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The ureteral access sheath is used to establish a working channel during endoscopic urological procedures, facilitating the passage of endoscopes and other instruments into the urinary tract. The intended population of this device should be adult only.

This is a single-use device. A re-sterilization by users and re-use of the device are not allowed.

The Ureteral Access Sheath consist of an outer sheath, a tapered dilator and their sockets. The hydrophilic coating are applied to the sheath and the tip of dilator.

The Ureteral Access Sheath is a single use sterile single-lumen access sheath, it contains two models of devices, FS and GS. The FS type can be available with inner diameters ranging from 9 to 15 French and lengths ranging from 35 to 55 cm. and the GS type can be available with inner diameters ranging from 9 to 15 French, and lengths ranging form 20 to 55 cm.

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The Ureteral Access Sheath is used to establish a conduit during endoscopic urological procedures facilitating the passage of endoscopes and other instruments into the urinary tract. It is designed to establish a conduit for the treatment of urinary stones or other urinary diseases during the endoscopic procedures.

Ureteral Access Sheath is used to establish a conduit during endoscopic urological procedures facilitating the passage of endoscopes and other instruments into the urinary tract. The Ureteral Access Sheath provides ureteral dilation and a continuous working channel for the introduction of endoscopes and instruments during ureteral access procedures. Ureteral Access Sheath comes in two models: Tip-unbendable Ureteral Access Sheath and Tip-bendable Ureteral Access Sheath with suction. The Tip-unbendable Ureteral Access Sheath is offered in French size ranging from 10Fr to 14Fr and length 28cm to 45cm. The Tip-bendable Ureteral Access Sheath with Suction is offered in French size ranging from 10Fr to 13Fr and length 33cm to 50cm.

The Seplou (Zhuhai) Co., Ltd. Ureteral Access Sheath (K243025) is a medical device used to create a conduit in the urinary tract for endoscopic urological procedures. The device's acceptance criteria and proven performance are outlined through various tests detailed in the 510(k) summary.

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size Used for the Test Set and Data Provenance:

The provided document does not explicitly state the sample sizes used for each specific performance test (biocompatibility, general performance, sterilization, shelf life). It notes that various tests were conducted.

The provenance of the data is not specified in terms of country of origin or whether it was retrospective or prospective. However, given that it is a 510(k) submission for a device manufactured by a Chinese company (SEPLOU (ZHUHAI) CO., LTD.), it is highly probable that the testing was performed in laboratories affiliated with or contracted by the manufacturer, potentially in China or other authorized testing facilities globally.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

This information is not applicable to this type of device submission. The device is a Ureteral Access Sheath, which is a physical instrument. The "ground truth" for its performance relies on objective measurements against engineering specifications and international standards, not on expert interpretations of data like in an AI/imaging study.

4. Adjudication Method for the Test Set:

This information is not applicable. Adjudication methods (like 2+1, 3+1 consensus) are typically used in clinical studies or studies involving subjective human interpretation (e.g., imaging reviews), which is not the case for the premarket testing of this physical medical device. The tests performed are objective, laboratory-based evaluations.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance:

This information is not applicable. The device is a physical Ureteral Access Sheath, not an AI or imaging diagnostic tool that would involve human readers or AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

This information is not applicable. The device is a physical Ureteral Access Sheath, not an algorithm or software.

7. The Type of Ground Truth Used:

The "ground truth" for the performance of the Ureteral Access Sheath is established through:

• Compliance with International Standards: ISO (International Organization for Standardization) standards for biocompatibility and sterilization, and ASTM/DIN standards for packaging and shelf-life.
• Engineering Specifications: The manufacturer's own design specifications for dimensions, material properties, mechanical strength (fracture force, bending resistance), and functional aspects (liquid leakage, surface friction).
• Predicate Device Equivalence: The ultimate purpose of the 510(k) submission is to demonstrate substantial equivalence to a legally marketed predicate device (ClearPetra Suction-Evacuation Sheath K161110) in terms of safety and effectiveness, meaning the subject device performs similarly or better than a device already proven safe and effective.

8. The Sample Size for the Training Set:

This information is not applicable. There is no "training set" for a physical medical device like a Ureteral Access Sheath. Training sets are relevant for machine learning algorithms.

9. How the Ground Truth for the Training Set Was Established:

This information is not applicable as there is no training set for this device.

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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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