(141 days)
Used for temporary stenting of the ureter in adult patients with extrinsic ureteral obstruction. Intended for one-time use only.
The Resonance™ Metallic ureteral stent is a device which is intended to achieve normal urine flow from the kidney to the urinary bladder in situations where obstructive pathological processes prevent it. The stent extends from the renal pelvis to the urinary bladder via the ureter and is placed by either endoscopic retrograde or percutaneous antegrade insertion.
Here's a breakdown of the acceptance criteria and study information based on the provided text for the Resonance™ Metallic Ureteral Stent (K063742).
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test/Performance Metric | Reported Device Performance | Study Type |
|---|---|---|---|
| Non-Clinical Testing | Flow | Equivalence to predicate devices | Bench |
| Elongation / Yield | Equivalence to predicate devices | Bench | |
| Tensile Strength | Equivalence to predicate devices | Bench | |
| Stent Migration | Equivalence to predicate devices | Bench | |
| Retention | Equivalence to predicate devices | Bench | |
| Clinical Testing | Adverse Events | (Not specified, but gathered for evaluation) | Clinical |
| Stent Function | (Not specified, but gathered for evaluation) | Clinical |
Note: The document states that the non-clinical testing was "carried out to determine the equivalence of the Resonance™ Metallic ureteral stent to the predicate devices and to verify the safety and effectiveness of the stent." While it confirms the tests were done and found equivalence, it does not provide specific numerical acceptance criteria or performance values beyond this general statement. Similarly, for clinical testing, it notes the information gathered but doesn't quantify performance against specific criteria in this summary.
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not explicitly stated for either non-clinical or clinical testing in this document excerpt.
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). The device manufacturer is Cook Ireland Ltd, implying potential European involvement, but this is not confirmed for the clinical data. The clinical testing was done "to primarily gather information on adverse events and stent function," suggesting it was prospective, but this is not explicitly stated.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This information is not provided in the document. The type of testing described (bench and clinical for adverse events/function) wouldn't typically involve human experts establishing a "ground truth" in the way an AI diagnostic device would.
4. Adjudication Method for the Test Set
- This information is not provided as the nature of the device (a physical stent) and the described testing (bench and clinical for safety/function) does not lend itself to an adjudication process in the contextual sense of expert review for diagnostic accuracy.
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
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic or assistive devices where human readers interpret medical images or data. The Resonance™ Metallic Ureteral Stent is a physical medical device, not a diagnostic AI.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- No, this is not applicable. The device is a physical stent, not an algorithm.
7. The Type of Ground Truth Used
- For non-clinical testing: The "ground truth" was established by predicate device equivalence for performance characteristics (flow, elongation/yield, tensile strength, stent migration, retention). This relies on the established safety and effectiveness of the predicate devices.
- For clinical testing: The "ground truth" related to adverse events and stent function would be determined through direct observation and patient outcomes during the clinical study. It's not the same type of "ground truth" as in a diagnostic study (e.g., pathology for image interpretation).
8. The Sample Size for the Training Set
- This information is not applicable/not provided. The Resonance™ Metallic Ureteral Stent is a physical device, not an AI algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
- This information is not applicable/not provided as there is no "training set" for this type of device.
§ 876.4620 Ureteral stent.
(a)
Identification. A ureteral stent is a tube-like implanted device that is inserted into the ureter to provide ureteral rigidity and allow the passage of urine. The device may have finger-like protrusions or hooked ends to keep the tube in place. It is used in the treatment of ureteral injuries and ureteral obstruction.(b)
Classification. Class II (performance standards).