(88 days)
The PhotoGenica ER laser is used for skin resurfacing in the treatment of wrinkles and for the incision, excision ablation or vaporization of soft bodily tissues.
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.
The provided FDA 510(k) summary for the Cynosure PhotoGenica ER Laser states "Clinical Performance Data: none" and "Nonclinical Performance Data: none". This indicates that the submission did not include specific acceptance criteria or a study demonstrating the device meets such criteria in the traditional sense of a clinical trial or performance study with quantified metrics.
Instead, the FDA determined substantial equivalence primarily based on the device's technical characteristics being comparable to a legally marketed predicate device (Continuum Biomedical CB Erbium / 2.94™ Er:YAG Laser) and the intended use. The 510(k) process for this type of device focuses on demonstrating that the new device is as safe and effective as a predicate device, often without requiring new clinical data if technological characteristics are sufficiently similar.
Therefore, the requested information cannot be fully provided as it pertains to a type of performance study that was not part of this 510(k) submission. However, I can infer what the "acceptance criteria" for the 510(k) itself were, which primarily revolved around demonstrating substantial equivalence.
Here's an attempt to answer based on the provided document, acknowledging the lack of a clinical performance study:
1. A table of acceptance criteria and the reported device performance
Since no clinical or nonclinical performance data was provided or required for this 510(k) submission, there are no explicit acceptance criteria for a performance study. The "acceptance criteria" for the 510(k) process in this case were met by demonstrating substantial equivalence to a predicate device.
| Acceptance Criteria (Inferred for 510(k) Submission) | Reported Device Performance (Inferred for 510(k) Submission) |
|---|---|
| Criterion: Device is substantially equivalent to a legally marketed predicate device in terms of intended use and technological characteristics. | Performance: "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." |
| Criterion: Intended use is consistent with the predicate device. | Performance: Intended for "Skin resurfacing in the treatment of wrinkles" and "incision, excision, ablation or vaporization of soft bodily tissues," similar to the predicate. |
| Criterion: Device is safe and effective for its intended use. | Performance: "The PhotoGenica ER Laser is another safe and effective way to remove or reduce wrinkles, and to ablate or excise tissue." (Conclusion reached by the submitter and accepted by FDA through substantial equivalence.) |
2. Sample size used for the test set and the data provenance
- Sample Size: Not applicable. No clinical or nonclinical test set was used for performance evaluation as part of this 510(k) submission.
- Data Provenance: Not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. No ground truth for a test set was established as no clinical or nonclinical performance study was conducted.
4. Adjudication method for the test set
- Not applicable.
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 device is a physical laser system, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not applicable. No ground truth was used for a performance study. The ground for substantial equivalence was based on comparison to an existing, legally marketed predicate device.
8. The sample size for the training set
- Not applicable. This is not an AI/ML device requiring a training set.
9. How the ground truth for the training set was established
- Not applicable.
§ 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.