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The Manan™ Malecot Basket Drainage Catheter is for percutaneous nephrostomy and abcess drainage.

Manan drainage catheters are made from a biocompatible urethane (Tecoflex) that has been used extensively in both short and long term implantable medical devices. This material softens at body temperature thus minimizing tissue trauma. The catheters come in malecot end configuration. Also included with the catheters are flexible stiffening cannula.

The provided document is a 510(k) summary for a medical device called the Manan™ Malecot Basket Drainage Catheter. This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving the device meets specific acceptance criteria through a clinical study. Therefore, the document does not contain the information requested regarding acceptance criteria or a study proving the device meets those criteria.

Here's why the requested information is absent:

• Acceptance Criteria and Device Performance Table: This document is a regulatory submission for substantial equivalence. It focuses on comparing the new device to a legally marketed predicate device (Manan Medical Products' Malecot Basket Drainage Catheter, K954147), not on demonstrating performance against pre-defined acceptance criteria through a clinical study.
• Sample Size, Data Provenance, Expert Ground Truth, Adjudication, MRMC, Standalone Performance, Type of Ground Truth, Training Set Size, and Training Set Ground Truth: These are all elements typically found in a clinical study report or a detailed validation study, especially for AI/ML-based devices. The Manan™ Malecot Basket Drainage Catheter is a physical medical device (a catheter), and its 510(k) submission largely relies on material compatibility and design similarity to its predicate, rather than on performance metrics from a diagnostic or algorithmic standpoint.

Summary:

This 510(k) submission is for a physical medical device (a catheter) and aims to demonstrate substantial equivalence to a predicate device. It does not include information about clinical studies with specific acceptance criteria, test sets, expert ground truth, or AI/ML performance metrics.

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