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Actreen Mini Intermittent Urinary Catheters are indicated for intermittent urinary catheterization by female patients with chronic urine retention or voiding dysfunction.

The Actreen Mini Intermittent Urinary Catheters include the Actreen Mini Cath and the Actreen Mini Set. The Actreen Mini Set is identical to the Actreen Mini Cath, except that the Actreen Mini Set includes a urine collection bag which is pre-attached to the catheter. The proposed devices are available in one length of 3.5 in with a straight tip, and offered in gauges 10 FR, 12 FR, 14 FR.

This document is a 510(k) Premarket Notification from the FDA regarding the Actreen® Mini Intermittent Urinary Catheters. It does not describe a study that uses AI or machine learning algorithms, nor does it provide detailed acceptance criteria and performance data in the context of such studies.

Therefore, I cannot provide a description of acceptance criteria and a study proving device performance as requested, because the provided text does not contain information about an AI/ML powered device, acceptance criteria or performance studies of the type requested in the prompt.

The document states that biocompatibility and performance testing were performed in accordance with ISO 10993-1 and EN 1616 to support substantial equivalence to predicate devices, but it does not specify the details of these tests, acceptance criteria, or the results.

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