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Lighting posterior segment of eye and/or tool for manipulation of elements in eye or aspiration and irrigation within the eye.

The device is a Coaxial Illuminated Retinal Pick. It is a hand held surgical instrument that combines a fiberoptic illuminator with a manipulating tool and has a lumen for aspiration or irrigation. It consists of a stainless steel tube enclosing six smaller fiberoptic filaments made of polymethyl methacrylate with polytetra fluoroethylene sheathing. The distal end has a small amount of "Helioseal" to position and prevent leakage between the fibers and the tool. The device will be marketed as non-sterile not non-pyrogenic.

This document is a 510(k) summary for a medical device called the "MBI Coaxial Illuminated Retinal Pick." It aims to demonstrate substantial equivalence to predicate devices, not to present a study proving the device meets specific performance criteria.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness is not available in this document.

The document primarily focuses on:

• Device Description: Comparing the submitted device's features and materials to predicate devices.
• Intended Use: Showing that the intended use is the same as predicate devices.
• Technological Characteristics: Highlighting similarities and minor modifications.

There is no mention of a performance study with defined acceptance criteria or detailed methodologies for evaluating the device's clinical performance. The statement "Performance is identical to that of the predicate devices" is a claim of equivalence, not a result from a specific performance study outlined in the provided text.

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