(271 days)
Endoscopic removal of stones in the biliary system and foreign bodies.
The Non-Lithotripsy Extraction Basket is a sterile, single use device compatible with the accessory channel of endoscopes. The device consists of basket, catheter, and handle components. The basket component is constructed of monofilament or multifilament metal wires joined at the distal and proximal ends, and is advanced out of and retracted into the single or double lumen polytetrafluoroethylene catheter sheath using the handle component's actuator. The device is not compatible with any mechanical lithotripter.
This is a 510(k) premarket notification for a medical device called the "Non-Lithotripsy Extraction Basket," which is used for the endoscopic removal of stones and foreign bodies in the biliary system. The document states that performance testing, consisting of sterilization, shelf life, biocompatibility, and nonclinical bench testing, demonstrates that the device meets the performance criteria.
However, the provided text does not include acceptance criteria for device performance or a detailed study proving the device meets specific performance criteria. The performance data section is very high-level and only lists the types of tests conducted:
- Stone and Foreign Body Capture Testing
- Tensile Testing
- Flexibility Testing
- Post-Aging Functional Testing
Therefore, I cannot provide the requested information about acceptance criteria, specific performance metrics, sample sizes, ground truth establishment, or expert involvement, as this information is not present in the provided document.
To answer your request, here's what the document does provide in relation to a study, but falls short of a comprehensive answer to your questions:
1. A table of acceptance criteria and the reported device performance:
Not provided in the document. The document only lists types of tests performed, not the specific criteria or results.
2. Sample sized used for the test set and the data provenance:
Not provided in the document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable as this is a physical device testing, not an AI or diagnostic study requiring expert ground truth for interpretation.
4. Adjudication method for the test set:
Not applicable/not provided.
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 a physical medical device, not an AI or diagnostic imaging device that would involve human readers or AI assistance in interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used:
For the physical tests listed (Stone and Foreign Body Capture, Tensile, Flexibility, Post-Aging Functional), the "ground truth" would be the measurable physical properties and functional performance of the device against pre-defined engineering specifications. The document does not detail these specifications.
8. The sample size for the training set:
Not applicable. This is a physical medical device, not an AI or machine learning model that requires a training set.
9. How the ground truth for the training set was established:
Not applicable.
In summary: The provided 510(k) notification states that non-clinical bench testing was performed and that the device meets the performance criteria. However, it does not provide the specific acceptance criteria, quantitative performance results, sample sizes, or detailed methodologies of these tests.
§ 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.