(271 days)
FAQ™ 101 devices are over-the-counter home use device intended for non-invasive treatment of mild to moderate periorbital wrinkles for adult women who have Fitzpatrick skin types I-VI.
Not Found
The provided documents are FDA 510(k) clearance letters for the device FAQ 101. These letters indicate that the device has received substantial equivalence determination, allowing it to be marketed. However, these documents do not contain any information regarding acceptance criteria, study details, device performance data, sample sizes, expert qualifications, adjudication methods, ground truth establishment, or any comparative effectiveness studies (MRMC) or standalone performance studies.
The letters primarily focus on:
- Notifying the applicant (Foreo, Inc.) of the substantial equivalence determination for the FAQ 101 device.
- Listing the regulation number, regulation name, regulatory class, and product codes.
- Providing administrative updates (like adding a product code).
- Stating the general controls provisions of the Act that apply to the device.
- Listing the Indications for Use for the device: "FAQ™ 101 devices are over-the-counter home use device intended for non-invasive treatment of mild to moderate periorbital wrinkles for adult women who have Fitzpatrick skin types I-VI."
Therefore, I cannot provide the requested information based on the given input. To answer your questions, I would need a different type of document, such as a study report, clinical trial summary, or a more detailed section of the 510(k) submission that outlines the performance testing and acceptance criteria.
§ 878.4420 Electrosurgical device for over-the-counter aesthetic use.
(a)
Identification. An electrosurgical device for over-the-counter aesthetic use is a device using radiofrequency energy to produce localized heating within tissues for non-invasive aesthetic use.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Non-clinical performance data must demonstrate that the device meets all design specifications and performance requirements. The following performance characteristics must be tested: Over-heating, power accuracy radiofrequency, pulse cycle, waveform, pulse duration, and device characterization parameters.
(2) Label comprehension and self-selection performance evaluation must demonstrate that the intended over-the-counter users can understand the package labeling and correctly choose the device for the indicated aesthetic use.
(3) Usability performance evaluation must demonstrate that the over-the-counter user can correctly use the device, based solely on reading the directions for use, to treat the indicated aesthetic use.
(4) Clinical performance evaluation must demonstrate that the device performs as intended under anticipated conditions of use to achieve the intended aesthetic results.
(5) The patient-contacting components of the device must be demonstrated to be biocompatible.
(6) Instructions for cleaning the device must be validated.
(7) Performance data must be provided to demonstrate the electromagnetic compatibility and electrical safety, including the mechanical integrity, of the device.
(8) Software verification, validation, and hazard analysis must be performed.
(9) Labeling must include:
(i) Warnings, precautions, and contraindications to ensure the safe use of the device for the over-the-counter users.
(ii) A statement that the safety and effectiveness of the device's use for uses other than the indicated aesthetic use are not known.
(iii) A summary of the clinical information used to establish effectiveness for each indicated aesthetic usage and observed adverse events.