(224 days)
The SCUBA™ Biliary Stent System is indicated for use in the palliation of malignant neoplasms in the biliary tree
The SCUBA Biliary Stent System consists of a balloon-expandable MP35N (cobalt, nickel, chromium molybdenum alloy) stent mounted on a 5 F over-the-wire (OTW) balloon catheter. The stent is provided in nominal expanded diameters of 5 mm to 10 mm, and stent lengths of 18 to 75 mm. The SCUBA Biliary Stent System has an 80 cm usable length and is compatible with 6 or 7 F introducer sheaths, and guidewires up to 0.035" diameter.
The provided text does not contain specific acceptance criteria or an explicit study description with detailed performance metrics.
The "Performance Data" section states:
"Preclinical bench and biocompatibility testing was conducted to evaluate the safety and performance of the SCUBA Biliary Stent System. Testing included comparative testing with the predicate devices. Test results indicate that the SCUBA Biliary Stent System is safe and effective for the intended purpose, has comparable performance to the predicate devices, and is biocompatible."
This is a general statement and lacks the quantitative data, sample sizes, and detailed methodology typically found in a study proving device meets acceptance criteria.
Therefore, most of the requested information cannot be extracted from the provided text.
Here's a breakdown of what can and cannot be answered based on the provided document:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | "safe and effective for the intended purpose, has comparable performance to the predicate devices, and is biocompatible." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified.
- Data Provenance: Not specified (the testing was "preclinical bench and biocompatibility testing," implying laboratory tests, not clinical data from specific countries or patients).
- Retrospective/Prospective: Not specified.
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. The testing described is preclinical bench and biocompatibility testing, which typically does not involve human experts establishing ground truth in the way clinical studies do.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. (See #3)
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
- No, an MRMC study was not done (the device is a physical medical device, not an AI-powered diagnostic tool).
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable (the device is a physical medical device, not an algorithm).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. For preclinical bench and biocompatibility testing, "ground truth" would be established by validated testing methods and reference standards for material properties, mechanical integrity, and biological response, rather than medical expert consensus or patient outcomes.
8. The sample size for the training set
- Not applicable (the device is a physical medical device, not an AI model that requires a training set).
9. How the ground truth for the training set was established
- Not applicable (See #8).
§ 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.