(85 days)
Hair Growth Device is indicated to promote hair growth in females with androgenetic alopecia who have Ludwig-Savin Classifications of I-II, in males with androgenetic alopecia who have Norwood-Hamilton Classifications of IIa-V and for both, Fitzpatrick Classification of Skin Phototypes I to IV.
The product is composed of main unit, USB cable, and silicone pad. The main unit consists of laser diodes that are spread throughout the helmet. Low-energy laser therapy (LLLT) is a safe and effective treatment for androgenic alopecia (AGA). The Hair Growth Device employs intelligent LLLT technology, utilizing a 650 nm, 5-milliwatt low-energy laser that penetrates the scalp surface to a depth of 3-5 mm, reaching the hair follicles. Hair Growth Device is a small over-the-counter, portable, noninvasive, low-level laser device intended to treat Androgenetic Alopecia (Hair Loss) and to promote hair growth in Males and Females. The product uses diode lasers to cover the entire area of the head that is normally covered with hair, and this unique design allows the treatment of the entire scalp without manual movement. Hair Growth Device consists of main unit, USB cable and silicone strap and no communication function. The device will then turn on and you'll hear an audible beep.
This FDA 510(k) clearance letter is for a medical device (Hair Growth Device) rather than a software algorithm used for interpretation/diagnosis. As such, the information typically requested for AI-powered diagnostic devices (e.g., test set sample size, expert qualifications, adjudication methods, MRMC studies, ground truth types for training/test sets, etc.) is not applicable or present in this document.
The document primarily focuses on demonstrating substantial equivalence to predicate devices through technical specifications and non-clinical testing. It explicitly states, "No clinical test data was used to support the decision of substantial equivalence."
Therefore, I cannot provide the requested information about acceptance criteria for an AI algorithm's performance or details about a study proving such performance, as this document does not pertain to such a device or study.
However, I can extract the general acceptance criteria and the type of study performed to prove substantial equivalence based on the provided text, recognizing these are not related to AI performance.
Based on the provided FDA 510(k) clearance letter for the Hair Growth Device:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Reported Device Performance (Summary) |
|---|---|
| Safety | Complies with IEC 60601-1, IEC 60601-1-2, IEC 60825-1, IEC 60601-1-11, ISO 10993-5, ISO 10993-10 (electromagnetic compatibility, electrical safety, laser safety, biocompatibility). Differences in physical parameters (dimensions, weight, operating/storage environment) do not affect safety. |
| Effectiveness (Substantial Equivalence) | Energy and power parameters' range of subject device can be covered by predicate device's range; very similar. Differences in "Amounts of Laser Lamp", "Treatment Time", "Treatment Area", "Irradiance", and "Fluence" will not raise any safety or effectiveness issue. |
| Performance (Non-Clinical) | Meets requirements of predefined acceptance criteria for: |
- Product service life
- Software validation
- Biocompatibility evaluation
- Electromagnetic compatibility and electrical safety
- Safety of laser products
- Performance test |
Regarding the study that proves the device meets the acceptance criteria (note: this is a substantial equivalence study, not an AI performance study):
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Sample size used for the test set and the data provenance: Not applicable. No clinical test set or patient data was used. The study primarily relies on comparison to predicate devices and non-clinical engineering tests.
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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 requiring expert ground truth was used for this substantial equivalence determination.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No clinical test set requiring adjudication was used.
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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: Not applicable. This device is not an AI-powered diagnostic tool, and no MRMC study was conducted.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI algorithm. The device operates independently (Over-The-Counter).
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to an AI context. For substantial equivalence, the "ground truth" is established by compliance with recognized standards (e.g., IEC, ISO) and comparison to legally marketed predicate devices that have established safety and effectiveness.
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The sample size for the training set: Not applicable. This is not an AI algorithm, so there is no training set in the machine learning sense.
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How the ground truth for the training set was established: Not applicable. No AI training set.
§ 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.