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The Ureteral Access Sheath Set is indicated for use in endoscopic urology procedures, by facilitating the passage of endoscopes and other instruments through the urinary tract.

The Ureteral Access Sheath Set is a single use sterile device, indicated for use in endoscopic urology procedures, to facilitate the passage of endoscopes and other instruments through the urinary tract. It is comprised of two components: a dilator with a tapered tip and a tapered sheath. Both the sheath and the dilator are made from polyurethane. The sheath length varies from 20 cm (shortest) to 60 cm (longest) by model. A luer fitting made attached to the proximal end of the dilator may be used to introduce contrast during a retrograde pyelogram procedure. The dilators range in length from 25 cm (shortest) to 70 cm (longest). The thru-lumen of the dilator tip is 0.040 - 0.045 inches and it can be used over a guidewire of up to .038 inches diameter. The sheath and the dilator are coated with a hydrophilic coating, which is activated by wetting the device in saline or sterile water. The hydrophilic feature allows for easier insertion and removal of the ureteral sheath. The luer fitting on the dilator cannot be pushed through the lumen of the cone shaped handle because of its larger size and therefore acts as a safety feature by preventing the dilator from being over inserted into the sheath. A latch mechanism is added to the ureteral access sheath set, which locks the dilator in place inside the sheath during insertion of the dilator and sheath in the urological tract. Two suture loops are attached at the cone of the sheath, which may be used to secure the sheath to the drapes of the patient to retain the sheath in position during surgery.

The provided text describes a 510(k) summary for a medical device, the Ureteral Access Sheath Set, not an AI/ML-powered device. Therefore, the requested information regarding AI/ML-specific study design elements (such as sample sizes for test/training sets, ground truth establishment for AI, MRMC studies, standalone performance, and expert qualifications/adjudication methods) is not applicable and not present in the given document.

The document discusses performance data related to the physical characteristics and functionality of the device, which are traditional engineering and material science tests, not clinical performance studies involving a test set, ground truth, or human-in-the-loop performance.

Here's a breakdown of the available information regarding acceptance criteria and the study, adapted to the context of this traditional medical device:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the "Performance Data Summary" section, which lists the types of tests performed to demonstrate the device's functionality and equivalence to predicate devices. The reported device performance is that these tests were successfully completed, indicating substantial equivalence.

2. Sample size used for the test set and the data provenance

• Sample Size: Not specified. This type of device performance testing typically involves a specific number of units from manufacturing lots, but the document does not detail this.
• Data Provenance: Not applicable in the context of clinical data for AI/ML. The data comes from internal laboratory testing of the device itself.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. Ground truth, in the context of AI/ML, refers to clinically validated diagnoses or outcomes. For this device, "ground truth" is adherence to engineering specifications and functional requirements. The "experts" would be the engineers and quality control personnel performing or overseeing the tests.

4. Adjudication method for the test set

Not applicable. There is no ambiguous clinical data requiring adjudication. Tests have objective pass/fail criteria based on specifications.

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, as this is not an AI/ML device.

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

Not applicable, as this is not an AI/ML device.

7. The type of ground truth used

For this device, the "ground truth" is the engineering specifications and quality control standards against which the device's physical and functional properties are measured. For example, a "Fluid Flow" test would have an expected flow rate range that constitutes a "pass."

8. The sample size for the training set

Not applicable, as this is not an AI/ML device and therefore has no training set in that context.

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

Not applicable, as this is not an AI/ML device.

Summary of the Study:

The study referenced in the document is a series of performance and functional tests conducted on the Ureteral Access Sheath Set. These tests were designed to verify the device's physical and functional properties, specifically:

• Surface Friction
• Hydrophilic Coating Adhesion
• Fluid Flow
• Handle Pull Strength
• Luer Fitting Pull Strength

The stated purpose of these tests was to demonstrate that the device is substantially equivalent to predicate devices and introduces no new safety and effectiveness issues. The document explicitly states that "The performance and functional testing demonstrates that the Ureteral Access Sheath Set is substantially equivalent to the predicate devices and it introduces no new safety and effectiveness issues when used as instructed." This implicitly means the device met the pre-defined acceptance criteria for each of these tests.

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