(57 days)
The CurrentBody Skin™ Led Hair Regrowth (MZ-07) is indicated to treat Androgenetic Alopecia and to 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 CurrentBody Skin™ Led Hair Regrowth, model: MZ-07 is an over-the-counter light-emitting diode (LED) device designed to promote hair growth in women and men by exposing the entire scalp to the photostimulation of visible red light-emitting diodes at 660nm. The CurrentBody Skin™ Led Hair Regrowth includes a hair-growing cap, a device base and a USB power cord. The user turns on the device and then wears the device on his/her head, and the device will turn off automatically after a 10-minute treatment default.
The provided text does not describe a study that proves the device meets specific acceptance criteria related to its clinical efficacy (i.e., hair regrowth performance) with quantitative metrics for artificial intelligence (AI) performance. Instead, it refers to a 510(k) premarket notification for a medical device (CurrentBody Skin™ Led Hair Regrowth) which is largely relying on substantial equivalence to a predicate device (Revian Red).
The "acceptance criteria" and "device performance" mentioned in the document primarily relate to non-clinical performance testing (e.g., electrical safety, electromagnetic compatibility, biocompatibility, software validation), rather than clinical outcomes or AI performance. The document explicitly states: "Clinical testing was not needed for this 510(k). The non-clinical performance testing described above is sufficient to support that the device can be used safely and effectively."
Therefore, I cannot directly fulfill all aspects of your request as it pertains to a study proving the device meets AI performance acceptance criteria or clinical efficacy data with AI assistance. However, I can provide the information available in the text regarding the non-clinical acceptance criteria and testing.
Here's an analysis based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical)
| Acceptance Criteria | Reported Device Performance |
|---|---|
| General requirements for basic safety and essential performance (IEC 60601-1): Test result is within the test acceptance range of the standard. | Pass |
| Electromagnetic disturbances (IEC 60601-1-2): No degradation of performance was found during test or Lower than limits of measurement. | Pass |
| Requirements for medical electrical equipment and systems used in the home healthcare environment (IEC 60601-1-11): The device operates normally, and can provide basic safety and essential performance. | Pass |
| Particular Requirements for The Basic Safety And Essential Performance Of Non-Laser Light Source Equipment Intended For Therapeutic, Diagnostic, Monitoring And Cosmetic/Aesthetic Use (IEC 60601-2-57): Test result is within the test acceptance range of the standard. | Pass |
| Photobiological safety of lamps and lamp systems (IEC 62471): Test result is within the test acceptance range of the standard. | **Pass |
| Biocompatibility (ISO 10993-5, ISO 10993-10 for Cytotoxicity, Irritation/Intracutaneous reactivity, Sensitization): All patient contacting materials are complied with these standards. (Note: This is stated as compliance with standards rather than specific test results being presented in the table). | Pass (Implied by "complied with") |
| Usability (IEC 62366-1 and IEC 60601-1-6): The device complies with these standards. | Complies |
| Software verification and validation: Software considered "moderate" level concern, V&V testing conducted and documentation provided. (Acceptance criteria not explicitly quantified, but compliance with FDA guidance is implied). | Conducted (Implied as sufficient for "moderate" concern) |
| Cybersecurity: No external interfaces, no need for cybersecurity evaluation per FDA guidance. | N/A (No evaluation needed) |
Notes on Clinical Efficacy / AI Performance:
- This document is a 510(k) summary, which typically relies on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting new major clinical trials for efficacy.
- The device (CurrentBody Skin™ Led Hair Regrowth) is a light-emitting diode (LED) device, not an AI software. The request itself is framed around AI performance, but the document describes a hardware device.
2. Sample Size Used for the Test Set and Data Provenance
- Non-Clinical Testing: For most tests (General safety, EMC, Home healthcare, Particular requirements for light source equipment, Photobiological safety), the "Device Description/Sample Size" is stated as "The test sample is the final, finished product." This generally implies a very small sample size, often one or a few units, for regulatory compliance testing.
- Biocompatibility: The document states "All patient contacting materials are complied with ISO 10993-5, ISO 10993-10," citing prior clearance (K221444) for identical materials used in another device. This means the actual biocompatibility testing was likely performed for the predicate or a previously cleared device.
- Data Provenance: Not specified beyond standard lab bench testing for regulatory compliance. It's not clinical data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Not applicable. This is a hardware device undergoing non-clinical safety and performance testing for regulatory submission (510(k)). There is no "ground truth" derived from expert consensus for clinical outcomes or AI performance, as no clinical efficacy study or AI component is described as being part of the evaluation for this submission.
4. Adjudication Method for the Test Set
- Not applicable. See point 3.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No. An MRMC study is typically performed for imaging diagnostic AI devices to compare human reader performance with and without AI assistance. This document describes a therapeutic LED device, not a diagnostic AI. The document explicitly states: "Clinical testing was not needed for this 510(k)."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. The device is a physical LED hair regrowth cap, not an algorithm.
7. The Type of Ground Truth Used
- Not applicable for clinical efficacy or AI performance. For the non-clinical tests, the "ground truth" is defined by the requirements and performance limits specified in the referenced international standards (e.g., IEC 60601 series, IEC 62471, ISO 10993 series).
8. The Sample Size for the Training Set
- Not applicable. This device is not an AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. See point 8.
In summary, the provided document focuses on the regulatory clearance process for a physical medical device (LED hair regrowth cap) based on substantial equivalence and compliance with non-clinical safety and performance standards. It does not contain information about studies involving AI, human reader performance, or detailed clinical efficacy trials with quantifiable acceptance criteria for hair regrowth.
§ 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.