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510(k) Data Aggregation
(88 days)
The iHelmet Laser Comb is indicated to promote hair growth in males with androgenic alopecia who have Norwood-Hamilton classifications of Ha-V or females with androgenic alopecia who have Ludwig-Savin Classifications of I-4, II-1, II-2, or frontal and both with Fitzpatrick Skin Phototypes I-IV.
The iHelmet Laser Comb is a comb-shaped low level laser therapy (LLLT) device that emits laser light with the intention to promote hair growth. The device provides distributed laser to the scalp at 650+/-10nm while the comb teeth simultaneously part the user's hair to ensure the laser light reaches the user's scalp. The Laser Hair Therapy is designed as handheld product, and it consists of main unit, the charging dock and a power cable, as well as it is powered by the built-in rechargeable lithium battery. The device is one-button operated, and has an audible timer that automatically turns the lasers off after the treatment is completed.
This document is a 510(k) Pre-Market Notification, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a novel clinical study with acceptance criteria for a new AI device. Therefore, much of the requested information regarding AI device acceptance criteria and study design is not available in this document.
However, I can extract the relevant information from the provided text about the device and its claimed equivalence.
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't provide specific acceptance criteria in terms of performance metrics (like sensitivity, specificity, accuracy) for a new AI algorithm. Instead, it demonstrates an acceptance of "substantial equivalence" based on various technical and safety benchmarks compared to a predicate device.
| Acceptance Criteria (Demonstration of Substantial Equivalence) | Reported Device Performance (iHelmet Laser Comb) |
|---|---|
| Intended Use (promote hair growth in specific populations with androgenic alopecia) | Matches predicate: "The iHelmet Laser Comb is indicated to promote hair growth in males with androgenic alopecia who have Norwood-Hamilton classifications of IIa-V or females with androgenic alopecia who have Ludwig-Savin Classifications of I-4, II-1, II-2, or frontal and both with Fitzpatrick Skin Phototypes I-IV." |
| Product Code (OAP) | Matches predicate: OAP |
| Classification (Class II) | Matches predicate: Class II |
| Location for use (OTC) | Matches predicate: OTC |
| Type of Laser (Visible red light-emitting diodes) | Matches predicate: Visible red light-emitting diodes |
| Power (<5mW) | Matches predicate: <5mW |
| Applicable people (Norwood-Hamilton IIa-V (males); Ludwig-Savin I-4, II-1, II-2, or frontal (females)) | Matches predicate |
| Applicable skin (Fitzpatrick Skin Phototypes I-IV) | Matches predicate |
| Appearance design (Comb) | Matches predicate: Comb |
| Safety Compliance (IEC 60601-1-2; IEC 60601-1; IEC 60601-1-11; IEC 60825-1) | Complied with: IEC 60601-1-2; IEC 60601-1; IEC 60601-1-11; IEC 60825-1 |
| Biocompatibility Compliance (ISO 10993-5; ISO 10993-10) | Complied with: ISO 10993-5; ISO 10993-10 |
| Light Class (Difference explained not to raise safety/effectiveness issue) | Subject Device: Class 1; Predicate Device: Class 3R. Note 1 states "they all meet the IEC 60825-1 requirements. So the differences will not raise any safety or effectiveness issue." |
| Amount of Light-emitting diodes (Slight differences explained not to raise safety/effectiveness issue) | Subject Device: 12-16 pcs (model dependent); Predicate Device: 12 pcs. Note 2 states "they are very similar to the predicate device and comply with the regulation requirements, so the differences will not raise any safety or effectiveness any issue." |
| Wavelength (Slight differences explained not to raise safety/effectiveness issue) | Subject Device: 650nm±10nm, 624 nm (model dependent); Predicate Device: 655±5nm. Note 2 states "they are very similar to the predicate device and comply with the regulation requirements, so the differences will not raise any safety or effectiveness any issue." |
| Treatment time (Slight differences explained not to raise safety/effectiveness issue) | Subject Device: 6-11 minutes per treatment (model dependent); Predicate Device: 8 minutes per treatment. Note 2 states "they are very similar to the predicate device and comply with the regulation requirements, so the differences will not raise any safety or effectiveness any issue." |
2. Sample size used for the test set and the data provenance:
- This document describes safety and performance testing against electrical and biocompatibility standards, not a clinical trial with a "test set" in the context of an AI algorithm.
- The tests mentioned in section 7 ("Test Summary") are bench tests against specific IEC and ISO standards (e.g., IEC 60601-1 for electrical safety, IEC 60825-1 for laser safety, ISO 10993-5/10 for biocompatibility). These standards define test methods and acceptance criteria for the device's physical and electrical characteristics, not for clinical performance or AI algorithm validation.
- Therefore, there is no information about a "sample size" of patients or data, nor data provenance (country of origin, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This document does not describe the establishment of ground truth by clinical experts for a test set of an AI algorithm. The predicate device and the subject device are low-level laser therapy devices, not AI-powered diagnostic or treatment algorithms.
4. Adjudication method for the test set:
- Not applicable. This document does not describe a test set or an adjudication method for an AI algorithm.
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:
- Not applicable. This document does not describe an AI device, an MRMC study, or human reader performance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This document is for a physical medical device (laser comb) and not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable. For the purpose of establishing substantial equivalence, the "ground truth" refers to the established safety and performance of the predicate device and compliance with recognized safety standards for the subject device. There is no AI algorithm requiring a specific type of clinical ground truth.
8. The sample size for the training set:
- Not applicable. This document does not describe an AI device or a training set.
9. How the ground truth for the training set was established:
- Not applicable. This document does not describe an AI device, a training set, or the establishment of ground truth for it.
In summary: The provided document is a 510(k) summary for a low-level laser therapy device (iHelmet Laser Comb), demonstrating its substantial equivalence to a predicate device. It addresses technical safety and performance aspects, not the validation of an AI algorithm with clinical performance metrics. Therefore, most of the questions related to AI-specific study design (sample size, data provenance, expert ground truth, MRMC studies, standalone performance, training sets) are not applicable to the content of this document.
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