(31 days)
The S.M.A.R.T. TM Nitinol Stent Endoscopic Biliary System is intended for use in the palliation of malignant neoplasms in the biliary tree.
The device description of the proposed S.M.A.R.T. TM Nitinol Stent Endoscopic Biliary System is as follows.
7 French stent delivery system profile;
Stent material – Nickel Titanium alloy and tantalum micromarkers;
Expanded stent diameters, 8, 9, and 10 mm;
Stent lengths 40, 60, and 80 mm;
Stent delivery system usable length 190 cm; and
Guidewire lumen 0.035".
The provided document does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the manner typically associated with clinical performance studies for diagnostic or AI-based devices.
Instead, this document is a 510(k) summary for a medical device (S.M.A.R.T.™ Nitinol Stent Endoscopic Biliary System) seeking marketing clearance from the FDA. The "study" mentioned is a "pre-clinical testing" conducted to demonstrate substantial equivalence to predicate devices, not a clinical effectiveness study with performance metrics as requested in the prompt.
Here's a breakdown based on the available information, highlighting what is not present:
1. Table of acceptance criteria and reported device performance:
This information is not provided in the document. The document describes the device and its intended use, and states that substantial equivalence was confirmed through pre-clinical testing, but it does not specify any quantitative acceptance criteria or performance metrics (like sensitivity, specificity, accuracy, etc.) for the device itself.
2. Sample size used for the test set and data provenance:
This information is not provided. The document only mentions "pre-clinical testing" without detailing the nature of this testing, the sample size, or data provenance.
3. Number of experts used to establish the ground truth for the test set and their qualifications:
This information is not provided. As no clinical or expert-reviewed test set is described, there's no mention of experts or their qualifications.
4. Adjudication method for the test set:
This information is not provided. No adjudication method is mentioned.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size:
An MRMC study was not mentioned or conducted. The device is a physical stent, not an AI or diagnostic tool that would typically involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
A standalone performance study of an algorithm was not done. This device is a medical stent, not an algorithm.
7. The type of ground truth used:
This information is not provided. Given the nature of a stent approval through substantial equivalence, the "ground truth" would likely relate to material properties, mechanical performance, and biological compatibility, rather than clinical outcomes or expert consensus in the diagnostic sense. The document refers to "pre-clinical testing" which would assess these physical and biological characteristics.
8. The sample size for the training set:
This information is not provided. Training sets are relevant for AI/ML models, not for a physical device like a stent.
9. How the ground truth for the training set was established:
This information is not provided.
Summary of the study that proves the device meets the acceptance criteria (based on the document):
The document states that the S.M.A.R.T.™ Nitinol Stent Endoscopic Biliary System is substantially equivalent to predicate devices, and this equivalence was confirmed through pre-clinical testing.
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Predicate Devices:
- Cordis S.M.A.R.T.™ Nitinol Stent Endoscopic Biliary System (510(k) # K003365 – November 22, 2000)
- Cordis S.M.A.R.T.™ Control Nitinol Stent Transhepatic Biliary System (510(k) # K021898 – August 14, 2002)
- SMART Nitinol stent Transhepatic Biliary System (Enhanced Radiopacity) (510(k) # K001843 – July 20, 2000)
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Nature of the "Study" / Justification: The primary "study" is the pre-clinical testing which demonstrated the substantial equivalence of the new device to the already-cleared predicate devices. This type of submission relies on showing that the new device has the same intended use, technological characteristics (or differences that do not raise new questions of safety or effectiveness), and performs as safely and effectively as the predicate devices. The document highlights various technical specifications of the device (e.g., 7 French stent delivery system profile, stent material, expanded stent diameters, stent lengths, usable length, guidewire lumen) and states all materials are biocompatible, which would be assessed in such pre-clinical tests.
In essence, this 510(k) is about demonstrating substantial equivalence through non-clinical means (pre-clinical testing), not about meeting specific clinical performance acceptance criteria in a trial setting.
§ 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.