(98 days)
The JOSTENT SelfX is intended for use in the palliation of malignant strictures in the biliary tree.
The JOSTENT SelfX Biliary Stent consists of a self-expanding Nitinol stent mounted on a catheter delivery system. The stent will be available in lengths of 44 and 68 mm and diameters of 6, 8, and 10 mm. The delivery system has a usable length of 75 cm and is compatible with 0.035" diameter guidewires and 7F introducers.
The provided text describes a 510(k) summary for the JOSTENT® SelfX Biliary Stent, which is a medical device. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than conducting a de novo study with strict acceptance criteria and performance metrics against a defined ground truth.
Therefore, many of the requested elements for a study proving acceptance criteria are not directly applicable or available in this document. The submission is primarily based on performance data from bench and biocompatibility testing to show equivalence, rather than a clinical study evaluating specific performance criteria against a ground truth.
Here's an attempt to address your request based on the available information, noting where information is not present in the document.
1. Table of Acceptance Criteria and Reported Device Performance
As this is a 510(k) submission for substantial equivalence, formal "acceptance criteria" for clinical performance as might be seen in a de novo clinical trial are not explicitly stated in this summary. The "performance data" mentioned refers to bench and biocompatibility testing. The "reported device performance" is essentially the finding of substantial equivalence based on these tests and comparison to predicate devices.
| Acceptance Criteria (Implied for Substantial Equivalence) | Reported Device Performance (Summary of Findings) |
|---|---|
| Material Equivalence: Stent material is comparable to currently marketed Nitinol Biliary stents. | The stent material is substantially equivalent to currently marketed Nitinol Biliary stents. |
| Catheter Material Equivalence: Catheter materials are comparable to currently marketed stent delivery systems and PTA catheters. | The catheter materials are substantially equivalent to currently marketed stent delivery systems and PTA catheters. |
| Dimensional Equivalence: Range of device lengths and diameters are comparable to currently marketed Biliary stent/catheter systems. | The range of device lengths and diameters are equivalent to currently marketed Biliary stent/catheter systems. |
| Deployment Mechanism Equivalence: Deployment mechanism is similar to predicate devices. | The JOSTENT SelfX is constrained within an outer catheter and is deployed in the biliary tree by retracting the outer catheter until the stent is unconstrained (implying similar mechanism to predicate). |
| Biocompatibility: Device demonstrates appropriate biocompatibility. | Demonstrated through biocompatibility testing. |
| Mechanical Performance (Bench): Device meets mechanical performance standards (e.g., radial force, flexibility, fatigue resistance). | Demonstrated through bench testing. |
| Safety and Effectiveness: Data demonstrates safety and effectiveness (as inferred through equivalence). | The safety and effectiveness of the JOSTENT SelfX has been demonstrated through the data collected in bench and biocompatibility testing. Conclusion: Substantially equivalent to predicate devices. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not applicable/not provided for a "test set" in the context of clinical performance. The document refers to "bench and biocompatibility testing," which would have their own sample sizes for material and mechanical tests, but these are not specified.
- Data Provenance: Not applicable for clinical data. Bench and biocompatibility testing data would typically be generated in a lab setting, details of which are not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This is not applicable as there is no clinical "test set" for which ground truth was established by experts in this 510(k) summary. The submission relies on equivalence to devices already accepted as safe and effective.
4. Adjudication method for the test set
- Not applicable, as no clinical test set requiring expert adjudication is described.
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
- Not applicable. This device is a physical stent system, not an AI-assisted diagnostic tool, so an MRMC study related to AI assistance would not be relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical stent system, not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable for a clinical ground truth. The "ground truth" for this 510(k) relies on the established safety and effectiveness of the predicate devices and the demonstration of equivalence through non-clinical (bench and biocompatibility) data.
8. The sample size for the training set
- Not applicable. There is no "training set" in the context of an AI/algorithm. For the bench and biocompatibility testing, specific sample sizes would have been used for different tests (e.g., number of stents tested for radial force, number of samples for material characterization), but these details are not provided in the summary.
9. How the ground truth for the training set was established
- Not applicable. As there is no training set for an AI/algorithm, there is no corresponding ground truth to be established.
§ 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.