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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.

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

The Hair Up is basically an identical device with the 510(k)-cleared device Hair Up (K172968). A new 510(k) clearance is applied this time with a new indications for use (IFU). Subject device, Hair up and its primary predicate device consist of 21 red visible laser diodes (LDs) and 30 red light emitting diodes (LEDs) configured within an outer helmet and protective inner liner. The use of LDs and LEDs provides full coverage of the upper 1/3 of the head which is commonly covered with stylized hair. The system will automatically pause therapy until the correct head position is re-established. At the end of the therapy cycle, the subject device Hair Up signals that therapy is complete and the device is ready to be powered down.

The provided text is a 510(k) summary for the "Hair Up" device, an infrared lamp intended to promote hair growth. It does not contain information about acceptance criteria or a study proving the device meets specific performance metrics in terms of effectiveness in promoting hair growth.

The document primarily focuses on demonstrating substantial equivalence to legally marketed predicate devices through a comparison of technical characteristics and indications for use. The "Performance Data" section describes non-clinical tests related to safety, electrical requirements, and biological evaluation, not a clinical study on hair growth.

Therefore, I cannot provide the requested table and detailed study information based on the given input. The categories below are answered based on the information that is available in the document, and where information is not present, it is explicitly stated.

Acceptance Criteria and Device Performance Study Information for Hair Up

This 510(k) summary for the "Hair Up" device does not contain a clinical study with acceptance criteria and reported device performance related to its primary intended use of promoting hair growth. The document focuses on demonstrating substantial equivalence to predicate devices through technical comparisons and non-clinical safety testing.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size (Test Set): Not applicable. No clinical test set is described for evaluating hair growth performance.
• Data Provenance: Not applicable.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable. No clinical test set is described with expert-established ground truth for hair growth.

4. Adjudication method for the test set

• Not applicable. No clinical test set is described.

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 as the device is an infrared lamp for hair growth, not an AI-based diagnostic or imaging device used by human readers.

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

• Not applicable. The "Hair Up" is a physical device (infrared lamp), not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Not applicable for hair growth performance. The non-clinical tests mentioned (wavelength, power, safety, EMC, biological evaluation) would have their own defined test conditions and standards, but these are not 'ground truth' in the context of clinical efficacy for hair growth.

8. The sample size for the training set

• Not applicable. The device is a physical infrared lamp, not an AI or algorithm that requires a training set.

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

• Not applicable.

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