(90 days)
Diode Laser Cap is indicated to promote hair growth in males with androgenic alopecia who have Norwood-Hamilton classifications of Ila-V or females with androgenic alopecia who have Ludwig-Savin Classifications of I-II and both with Fitzpatrick Skin Phototypes I-IV.
The COSMO-030 and COSMO-010 Diode Laser Cap is a dome-shaped low level laser therapy (LLLT) device designed to promote hair growth in women and men by exposing the entire scalp to the photobiostimulation of 272visible red light-emitting diodes at 650nm and 5mW each. The Cap is designed with an outer plastic cover and a protective inner (containing the electronics and laser array) and is powered by an included battery pack. The COSMO-020 Diode Laser Cap is exactly the same as the COSMO-030 with the exception of the number of diodes which is respective of model (148 diodes in COSMO-020).
The provided text is a 510(k) Summary for the Diode Laser Cap. It focuses on demonstrating substantial equivalence to predicate devices, primarily through a comparison of technical characteristics and compliance with safety and biocompatibility standards. It does not contain information about acceptance criteria or a study proving the device meets those criteria in terms of efficacy for hair growth, nor does it discuss AI performance or ground truth establishment.
Therefore, I cannot provide the detailed information requested in the prompt based on the given text.
However, I can extract and state what information is present:
1. A table of acceptance criteria and the reported device performance:
The document presents a comparison of technological characteristics with predicate devices to establish substantial equivalence, rather than specific acceptance criteria for a performance study. No quantitative efficacy criteria for hair growth or reported performance against such criteria are provided. The performance data presented are for safety and biocompatibility.
| Criterion (Implicit for Substantial Equivalence) | Reported Device Performance |
|---|---|
| Biocompatibility: | |
| In Vitro Cytotoxicity (ISO 10993-5) | Passed |
| Irritation & Skin Sensitization (ISO 10993-10) | Passed |
| Electrical & EMC Safety: | |
| Basic Safety & Essential Performance (IEC 60601-1) | Passed |
| Home Healthcare Environment (IEC 60601-1-11) | Passed |
| Electromagnetic Compatibility (IEC 60601-1-2) | Passed |
| Laser Classification: | |
| IEC 60825-1 (Laser System) | Complied with Class 3R |
| Charger Safety: | |
| IEC 60950 | Conforms |
| Battery Safety: | |
| IEC 62133 | Complied with |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
No information is provided regarding sample sizes or data provenance for any hair growth efficacy study. The document only references testing for biocompatibility, electrical safety, and EMC, which are typically performed on device components or the device itself, not human subjects for efficacy.
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. The document does not describe any test set for hair growth efficacy where expert ground truth would be established.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. No test set for hair growth efficacy is 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:
Not applicable. This device is a laser cap for hair growth, not an AI software intended for interpretation by human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a hardware product, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
Not applicable for hair growth efficacy from the provided document. The "ground truth" for the safety and biocompatibility tests would be the pass/fail criteria defined by the respective international standards.
8. The sample size for the training set:
Not applicable. The document does not describe any AI component or a training set.
9. How the ground truth for the training set was established:
Not applicable. The document does not describe any AI component or a training set.
§ 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.