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The Flexor® 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. Thirteen (13) cm length is intended for use in pediatric patients two (2) years of age and over.

The Flexor® Parallel™ Rapid Release™ 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 Flexor® Ureteral Access Sheath and Flexor® ParalleI™ Rapid Release™ Ureteral Access Sheath are available with outside diameters ranging from 9.5 to 14 French and lengths ranging from 13 to 55 centimeters. These devices are available in a single lumen configuration and include a sheath and a dilator. The dilator component includes a tapered and a hydrophilically coated distal tip. In addition, the Flexor Parallel Rapid Release Ureteral Access Sheath also includes a skive and slit in the tip of the dilator which allows the wire guide to run outside and parallel to the sheath and to be separated from the sheath while inside the body to serve as a safety wire. Both Ureteral Access Sheaths are constructed of Nylon with a 304 Stainless Steel coil and a TFE liner. The dilator component is constructed of polyethylene.

The provided text is a 510(k) summary for the Flexor® Ureteral Access Sheath and Flexor® Parallel™ Rapid Release™ Ureteral Access Sheath. It describes the device, its intended use, and compares it to predicate devices to establish substantial equivalence.

However, the document does not contain information about:

• A table of acceptance criteria and reported device performance for specific metrics. It lists types of tests performed (e.g., Dilator Buckling Force, Sheath Tensile Strength, Kink Resistance) but does not provide quantitative acceptance criteria or the specific numerical results obtained for these tests.
• Sample sizes used for a test set (clinical or otherwise)
• Data provenance (country of origin, retrospective/prospective)
• Number of experts or their qualifications for establishing ground truth
• Adjudication method
• Multi-reader multi-case (MRMC) comparative effectiveness study
• Standalone algorithm performance
• Type of ground truth used (pathology, expert consensus, outcomes data)
• Sample size for the training set
• How ground truth for the training set was established

This type of information is typically found in clinical study reports or detailed engineering design verification reports, which are not included in this 510(k) summary. The summary focuses on demonstrating substantial equivalence through a comparison of technological characteristics and general testing categories.

Therefore, for the requested information, I must state:

The provided document does not contain the specific details regarding acceptance criteria, reported device performance, sample sizes, expert qualifications, adjudication methods, or ground truth establishment relevant to the performance metrics of the device as if it were an AI/CADe device.

The document primarily states that "The following tests were performed to demonstrate that the Flexor® Ureteral Access Sheath and Flexor® Parallel™ Rapid Release™ Ureteral Access Sheath met applicable design and performance requirements and support a determination of substantial equivalence." It then lists categories of tests:

1. Table of Acceptance Criteria and Reported Device Performance:

Note: The document only provides categories of tests and a general statement of compliance, not specific quantitative criteria or results.

2. Sample size used for the test set and the data provenance: Not mentioned in the provided text. The listed tests appear to be bench and laboratory tests, not clinical trials with patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/not mentioned. This device is not an AI/CADe system requiring expert ground truth in this context.

4. Adjudication method for the test set: Not applicable/not mentioned.

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 not an AI/CADe device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm-based device.

7. The type of ground truth used: For the physical and functional tests, the ground truth would be the established engineering specifications and recognized testing standards (e.g., ISO, ASTM). For biocompatibility, it's defined by biological response criteria.

8. The sample size for the training set: Not applicable. This is not an AI/CADe device.

9. How the ground truth for the training set was established: Not applicable. This is not an AI/CADe device.

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To establish a continuous conduit during urological endoscopic procedures facilitating the in and out passage of endoscopes and other instruments into the urinary tract.

The Re-Trace Ureteral Access Sheath 10/12 Ch/Fr & Ureteral Access Sheath are line extensions of the Re-Trace Ureteral Access Sheath 12/14 Ch/Fr. All these devices comprise the following components:

• Reinforced tube/sheath .
• Introducer/dilator .
• Connector .
• Clip .
  The only design addition to the 10/12 Ch/Fr reinforced tube/sheath compared to the 12/14 Cly/Fr sheath is the presence of a reinforcing Stainless Steel ring at the distal tip.
  For the Ureteral Access Sheath, the introducer/dilator also only has a guidewire entry eye at the distal tip compared with guidewire entry and exit eyes and three exit holes for fluid delivery on the Re-Trace Ureteral Access Sheath introducer/dilator.
  Apart from these modifications, all the Re-Trace Ureteral Access Sheath & Ureteral Access Sheath range is very similar in design.

The provided text describes a 510(k) summary for the Re-Trace Ureteral Access Sheath. It outlines the device's description, intended use, and a comparison to predicate and reference devices for establishing substantial equivalence. However, it does not include the detailed information requested regarding specific acceptance criteria, study methodologies for device performance, ground truth establishment, or human-in-the-loop studies.

This submission is for a medical device (Ureteral Access Sheath) which is typically evaluated through non-clinical performance testing and biocompatibility. The type of "acceptance criteria" and "study" described in the input prompt (e.g., sample size, ground truth, expert consensus, MRMC studies) are characteristic of studies evaluating diagnostic accuracy or clinical effectiveness for devices that generate data (like AI/ML algorithms). The Re-Trace Ureteral Access Sheath is a physical medical instrument, not a diagnostic or AI device.

Therefore, the requested information cannot be fully extracted from the provided text for this specific device.

Based on the provided text, here's what can be inferred and what information is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Not Applicable / Not Provided: The submission describes non-clinical performance testing and biocompatibility testing, not a clinical study involving a "test set" of patient data.

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

• Not Applicable / Not Provided: Ground truth as described (e.g., expert consensus on medical images) is not relevant to the non-clinical performance and biocompatibility testing performed for this physical device.

4. Adjudication method for the test set:

• Not Applicable / Not Provided: As there is no "test set" in the context of diagnostic accuracy, there is no adjudication method described.

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 / No: This device is a physical medical instrument, not an AI/ML diagnostic or assistive device. An MRMC study is not relevant to its evaluation.

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

• Not Applicable / No: This device is not an algorithm or AI system.

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

• Not Applicable / Not Provided: For the performance tests, the "ground truth" would be engineering specifications and standards for device functionality and material integrity. For biocompatibility, it's compliance with ISO 10993 standards.

8. The sample size for the training set:

• Not Applicable / Not Provided: There is no "training set" as this is not an AI/ML device.

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

• Not Applicable / Not Provided: There is no "training set" for this type of device.

In summary: The provided document is a 510(k) summary for a physical medical device (Ureteral Access Sheath), not a diagnostic device or an AI/ML product. The evaluation focuses on non-clinical performance testing (e.g., break force, friction, kink resistance) and biocompatibility to demonstrate substantial equivalence to a predicate device. The questions in the prompt, while relevant for AI/ML or diagnostic devices, do not directly apply to the information presented for this type of product.

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