(46 days)
The LumiPhase-R ™ is indicated for treatment of wrinkles, rhytids and fine lines in the periorbital region.
The LumiPhase-R system delivers visible light at a wavelength of 660 nanometers. This LED device consists of three interconnected sections: the base which houses the power supply, the articulated arm and the treatment head consisting of the controller, the ventilation (heat sink) system, the LED based optics and the positioning system.
The provided 510(k) summary for the Opusmed Inc. LumiPhase-R™ device does not contain specific acceptance criteria or a detailed study description with performance metrics that would allow for a complete answer to your request.
Here's a breakdown of what can and cannot be extracted from the provided text based on your questions:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated. The document mentions "Results were acceptable" for clinical studies but does not provide quantitative targets or thresholds.
- Reported Device Performance: Not explicitly stated in quantitative terms. The document highlights the general finding that the device's performance is "equivalent to the predicate devices" and "did not raise any new issues of safety and effectiveness."
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 the test set: Not specified.
- Data provenance: Not specified (e.g., country of origin, retrospective or prospective).
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 specified. The document only states that "Clinical studies were conducted" but provides no details on how outcomes were assessed or by whom.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not specified.
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
- None. This device is a light-based therapeutic device, not an AI-assisted diagnostic or assistive device that would involve human readers interpreting results. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This question is not applicable. The LumiPhase-R™ is a light therapy device, not an algorithm or AI system. Its performance is related to its physical effects rather than its interpretive accuracy.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not specified. The document generally refers to "Clinical studies" and "results were acceptable," implying some form of clinical assessment of wrinkle reduction. However, the specific method (e.g., blinded expert photographic assessment, patient-reported outcomes, objective measurement like profilometry) is not disclosed.
8. The sample size for the training set
- Not applicable. This device is not an AI or machine learning model that requires a training set.
9. How the ground truth for the training set was established
- Not applicable for the same reason as #8.
Summary of Findings from the 510(k) Summary:
The provided document focuses on demonstrating substantial equivalence to predicate devices (Omnilux Revive K030426 and GentleWaves LED Photomodulation Device K031425) rather than providing detailed de novo performance data with specific acceptance criteria.
The key statements regarding performance are:
- "Clinical studies were conducted to provide assurance that the performance of the device is equivalent to the predicate devices."
- "Results were acceptable and did not raise any new issues of safety and effectiveness."
- "The LumiPhase-R device, as designed, is as safe and effective as the predicate devices, and the device is determined to be substantially equivalent to the referenced predicate devices."
This means the FDA cleared the device based on its similarity in intended use and technological characteristics to already approved devices, and general statements of acceptable clinical performance, without requiring specific quantitative metrics or detailed study reporting in this 510(k) summary.
§ 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.