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The Disposable Ureteral Access Sheath is one single use device, which is provided after EO sterilization. The shelf life of Disposable Ureteral Access Sheath is 3(three) years. The Disposable Ureteral Access Sheath consists of two major components: sheath assembly and dilator assembly. Sheath assembly consists of sheath hub, the dilator assembly consists of dilator, dilator hub and dilator clip. And there is a hydrophilic coating on the surface of the sheath and dilator. The Disposable Ureteral Access Sheath is designed to provide the physician with reliable access to the urinary tract, the ability to inject fluids, and act as a conduit for device changes. Like all ureteral access sheath sets, Beyo's Disposable Ureteral Access Sheath also protects the ureter during device exchanges, thus helping reduce tissue trauma. Both the dilator and sheath are radiopaque and have a lubricous hydrophilic coating. To guide the access sheath into the body orifice, the dilator is advanced over up to a 0.038" guidewire. The device can be visualized under X-ray(fluoroscopy) during placement to confirm location. The device can accept other urological instruments with OD's compatible with the sheath's OD of 10,12 and 14 Fr. The device has two assemblies, sheath assembly and dilator assembly, the two assemblies are combined through dilator clip, the dilator can insert and withdrawn easily from sheath, The dilator assembly can be fixed on the sheath assembly.

AI/ML Overview

The provided text describes a 510(k) summary for a Disposable Ureteral Access Sheath, not a medical device that uses AI or machine learning. Therefore, the document does not contain information regarding acceptance criteria and study data for an AI/ML powered medical device.

The information I can extract pertains to the acceptance criteria for the physical ureteral access sheath device and how its performance was tested to establish substantial equivalence to a predicate device.

Here's a breakdown of what is available in the document, which primarily focuses on non-clinical performance testing for a physical device:

Acceptance Criteria and Device Performance (for a physical ureteral access sheath)

1. Table of Acceptance Criteria and Reported Device Performance:

No.	Characteristics	Acceptance Criteria	Test Method	Reported Device Performance (Implied "SE" or "Complies")
1	Dimensions	Dimension of ureteral access sheath shall comply with the requirements of Table 3 Dimensions.	Using a universal gage.	SE (Substantially Equivalent)
2	Dilator & Sheath Compatibility	The dilator should be able to enter and withdraw smoothly and unobstructed within the sheath.	Pull the dilator out of the sheath, then insert it into the sheath cavity, repeat three times, the results should meet the requirements.	SE
3	Hub security	Dilator hub can lock onto the sheath hub, dilator can be fixed on the sheath hub, no relative slip.	The dilator hub is screwed off from the sheath hub and then inserted into the sheath in the same direction. The results should meet the requirements.	SE
4	Sheath Inner Lumen Passability	The dilator should be able to pass through the sheath with a minimum bending radius of 55 mm.	The sheath is bent under the condition that the marking length is 55 mm, the dilator pass through the sheath inner cavity, the results should meet the requirements.	SE
5	Dynamic Friction Force	The surface dynamic friction of the sheath after water contact should be <0.5N.	Soaking the samples with the distilled water, use the Automatic friction tester, set the grip force 200g force, speed 200mm/min, distance 15mm. Back and forth 10 times, the results should meet the requirements.	SE
6	Dilator to Hub Tensile Strength	The Dilator to Hub Strength ≥15N.	Cut out a 5cm sample from the dilator (with hub part); place the sample on the clamp of the tension machine and clamp it. Set the standard distance as 20mm and the tensile speed as 400mm/min. Run the tension machine to test and record the maximum force value when the product breaks.	SE
7	Sheath to Hub Tensile Strength	The Sheath to Hub Strength ≥15N.	Cut out a 5cm sample from the sheath (with hub part); place the sample on the clamp of the tension machine and clamp it. Set the standard distance as 20mm and the tensile speed as 400mm/min. Run the tension machine to test and record the maximum force value when the product breaks.	SE
8	Guidewire compatibility	0.038" (0.97mm) guidewire can smoothly enter and exit the inner cavity of the dilator.	Inject liquid and simulate the medical guidewire lumen to verify that it can pass smoothly.	SE
9	Sheath Flexibility	Sheath & Dilator should be flexible; when the tip bending 90°, the sheath and dilator can recover; when bending 10 times with a minimum bending radius of 55 mm, the sheath and dilator cannot kink or break.	Fix the sheath and dilator tip, rotate the hub 90°, the sheath and dilator should not permanent deformation, after the sheath and dilator recover, bending 10 times with a minimum bending radius of 55 mm, the results should meet the requirements.	SE
10	Sheath Bending Resistance	The bending force should be more than 2.1N, less than 7.6N.	Cutting 25cm samples from the distal end of sheath, set the sample into the tensile machine fixture with vertical direction, set the speed 10mm/min, fix the samples, compressed down 3cm. The results should meet the requirements.	SE

2. Sample Size and Data Provenance for Test Set:
The document does not specify the sample size used for each non-clinical performance test (e.g., how many sheaths were tested for tensile strength). The data provenance is implied to be from the manufacturer's internal testing (Suzhou Beyo Medical Technology Co., Ltd. in China), and it is non-clinical/bench testing, not patient data (retrospective or prospective).

3. Number of Experts and Qualifications for Ground Truth:
Not applicable. This document pertains to physical device performance testing (bench testing), not clinical image analysis or AI model evaluation that would require expert human review for ground truth establishment.

4. Adjudication Method for Test Set:
Not applicable, for the same reason as above.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Not applicable. This is not an AI-powered device, and no human reader study was conducted or is relevant for this type of submission.

6. Standalone (Algorithm Only) Performance:
Not applicable. This is a physical medical device, not an algorithm.

7. Type of Ground Truth Used:
The "ground truth" for the physical device performance tests was established through defined engineering standards, test methods, and quantitative measurements (e.g., force, dimensions, friction). It's essentially "physical measurement ground truth" based on established engineering principles and standards (e.g., EN 1618:1997, internal requirements).

8. Sample Size for Training Set:
Not applicable. This is a physical device, not an AI/ML model that requires a training set.

9. How Ground Truth for Training Set Was Established:
Not applicable.

Summary of Non-Applicable Sections for this document:
It is crucial to understand that the provided text is a 510(k) summary for a physical medical device (Disposable Ureteral Access Sheath), not a software or AI/ML-powered device. Therefore, many of the requested elements pertaining to AI/ML model validation (e.g., training/test sets, human experts for ground truth, MRMC studies) are not present in this type of regulatory submission and are not relevant to demonstrating the substantial equivalence of a physical instrument. The "performance data" section in this document refers to physical, chemical, and biological (biocompatibility) testing of the device itself.

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