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The Vidco Ophthalmoscope is intended to be used by trained personnel to examine the cornea, aqueous, lens, vitreous, and retina of the eye.

The Precision Optics Corporation Video Ophthalmoscope is a hand held indirect and direct monocular device for use by trained personnel for viewing / examining the cornea, agueous, lens, vitreous, and retina of the patient's eye(s). The viewing path is split in two via a beamsplitter to provide for direct viewing by the trained personnel as well as simultaneous video imaging on a monitor either near or at the patient or at a remote site via telemedicine techniques. The viewing system is comprised of objective lenses, relays, a beamsplitter, and eyepiece and provides an erect, un-reversed image of the patient's retina to the trained personnel.

This submission does not contain information about an AI/ML device. The provided text describes a traditional medical device, the "Precision Optics Corporation Video Ophthalmoscope, Model 2500-VOS."

The document focuses on:

• Its intended use: "to examine the cornea, aqueous, lens, vitreous, and retina of the eye."
• Comparison to a predicate device (Welch Allyn Video Ophthalmoscope) to establish substantial equivalence.
• Compliance with electrical and optical radiation safety standards (IEC 60601-1, ISO 10942, ISO 10943 - Section 5.5).

There is no mention of any software or algorithm performance evaluation, nor any data related to diagnostic accuracy (sensitivity, specificity, AUC), reader studies, or training/test datasets.

Therefore, I cannot provide details on acceptance criteria, reported device performance, sample size, ground truth, or MRMC studies as these are not relevant to the information presented for this traditional ophthalmoscope.

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