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510(k) Data Aggregation
(276 days)
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.
Not Found
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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(258 days)
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.
Not Found
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.
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(371 days)
ALADDIN is intended for biometric determination of the following ocular measures: axial length, corneal radius, corneal cylinder axis, anterior chamber depth, white-to-white (WTW) and pupil diameter of the human eye. ALADDIN also measures corneal topography. For patients who are candidates for intraocular lens (IOL) implantation, ALADDIN also aids in the calculation of the appropriate IOL power and type to be implanted.
Not Found
The provided text is a 510(k) Premarket Notification for the ALADDIN device, which is an ophthalmic device. It does not contain information about the acceptance criteria or a study proving the device meets acceptance criteria.
The document is a letter from the FDA to Visia Imaging S.r.l. (c/o Ms. Marisa Testa) acknowledging the review of their 510(k) premarket notification for the ALADDIN device. It states that the device is substantially equivalent to legally marketed predicate devices. The document outlines regulatory requirements for the device and includes an "Indications for Use" statement.
Therefore, I cannot provide the requested information from the provided text. The document describes regulatory approval based on substantial equivalence, not the results of a study demonstrating adherence to specific acceptance criteria.
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