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The Re-Trace Ureteral Access Sheath is used to establish a continuous conduit during urological endoscopic procedures facilitating the passage of endoscopes and other instruments into the urinary tract.

The Re-Trace Ureteral Access Sheath is comprised of the following components: Reinforced tube/sheath, Introducer/dilator, Connector, Clip. The reinforced introducer sheath is composed of a polyether block amide (PEBA) outer surface with a hydrophilic coating. The inner surface of the sheath is polytetralluoroethylene (PTFF). The sheath is reinforced with a stainless steel coil between the PEBA and PTFE materials. The distal tip of the sheath is fitted with a radiopaque ring. A white connector and orange clip is fitted on the proximal end of the sheath. The introducer/dilator is a radiopaque polyvinyl chloride (PVC). The introducer is fitted with a luer connector on the proximal end and has a hydrophilic coating on the distal end. A guidewire entry and exit eye and three exit holes for fluid delivery are located at the distal end of the introducer. A 4cm length Nitinol tube is inserted in the injection channel of the introducer to stiffen the guide wire exit eye section of this introducer.

The request concerns a 510(k) submission for the "Re-Trace Ureteral Access Sheath," focusing on modifications made to a previously cleared device. The provided text, however, details nonclinical (bench) testing and biocompatibility assessments, not a study evaluating device performance with human interaction or AI assistance. Therefore, many of the requested details about acceptance criteria, human study design, and AI elements are not present in the provided document.

Here's a breakdown of the information that can be extracted or inferred, and what cannot:

1. A table of acceptance criteria and the reported device performance

The document states that biocompatibility and performance testing were conducted, and the conclusions state that the modified device "is as safe and effective and performs as well as the predicate device." However, specific quantitative acceptance criteria or reported performance values for each test are not provided in the given text. The tests performed are listed as:

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

This information is not provided in the document, as the tests described are nonclinical (bench testing) and biocompatibility studies, not human clinical trials.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This information is not applicable as the document describes nonclinical testing, not studies requiring expert interpretation or ground truth establishment.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable as the document describes nonclinical testing.

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

This information is not applicable. The device is a ureteral access sheath, a physical medical device, not an AI-powered diagnostic tool or system 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 as the device is not an algorithm.

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

For the nonclinical tests described, the "ground truth" would be established by objective physical and chemical measurements and standard protocols for biocompatibility testing, rather than expert consensus, pathology, or outcomes data typically associated with clinical studies of diagnostic or prognostic devices.

8. The sample size for the training set

This information is not applicable as the device is not an AI algorithm requiring a training set.

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

This information is not applicable as the device is not an AI algorithm requiring a training set.

In summary, the provided document details a 510(k) submission for a modified physical medical device (Ureteral Access Sheath). The "study" referenced is a series of nonclinical bench tests and biocompatibility tests designed to demonstrate substantial equivalence to a predicate device. It does not involve human subjects, AI, or expert adjudication in the context of the requested questions.

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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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The Re-Trace Ureteral Access Sheath is used to establish a continuous conduit during urological endoscopic procedures facilitating the passage of endoscopes and other instruments into the urinary tract.

Not Found

I am sorry but this document is an FDA Premarket Notification (510k) letter, which confirms that a medical device (Re-Trace Ureteral Access Sheath) is substantially equivalent to a predicate device. This type of document does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth methods. Therefore, I cannot provide the requested information based on the given context.

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