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The AMSure ™ PVC Intermittent Catheter is intended for use in the drainage of urine from the bladder.

The AMSure ™ PVC Intermittent Catheter is a sterile, single- use patient device, compromising a PVC tubing and funnel.

This document describes a Special 510(k) Submission for the AMSure™ PVC Intermittent Catheter. This type of submission is for modifications to a previously cleared device, asserting substantial equivalence to its predicate device. As such, the focus of the submission is on demonstrating that the modifications do not raise new questions of safety or effectiveness.

Therefore, the provided text does not contain information about:

• Acceptance criteria in the context of specific performance metrics for a novel device.
• A "study that proves the device meets the acceptance criteria" in terms of clinical performance or diagnostic accuracy.
• Sample sizes for test sets or training sets in the context of algorithm development.
• Data provenance, expert ground truth establishment, or adjudication methods.
• Multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.

Instead, the document focuses on:

• Non-Clinical Testing: "Performance and biocompatibility testing has demonstrated the safety and effectiveness of the AMSure™ PVC Intermittent Catheter for its intended use." This is very general and does not provide specific criteria or results.
• Comparison to Predicate: "The AMSure™ PVC Intermittent Catheter is a configuration and label modification of the AMSure™ Urethral Catheterization Tray (K030712) and is intended for the same use." This implies that the device meets the same performance standards as the predicate device by virtue of being a minor modification.

Based on the provided text, the specific information requested in your prompt cannot be extracted because the submission is for a medical device (catheter), not an AI/software device, and thus the acceptance criteria and study designs are fundamentally different.

The document confirms that:

• Device Name: AMSure™ PVC Intermittent Catheter
• Intended Use: For use in the drainage of urine from the bladder.
• Predicate Device: AMSure™ Urethral Catheterization Tray (K030712)
• Changes: Configuration and label modification.
• Testing: Performance and biocompatibility testing was performed to demonstrate safety and effectiveness. (No specific details provided).

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