Search Results

The Irradiation Cosmetic Device (Model: HairPro Plus) is indicated to promote hair growth in females with androgenetic alopecia who have Ludwig-Savin Classifications of I - II and males with androgenetic alopecia who have Norwood-Hamilton Classifications of IIa - V and for both, Fitzpatrick Classification of Skin Phototypes I to IV

Irradiation Cosmetic Device (Model: HairPro Plus) consists of laser diodes that are spread throughout the cap. The device uses diode lasers to cover the entire area of the head that is normally covered with hair, and this unique design allows the treatment of the entire scalp without manual movement. In the process of the cap working, the indicator blinks red based on the working frequency of the laser diodes. Built-in timing function, the cap can record the time per treatment, and the cap can stop working automatically after each 30 minutes treatment. When the built-in IR detected the cap is not worn on the head, the laser light output will be automatically suspended immediately and the cap will automatically shut down after 10 minutes.

The provided FDA 510(k) summary for the "Irradiation Cosmetic Device (Model: HairPro Plus)" describes a device clearance based on substantial equivalence to predicate devices, rather than a study demonstrating clinical performance against established acceptance criteria for a new clinical claim.

Therefore, the information requested regarding acceptance criteria, study details, expert involvement, and ground truth establishment, which are typical for studies supporting novel clinical claims for AI/ML-driven devices, is largely not applicable to this submission. This device is cleared based on demonstrating that it is as safe and effective as existing legally marketed predicate devices, primarily through engineering and biocompatibility testing.

Here's an breakdown based on the provided document:

1. A table of acceptance criteria and the reported device performance

The submission does not present a table of specific clinical acceptance criteria with corresponding performance metrics for hair growth promotion. Instead, the "acceptance criteria" are implied by compliance with various safety and performance standards for medical electrical equipment and biocompatibility, as well as demonstrating substantial equivalence to predicate devices in their design, intended use, and specifications.

The table in the document (pages 5-6) is a comparison table to predicate devices, not a performance table against clinical acceptance criteria for the subject device itself. It indicates that the subject device's specifications (e.g., wavelength, energy, treatment time, irradiance, fluence) are comparable to those of the predicate devices. The "Verdict" column indicates "SE" (Substantial Equivalence) rather than a specific performance measure.

2. Sample size used for the test set and the data provenance

No clinical test set of patients or medical images is described for this submission. The tests performed are laboratory bench tests and comparisons to predicate device specifications. Therefore, information about sample size and data provenance for a test set is not provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable, as no clinical test set requiring expert ground truth establishment was conducted for this 510(k) submission.

4. Adjudication method for the test set

Not applicable, as no clinical test set requiring adjudication was conducted.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No, an MRMC comparative effectiveness study was not done. The submission relies on substantial equivalence to predicate devices, supported by engineering and biocompatibility testing, not human-in-the-loop performance studies comparing AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Based on the provided document, the "Irradiation Cosmetic Device" is a hardware device (laser cap) for promoting hair growth. It does not appear to be an AI/ML algorithm or software device that would have "standalone performance" in the typical sense of AI/ML. The performance demonstrated is related to its physical specifications, safety, and biocompatibility, as compared to predicate devices.

7. The type of ground truth used

For the safety and performance evaluations, the "ground truth" is implied by compliance with international standards (IEC, ISO) for electrical safety, electromagnetic compatibility, laser safety, and biocompatibility. For the substantial equivalence claim, the "ground truth" is the established safety and effectiveness profile of the predicate devices. There is no mention of a ground truth established from expert consensus, pathology, or outcomes data related to hair growth efficacy for the subject device within this 510(k) summary. Efficacy for hair growth is assumed due to the substantial equivalence to predicate devices that have prior clearance for this indication.

8. The sample size for the training set

Not applicable, as this is not an AI/ML device that requires a training set.

9. How the ground truth for the training set was established

Not applicable, as this is not an AI/ML device that requires a training set.

Ask a specific question about this device