(28 days)
The OASIS Biliary Stent Introduction System is intended for endoscopic biliary stent placement to drain obstructed bile ducts.
The device is supplied sterile and intended for single use only.
The proposed Stent Introduction system is a modification to Stent Introduction systems currently sold by Wilson-Cook. The OASIS Stent Introduction system is supplied sterile and intended for single use only.
The provided text is a 510(k) summary for the Wilson-Cook OASIS Biliary Stent Introduction System. This type of regulatory submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving a device meets specific acceptance criteria through extensive clinical studies comparing its performance against a defined ground truth.
Therefore, many of the requested details about acceptance criteria, study design, expert involvement, and ground truth establishment are not applicable to this document. The submission focuses on demonstrating the device is substantially equivalent to existing devices.
Here's a breakdown of what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
- Not Applicable. This document does not specify quantitative acceptance criteria or report performance data against such criteria in the way a clinical trial would for AI model evaluation. The "Performance Data" section states, "We believe the proposed device to be substantially equivalent to the named predicate in terms of Intended Use, performance characteristics tested and biocompatibility." This implies that the performance characteristics were tested to ensure they were comparable to the predicate device, but no specific metrics or thresholds are provided.
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 is a medical device submission, not a study evaluating an AI algorithm's performance on a test set. There is no mention of a "test set" in the context of data used to evaluate an AI algorithm. The performance evaluation would likely involve engineering tests, biocompatibility testing, and functional assessments, not an AI test set.
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 for AI model evaluation is not relevant here. The "ground truth" in this context would be industrial standards for device performance and safety, which are not established by a panel of medical experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. As there is no AI test set, there is no adjudication method 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 stent introducer system, a physical medical device, not an AI diagnostic or assistive tool. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. The device is a physical stent introduction system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable. "Ground truth" in the context of AI performance evaluation is not relevant for this physical device. The "truth" here revolves around mechanical, material, and functional integrity, and biocompatibility, as per medical device standards.
8. The sample size for the training set
- Not Applicable. There is no AI training set for a physical medical device.
9. How the ground truth for the training set was established
- Not Applicable. There is no AI training set or associated ground truth for a physical medical device.
Summary of Relevant Information from the Provided Text:
The document describes a medical device called the Wilson-Cook OASIS Biliary Stent Introduction System.
Its Intended Use is "for endoscopic biliary stent placement to drain obstructed bile ducts."
The submission is a 510(k) premarket notification, which aims to demonstrate substantial equivalence to a predicate device.
The Predicate Device is "Zimmon Endoscopic Biliary Stent Sets (K851962/A)."
The Performance Data section states that the device is believed to be substantially equivalent to the predicate "in terms of Intended Use, performance characteristics tested and biocompatibility." This indicates that tests were performed to ensure comparable performance, but the details of those tests, specific acceptance criteria beyond "substantial equivalence," and the raw results are not provided in this summary. They would typically be in a more detailed submission document.
§ 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.