(46 days)
The Express SD Biliary Monorail Premounted Stent System is indicated for palliation of malignant neoplasms in the biliary tree.
Not Found
The provided text describes the 510(k) premarket notification for the Express® SD Biliary Monorail® Premounted Stent System. This document does not describe an AI/ML-driven medical device, but rather a traditional medical device (biliary stent). Therefore, much of the information typically requested for AI/ML device evaluations (such as acceptance criteria, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for AI models) is not applicable or present in this document.
However, I can extract the relevant information regarding the device's acceptance, testing, and comparison to a predicate device.
Device Name: Express® SD Biliary Monorail® Premounted Stent System
Intended Use/Indications for Use: Palliation of malignant neoplasms in the biliary tree.
Acceptance Criteria and Device Performance
The document functions as a 510(k) summary, which establishes substantial equivalence to a predicate device rather than setting specific performance acceptance criteria like sensitivity/specificity for an AI model.
The "acceptance criteria" here are implicitly related to demonstrating that the new device is as safe and effective as the predicate device, especially regarding its Magnetic Resonance (MR) compatibility, which was the focus of the non-clinical testing.
| Acceptance Criteria (Implicit for 510(k) Equivalence) | Reported Device Performance (Summary of Non-Clinical Test) |
|---|---|
| Safety and effectiveness comparable to predicate device | Bench testing performed to support determination of Magnetic Resonance compatibility. |
| No new safety or performance issues | The results provide reasonable assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use. No new safety or performance issues were raised during the device testing. |
| Compatibility with Magnetic Resonance Environment | Labeling updated to include language and test data to support the Magnetic Resonance Environment conditions under which the Express SD Biliary device is compatible. |
Study Details (as inferable from the document):
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A table of acceptance criteria and the reported device performance: See table above.
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Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated. The document mentions "Bench testing was performed" but does not detail the number of stents or test configurations used.
- Data Provenance: The testing was "non-clinical bench testing" performed by Boston Scientific Corporation.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This is a physical device, and the testing described is non-clinical (bench testing) for MR compatibility, not expert-adjudicated clinical performance.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable as it's not a clinical study requiring expert adjudication of results.
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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-assisted device.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the context of AI models. For MR compatibility, the "ground truth" would be established by validated test methods and standards for assessing electromagnetic compatibility and material safety in MR environments.
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The sample size for the training set: Not applicable. This is not an AI/ML device that requires a training set.
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How the ground truth for the training set was established: Not applicable.
§ 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.