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The O'Brien Suprapubic Peel-Away Access Set is used for introducing a drainage catheter suprapubically into the bladder.

The Cook® SP Tube Introducer Set is used for introducing a drainage catheter suprapubically into the bladder.

The O'Brien Suprapubic Peel-Away Access Set includes a peel-away sheath, dilator, trocar needle and wire guide. The peel-away sheath is available in even-numbered French sizes ranging from 16.0 to 20.0 and measures 22 centimeters in length. Dual knobs allow the sheath, manufactured from thick wall radiopaque polytetrafluoroethylene material, to be peeled back and removed.

The Cook SP Tube Introducer Set is comprised of a 20 Fr sheath which is 15 cm in length, an introducer that fits within this sheath, two dilators, a wire guide and needle.

This document is a 510(k) Premarket Notification for the O'Brien Suprapubic Peel-Away Access Set and the Cook® SP Tube Introducer Set. It does not describe an AI/ML device or its performance characteristics.

Therefore, I cannot provide details on the acceptance criteria and study proving device meets acceptance criteria as typically requested for AI/ML medical devices. The document concerns traditional medical devices (catheter introducer sets) and focuses on demonstrating substantial equivalence to a predicate device through engineering and biocompatibility testing, not clinical performance metrics of an AI algorithm.

The document states:

• Performance Data: "The subject devices... were subjected to applicable testing to assure reliable design and performance under the testing parameters. The following tests have been conducted... Radiopacity Testing, Peel-Away Shaft Tensile Test, Dilator Shaft Tensile Test, Peel Force, Rollback Testing, Dilator Hub-to-Shaft Tensile Test, Compatibility Testing, Biocompatibility Cytotoxicity, Sensitization, Irritation/Intracutaneous Reactivity, and Acute Systemic Toxicity, Sterilization, Package integrity and stability, Shelf-life. All predetermined acceptance criteria were met."

However, it does not provide the specific acceptance criteria or the detailed results of these tests. It only states that they were met, which is common in a 510(k) summary where full test reports are not typically included.

The information you requested (sample sizes for test/training sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth types, etc.) are all relevant for AI/ML device evaluations and are not applicable or present in this submission for conventional medical devices.

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