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The EndoGl S-Path Biliary Stent System is intended for delivery of stent(s) to the biliary tract for drainage of the bile ducts, for splinting of a bile duct during healing, or for providing bile duct patency in a stricture or past a stone.

The revised EndoGI S-Path System incorporates one preloaded stent which has a straight body and one end incorporating a 65° bend (duodenal bend). The stent is identical to the previously cleared EndoGI stent and is comprised of a biocompatible radiopaque plastic which allows visualization of the stent post deployment.

The EndoGI S-Path System is available 10 Fr and includes a single preloaded stent available in three lengths (80, 110 and 140 mm). The system is compatible with a guidewire of up to 0.035".

The provided text is a 510(k) summary for the EndoGI S-Path Biliary Stent System. It primarily focuses on demonstrating substantial equivalence to a predicate device based on intended use, technology, and performance data from mechanical, dimensional, biocompatibility, and sterilization tests. It does not contain information about clinical study acceptance criteria or the specifics of a clinical study aimed at proving device performance against such criteria.

Therefore, I cannot provide the requested information from the given text. The document does not describe:

1. A table of acceptance criteria and reported device performance.
2. Sample size for a test set or its provenance.
3. Number or qualifications of experts used for ground truth.
4. Adjudication method for a test set.
5. Multi-reader multi-case (MRMC) comparative effectiveness study or effect size.
6. Standalone (algorithm-only) performance.
7. Type of ground truth used (expert consensus, pathology, outcomes data, etc.).
8. Sample size for a training set.
9. How ground truth for a training set was established.

The document discusses "performance data" in a general sense within Section 7, referring to mechanical performance, dimensional testing, and kink tests, as well as biocompatibility and sterilization tests to support modifications made to the delivery system. These are typically engineering and laboratory tests, not clinical performance studies with human subjects or expert readers that would generate the kind of data requested in the prompt.

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The EndoGI S-Path Biliary Stent System is intended for delivery of stent(s) to the biliary tract for drainage of the bile ducts, for splinting of a bile duct during healing, or for providing bile duct patency in a stricture or past a stone.

The EndoGI S-Path Biliary Stent System consists of a stent and stent delivery catheter. The EndoGI S-Path Biliary Stent System catheter is 10 Fr in diameter and includes a single preloaded stent available in three lengths (80, 110 and 140 mm). The delivery catheter is compatible with a guidewire of up to 0.035". EndoGI S-Path Biliary System stents have a straight body and one end incorporating a 65° bend (duodenal bend). Stents are comprised of a biocompatible radiopaque plastic which allows visualization of the stent post deployment.

This document is a 510(k) Summary for the EndoGI S-Path Biliary Stent System. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove the device meets acceptance criteria. Therefore, much of the requested information regarding acceptance criteria, specific performance metrics, sample sizes, ground truth establishment, and expert involvement is not available in the provided text.

Based on the information provided, here's what can be extracted:

Acceptance Criteria and Reported Device Performance (as inferred from the context of a 510(k) for device modification):

The document primarily states that "repeat bench testing demonstrated that the system functions as intended and yielded substantially equivalent results to the results obtained with the predicate." It also notes that "the results of the validation testing demonstrated that the EndoGI S-Path system is as safe and effective as its predicate and that the modifications to the system did not raise new questions of safety and effectiveness."

While specific numerical acceptance criteria are not presented, the implicit acceptance criterion is that the modified device's performance is substantially equivalent to the predicate device for a set of defined performance tests.

Missing Information (Not provided in the document):

1. Sample size used for the test set and the data provenance: Not mentioned. The document only refers to "bench testing" and "validation testing" without detailing the number of units tested or if any clinical data was used (which is unlikely for a 510(k) for minor modifications).
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/Not mentioned. The testing described appears to be bench testing of physical properties, not a clinical trial requiring expert ground truth establishment.
3. Adjudication method for the test set: Not applicable/Not mentioned.
4. 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 document describes a physical medical device (biliary stent system), not an AI-powered diagnostic tool.
5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an algorithm.
6. The type of ground truth used: For physical performance tests, the "ground truth" would be established by validated measurement standards and physical testing methodologies. No human-expert derived ground truth is applicable here.
7. The sample size for the training set: Not applicable. This is not an AI/machine learning device that requires a training set.
8. How the ground truth for the training set was established: Not applicable.

Study Description (as inferred from the 510(k) Summary):

The "study" or rather, the performance evaluation, was a bench testing validation study. It was conducted to demonstrate that the modified EndoGI S-Path Biliary Stent System (which includes new stent sizes and minor delivery system improvements) performs as intended and is substantially equivalent to its predicate device (EndoGI Biliary Stent System, K202477).

The modifications included two new stent sizes (80mm and 140mm) and an extended overall system length.

The specific tests performed were:

• Mechanical testing
• Dimensional testing
• Kink resistance testing
• Flow rate testing

The conclusion was that these repeat performance tests demonstrated that the modified system functions in an equivalent manner to the predicate and that the modifications did not raise new questions of safety or efficacy. The data provenance is implied to be from the manufacturer's internal testing.

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The EndoGI Biliary Stent System is intended for delivery of stent(s) to the biliary tract for drainage of the bile ducts, for splinting of a bile duct during healing, or for providing bile duct patency in a stricture or past a stone.

The EndoGI System incorporates two preloaded stents. Both stents are identical in design with a straight body and one end incorporating a 65° bend (duodenal bend). The stents are comprised of a biocompatible radiopaque plastic which allows visualization of the stents post deployment. Both stents are pre-mounted on the delivery system and are delivered via near-the-wire and over-the-wire methods. The EndoGI System is available 10 Fr and includes two 110 mm stents. The system is compatible with a guidewire of up to 0.035". The safety lock mechanisms are incorporated within the delivery device handle.

The provided text describes the EndoGI Biliary Stent System and its substantial equivalence to a predicate device, primarily through bench and animal testing. It does not contain information about an AI/ML powered device, therefore, many requested sections about human readers, ground truth establishment for training, and sample sizes for training/test sets are not applicable.

However, I can extract information related to the performance testing and acceptance criteria as presented for the non-AI medical device.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly define a "test set" in the context of an AI/ML device. For the animal study, the sample size was 6 repeats on a porcine model. The provenance is an animal model, specifically a "GLP-like animal study on porcine model," which implies a controlled, prospective study designed to evaluate product performance.

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

Not applicable as this is not an AI/ML powered device requiring expert ground truth for image interpretation or diagnosis. The "ground truth" for this device's performance is derived from physical and biological observations during bench and animal testing.

4. Adjudication method for the test set

Not applicable. The "test set" here refers to the physical and biological tests, not a dataset requiring adjudication.

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/ML powered device.

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

Not applicable. This is not an AI/ML powered device. The device's "standalone" performance is evaluated through the specified bench and animal tests.

7. The type of ground truth used

For the bench testing (e.g., mechanical evaluations), the ground truth is based on engineering specifications and measurable physical properties.
For the animal study, the ground truth is based on direct observation of successful stent delivery, absence of local tissue reaction, and successful stent removal by the study investigators.

8. The sample size for the training set

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

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

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

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