(131 days)
The igrow-II Hair Growth System is indicated to promote hair growth in males with androgenetic alopecia who have Norwood Hamilton Classifications of IIa to V and Fitzpatrick Skin Phototypes I to IV.
The Igrow-II 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 liner. 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.
Here's a breakdown of the acceptance criteria and study information for the igrow-II Hair Growth System, based on the provided 510(k) summary:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Promotion of hair growth in males with androgenetic alopecia, Norwood Hamilton Classifications IIa to V, and Fitzpatrick Skin Phototypes I to IV. | Subjects in the active group demonstrated 100% effectiveness (positive result for an increase in terminal hair counts). |
| Significant increase in terminal hair counts compared to placebo. | The active group showed a 39% positive variance over the placebo group from baseline. |
| Decrease in terminal hair counts in the active group should be zero or negligible. | The actual test group's decrease in terminal hair counts was zero, compared to a significant decrease in the placebo group. |
| No anticipated or reported adverse events related to the therapy. | No anticipated adverse events and none were reported from either therapy administered that were study related. |
| Device functions as anticipated. | In all instances, the igrow-II Hair Growth System functioned as anticipated. |
Study Details
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Sample Size used for the test set and the data provenance:
- Sample Size: Not explicitly stated as a number, but the study refers to "subjects" and "all of the subjects" in the active group demonstrating effectiveness, implying a sufficiently powered sample for the observed effect.
- Data Provenance: Prospective, multi-center, randomized, double-blinded, placebo-controlled trial conducted at two sites in the United States.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the summary. The "ground truth" seems to be based on an objective measurement: "increase in terminal hair counts," which would likely be quantified measurements rather than expert consensus on images.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Adjudication method is not explicitly stated. The "ground truth" is based on "increase in terminal hair counts" as a primary outcome.
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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, an MRMC comparative effectiveness study involving human readers and AI assistance was not done. This study is evaluating the device itself, not AI assistance for human reading.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, a standalone performance study was done. The device (igrow-II Hair Growth System) was tested on its own, with subjects self-administering treatments, and its efficacy was measured against a placebo device. There is no human-in-the-loop component mentioned for interpreting results or guiding the device's action, only for administering the treatment.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The primary ground truth used was outcomes data, specifically "increase in terminal hair counts."
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The sample size for the training set:
- Not applicable / Not explicitly stated. This is a performance study of a physical device, not an AI/algorithm that requires a training set in the typical sense. The summary mentions "Adequate data, from prior testing, was already available to the sponsor, validating the efficacy of the igrow-II Hair Growth System." This likely refers to previous internal testing and development, not a formal training set for an algorithm.
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How the ground truth for the training set was established:
- Not applicable. See point 7.
§ 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.