(21 days)
The Protégé® RX GPS™ Self-Expanding Nitinol Stent 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 lo elour porthe constrained stent self-expands to conform to the duct inner luminal surface.
The provided text is a 510(k) Premarket Notification summary and accompanying FDA correspondence for the Protégé® Rx GPS™ Self-Expanding Nitinol Stent (Biliary Indication). This document does not describe a study involving device performance metrics against acceptance criteria in the way typically associated with AI/software devices.
Instead, this is a traditional medical device submission focused on demonstrating substantial equivalence to a previously marketed device. The "device performance" referred to in the document relates to bench testing to support the substantial equivalence claim, rather than clinical performance metrics in a study with a test set, ground truth, or expert review.
Therefore, many of the requested fields cannot be filled based on the provided text, as they pertain to studies typically conducted for AI/ML or diagnostic devices where performance is measured against a ground truth.
Here's an attempt to answer the questions based only on the provided text, noting where information is absent for an AI/ML context:
Analysis of Acceptance Criteria and Device Performance for Protégé® Rx GPS™ Self-Expanding Nitinol Stent
The provided documentation does not detail quantitative acceptance criteria or a specific study proving the device meets particular performance metrics in the way an AI/ML or diagnostic device would. This submission is for a conventional medical device (biliary stent) and relies on demonstrating substantial equivalence to a predicate device, supported by bench testing and similar design/materials.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Not explicitly stated as quantitative for clinical performance) | Reported Device Performance (Summary from text) |
|---|---|
| Substantial equivalence to predicate device (Protégé® GPS™ Self-Expanding Nitinol Stent) in design, materials, technological characteristics, and performance. | "The modified device is substantially equivalent to the currently marketed stent and modified as to size, materials, technological characteristics and performance." |
| Functional integrity after modification (delivery system changed to rapid exchange). | "Performance testing (bench) further supports a substantial equivalence claim." |
| Suitable for the intended use (palliative treatment of malignant neoplasms in the biliary tree). | "The collective evidence therefore provides assurance that the Protégé Rx GPS Self-Expanding Nitinol Stent meets the requirements that are considered acceptable for the intended use." |
Note: The FDA letter explicitly notes a limitation: "The safety and effectiveness of this device for use in the vascular system have not been established." This implies the acceptance criteria (and supporting data) were focused solely on the biliary indication.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable. The document mentions "Performance testing (bench)" but does not specify a sample size for any clinical test set or experimental data in patients. The evaluation is based on substantial equivalence to a predicate device and bench testing for device characteristics.
- Data Provenance: Not applicable for a clinical test set. The bench testing would have been conducted by the manufacturer, ev3 Inc., likely in the USA (where the company is based).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable. There is no mention of a test set requiring expert-established ground truth. This is a physical device, and its performance evaluation (for substantial equivalence) would involve engineering tests, material characterization, and comparisons to the predicate device, not expert adjudication of diagnostic outcomes.
4. Adjudication Method for the Test Set
- Not applicable. No test set requiring adjudication in the context of diagnostic or AI performance is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, Effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This is a medical device (stent), not an AI/ML diagnostic or assistive technology for human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a medical device (stent), not an algorithm.
7. The Type of Ground Truth Used
- For the substantial equivalence claim: The "ground truth" implicitly used is the established performance and safety profile of the predicate device (Protégé® GPS™ Self-Expanding Nitinol Stent). The modified device is compared against the characteristics and performance of this existing, legally marketed device.
- For bench testing: The ground truth would be engineering specifications, material standards, and functional requirements for a biliary stent.
8. The Sample Size for the Training Set
- Not applicable. This is a medical device (stent), not an AI/ML algorithm requiring a training set.
9. How the Ground Truth for the Training Set was Established
- Not applicable. No AI/ML training set is involved.
§ 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.