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The Circle Nephrostomy Catheter Set is used for temporary or permanent urinary diversion following nephrostomy, nephroureterostomy or other stenotic or obstructed UPJ procedures.

The Circle Nephrostomy Catheter Set is used for temporary or permanent urinary diversion following nephrostomy, nephroureterostomy or other stenotic or obstructed UPJ procedures. The materials used in this device are slicone, polyvinylchloride and polypropylene. Biocompatibility testing has been performed on the silicone. Results show the nuterial to meet the requirements of these tests. The polyvinylchloride and polypropylene do not come into contact with body tissue.

This 510(k) Premarket Notification for the Circle Nephrostomy Catheter Set does not contain any information about acceptance criteria or a study proving device performance using the metrics you've outlined.

The document is a summary for regulatory submission, focusing on substantial equivalence to existing predicate devices. It primarily addresses:

• Device Identification: Trade name, classification name.
• Predicate Devices: Identifying similar devices already on the market.
• Device Description: Intended use, materials, basic design.
• Substantial Equivalence Argument: How the new device is similar to predicates regarding indications for use, materials, physical construction, manufacturing controls, packaging, and sterilization.

The entire submission is built on the premise that because the new device is "substantially equivalent" to already approved devices, it can be marketed without requiring new clinical performance studies or specific acceptance criteria for metrics like accuracy, sensitivity, or specificity.

Therefore, I cannot populate the table or answer your specific questions related to acceptance criteria, sample sizes, ground truth, expert opinions, or MRMC studies because this information is not present in the provided text. The device's approval hinges on its similarity to older, already-approved devices, not on proving new performance metrics.

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