(84 days)
REVIAN RED is indicated to treat Androgenetic Alopecia and promote hair growth in males who have Norwood-Hamilton Classifications of IIa - V patterns of hair loss and to treat Androgenetic Alopecia and promote hair growth in females who have Ludwig-Savin Scale I-1 to I-4, II-1, II-2 or frontal patterns of hair loss; both with Fitzpatrick Skin Types I - IV.
REVIAN RED is a non-invasive, hands-free device indicated to treat androgenetic alopecia in both men and women. It is operated via a mobile application to promote hair growth using Modulated Light Therapy (MLT) for a recommended 10-minute daily treatment. REVIAN RED is a system comprised of a wearable soft textile Cap using driver electronics, a rechargeable battery, and integrated light emitting diode (LED) flexible printed circuit board. REVIAN RED is designed as an over-the-counter (OTC) home-based device to treat the entire scalp area of the user and is controlled via a wireless Bluetooth connection to a mobile application operating on a wireless device.
The provided document is a 510(k) summary for the Revian Red device. It states that no clinical trial data for the REVIAN RED System was submitted for this 510(k). Therefore, the device's acceptance criteria and studies demonstrating its performance in a clinical setting against those criteria are not detailed in this document.
The document focuses on demonstrating substantial equivalence to predicate devices through non-clinical performance testing.
Here's a breakdown of the information that is available in the document, framed by your request for acceptance criteria and studies:
1. A table of acceptance criteria and the reported device performance
Since no clinical trial data was submitted, there are no specific performance metrics like sensitivity, specificity, or accuracy that would constitute clinical acceptance criteria in this document. Instead, the "performance" here refers to meeting safety and engineering standards:
| Acceptance Criteria Category | Reported Device Performance (as stated in the 510(k) Summary) |
|---|---|
| Electrical Safety | Conforms to IEC 60601-1 |
| Electromagnetic Compatibility (EMC) | Conforms to IEC 60601-1-2 |
| Specific Safety for Medical Electrical Equipment | Conforms to ANSI/AAMI HA60601-1-11:2015 |
| Safety of Lamps & Lamp Systems | Conforms to IEC 60601-2-57 (Edition 1.0) |
| Photobiological Safety | Conforms to IEC 62471 (Edition 1.0) |
| Biocompatibility | Conforms to ISO 10993-1, no effects of applied parts noted for cytotoxicity, skin irritation, or skin sensitization. |
| Performance Verification & Validation | "Demonstrates REVIAN RED meets user needs and design inputs and met requirements for its intended use." (General statement, no specific metrics provided.) |
| Human Factors Engineering & Usability | "Evaluated representative users of the device under expected use conditions during simulated and actual use of the device" following ANSI/AAMI/IEC 62366-1 and 60601-1-6. (No specific performance metrics provided.) |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- No clinical trial test set was used or described for clinical performance. The testing mentioned in the 510(k) is non-clinical (e.g., electrical safety, EMC, biocompatibility, human factors).
- For human factors evaluation, the study protocol "was designed to evaluate representative users of the device." The specific sample size is not stated, nor is the country of origin or whether it was retrospective/prospective, though formative and summative user testing implies a prospective approach.
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)
- This is not applicable as no clinical test set requiring expert ground truth was described in the submitted 510(k).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This is not applicable as no clinical test set requiring adjudication was described.
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
- This is not applicable. The Revian Red is a light therapy device, not an AI-powered diagnostic tool for human readers. No MRMC study was mentioned or required for this type of device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This is not applicable. The Revian Red is a device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the non-clinical tests mentioned, the "ground truth" would be the standards themselves (e.g., IEC 60601-1, ISO 10993-1) and the demonstrated adherence to their requirements.
- For the biocompatibility testing, the "ground truth" was likely established through standardized laboratory procedures and observation of biological responses.
- For human factors, the "ground truth" relates to usability and safety observed during user interactions, evaluated against usability principles and safety critical tasks.
8. The sample size for the training set
- This is not applicable as no machine learning algorithm development (which would require a training set) is described for this device.
9. How the ground truth for the training set was established
- This is not applicable for the same reason as above.
§ 890.5500 Infrared lamp.
(a)
Identification. An infrared lamp is a device intended for medical purposes that emits energy at infrared frequencies (approximately 700 nanometers to 50,000 nanometers) to provide topical heating.(b)
Classification. Class II (special controls). The device, when it is an infrared therapeutic heating lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.