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For Illumination, coagulation, irrigation/aspiration, and tissue manipulation during ophthalmic surgery.

The Peregrine Fiber Optic Multi-Function Manipulator is a fiberoptic illuminator with capabilities to minipulate tissue, irrigate and aspirate, and coagulate blood. It consists of the following: A connector at the proximal end to fit into a surgical light source. A polyethylene jacket through which an Acrylic Fiber and fine insulated electrical wires run. A Delrin handpiece with a 20 GA stainless steel needle at the distal end. An insulated inner blunt needle running through the handprece and outer stainless needle, protruding beyond the tip approximately 2.5mm. Electrical connection for RF current is made via fine insulated wires from the inner and outer needles to the solderless connectors which attach to the coagulator. A 30" length of silicone tubing with a luer connector at the proximal end of the handpiece. The luer connector may be attached to a syringe for irrigation asperation The 2.5mm extension may be used for tissue manipulation.

This document is a 510(k) Premarket Notification for the Peregrine Fiber Optic Multi-Function Manipulator, indicating it's a submission for clearance to market a medical device, not a study reporting on the device's performance against acceptance criteria.

The provided text does not contain acceptance criteria or detailed information about a study proving the device meets specific performance metrics. It's a regulatory submission document for market clearance based on substantial equivalence to a predicate device.

Therefore, I cannot fulfill the request for a table of acceptance criteria, reported device performance, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, type of ground truth used, or training set details. This information is typically found in design verification and validation reports, clinical study reports, or specific performance testing summaries, which are not present in this 510(k) summary.

The document primarily states:

• Device Description: Peregrine Fiber Optic Multi-Function Manipulator is a fiberoptic illuminator with capabilities to manipulate tissue, irrigate and aspirate, and coagulate blood.
• Indications for Use: For Illumination, coagulation, irrigation/aspiration, and tissue manipulation during ophthalmic surgery.
• Predicate Device: Grieshaber & Co. 3-Function Manipulator. The document presents a comparison of features between the two devices but no performance data.
• Sterilization: The device will be ETO sterilized using the AAMI Overkill Method for validation.
• Regulatory Status: The FDA found the device substantially equivalent to pre-amendment devices for its stated indications for use.

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