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The Suprapubic Catheter and Introducer Set is indicated for drainage of the bladder through a needle puncture or stab wound over the bladder. For use no greater than 29 days.

Suprapubic catheters are Foley catheters that are placed with an introducer through a needle puncture or stab wound over the bladder to allow bladder irrigation and / or drainage of the bladder. They are available in two (2) tip styles, closed and open tip, The introducer kit includes a number of components including: Scalpel, Syringe, 18 gauge needle, Dilator and Peelable sheath, and Guidewire

This is a 510(k) summary for a medical device and does not contain information about a clinical study with detailed acceptance criteria and performance metrics in the way you've requested for an AI/ML device.

Here's an explanation of why the requested information cannot be fully provided based on the provided text, and what can be extracted:

• Device: Suprapubic Catheter and Introducer Set
• Submission Type: 510(k) Premarket Notification. This type of submission primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel efficacy or performance through extensive clinical trials as might be required for a PMA or for an AI/ML device.

Analysis of the Provided Text (and why it doesn't fit the AI/ML study request)

The document describes a conventional medical device (catheter and introducer set) and its comparison to predicate devices, focusing on demonstrating substantial equivalence based on:

• Indications for Use: Identical or similar to predicates.
• Technology and Construction: Identical or substantially equivalent materials, design, manufacturing, shape, and sizes, with the catheter often being an OEM product from a predicate manufacturer.
• Environments of Use: Identical to predicates.
• Patient Population: Identical to predicates.
• Indwelling Time: Identical to predicates.
• Convenience Kit: Comparison of kit components.
• Non-Clinical Testing Summary: This is the only area where "testing" is mentioned, but it's for physical performance of the device components (balloon burst, volume maintenance, deflation, guidewire fracture, flexion, tensile strength, corrosion) against established standards (ASTM F623, ISO 11070). This is not a study assessing diagnostic accuracy or clinical outcomes in humans, nor does it involve AI/ML.
• Materials: Biocompatibility testing per ISO 10993-1 and G95-1.

Therefore, many of your specific requests are not applicable to this 510(k) submission:

1. A table of acceptance criteria and the reported device performance: The "performance" reported here is adherence to physical/material standards, not diagnostic accuracy. The acceptance criteria are "met the performance requirements of the standards" (ASTM F623, ISO 11070).
2. Sample size used for the test set and the data provenance: Not applicable. There's no "test set" of patient data for an algorithm. The testing is material/device-specific.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No "ground truth" establishment in a clinical sense.
4. Adjudication method: Not applicable.
5. MRMC comparative effectiveness study: Not applicable. This is not an AI-assisted device.
6. Standalone (algorithm only) performance: Not applicable. There's no algorithm.
7. Type of ground truth used: Not applicable.
8. Sample size for the training set: Not applicable. No training set for an algorithm.
9. How the ground truth for the training set was established: Not applicable.

What can be extracted (re-interpreting "acceptance criteria" for a 510(k) of a conventional device):

For a 510(k) submission like this, "acceptance criteria" are generally framed as demonstrating substantial equivalence to predicate devices and meeting relevant recognized standards for the device's physical and material properties.

1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical/Material Focus)

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