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MYAH is intended to be used by an eye care professional:

• to measure the axial length of the eye in a population age 5 and above
• to capture and store digital images of the meibomian glands under near-infrared illumination in adult population.
  MYAH is not intended to be used in patients with cataracts.

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I am sorry, but the provided text only contains an FDA 510(k) clearance letter for a device called "MYAH," which is an AC-Powered Slitlamp Biomicroscope. The letter states its indications for use (measuring axial length and capturing meibomian gland images) and mentions it's a Class II device.

However, the document does not contain any information regarding acceptance criteria, study details, sample sizes, expert qualifications, ground truth establishment, or any of the other specific questions you've asked about device performance and validation.

Therefore, I cannot provide the requested information based on the text provided.

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MY AH is intended for measuring the axial length of the eye in a population age 5 and above and is intended for use under the care of an eye care professional. MYAH is not intended to be used in patients with cataracts.

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The provided FDA documentation for the Myah device (K211868) does not contain information regarding detailed acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or adjudication methods typically associated with AI/ML device evaluations.

The document is a substantial equivalence (SE) determination letter for a traditional device (AC-powered slitlamp biomicroscope) used for measuring axial length, not an AI/ML diagnostic or assistive device. The letter updates an earlier SE determination to correct typographical errors.

Therefore, I cannot provide the requested information based on the given text.

Ask a specific question about this device