(63 days)
The Cynosure PhotoGenica VL laser is indicated for use in Dermatological and Plastic Surgery applications and the treatment of periocular wrinkles, vascular lesions and inflammatory acne vulgaris.
The PhotoGenica VL is a pulse-dye laser, having the organic dye as the lasing medium. It is a pulsed laser with a wavelength of 580 to 590nm. Laser activation is both by finger switch and footswitch. Overall weight of the laser is 285lbs, and the size is 44"x19"x24" (HxWxD). Electrical requirement is 110 VAC or 220 VAC, 20A, 50-60 Hz, single phase.
The provided document is a 510(k) summary for the Cynosure PhotoGenica VL laser, which establishes substantial equivalence to a predicate device rather than presenting a de novo study with acceptance criteria and performance data. Therefore, many of the requested categories related to a clinical study demonstrating acceptance criteria cannot be extracted from this document.
Here's the information that can be extracted, along with explanations for the missing categories:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | Not specified |
Explanation: This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device (Nlite Laser by ICN, and Cynosure PhotoGenica VL itself as a predicate). It does not contain information about specific performance acceptance criteria for a new clinical study. The device is deemed "safe and effective" based on its equivalence to existing devices with the same indications for use, principle of operation, wavelength, and pulse energy range.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not applicable (no clinical performance data or test set reported).
- Data Provenance: Not applicable.
Explanation: The 510(k) summary explicitly states "Nonclinical Performance Data: none" and "Clinical Performance Data: none." This indicates that no new clinical study was conducted for this submission to establish a test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Number of Experts: Not applicable.
- Qualifications of Experts: Not applicable.
Explanation: As no clinical performance data or test set was generated, there was no need for experts to establish ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable.
Explanation: No clinical performance data or test set was generated.
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
- MRMC Study: No.
- Effect Size: Not applicable.
Explanation: This device is a medical laser system, not an AI-assisted diagnostic device that would typically involve human readers. The submission explicitly states "Clinical Performance Data: none."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Study: No.
Explanation: This is a physical medical device (laser), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of Ground Truth: Not applicable.
Explanation: No clinical performance data was generated for a new study requiring ground truth establishment. The substantial equivalence relies on the established safety and efficacy of the predicate devices.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable.
Explanation: This is a physical medical device, not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
- Ground Truth Establishment for Training Set: Not applicable.
Explanation: This is a physical medical device.
§ 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.