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The UASS is indicated for use in endoscopic procedures to facilitate the passage of endoscopes, urological instruments and for the injection of fluids into the urinary tract via antegrade and/or retrograde access.

The UASS is designed to create a conduit for urological procedural instruments. This set consists of two components: an inner tapered semi-rigid dilator and an outer more flexible sheath. The outer flexible sheath fits over the semi-rigid inner dilator and it may be locked into place. These components are radiopaque and have a lubricous coating UroGlide™. The device is offered in two French sizes, 11/13 Fr, and 13/15 Fr. in lengths up to 49cm.

The UASS may be placed retrograde and/or antegrade. To guide the access sheath into the body orifice the dilator is advanced over up to a .038" guidewire. The device can be visualized under xray (fluoroscopy) during placement to confirm location. The proposed device can accept other urological instrumentation with OD's compatible with the sheath's working channel of 11 and 13 Fr, respectively.

The proposed device is provided sterile single use. The packaging materials used for the proposed UASS are commonly used materials for packaging medical devices and similar to the predicate devices. The device will be packaged in a labeled, single mylar and tyvek peel pouch, which will be placed in a labeled, paperboard shelf carton.

I am sorry, but based on the provided document, I cannot find the information requested regarding acceptance criteria and the study that proves the device meets them. This document is a 510(k) substantial equivalence letter for the UASS (Ureteral Access Sheath Set). It focuses on regulatory approval based on demonstrating equivalence to predicate devices, rather than presenting detailed study results against specific performance acceptance criteria.

The document discusses:

• The device name and its regulatory classification.
• The determination of substantial equivalence to predicate devices.
• General regulatory requirements for the device.
• Indications for Use.
• A summary of safety and effectiveness, including device description and intended use.

It does not contain:

• A table of acceptance criteria and reported device performance.
• Sample sizes, data provenance, or expert qualifications for a test set.
• Details on adjudication methods.
• Information about multi-reader multi-case (MRMC) comparative effectiveness studies.
• Standalone performance data.
• The type of ground truth used or details about training set size and ground truth establishment.

The purpose of this type of FDA document is to formally communicate the FDA's decision regarding substantial equivalence for marketing, not to provide the underlying performance studies in detail.

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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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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 is comprised of two components: a dilator with a tapered tip and a tapered sheath.

The provided 510(k) summary for the Ureteral Access Sheath Set does not contain information about acceptance criteria or a study proving the device meets specific performance metrics.

Instead, this document is a summary of the regulatory submission that declares the device as substantially equivalent to predicate devices. Substantial equivalence claims typically mean that the new device has the same intended use and similar technological characteristics as a legally marketed predicate device, and does not raise new questions of safety and effectiveness. This often relies on comparative testing to show similar performance, or demonstrating that the differences do not affect safety or efficacy, rather than establishing and meeting novel acceptance criteria through a dedicated study with performance metrics.

Therefore, I cannot populate the requested table and answer the study-related questions based on the provided text, as this information is not present. The document focuses on regulatory classification and substantial equivalence, not a detailed performance study against specific acceptance criteria.

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