(127 days)
The VersaClear Skin Therapy System is generally indicated to treat dermatological conditions. Blue light modules are indicated to treat moderate inflammatory acne vulgaris. Red light modules are indicated for use in combination with blue light for the treatment of moderate inflammatory acne vulgaris, and for use alone in the treatment of superficial, benign vascular, and pigmented lesions. UVA light modules are indicated for individuals who require specific ultraviolet radiation therapy for diagnosed skin disorders.
The VersaClear™ Skin Therapy System is a 120/240V 50/60 Hz AC illumination source consisting of one or more light modules. A set of light modules emits a specific narrow spectrum of light, namely blue (420 ± 2nm), red (615 ± 3nm), or UVA (368 ± 3nm). The light modules are mounted on a positioning arm attached to a mobile or stationary pedestal, a wall, or a countertop. This flexible design accommodates varying office spatial settings, and allows for the treatment of patients who are sitting, reclining, or lying down. Light modules are interchangeable to maximize System versatility.
The document provided is a 510(k) summary for the VersaClear™ Skin Therapy System. It states that the device is substantially equivalent to predicate devices based on its performance characteristics and that there are no new safety or efficacy issues. However, it does not include a detailed study or specific acceptance criteria with reported performance data for the VersaClear™ Skin Therapy System itself.
Instead, the submission relies on the concept of "substantial equivalence" to predicate devices. This means that the FDA determined the new device is as safe and effective as a legally marketed device that was already on the market before May 28, 1976 (preamendments device) or to a device that has been reclassified.
Therefore, many of the requested details about a specific study and its acceptance criteria are not present in this document.
Here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated as pass/fail thresholds in this document for the VersaClear™ System. The implicit "acceptance criterion" is proving substantial equivalence to predicate devices, meaning the performance characteristics are similar enough not to raise new safety/efficacy concerns.
- Reported Device Performance: The document states, "The performance characteristics of the VersaClear System are substantially similar to the cited predicate devices. The technological differences do not raise new types of safety or efficacy issues." No specific quantitative performance data for the VersaClear™ System is provided.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Not provided. The document does not describe a new study with a test set for the VersaClear™ System. It relies on the performance of predicate devices.
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):
- Not applicable/Not provided. No new test set data is discussed.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable/Not provided. No new test set data is discussed.
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 light therapy system, not an AI-driven image analysis or diagnostic tool involving human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a light therapy system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable/Not provided. No new study data is discussed. The "ground truth" for the substantial equivalence claim relies on the established safety and efficacy of the predicate devices for their respective indications.
8. The sample size for the training set:
- Not applicable/Not provided. This is not an AI/machine learning device.
9. How the ground truth for the training set was established:
- Not applicable/Not provided. This is not an AI/machine learning device.
Summary based on the provided text:
| Criteria / Study Detail | Information from Document |
|---|---|
| Acceptance Criteria | Not explicitly defined with quantitative thresholds for the VersaClear™ System in this document. The stated basis for clearance is substantial equivalence to predicate devices, meaning performance is similar enough such that no new safety or efficacy issues are raised. |
| Reported Device Performance | "The performance characteristics of the VersaClear System are substantially similar to the cited predicate devices. The technological differences do not raise new types of safety or efficacy issues." No specific numerical performance data (e.g., treatment efficacy rates, adverse event rates) for the VersaClear™ System itself are provided in this summary. Instead, it relies on the established performance of the predicate devices for their respective indications. |
| Sample Size (Test Set) | Not applicable. No new study for the VersaClear™ System is detailed. |
| Data Provenance (Test Set) | Not applicable. |
| Number & Qualifications of Experts (Test Set Ground Truth) | Not applicable. |
| Adjudication Method (Test Set) | Not applicable. |
| MRMC Comparative Effectiveness Study | Not applicable. This is not an AI/diagnostic device. |
| Standalone Performance Study | Not applicable. Not an algorithm. |
| Type of Ground Truth Used | The "ground truth" implicitly relies on the established safety and efficacy profiles of the predicate devices, which would have been demonstrated through clinical studies, pathology, or outcomes data during their initial clearances. |
| Sample Size (Training Set) | Not applicable. Not an AI/machine learning device. |
| How Ground Truth for Training Set Established | Not applicable. Not an AI/machine learning device. |
Conclusion from document:
The VersaClear™ Skin Therapy System received 510(k) clearance based on its substantial equivalence to previously cleared predicate devices. The submission affirms that the performance characteristics are "substantially similar" and "technological differences do not raise new types of safety or efficacy issues," thus eliminating the need for a de novo performance study with specific acceptance criteria in this submission.
§ 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.