(107 days)
The Red Light Hair Growth Cap is indicated to treat Androgenetic Alopecia and promote hair growth in males who have Norwood-Hamilton Classifications of IIa-V patterns of hair loss and to treat Androgenetic Alopecia and promote hair growth in females who have Ludwig-Savin Scale I-1 to I-4, II-1, II-2 or frontal patterns of hair loss; both with Fitzpatrick Skin Types I-IV.
The Red Light Hair Growth Cap is an over the counter (OTC) home-use, non-invasive device indicated to treat androgenetic alopecia and promote hair growth in males who have Norwood-Hamilton Classifications of IIa-V patterns of hair loss and to treat Androgenetic Alopecia and promote hair growth in females who have Ludwig-Savin Scale I-1 to I-4, II-1, II-2 or frontal patterns of hair loss; both with Fitzpatrick Skin Types I-IV.
The Red Light Hair Growth Cap is a portable, therapeutic device whose purpose is to provide even, cool, narrow-band wavelengths of polychromatic light (660nm red light) produced by LEDs to treat androgenetic alopecia and promote hair grown.
The device comprises of a wearable soft textile cap, a controller, an AC adaptor and a USB cable. The device can be powered by the AC adaptor which connected to the mains directly, also it can be powered by a power bank. The device is operated by the controller. There are 2 buttons on controller, ON/Off button is used to turn on/off the device, time button is used for setting treatment time from 10 to 30 minutes, each press in 5-minute increments./decrements. The device will shut off automatically after reach treatment time.
The provided FDA 510(k) clearance letter and summary for the "Red Light Hair Growth Cap" do not contain the detailed clinical study information typically associated with acceptance criteria, reported device performance for clinical endpoints, sample sizes for test/training sets, expert qualifications, or adjudication methods for AI/software devices. This is because the device, an "Infrared Lamp" (a physical medical device), was cleared based on its substantial equivalence to predicate devices and extensive non-clinical (electrical safety, EMC, software verification/validation) testing, rather than a clinical effectiveness study.
The summary clearly states: "Clinical testing was not needed for this 510(k). The non-clinical performance testing described above is sufficient to support that the device can be used safely and effectively."
Therefore, I cannot directly extract the requested information (points 1-9) in the manner typically expected for an AI/software medical device that undergoes rigorous clinical validation with specific performance metrics against a ground truth.
However, I can describe the acceptance criteria and study type that proves the device meets those criteria based on the provided document:
Acceptance Criteria and Study for the Red Light Hair Growth Cap
The Red Light Hair Growth Cap (LP-RJVGRW-BLK) received FDA 510(k) clearance based on its substantial equivalence to legally marketed predicate devices, combined with comprehensive non-clinical performance testing. The core "acceptance criteria" for this specific submission were centered around safety and effectiveness being comparable to existing devices and meeting established electrical and software safety standards.
1. A table of acceptance criteria and the reported device performance
Since this was a 510(k) based on substantial equivalence and non-clinical testing, the "acceptance criteria" are primarily related to safety standards and comparison to predicate device characteristics. There are no specific clinical performance metrics for "hair growth" reported in this document.
| Acceptance Criteria Category | Specific Criteria/Standard Met | Reported Device Performance/Compliance |
|---|---|---|
| Electrical Safety | IEC 60601-1: 2020 | Conforms to standard |
| IEC 60601-1-2: 2020 (EMC) | Conforms to standard | |
| IEC 60601-1-11: 2020 (Home Healthcare) | Conforms to standard | |
| IEC 60601-2-57: 2011 (Non-Laser Light Source) | Conforms to standard | |
| Photobiological Safety | IEC 62471: 2006 | Conforms to standard |
| Software Verification & Validation | FDA Guidance for Industry and Staff: "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (Basic Documentation Level) | Software verification and validation conducted; documentation provided. |
| Substantial Equivalence (Indications for Use) | Treat Androgenetic Alopecia and promote hair growth in specific male (Norwood-Hamilton IIa-V) and female (Ludwig-Savin I-1 to I-4, II-1, II-2 or frontal) hair loss patterns, with Fitzpatrick Skin Types I-IV. | Same as predicate devices (CurrentBody Skin™ Led Hair Regrowth and Biophotas Celluma RESTORE). |
| Substantial Equivalence (Technical Characteristics) | Similar design principle, energy type (LED red light), peak wavelength, intensity, treatment dose, treatment time, control mechanisms, and electrical power. | Similar to predicate devices. Differences in intensity, treatment dose (Note 1) and treatment time (Note 2) were deemed not to affect safety or effectiveness. Electrical power differences (Note 3) met safety standards. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set (Clinical): Not applicable. Clinical testing was explicitly stated as "not needed" for this 510(k). The evaluation relied on non-clinical engineering and software testing.
- Data Provenance: The document does not specify country of origin for any safety testing data, only that the sponsor is Shenzhen Idea Light Limited, China. The testing itself is non-clinical (lab-based engineering/software V&V).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. There was no clinical "test set" requiring expert ground truth establishment for clinical endpoints.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. There was no clinical "test set" requiring adjudication.
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 device is not an AI/software diagnostic tool; it is a therapeutic device that does not involve human readers interpreting output or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical therapeutic device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the non-clinical testing, the "ground truth" refers to the established requirements and specifications of the referenced IEC standards (e.g., IEC 60601-1 for electrical safety) and FDA software guidance. Compliance with these standards served as the "ground truth" for safety and performance.
- For substantial equivalence for indications for use, the "ground truth" was the cleared indications for use of the predicate devices.
8. The sample size for the training set
- Not applicable. This device is not an AI/machine learning model and therefore does not have a "training set" in the context of data-driven algorithm development.
9. How the ground truth for the training set was established
- Not applicable, as there is no 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.