(303 days)
The ENDOCULAR VIEWING LENSES AND SILICONE RING family allows visualizations of the retina, the vireous humor, the lens, the iris, the anterior chamber, as well as other ocular structures during surgical procedures or consultation.
The endocular viewing lens is a passive device that is used to view the fundus of the eye by placing it on the cornea.
The "ENDOCULAR VIEWING LENSES AND SILICONE RING" family includes devices comprised of an endocular viewing lens and/or of a cornea support that allows for stabilization of this lens on the eye. This range allows one to view the retina, the vitreous humor, the lens, the iris, the angle of the anterior chamber, as well as other ocular structures during surgical procedures or consultation.
This document is a 510(k) Premarket Notification summary for the "ENDOCULAR VIEWING LENSES AND SILICONE RING" device. Based on the provided text, the device is not an AI/ML medical device and therefore the concepts of acceptance criteria for an AI model, training/test sets, ground truth establishment by experts, adjudication, or MRMC studies, do not apply.
The device is a passive ophthalmic viewing lens classified as a Class II medical device. The 510(k) submission establishes substantial equivalence to legally marketed predicate devices, primarily based on the following:
- Intended Use: The device is used to view ocular structures during surgical procedures or consultation, which is similar to the predicate devices.
- Design: The device includes various types of viewing lenses and a silicone ring, comparable to the predicate devices.
- Materials: The materials used (PMMA, OKP4 Polyester Optical Plastic, silicone) are similar to those used in predicate devices.
- Mechanical Safety and Performance: No specific details are provided on performance metrics, but the claim of substantial equivalence implies comparable safety and performance.
Non-clinical tests performed:
- ISO 10993-5 In vitro cytotoxicity
- ISO 10993-10 Irritation
- ISO 10993-10 Sensitization
Clinical tests:
- No clinical studies were performed. The submission states: "No clinical studies were performed."
Therefore, the request for acceptance criteria and study details related to AI/ML performance is not applicable to this 510(k) submission.
§ 886.1385 Polymethylmethacrylate (PMMA) diagnostic contact lens.
(a)
Identification. A polymethylmethacrylate (PMMA) diagnostic contact lens is a device that is a curved shell of PMMA intended to be applied for a short period of time directly on the globe or cornea of the eye for diagnosis or therapy of intraocular abnormalities.(b)
Classification. Class II.