(153 days)
The easy Claire is an over-the-counter medical device intended for the treatment of full face wrinkles.
The easy Claire is a device that allows the emission of 630nm LED light and 850nm IRED light on the face, which induces photobiological effects for the treatment of facial wrinkles. The easy Claire is an over-the-counter device and consists of a collection of 99 LEDs (630nm) and 99 IREDs (850nm) for the treatment of facial wrinkles. Users place the lightweight mask over the face and use the touch switch button to operate the easy Claire. The device will automatically turn off after treatment. To prevent irradiation of LED lights to the eye during the treatment, easy Claire has a protective eye-shield that blocks light from LEDs. The device is powered by the internal rechargeable lithium-ion battery which is recharged by the specified external adapter with Input AC 100-240V, 50/60Hz, and Output DC 5V, 2A.
The provided text does not contain information about the acceptance criteria or a study that proves the device meets the acceptance criteria in the manner requested (i.e., in terms of AI/algorithm performance against a ground truth and human reader performance).
The "510(k) Summary" (pages 3-5) describes the "easy Claire" device, which is a light-based mask for the treatment of full-face wrinkles. The summary primarily focuses on establishing substantial equivalence to a predicate device (Rejuvalite MD) and a reference device (Pulsaderm Wrinkle Mask).
The "Performance Data" section (page 5) lists a series of non-clinical tests conducted to demonstrate the safety and effectiveness of the device. These tests align with various IEC and ISO standards related to medical electrical equipment, electromagnetic disturbances, usability, home healthcare environments, photobiological safety, and biocompatibility (in vitro cytotoxicity, irritation, and skin sensitization). Risk management was also conducted according to ISO 14971.
There is no mention of:
- Acceptance criteria related to algorithm performance (e.g., sensitivity, specificity, AUC).
- A test set with a specific sample size for evaluating an algorithm or human readers.
- Data provenance (country of origin, retrospective/prospective).
- Experts establishing ground truth or their qualifications.
- Adjudication methods.
- Multi-reader multi-case (MRMC) comparative effectiveness studies.
- Standalone algorithm performance.
- Type of ground truth used (expert consensus, pathology, outcomes data).
- Training set sample size or how its ground truth was established.
This document is a 510(k) summary, which typically demonstrates substantial equivalence of a new device to an existing legally marketed predicate device, rather than providing detailed clinical study results of a novel AI-powered diagnostic or treatment device. The easy Claire product appears to be a physical light therapy device, not an AI/software-as-a-medical-device (SaMD) that would require the types of performance studies outlined in the prompt's request.
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.