(209 days)
The Nutra Stim Hair Laser Comb is indicated to treat androgenetic alopecia, promote hair growth and prevent further hair loss in males who have Norwood Hamilton Classifications of IIa to V patterns of hair loss and Fitzpatrick Skin Types I to IV.
The Nutra Stim Hair Laser Comb is a hand-held low level laser device that emits laser light with the intention to promote hair growth. The device provides distributed laser light to the scalp while the comb teeth simultaneously part the user's hair to ensure the laser light reaches the user's scalp. The Nutra Stim Hair Laser Comb unit contains the power supply, internal NI-MH rechargeable battery and the control unit. The enclosure and laser lens are made of medical grade biocompatibility plastics via injection molding. The STOP button directly on the unit allows the user to immediately remove all power to the unit. The Nutra Stim Hair Laser Comb does not use any software.
The provided text describes a 510(k) premarket notification for the Nutra Stim Hair Laser Comb. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with detailed acceptance criteria and performance data for a new device's efficacy.
Therefore, many of your requested details, particularly those related to a clinical study establishing performance against specific acceptance criteria for a novel device, are not directly available in this document. The document primarily relies on the predicate device's established effectiveness and safety, and direct comparison of technological characteristics.
However, I can extract the information that is present:
1. Table of Acceptance Criteria and Reported Device Performance
This specific table, comparing acceptance criteria to performance, is not provided in the document. The document describes an "OTC Usability Study" and lists its goals, which could be interpreted as acceptance criteria for usability, but it does not present quantifiable performance metrics against those goals.
| Acceptance Criteria (Implied from Usability Study Goals) | Reported Device Performance |
|---|---|
| Attract participants representing "intended users" of the device | Met (80 participants) |
| Consumers could correctly self-select using packaging labeling only | Met |
| Consumer knowledge of packaging labeling and user manual, and ability to assemble, operate, and care for the device correctly | Met |
2. Sample Size for Test Set and Data Provenance
The document mentions an "OTC Usability Study" with:
- Sample Size: 80 participants
- Data Provenance: Not explicitly stated, but it's an "OTC Usability Study," implying it was conducted with potential end-users for over-the-counter use, likely within the US, where the FDA is regulating it. It is a prospective study as participants were actively recruited to test the device's usability.
3. Number of Experts and Qualifications for Ground Truth
- This information is not provided as the usability study did not involve establishing a medical ground truth in the way a diagnostic device study would. The "ground truth" for the usability study was whether participants could successfully interact with the device and understand its labeling.
4. Adjudication Method for Test Set
- This information is not provided. Given it's a usability study where success was measured against understanding and operating the device, a formal adjudication process as seen in clinical trials for diagnostic accuracy is unlikely to have been implemented or necessary.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not conducted. This type of study is relevant for diagnostic devices where human readers interpret results, often with and without AI assistance. The Nutra Stim Hair Laser Comb is a therapeutic device for hair growth, not a diagnostic one.
6. Standalone (Algorithm Only) Performance Study
- No, a standalone performance study (algorithm only) was not conducted. The device is a physical laser comb, not an AI algorithm. The document mentions "The Nutra Stim Hair Laser Comb does not use any software," further confirming the irrelevance of an algorithm-only study.
7. Type of Ground Truth Used
- For the "OTC Usability Study," the "ground truth" was essentially observational success/failure in performing tasks (self-selection, understanding instructions, operating the device) and participant feedback. It was not based on expert consensus, pathology, or outcomes data in a medical sense for efficacy.
8. Sample Size for Training Set
- This information is not applicable and therefore not provided. The Nutra Stim Hair Laser Comb is a hardware device for therapeutic use; it does not involve AI or machine learning algorithms that require a "training set."
9. How Ground Truth for Training Set Was Established
- This information is not applicable and therefore not provided for the same reasons as #8.
§ 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.