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The Aduro light therapy Handheld (Model:HD-03A,HD-25A,HD-07A),the red light is intended for the treatment of periorbital wrinkles, and the blue light is intended for the mild to moderate inflammatory acne.

Aduro light therapy Handheld (Model: HD-03A, HD-25A, HD-07A)

The provided document is a 510(k) clearance letter from the FDA for a light therapy device. It primarily focuses on regulatory approval and indications for use.

Therefore, the document does not contain the detailed information necessary to describe the acceptance criteria and the study that proves the device meets those criteria.

Specifically, the document does not include:

• A table of acceptance criteria and reported device performance.
• Sample sizes used for test sets or their data provenance.
• Information on the number or qualifications of experts for ground truth establishment.
• Adjudication methods.
• Results or even mention of a multi-reader, multi-case (MRMC) comparative effectiveness study.
• Results or mention of a standalone algorithm performance study.
• The type of ground truth used (e.g., expert consensus, pathology, outcomes data).
• The sample size for the training set.
• How the ground truth for the training set was established.

This type of information would typically be found in the 510(k) submission itself or a summary thereof, which is a much more comprehensive technical document than the clearance letter. The clearance letter only states that the FDA reviewed the submission and found the device substantially equivalent based on the provided information.

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