(238 days)
The igrow-II Hair Growth System is indicated to promote hair growth in females with androgenetic alopecia who have Ludwig-Savin Classifications of I-II and Fitzpatrick Classification of 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. 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 provided text is a 510(k) Summary for the iGrow-II Hair Growth System. It describes a clinical study to demonstrate the device's performance. Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state "acceptance criteria" with numerical thresholds in the typical sense for a diagnostic device. Instead, it describes efficacy in terms of hair growth and safety. The primary performance metric is the increase in terminal hair counts and effectiveness against a placebo.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Promotion of Hair Growth (Primary Efficacy) | 100% effectiveness: All subjects in the active group showed a positive result for an increase in terminal hair counts. |
| Demonstrated superiority/positive variance over placebo (Efficacy) | The active group demonstrated a 39% positive variance over the placebo group from baseline. |
| Safety (Adverse Events) | No anticipated adverse events and none were reported from either therapy administered that were study-related. |
| Decrease in terminal hair counts (Measure of stability/efficacy) | The actual test group's decrease in terminal hair counts was zero, compared to the placebo group which was highly significant (implying the placebo group had decreases in some subjects). This is highlighted as pointing to the importance of precise, consistent irradiance. |
| Overall functionality | In all instances, the iGrow-II Hair Growth System functioned as anticipated. |
| Hair re-growth comparison | Hair re-growth was observed to be significantly greater than that of the incandescent placebo system. |
| Indication | Promote hair growth in females with androgenetic alopecia (Ludwig-Savin Classifications I-II, Fitzpatrick Skin Phototypes I to IV). (The reported performance directly supports this indication by showing increased hair growth in the study population, which aligns with these classifications through the inclusion criteria of the study, though the specific classifications of the subjects in the results are not further detailed.) |
2. Sample size used for the test set and the data provenance
- Sample Size: The document does not explicitly state the exact number of subjects in the test set or placebo group. It uses the phrase "All subjects self-administered treatments..." and "All of the subjects showed a positive result for an increase in terminal hair counts." indicating a cohort of subjects. It also mentions "a multi-center, randomized, double blinded, placebo controlled, prospective trial." Without a specific numerical count, the exact sample size remains unclear from this document alone.
- Data Provenance:
- Country of Origin: United States ("two sites in the United States").
- Study Design: Prospective, multi-center, randomized, double-blinded, placebo-controlled trial.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not provide information about experts establishing ground truth for the test set. The efficacy assessment centers on objective measures such as "increase in terminal hair counts" and "decrease in terminal hair counts," implying quantitative measurement rather than subjective expert consensus on the images themselves.
4. Adjudication method for the test set
The document does not describe any adjudication method (e.g., 2+1, 3+1) for the test set. The assessment appears to be based on direct measurement of terminal hair counts.
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. The iGrow-II Hair Growth System is a low-level light therapy device (infrared lamp) for promoting hair growth, not an AI-assisted diagnostic tool that would involve human readers interpreting cases.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The iGrow-II Hair Growth System is a physical device used by individuals for hair growth, not an algorithm.
7. The type of ground truth used
The ground truth for evaluating device efficacy was based on objective measurement of "terminal hair counts." This implies a quantitative assessment of hair growth, likely through direct counting or imaging analysis, rather than expert consensus, pathology, or outcomes data in the traditional sense of a diagnostic study.
8. The sample size for the training set
The document mentions "Adequate data, from prior testing, was already available to the sponsor, validating the efficacy of the iGrow-II Hair Growth System, obviating the need to test lasers versus LEDs." However, it does not specify a separate "training set" or its sample size in the context of a new clinical trial for this specific submission. The details provided pertain to the prospective controlled trial described.
9. How the ground truth for the training set was established
As there's no explicitly defined "training set" for the current submission's clinical trial, details on how its ground truth was established are not provided. The phrase "prior testing" suggests earlier studies, but their methodology for establishing ground truth is not elaborated upon in this document.
§ 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.