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The ophthalmoscope is a hand-held, battery-powered device containing illumination and viewing optics intended to examine media (cornea, aqueous, lens, and vitreous) and the retina of the eye. It is intended to be used by a trained healthcare professional.

The ophthalmoscope is a hand-held, battery-powered device containing illumination and viewing optics.

I am sorry, but based on the provided text, there is no information about the acceptance criteria or a study that proves the device meets any specific acceptance criteria. The document is an FDA 510(k) clearance letter for "Ophthalmoscopes Diagnostic Instrument Kits." It confirms that the device is substantially equivalent to legally marketed predicate devices and is subject to general controls.

The document does not contain details regarding:

• A table of acceptance criteria and reported device performance
• Sample sizes or data provenance for any test sets
• Number or qualifications of experts for ground truth establishment
• Adjudication methods
• Multi-reader multi-case (MRMC) comparative effectiveness studies or effect sizes
• Standalone algorithm performance studies
• Type of ground truth used
• Sample size for training sets
• How ground truth for training sets was established

The letter primarily focuses on the regulatory aspects of the device's clearance based on substantial equivalence.

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