(32 days)
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.
§ 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.