a clinical study within this 510(k) submission. The "ground truth" for a 510(k) is essentially that the predicate device is already recognized as safe and effective, and the new device is equivalent.

8. The Sample Size for the Training Set

Not Applicable. There was no training set for an AI algorithm or a clinical trial in this 510(k). This is a hardware submission.

9. How the Ground Truth for the Training Set was Established

Not Applicable. As there was no training set (see point 8), no ground truth for it was established.

In summary: The provided document is a 510(k) premarket notification for a laser system. This regulatory pathway primarily focuses on demonstrating "substantial equivalence" to a previously cleared device. It does not typically require new clinical studies, performance data, or AI-related metrics like those you've inquired about, unless significant technological differences exist that could raise new safety and effectiveness questions, which was not the case here. The FDA concluded that the PhotoGenica Er Laser is "another safe and effective laser" based on its substantial equivalence to the predicate 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.