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Bard malecot and pezzer drains are intended for use in the drainage of urine. The drains are inserted suprapubically into the bladder or through a nephrostomy tract.

The drains are composed of a straight or angled, single lumen catheter shaft. The proximal end, which remains external to the patient, is a funnel for connection to a urine collection device. The funnel is printed with a product code, date code, product type and French size, The distal end, which is placed in the patient, is offered in various configurations including whistle tip, 2-wing, 4-wing, retention head with drainage eyes or open end retention head. The entire drain is composed of natural rubber latex.

The provided 510(k) summary for the "Bard malecot and pezzer drains" (K070879) does not contain any information regarding acceptance criteria or a study proving the device meets specific performance criteria through a rigorous scientific study with ground truth and expert adjudication.

Instead, this document is a regulatory submission demonstrating substantial equivalence to previously marketed predicate devices (K910197 and K910846).

Here's what the document does state regarding performance:

• G. Performance Data Summary: "The Bard malecot and pezzer drains referenced in this submission are held to the same design, manufacture, and performance specifications as those catheters currently manufactured by Bard. The appropriate design verification and validation activities for the modifications to the device were conducted."

This statement implies that the device was tested to ensure it met internal company specifications, but it does not detail those specifications, provide quantitative acceptance criteria, or describe a study design that would involve a test set, ground truth, or expert review in the way typically expected for medical imaging AI devices or diagnostic tests.

Therefore, I cannot populate the requested table or sections with the information provided in this document. The information in the 510(k) pertains to design, manufacturing, and general performance equivalence, not a detailed clinical or technical performance study with specified metrics.

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