FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

This document is an FDA 510(k) clearance letter for a medical device called "The S.M.A.R.T. RE-FLEX™ Biliary Self Expanding Stent System". It confirms that the device is substantially equivalent to legally marketed predicate devices.

However, this document does not contain the detailed information necessary to describe acceptance criteria or a study proving the device meets those criteria, as typically found in clinical trial reports or detailed premarket submission documents.

The provided text is an FDA clearance letter, which is a regulatory decision document. It states that the device is substantially equivalent and can be marketed, but does not explain the data leading to that conclusion in the format requested.

Therefore, I cannot populate the table or answer most of the questions based on the input provided. The document primarily focuses on regulatory approval, labeling requirements, and general controls, not on the specifics of performance testing or clinical study results.

Here's what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance

Cannot be provided. This document does not specify acceptance criteria (e.g., specific clinical endpoints, success rates, patency rates) or detailed performance results in a quantitative manner.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Cannot be provided. This information is not present in the FDA clearance letter.

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/Cannot be provided. This type of detail is relevant for studies involving human interpretation (e.g., medical imaging AI), not typically for a self-expanding stent device in this context where "ground truth" would be related to clinical outcomes or device functionality established through different types of studies (e.g., mechanical testing, animal studies, human clinical trials). The document mentions no such experts or ground truth establishment.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable/Cannot be provided. Similar to point 3, this is for studies involving human interpretation.

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/Cannot be provided. This type of study relates to AI-assisted diagnostic or interpretative devices. The S.M.A.R.T. RE-FLEX™ Biliary Self Expanding Stent System is a physical interventional device, not an AI diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This pertains to AI algorithms.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Cannot be provided. The document does not describe the types of data (e.g., clinical trial results, pathology) that would have established the ground truth for the performance claims in the actual submission to the FDA.

8. The sample size for the training set

Not applicable/Cannot be provided. This applies to machine learning models, not to a physical medical device like a stent.

9. How the ground truth for the training set was established

Not applicable/Cannot be provided. This applies to machine learning models.

In summary: The provided FDA 510(k) clearance letter serves as proof of regulatory approval based on substantial equivalence, but it is not the study report itself. The detailed clinical or performance study data (including acceptance criteria, sample sizes, and specific results) that informed this FDA decision would be found in the actual 510(k) submission and associated technical reports, which are not included in this extract.

Summary

Regulation Number and Section

§ 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.