(90 days)
FAQ™ 302 is indicated to promote hair growth in males with androgenetic alopecia who have Hamilton-Norwood Classifications of Ila-V and females with androgenetic alopecia who have Ludwig-Savin Classifications of I-II and Fitzpatrick Classification of Skin Phototypes I to IV.
FAQ™ 302 is a handheld rechargeable square shaped device designed for improving hair growth with 20 laser diodes (wavelength 650±10m) and 20 RED LED beads (640-660nm) on the inside surface.
By pressing the universal button, the user can power the device on, start treatment and change the intensity by quick-pressing the button again. Once the treatment is complete, the device is turned off by pressing and holding the universal power button for 3 seconds.
The device can also be connected wirelessly via Bluetooth to an FAQ App in order to manage treatment. After the treatment is completed, the device automatically powers off.
The device uses a non-detachable polymer lithium battery for power supply in compliance with IEC 62133-2:2017+A1:2021 standard.
Here's a breakdown of the acceptance criteria and study information for the FAQ™ 302 device, based on the provided FDA 510(k) summary:
This device (FAQ™ 302) is an Infrared Lamp intended to promote hair growth. The 510(k) summary explicitly states that clinical testing was considered not to be needed for this 510(k). Therefore, the provided document does not contain information about a study proving the device meets acceptance criteria related to its clinical effectiveness (i.e., promoting hair growth). Instead, the studies presented are non-clinical tests to demonstrate safety and performance equivalence to predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
Since clinical efficacy was "considered not to be needed," the acceptance criteria are not for clinical effectiveness but rather for safety, electrical performance, software functionality, cybersecurity, and usability. The document focuses on demonstrating that the new device is substantially equivalent to predicate devices based on these non-clinical aspects.
| Acceptance Criteria Category | Specific Standard/Requirement | Reported Device Performance |
|---|---|---|
| Biocompatibility | ISO 10993-5: In Vitro Cytotoxicity | Device tested in compliance; no additional risks noted. |
| ISO 10993-10: Irritation and Skin Sensitization | Device tested in compliance; no additional risks noted. | |
| ISO 10993-23: Tests for irritation | Device tested in compliance. | |
| Electrical Safety | IEC 60601-1:2005/AMD1:2012/AMD2:2020, CAN/CSA-C22.2 NO. 60601-1:14, AAMI 60601-1:2005 + AMD 1:2012 (General Req.) | Device tested to applicable electrical performance standards. |
| IEC 60601-1-6:2010+AMD1:2013+AMD2:2020 (Usability Collateral Standard) | Device tested to applicable electrical performance standards. | |
| IEC 62366-1:2015+AMD1:2020 (Usability Engineering) | Device tested to applicable electrical performance standards. | |
| IEC 60601-1-11:2015+AMD1:2020 (Home Healthcare Environment) | Device tested to applicable electrical performance standards. | |
| IEC 60601-2-57: 2011 (Non-laser light source) | Device tested to applicable electrical performance standards. | |
| EMC | EN 60601-1-2: 2015, IEC 60601-1-2: 2014 (Edition 4) (Electromagnetic disturbances) | Device tested to applicable electrical performance standards. |
| IEC TR 60601-4-2:2016 (Electromagnetic immunity) | Device tested to applicable electrical performance standards. | |
| Software Functionality | Minor level of concern per FDA guidance "Content of Premarket Submissions for Device Software Functions" | All software requirement specifications are met and all software hazards have been mitigated to acceptable risk levels. |
| Cybersecurity | Evaluation of assets, threats, vulnerabilities, impact, likelihood, risk levels, mitigation, residual risk | All risks associated with network capable interfaces adequately mitigated. Cybersecurity risk analysis performed, controls identified, comparison with National Vulnerability Database, and labeling information detailed in Cybersecurity Assessment. |
| Usability | User instruction provides adequate guidance for independent and appropriate home use for Laser and LED treatment | Test results in "Usability validation report" clearly indicate this. |
2. Sample Size Used for the Test Set and Data Provenance
- Biocompatibility Testing: The document does not specify the sample size (e.g., number of test specimens or replicates) for the biocompatibility tests.
- Electrical Safety and EMC Testing: The document does not specify the sample size used for these compliance tests, as these are typically conducted on a representative sample of the device itself rather than patient data.
- Software Verification and Validation: The document does not specify the number of test cases or data points for software validation.
- Cybersecurity: This involved an analysis, not a test set with patient data.
- Usability Study:
- Sample Size: 15 adults
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). It is implied to be prospective as it's a "validation testing" that "was conducted."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- For all non-clinical tests (biocompatibility, electrical safety, EMC, software, cybersecurity): "Ground truth" in the sense of clinical expert consensus is not applicable. These tests rely on established engineering and scientific standards. The "experts" involved would be the testing engineers and scientists responsible for conducting and interpreting these standard-based tests. Qualifications are not specified, but they would be presumed to be competent in the relevant fields.
- For the Usability Study: The document does not mention experts establishing a "ground truth" for usability. The study assessed whether adult users could follow instructions.
4. Adjudication Method for the Test Set
- Not applicable as no clinical test set requiring expert adjudication was performed.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document explicitly states: "Clinical testing was considered not to be needed for this 510(k)." The device's substantial equivalence is based on non-clinical performance and a comparison of its technical specifications and indications for use with legally marketed predicate devices.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Not applicable. This device is a hardware device (infrared lamp) with embedded software, not a standalone AI algorithm. The software verification and validation section relates to its internal software functionality, not an AI or standalone diagnostic/treatment algorithm.
7. Type of Ground Truth Used
- Biocompatibility, Electrical Safety, EMC: Ground truth refers to compliance with established international and national standards (e.g., ISO, IEC, AAMI compliance).
- Software: Ground truth refers to predefined software requirements and specifications, and the mitigation of identified software hazards.
- Cybersecurity: Ground truth refers to industry best practices, identified risks and vulnerabilities (including comparison with the National Vulnerability Database), and the effectiveness of mitigation strategies.
- Usability Study: Ground truth for this study was the ability of the users to follow the provided instructions to safely and appropriately use the device.
8. Sample Size for the Training Set
- Not applicable. This device is not an AI/ML algorithm that requires a "training set" in the context of learning from data to perform a diagnostic or treatment task. Software validation was performed but does not involve a training set as understood in AI/ML.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as no training set was used for an AI/ML algorithm.
§ 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.