(33 days)
The reVive Light Therapy® Wrinkle and Acne LED Device is intended for treatment of wrinkles and mild to moderate inflammatory acne.
The reVive Light Therapy® Wrinkle and Acne LED Device is an over-the counter light emitting diode (LED) device, that emits energy for use in dermatology for the treatment of wrinkles and mild to moderate inflammatory acne, as defined in 21 CFR § 878.4810. The reVive Light Therapy® Wrinkle and Acne LED Device components include the device containing the LED module. The unit is applied directly to the skin to ensure consistent administration of light during each treatment. The device does not contain any user serviceable components.
The provided text is a 510(k) summary for the reVive Light Therapy® Wrinkle and Acne LED Device. It details the device's characteristics, its intended use, and its substantial equivalence to predicate devices. However, this document primarily focuses on regulatory approval based on equivalence rather than presenting a detailed clinical study demonstrating the device's performance against specific acceptance criteria.
The information sought in your request (acceptance criteria, specific study details like sample size, expert involvement, and ground truth establishment) is typically found in clinical study reports or performance testing reports, which are separate from a standard 510(k) summary focused on substantial equivalence.
Based on the provided text, here's what can be extracted and what is missing:
1. A table of acceptance criteria and the reported device performance
- Mentioned in text:
- The document states: "Testing confirmed that the performance of the reVive Light Therapy® Wrinkle and Acne LED Device meets the product system requirements, which is based on the predicate devices."
- And, "The Testing confirmed that modifications made to the device were correctly implemented and that the device performs as well as the legally marketed devices."
- Missing from text: Specific quantitative acceptance criteria (e.g., X% reduction in wrinkles, Y% clearance of acne lesions) and the actual numerical performance results against these criteria are not provided. The document focuses on equivalence rather than a direct performance claim with specific metrics.
2. Sample size used for the test set and the data provenance
- Missing from text: The document does not describe a clinical test set in the traditional sense for evaluating clinical efficacy. It refers to "software was tested and validated" and general "Testing" to confirm modifications and performance relative to predicate devices. There is no mention of human subjects, data provenance (country, retrospective/prospective), or numbers of patients/treatments.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Missing from text: Given that no human-in-the-loop clinical efficacy study or test set with specific ground truth establishment is described, this information is not present.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Missing from text: Not applicable, as no such test set or ground truth establishment process is detailed.
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
- Missing from text: This is an LED device for direct patient use, not an AI-assisted diagnostic tool. Therefore, an MRMC study is not relevant and not discussed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Missing from text: This is a physical LED device, not a standalone algorithm. The mention of "software was tested and validated" refers to the device's internal operational software, not an AI or diagnostic algorithm providing standalone performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Missing from text: Not applicable, as detailed clinical efficacy testing with specific ground truth data is not described in this 510(k) summary. The "ground truth" for this submission appears to be the performance characteristics of the predicate devices and confirmation that the new device's modifications do not negatively impact those.
8. The sample size for the training set
- Missing from text: Not applicable. This document refers to the validation of device software and confirms equivalence to predicate devices, not the training of a machine learning model.
9. How the ground truth for the training set was established
- Missing from text: Not applicable, as no machine learning training set is mentioned.
In summary:
The provided 510(k) summary (K223482) is a regulatory document focused on demonstrating substantial equivalence to previously cleared predicate devices (K210965 and K210968) for the reVive Light Therapy® Wrinkle and Acne LED Device. It asserts that the device performs "as well as" or "the same as" the predicate devices and that modifications (primarily software and associated hardware) were correctly implemented.
However, it does not contain the detailed clinical study information often associated with performance evaluation of AI or diagnostic devices, which would typically include specific acceptance criteria, sample sizes of test sets, details on expert ground truth establishment, or specific efficacy metrics from clinical trials. For a device like this, the primary evidence for 510(k) clearance is often bench testing, electrical safety, EMC compatibility, and demonstration that its operating parameters (wavelengths, irradiance, treatment area, time) are similar to those of devices already deemed safe and effective. Any clinical data presented for such devices in a 510(k) would be to support the efficacy claims, but this summary primarily relies on the predicate devices' established performance.
§ 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.