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The HairMD is indicated to promote hair growth in females with androgenetic alopecia who have Ludwig-Savin Classifications I-II, in males with androgenetic alopecia who have Norwood Hamilton Classifications IIa-V and for both, Fitzpatrick Classification of Skin Phototypes of I-IV.

The HairMD consists of 21 red, visible-light, continuous wave diode lasers operating at 650 nanometers and 30 super luminescent light emitting diodes (LEDs), operating at 650 nanometers that are configured within a protective inner liner and outer helmet. The HairMD is physically similar to the iGrow Hair Growth System, except that it does not contain earphones or inner liner spacers. The use of these specific number of diode lasers and LEDs, provides for a full coverage of the upper 1/3 of the head; i.e., the area commonly covered with stylized hair. The helmet system will automatically pause therapy if the subject's head is moved outside of the zone of radiation and will resume therapy when the correct head position is re-established. This is achieved by a safety interlock. At the beginning and end of a therapy session, audible tones are delivered to the user, indicating that therapy has begun (2 beeps) or ended (one long beep). The system is powered by line voltage, operating at 110/220 volts.

The provided text describes a 510(k) premarket notification for the HairMD device, an infrared lamp intended to promote hair growth. However, it explicitly states that "No clinical trial data for the HairMD was submitted for this 510(k)." Therefore, a study proving the device meets acceptance criteria, as well as several of the requested data points (like sample sizes, expert details, adjudication methods, MRMC studies, standalone performance, and training set details), are not available in this document.

The submission focuses on demonstrating substantial equivalence to predicate devices (iGrow Hair Growth System and Hairmax Lasercomb) based on technological characteristics and intended use.

Here's a breakdown of what can be extracted and what cannot:

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

The document does not provide specific acceptance criteria or clinical performance data for the HairMD device. It states: "No clinical trial data for the HairMD was submitted for this 510(k)."

However, it does mention that the device was tested for conformance with safety standards.

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

• Sample Size for Test Set: Not applicable, as no clinical trial data was submitted.
• Data Provenance: Not applicable, as no clinical trial data was submitted.

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 trial data was submitted and thus no ground truth for a test set was established.

4. Adjudication method for the test set

• Not applicable, as no clinical trial data was submitted.

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 comparative effectiveness study was done. This device is not an AI-assisted diagnostic tool; it's a therapeutic device.

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

• Not applicable. This device is a therapeutic device, not an algorithm.

7. The type of ground truth used

• Not applicable, as no clinical trial data was submitted. The substantial equivalence argument relies on the established safety and efficacy of the predicate devices and the HairMD's comparable technological characteristics.

8. The sample size for the training set

• Not applicable, as no clinical trial data was submitted for the HairMD device itself. The device is not based on a machine learning model that requires a training set.

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

• Not applicable (see point 8).

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