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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 is a 510(k) summary for the medical device "easy Claire," a light-based device intended for the treatment of full face wrinkles. The document details the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain specific acceptance criteria or performance data from a study directly comparing the device's efficacy against such criteria.

The "Performance Data" section (Page 5) lists only non-clinical tests related to safety and electrical standards (e.g., IEC, ISO standards, risk management). It does not include any clinical study results demonstrating the device's effectiveness in wrinkle reduction or against any quantitative performance metrics for efficacy.

Therefore, I cannot fulfill the request to provide:

1. A table of acceptance criteria and the reported device performance
2. Sample size used for the test set and data provenance
3. Number of experts used to establish ground truth and their qualifications
4. Adjudication method
5. MRMC comparative effectiveness study results or effect size
6. Standalone performance study results
7. Type of ground truth used
8. Sample size for the training set
9. How ground truth for the training set was established

The document focuses solely on establishing substantial equivalence based on technological characteristics and safety standards, not on direct clinical efficacy data against predefined acceptance criteria for wrinkle reduction.

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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.

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