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The Malecot Nephrostomy Catheter/Stent Set is intended for use as a nephrostomy drainage catheter and ureteral stent. The catheter is placed percutaneously through an existing nephrostomy tract.

The Malecot Nephrostomy Catheter/Stent Set consists of a catheter/stent, two flexible stylets, a connecting tube, and a retention disc with pull tie. The Malecot catheter/stent is a single device consisting of an externally draining catheter in line with an internally draining ureteral stent. It is constructed from radiopaque polyurethane and has a malecot wing design located on the distal end of the catheter and proximal end of the stent. The stent (distal) portion of the device is available in an outer diameter of 7 Fr with a length of 20 cm. The catheter (proximal) portion of the device is available in an outer diameter between 12 Fr to 24 Fr with lengths of 25.5, 27.0, or 27.4 cm. The set will be supplied sterile and is intended for one-time use. The set is packaged in a peel-open pouch with a three-year shelf life.

The provided text describes the "Malecot Nephrostomy Catheter/Stent Set" and its 510(k) submission (K180029). However, it does not contain the specific details required to complete your request for acceptance criteria and a study proving device performance in the context of AI/ML or a diagnostic device.

The document discusses performance testing for a medical device (a catheter/stent), but this testing relates to physical properties, biocompatibility, and imaging safety, not diagnostic performance or AI model evaluation.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and reported device performance (in the context of a diagnostic AI/ML device)
• Sample size used for the test set and data provenance
• Number of experts and their qualifications for ground truth establishment
• Adjudication method for the test set
• Multi-reader multi-case (MRMC) comparative effectiveness study details
• Standalone performance details
• Type of ground truth used (e.g., pathology, outcomes data)
• Sample size for the training set
• How ground truth for the training set was established

The provided text pertains to a traditional medical device (catheter/stent) and its physical and material performance testing, not a diagnostic device involving AI or machine learning algorithms that would typically have the kind of acceptance criteria and studies you are asking about.

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