(456 days)
The MS-39 is designed to capture scans of the anterior segment of the eye which includes the cornea, pupil, anterior chamber and lens of the eye. To evaluate: - anterior and posterior corneal shape (elevation maps, curvature maps, power maps); - anterior chamber features (Anterior Chamber Depth ACD, Aqueous Depth AD); - corneal thickness (Central Corneal Thickness CCT, corneal thickness map); - corneal epithelia map; - corneal stroma map; - lens thickness.
Not Found
The provided document is an FDA 510(k) clearance letter for a device named MS-39, an ophthalmoscope. It describes the device's indications for use (capturing scans of the anterior segment of the eye and evaluating various features).
However, the document does NOT contain any information about acceptance criteria, performance studies, sample sizes, expert qualifications, ground truth establishment, or any details typically found in a clinical study report or device validation summary.
Therefore, I cannot provide a response that directly addresses your request based solely on the provided text. The document is an administrative clearance letter, not a technical report detailing the device's performance validation.
To answer your questions, you would need access to the actual 510(k) submission, which would include the performance data and the study details.
§ 886.1570 Ophthalmoscope.
(a)
Identification. An ophthalmoscope is an AC-powered or battery-powered device containing illumination and viewing optics intended to examine the media (cornea, aqueous, lens, and vitreous) and the retina of the eye.(b)
Classification. Class II (special controls). The device, when it is an AC-powered opthalmoscope, a battery-powered opthalmoscope, or a hand-held ophthalmoscope replacement battery, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.