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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 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 110 mm stent. 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, which is a medical device. This type of document is filed with the FDA to demonstrate that a new device is substantially equivalent to a legally marketed predicate device. As such, it does not typically contain detailed information about acceptance criteria and clinical study results in the same way an approval for a novel device would.

Instead, the document focuses on demonstrating substantial equivalence primarily through technological comparison and performance testing (bench testing) rather than extensive clinical studies with human subjects.

Here's a breakdown based on the categories you requested, highlighting what is (and isn't) present in the document:

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

This document does not provide a table of acceptance criteria and reported device performance in terms of clinical outcomes (e.g., sensitivity, specificity for a diagnostic device). Instead, it mentions that "Repeat bench testing demonstrated that the system functions as intended and yielded substantially equivalent results to the results obtained with the predicate." and "Due to the modifications to the delivery system mechanical and kink resistance testing were repeated to demonstrate the system functions as intended. 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."

The "acceptance criteria" here are implicitly related to the performance specifications of the predicate device and the ability of the modified device to meet those same specifications in bench testing, particularly for mechanical and kink resistance. Specific numerical acceptance criteria or performance metrics are not detailed.

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

The document refers to "bench testing" and "validation testing" for mechanical and kink resistance. These types of tests typically involve a sample size of devices tested in a lab setting, not human subjects. The document does not specify the sample size of devices used for these bench tests, nor is there any mention of data provenance in terms of country of origin or retrospective/prospective nature, as these are not clinical studies.

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 is not applicable to the information provided. The study mentioned is bench testing of physical device properties, not a study requiring expert interpretation or establishment of ground truth in a diagnostic or clinical context.

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

This is not applicable. Adjudication methods are used in clinical studies for resolving discrepancies in expert opinions or clinical outcomes, which is not the type of study described here.

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 is not applicable. The device is a biliary stent system, not an AI-powered diagnostic device. Therefore, no MRMC study or AI assistance evaluation was performed or is relevant to this submission.

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

This is not applicable. The device is a physical medical device (a stent delivery system), not an algorithm.

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

This is not explicitly stated in terms of a clinical ground truth. For the bench testing, the "ground truth" would be the engineering specifications and performance expectations derived from the predicate device and general medical device standards. The "results obtained with the predicate" serve as the benchmark for comparison.

8. The sample size for the training set

This is not applicable as this is not an AI/algorithm device that requires a training set. The "study" mentioned is bench testing of a physical device.

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

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

In summary:

The provided document describes a 510(k) submission for a modified biliary stent system. The "study" referenced is bench testing (mechanical and kink resistance testing) conducted to demonstrate that the delivery system functions as intended and is substantially equivalent to a previously cleared predicate device.

• Acceptance Criteria & Performance: The acceptance criteria are implicit, focusing on the new device performing as safely and effectively as the predicate during mechanical and kink resistance testing. Specific quantitative criteria and performance results are not detailed, beyond stating that it "functions as intended" and "yielded substantially equivalent results."
• Study Type: Bench testing.
• Sample Size: Not specified for bench tests.
• Data Provenance: Not applicable (lab-based testing).
• Experts/Ground Truth: Not applicable in the context of clinical experts or ground truth. The "ground truth" for compliance is based on engineering specifications and comparison to the predicate's established performance.
• No MRMC, Standalone, or AI-related studies were performed.

The core of this submission relies on demonstrating that the physical modification (changing from a double to a single stent system) did not negatively impact the device's safety and effectiveness compared to the predicate, as verified through standard engineering and performance tests.

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