(83 days)
The BioPhotas Celluma RESTORE system 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.
The BioPhotas Celluma RESTORE system uses visible red light (640nm) and 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.
In addition, the Biophotas Celluma RESTORE is a portable, therapeutic device whose purpose is to provide even, cool, narrow-band wavelengths of polychromatic light (blue, 465nm red, 640nm and Near infra-red, 880nm) produced by super-luminous LEDs (light emitting diodes) to treat a variety of skin and musculoskeletal conditions as previously cleared under K122237, K131113, K152280 and K171323.
The system comprises of a flexible, shape-taking frame upon which is mounted an array of LEDs, this allows the device to be contoured to the treatment area. The LEDs are embedded within a biocompatible foam covering that holds a transparent polycarbonate cover recessed within it. The biocompatibility nature of allows the device to be placed in contact with the skin. Nevertheless, the design of the device provides for maintaining a small distance between the surface of the skin and the surface of the device.
The flexible LED panel is permanently connected by a three-foot long cable attached to a control panel that contains the circuitry and software that controls the device. The control panel contains several push buttons beneath a sealed cover. A power button that switches the device ON/OFF, a mode button that allows the user to select from 3 preprogrammed treatment modes "Hair", "Wrinkles", and "Aches and Pains", and a Start button that activates the desired treatment mode. The control panel receives its power from a separate cable that connects via an AC adaptor for 110-220 Volts to a standard U.S. electrical power outlet. The control panel contains an automatic shut-off safety feature.
The provided text is a 510(k) summary for the Biophotas Celluma RESTORE device. This document focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and the results of a standalone performance study.
Specifically, the document does not contain the acceptance criteria or a study that directly proves the device meets specific performance metrics for hair growth in the same way a clinical trial might for a new drug or a direct performance study for a diagnostic AI. Instead, it relies on demonstrating that the device is "substantially equivalent" to previously cleared devices (predicates) that have already been deemed safe and effective for the indicated use.
Therefore, many of the requested items (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance) are not applicable or not directly addressed in this type of submission. This document highlights non-clinical testing for safety and electrical performance, and a usability study, but not a study proving the efficacy of hair growth directly.
Here's an analysis based on the information provided:
1. A table of acceptance criteria and the reported device performance
- No explicit performance acceptance criteria (e.g., % increase in hair count, specific hair density) for efficacy are listed or tested.
- The document primarily focuses on safety and technological equivalence.
- Safety and Electrical Performance:
- Acceptance Criteria (Implied): Compliance with IEC 60601-1 (Electrical safety) and IEC 60601-1-2 (EMC testing).
- Reported Performance: "The Biophotas Celluma RESTORE successfully passed testing per internal verification/validation requirements and national/international standards... The Biophotas Celluma RESTORE, and the predicate device have satisfied product safety testing to the IEC 60601-1 standard, and the electromagnetic safety testing to the IEC 60601-1-2 standard."
- Software Validation:
- Acceptance Criteria (Implied): Compliance with IEC 62304 and FDA Guidance document; software safety classification of Class A (low risk) and "Minor" level of concern.
- Reported Performance: Software has been classified and validated accordingly.
- Usability:
- Acceptance Criteria (Implied): No new use errors, hazards, or hazardous situations discovered; no suggested revisions to the user manual; comprehension and understanding of the User Manual.
- Reported Performance: "No new use errors, hazards, hazardous situations, or hazard-related use scenarios were discovered. Further improvement of the user interface design as it relates to safety was deemed unnecessary and there were no suggested revisions to the version of the user manual tested."
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- For Efficacy: Not applicable, no direct efficacy test set in this submission.
- For Usability: 25 test subjects.
- Data Provenance: Not specified for the usability study. The document describes the device itself and its testing to standards, not a clinical trial with patient data.
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 for efficacy data.
- For the usability study, "experts" in establishing ground truth (i.e., correct understanding of the manual) are not explicitly mentioned in terms of their qualifications or number. The "ground truth" for usability here would be the intended correct understanding of the manual.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable for efficacy data.
- Not specified for the usability study.
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
- No MRMC or comparative effectiveness study was done or reported in this 510(k) submission as it is not an AI-assisted diagnostic device, but rather a therapeutic device. The submission focuses on technological equivalence and safety, not on human interpretation or an AI component improving human performance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This device is a therapeutic light device, not an AI algorithm. Therefore, "standalone algorithm performance" is not applicable. The "performance" is its ability to emit light within specified parameters and its safety.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For Efficacy: No direct efficacy ground truth is discussed as no clinical efficacy study on hair growth is presented here. The "ground truth" for substantial equivalence is the previously cleared predicate devices and their established safety and efficacy.
- For Usability: The ground truth would be the intended correct interpretation and safe use of the device and its manual, as determined by the manufacturer's design and instructions.
8. The sample size for the training set
- This document does not describe the development of an AI model, so there is no "training set" in the context of machine learning.
9. How the ground truth for the training set was established
- As there is no AI training set, this question is not applicable.
§ 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.