(62 days)
The Protégé® GPS™ Self-Expanding Nitinol Stent and Delivery System is intended as a palliative treatment of malignant neoplasms in the biliary tree.
The Protégé stent is a self-expanding nitinol stent with an open lattice design. The stent is electropolished. The device is provided premounted on a delivery catheter. Upon deployment the constrained stent self-expands to conform to the duct inner luminal surface.
The provided text is a 510(k) summary for the Protégé® GPS™ Self-Expanding Nitinol Stent and Delivery System (Biliary Indication). This document focuses on demonstrating substantial equivalence to a previously marketed device rather than presenting a de novo study with acceptance criteria and performance data in the typical sense for a new clinical device.
Here's an analysis based on the provided text, addressing your questions with the information available:
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided text, there are no explicit acceptance criteria or specific device performance metrics (e.g., accuracy, sensitivity, specificity, or specific clinical outcomes like stent patency rates) reported. The submission relies on demonstrating substantial equivalence to a predicate device. The "acceptance criteria" can be inferred as fulfilling the evidence required by the FDA for a 510(k) submission to establish substantial equivalence.
| Acceptance Criteria (Inferred from 510(k) Process) | Reported Device Performance |
|---|---|
| Substantial equivalence in: | Reported as Substantially Equivalent |
| - Intended use | Yes |
| - Materials | Yes |
| - Technological characteristics | Yes |
| - Performance (bench testing) | Yes |
| Lower profile of delivery system | Achieved |
2. Sample Size Used for the Test Set and Data Provenance
The text does not mention a clinical test set or patient data for this specific 510(k) submission. The evaluation was primarily based on "Performance testing (bench)" which implies laboratory or engineering tests. Therefore, there is no information on sample size or data provenance (country of origin, retrospective/prospective). This is common for devices seeking substantial equivalence where the modifications are minor and validated through non-clinical testing.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. Since there was no clinical test set or patient data described for this submission, there would be no ground truth established by medical experts for device performance. The assessment was based on engineering and material characteristics to demonstrate equivalence.
4. Adjudication Method
Not applicable. As no clinical test set with corresponding ground truth was used, there was no need for an adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. The provided text does not mention an MRMC study or any comparison of human readers with or without AI assistance. This device is a physical medical device (stent), not an AI diagnostic tool.
6. Standalone Performance Study
No. The submission describes "Performance testing (bench)" which likely refers to engineering verification and validation tests for the physical device, not an algorithm's standalone performance.
7. Type of Ground Truth Used
The "ground truth" for this submission was the established performance and characteristics of the predicate device and the results of bench testing on the modified device to confirm it met design specifications and remained equivalent. There was no clinical ground truth (e.g., pathology, outcomes data) generated for this specific 510(k).
8. Sample Size for the Training Set
Not applicable. Since this is a physical medical device and not an AI/ML algorithm, there is no concept of a "training set" in the context you're asking.
9. How the Ground Truth for the Training Set Was Established
Not applicable. (See point 8).
Summary of the Study and Acceptance:
The FDA 510(k) submission K032580 for the Protégé® GPS™ Self-Expanding Nitinol Stent and Delivery System (Biliary Indication) focused on demonstrating substantial equivalence to an already marketed device. The "study" consisted primarily of bench performance testing to show that a minor modification (lower profile delivery system) did not alter the intended use, materials, technological characteristics, or overall performance such that it would raise new questions of safety or effectiveness compared to the predicate.
The acceptance criteria were implicitly met by providing sufficient evidence (bench testing results and comparison to the predicate) to convince the FDA that the modified device was substantially equivalent to the predicate, thus allowing it to be marketed for the palliative treatment of malignant neoplasms in the biliary tree. The FDA's 'substantially equivalent' determination served as the acceptance of the submission. The letter from the FDA explicitly states: "We have determined the device is substantially equivalent... You may, therefore, market the device..." subject to specific labeling requirements regarding vascular use.
§ 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.