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The Bioplate Shunt Connector is indicated for use in the joining and fixation of silicone rubber catheters with a nominal I.D. of 1.25 mm (.050%) when combined with nonabsorbable sutures in a surgical application.

Each device is intended for single use only and only in conjunction with other titanium and titanium alloy implants.

The Bioplate Shunt Connector

The provided text is a 510(k) premarket notification letter from the FDA for a device called "The Bioplate Shunt Connector." This document confirms the device's substantial equivalence to a predicate device and outlines regulatory information. However, it does not contain any information about acceptance criteria, study details, performance data, sample sizes, ground truth establishment, or expert involvement for proving the device meets acceptance criteria.

The information requested in your prompt (e.g., acceptance criteria table, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, type of ground truth) is typically found in a clinical study report or a more detailed technical submission than an FDA 510(k) clearance letter.

Therefore, I cannot provide a response to your request based on the given input text.

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