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The Proxis™ ureteral access sheath is indicated for use in endoscopic urology procedures where ureteral dilation and ureteral access is desired for injection of fluids and insertion and removal of endoscopes and related instruments.

Proxis™ Ureteral Access Sheath is a two component ureteral dilation system which contains 1) a sheath with a lumen for passage of endoscopes and related instruments and 2) a dilator with a lumen for passage over a guidewire and injection of fluids.

Proxis™ Ureteral Access Sheath is a hydrophilic-coated sheath tube comprised of a coil reinforced polymer with a PTFE liner and marker band near the distal end. On the proximal end of the sheath is a plastic hub which provides identification for the device and acts as an interface for introducing endoscopes and related instruments through the sheath. The dilator is comprised of a hydrophiliccoated polymer tube with a tapered distal end and a female luer connector with a lock mechanism on the proximal end to attach and lock to the hub on the sheath. The device will be offered in multiple sizes to accommodate different patient anatomies. The product is ethylene oxide sterilized (per ISO 11135:2014, Sterilization of health care products – ethylene oxide – Requirements for development, validation and routine control of a sterilized process for medical device is for single use.

The provided text describes a 510(k) premarket notification for a medical device called the Proxis™ Ureteral Access Sheath. It focuses on demonstrating substantial equivalence to a predicate device, not on presenting acceptance criteria and a study proving those criteria are met in the way a clinical performance study for an AI/ML device would.

Therefore, many of the requested categories are not applicable to this document. The document details non-clinical performance testing and biocompatibility testing to show the device is safe and effective in comparison to a predicate device.

Here's an attempt to answer the questions based on the available information, noting where information is not present:

1. Table of acceptance criteria and the reported device performance

   The document does not explicitly list acceptance criteria in a quantitative manner for a clinical study comparing the device's diagnostic or predictive performance against a ground truth. Instead, it refers to compliance with established international and national standards for medical devices and comparison to a predicate device.

   Acceptance Criteria	Reported Device Performance
   Compliance with BS EN 1616:1997 + A1:1999 (Sterile urethral catheters for single use)	Achieved (implied by "Nonclinical performance testing (bench) of the proposed device was conducted per the applicable requirements")
   Compliance with ISO 594-2:1998 (Conical fittings with a 6% (Luer) taper)	Achieved (implied by "Nonclinical performance testing (bench) of the proposed device was conducted per the applicable requirements")
   Compliance with JIS T 3260:2012 (Dilators)	Achieved (implied by "Nonclinical performance testing (bench) of the proposed device was conducted per the applicable requirements")
   Biocompatibility in accordance with ISO 10993-1:2009 and FDA Bluebook Memorandum G95-1	Achieved (implied by "Nonclinical biocompatibility testing was conducted...")
   Similar performance characteristics to predicate device (Boston Scientific Navigator™ HD Ureteral Access Sheath Set)	Demonstrated by "Additional testing was completed to compare additional performance characteristics of the subject and predicate devices."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

   Not applicable. The document describes non-clinical bench testing and biocompatibility testing for the physical device, not a test set of data for an AI/ML algorithm. Therefore, there is no "test set" in the context of diagnostic performance data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

   Not applicable. Ground truth as typically defined for AI/ML device performance (e.g., expert consensus on image interpretation) is not relevant to this type of device and study.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

   Not applicable. No "test set" in the context of diagnostic performance data requiring adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

   Not applicable. This is a physical medical device (ureteral access sheath), not an AI/ML diagnostic or assistive device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

   Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

   For the non-clinical tests, the "ground truth" would be the specifications and requirements defined by the referenced standards (e.g., BS EN 1616, ISO 594-2, JIS T 3260, ISO 10993-1). For the comparative performance, the "ground truth" would be the established performance characteristics of the predicate device.

8. The sample size for the training set

   Not applicable. This is a physical medical device; there is no "training set" of data.

9. How the ground truth for the training set was established

   Not applicable.

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