(201 days)
The iRestore Hair Growth System is indicated to promote hair growth in females with androgenetic alopecia who have Ludwig-Savin Classifications of I- II, males who have Norwood-Hamilton Classifications of IIa- V and for both, Fitzpatrick Classification of Skin Phototypes I to IV.
The iRestore Hair Growth System consists of 21 red visible light, diode lasers and 30 red light super-luminescent diodes configured within an outer helmet and protective inner. The use of diode lasers and non-laser 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. At the end of the therapy cycle, the system signals that therapy is complete and ready to be powered down, by emitting an audible beep pattern.
The iRestore Hair Growth System (Model ID-500) is indicated to promote hair growth in females with Ludwig-Savin Classifications of I-II and males with Norwood-Hamilton Classifications of IIa-V, for individuals with Fitzpatrick Classification of Skin Phototypes I to IV. The device is for Over-The-Counter Use.
The provided document indicates that "No clinical performance data was produced for this submission because the iRestore is an IDENTICAL device in optical, electronic and mechanical function as well as recommended clinical treatment regime, to the predicate device, the igrow." Therefore, the acceptance criteria and study detailed below refer to those used for the predicate device, the igrow Hair Growth System, as the iRestore is considered substantially equivalent based on these prior studies.
1. Table of Acceptance Criteria and the Reported Device Performance (based on predicate device, igrow):
| Acceptance Criteria (Endpoint) | Reported Device Performance (iGrow) |
|---|---|
| Hair count achieved | Males: Increase from baseline. Females: Increase from baseline. |
| Hair growth promotion | Statistically significant improvement over placebo in hair count. |
Note: The specific numerical acceptance criteria (e.g., minimum percentage increase in hair count) are not explicitly stated in this document but are implied to be met by the positive study findings compared to placebo.
2. Sample sizes used for the test set and the data provenance:
- Males: 41 subjects in the active device group and 42 in the placebo group.
- Females: 29 subjects in the active device group and 29 in the placebo group.
- Data Provenance: The studies were published in "Lasers in Surgery and Medicine" and do not explicitly state the country of origin. The studies were described as "clinical trials" which implies prospective data collection.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
The document does not specify the number of experts or their qualifications for establishing ground truth, beyond the mention of "clinical testing." However, the studies were published in a peer-reviewed journal ("Lasers in Surgery and Medicine").
4. Adjudication method for the test set:
The document does not describe a specific adjudication method beyond the general description of clinical trials.
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:
This is not applicable as the device is a therapeutic hair growth system, not an AI diagnostic tool involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This is not applicable as the device is a therapeutic hair growth system, not an algorithm.
7. The type of ground truth used:
The ground truth used was clinical outcome data, specifically hair count, assessed in "clinical trials." The studies compared the active device against a placebo.
8. The sample size for the training set:
There is no mention of a "training set" as this device is not an AI/ML algorithm. The sample sizes referenced are for the clinical trials that established the efficacy of the predicate device.
9. How the ground truth for the training set was established:
This is not applicable as there is no "training set" for this type of device. The efficacy of the predicate device (iGrow) was established through controlled clinical trials involving male and female subjects with androgenetic alopecia, using objective measurements of hair count change from baseline compared to a placebo group. These studies were peer-reviewed and published.
§ 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.