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Silkn FX is an over the counter device indicated to emit energy in the red and IR region of the spectrum for use in dermatology for the treatment of periorbital wrinkles.

Silk'n FX is a hand held device battery operated that uses low power light spectrum at red and infrared LED, at wavelength of 633 ±5nm, 830 ±5nm emitting optical power in a uniform distribution with no hot spots.

The provided 510(k) summary for the Silk'n FX device does not include any acceptance criteria or a study demonstrating the device meets such criteria.

Instead, the submission outlines the device's technical specifications and claims substantial equivalence to a predicate device based on identical output and intended use. The FDA's letter concurs with this substantial equivalence.

Therefore, most of the requested information cannot be extracted from this document, as a detailed performance study with acceptance criteria was not presented as part of this particular FDA submission for the Silk'n FX.

Here's what can be stated based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Not provided in the document. The submission claims substantial equivalence based on identical output and intended use to a predicate device, rather than meeting specific performance criteria.

2. Sample size used for the test set and data provenance:

Not applicable. No performance study data is presented.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. No performance study data is presented.

4. Adjudication method for the test set:

Not applicable. No performance study data is presented.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This device is an LED device for wrinkle treatment, not an AI-powered diagnostic tool. The submission does not mention any MRMC studies or human reader involvement.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This device is an LED device; there is no algorithm or AI component mentioned.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Not applicable. No performance study data is presented.

8. The sample size for the training set:

Not applicable. No performance study data or machine learning component is mentioned.

9. How the ground truth for the training set was established:

Not applicable. No performance study data or machine learning component is mentioned.

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