(188 days)
The Robin's Egg 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-I to I-4, II-I, II-2 or frontal patterns of hair loss; both with Fitzpatrick Skin Types I - IV.
The Telebrands' Robin's Egg is a non-invasive, helmet-style photobiomodulation device indicated to treat androgenetic alopecia in both men and women. It is operated using a single button at the front of the helmet to promote hair growth using Modulated Light Therapy (MLT) for a recommended 10-minute daily treatment. The Robin's Egg is a system comprised of a wearable soft textile Cap using driver electronics, a rechargeable battery, and integrated light emitting diode (LED) flexible printed circuit board containing 126 LEDs, as compared to 119 within the predicate device REVIAN RED. The Robin's Egg is designed as an over-the-counter (OTC) home-based device to treat the entire scalp area of the user and is controlled by means of a single button and illuminated control display at the front of the helmet. Emitting red light energy within the 625 - 660 nm at 2.376 mW/cm² for a treatment time of 10 minutes, the Robin's Egg provides a well-established photobiomodulation effect upon the scalp to stimulate hair growth.
This document is not a study that proves the device (Robin's Egg) meets acceptance criteria for efficacy. Instead, it is a 510(k) Premarket Notification from the FDA, confirming that the device has been reviewed and determined to be substantially equivalent to a legally marketed predicate device (REVIAN RED K173729) for its stated indications for use.
Crucially, no clinical trial data for the Robin's Egg was submitted for this 510(k). The clearance is based on the substantial equivalence of the device's technical characteristics and non-clinical performance to the predicate device. Therefore, a direct study proving the Robin's Egg meets specific efficacy acceptance criteria, as one might find in a clinical trial report, is not present here.
Given the information provided, I cannot fill out the requested table for "acceptance criteria and the reported device performance" as it pertains to efficacy, nor can I provide details on sample sizes, expert ground truth establishment, or MRMC studies for this specific device's efficacy. The regulatory review focused on equivalence, not a new demonstration of efficacy.
However, I can extract information regarding the basis for regulatory clearance and what non-clinical testing was performed:
Summary of Information from the 510(k) Document:
1. Table of (Non-Clinical) Acceptance Criteria and Reported Device Performance:
Since no clinical efficacy data for the Robin's Egg was submitted, the "acceptance criteria" here refer to non-clinical performance and substantial equivalence to the predicate.
| Acceptance Criteria (Non-Clinical) | Reported Device Performance (Non-Clinical) |
|---|---|
| Electrical Safety: Conformance to IEC 60601-1 (Edition 3.2 2020-08) and ANSI/AAMI 60601-1-11:2015. | Performance testing confirmed conformance. |
| Electromagnetic Compatibility (EMC): Conformance to IEC 60601-1-2:2014. | Performance testing confirmed conformance. |
| Photobiological Safety: Conformance to IEC 60601-2-57 (Edition 1.0) and IEC 62471 (Edition 1.0). | Performance testing confirmed conformance. |
| Biocompatibility: Conformance to ISO 10993-1:2018 (cytotoxicity, skin irritation, skin sensitization). | Biocompatibility testing of the Cap confirmed no effects related to cytotoxicity, skin irritation, or skin sensitization for the applied parts. |
| Software: (Implicitly, software validation and verification) | Testing performed. (Specific details not provided beyond "software performance testing"). |
| Human Factors/Usability: Conformance to ANSI/AAMI/IEC 62366-1:2015 and 60601-1-6 (Edition 3.2 2020-07). | Human factors evaluation was performed following current versions of the standards. The process involved observational user research, formative, and summative user testing to evaluate representative users under expected conditions during simulated and actual use. (Results implicitly indicate compliance as it was cleared). |
| Equivalence of Spectral & Irradiance Parameters: Robin's Egg parameters equivalent to predicate device. | The device emits red light energy within 625 - 660 nm at 2.376 mW/cm² for a 10-minute daily treatment. The device has 126 LEDs compared to 119 in the predicate. The wavelength range (625-660 nm) is very similar to the predicate (620-660 nm). Performance verification and validation testing demonstrated that the Robin's Egg's spectral and irradiance parameters are equivalent to the predicate device. |
| User Needs & Design Inputs: Device meets these requirements for intended use. | Performance verification and validation testing demonstrate that the Robin's Egg meets user needs and design inputs and met requirements for its intended use. (Implicitly passed, as clearance was granted). |
2. Sample Size Used for the Test Set and Data Provenance:
- For clinical efficacy: No test set (clinical data) was used or submitted for the Robin's Egg as part of this 510(k). The clearance is based on substantial equivalence to a predicate device, not on new clinical efficacy data for the Robin's Egg itself.
- For non-clinical testing (Electrical, EMC, Biocompatibility, etc.): The sample sizes for these engineering and lab tests are not specified in the document. The data provenance would be internal laboratory testing conducted by or for Telebrands Corporation. The FDA letter is dated September 17, 2024, and the submission was received on August 16, 2024.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
- For clinical efficacy: Not applicable, as no clinical efficacy test set for the Robin's Egg was submitted.
- For non-clinical testing: The document does not specify the number or qualifications of experts involved in establishing "ground truth" for the non-clinical tests (e.g., electrical safety, EMC). These tests typically rely on standardized methods and equipment calibration rather than expert consensus on a "ground truth" in the diagnostic sense.
4. Adjudication Method for the Test Set:
- Not applicable, as no clinical efficacy test set for the Robin's Egg was submitted.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, a MRMC comparative effectiveness study was not done or submitted for the Robin's Egg. This type of study is typically used to demonstrate the impact of AI algorithms on human reader performance, which is not relevant for this device's type of regulatory submission (substantial equivalence for a physical light therapy device).
6. Standalone (Algorithm Only) Performance Study:
- No, this is not applicable. The Robin's Egg is a physical light therapy device, not an AI algorithm.
7. Type of Ground Truth Used:
- For clinical efficacy: Not applicable, as no clinical efficacy data for the Robin's Egg was submitted.
- For non-clinical testing: The "ground truth" was based on adherence to recognized national and international standards (e.g., IEC, ANSI/AAMI, ISO) for electrical safety, electromagnetic compatibility, biocompatibility, photobiological safety, and human factors. This is a technical ground truth based on compliance with established engineering and safety testing protocols.
8. Sample Size for the Training Set:
- Not applicable. This device is not an AI algorithm that requires a "training set" in the machine learning sense.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable.
§ 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.