(27 days)
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.
§ 876.5010 Biliary catheter and accessories.
(a)
Identification. A biliary catheter and accessories is a tubular flexible device used for temporary or prolonged drainage of the biliary tract, for splinting of the bile duct during healing, or for preventing stricture of the bile duct. This generic type of device may include a bile collecting bag that is attached to the biliary catheter by a connector and fastened to the patient with a strap.(b)
Classification. Class II (special controls). The device, when it is a bile collecting bag or a surgical biliary catheter that does not include a balloon component, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.