(48 days)
The ParaMount™ Mini Stent and Delivery System is intended as a palliative treatment of malignant neoplasms in the biliary tree.
The ParaMount™ Mini Stent is a balloon expandable stainless steel stent with an open lattice design. The stent is electropolished. The device is provided premounted on a balloon delivery catheter. Upon balloon inflation the crimped stent expands to conform to the duct inner luminal surface and retains the expanded state upon balloon deflation.
The provided text describes a Premarket Notification (510(k)) Summary for the ParaMount™ Mini Stent and Delivery System (Biliary Indication). This document focuses on demonstrating substantial equivalence to a previously cleared device, not on proving new acceptance criteria through a study with specific performance metrics.
Therefore, many of the requested categories for AI/device performance studies are not applicable to this 510(k) submission, as it is a regulatory document addressing device modifications rather than a clinical trial report for new technology.
1. A table of acceptance criteria and the reported device performance
This document does not provide specific quantitative acceptance criteria or reported device performance in the manner of an AI diagnostic study. The "acceptance criteria" for a 510(k) are typically met by demonstrating substantial equivalence to a predicate device, which is implied by the successful review by the FDA.
| Acceptance Criterion (Implicit for 510(k) Substantial Equivalence) | Reported Device Performance/Evidence |
|---|---|
| Intended Use | The modified device has the same intended use: "palliative treatment of malignant neoplasms in the biliary tree." |
| Materials | The modified device uses the same materials: "balloon expandable stainless steel stent with an open lattice design. The stent is electropolished." |
| Technological Characteristics | The modified device has similar technological characteristics to the previously cleared stent and delivery system. Modifications include "additional diameters and lengths" for the stent, and for the delivery catheter: "smaller profile and additional guidewire compatibilities." |
| Performance (Bench Testing) | "Performance testing (bench) further supports a substantial equivalence claim." No specific quantitative results are provided in this summary. The collective evidence from these points provides "assurance that the ParaMount™ Mini Stent and Delivery Device meet the requirements that are considered acceptable for the intended use." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This 510(k) submission refers to "performance testing (bench)" which implies laboratory or engineering tests, not a clinical test set with patient data. No details on sample size or data provenance are provided for such bench tests.
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)
Not applicable. Ground truth assessment by experts in a clinical context is not relevant to a 510(k) submission focused on demonstrating substantial equivalence through bench testing for device modifications.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods for ground truth establishment are not relevant to this type of regulatory submission focusing on bench test performance and substantial equivalence.
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 is not an AI device, and no MRMC study or comparative effectiveness study involving human readers or AI assistance is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical device (stent and delivery system), not an algorithm or AI. Standalone performance as an algorithm is not relevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The concept of "ground truth" in the context of clinical disease diagnosis or outcomes is not directly applicable to the "performance testing (bench)" mentioned for this device's modifications. The "ground truth" for the bench tests would be engineering specifications or simulated physiological conditions.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device. There is no concept of a "training set" in this context.
9. How the ground truth for the training set was established
Not applicable. As above, this is not an AI/machine learning device, so there is no training set or associated ground truth establishment.
§ 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.