(68 days)
The proposed Precise™ Rx Nitinol Stent Transhepatic Biliary System is intended for use in the palliation of malignant neoplasms in the biliary tree.
The device description of the proposed Precise™ Rx Nitinol Stent Transhepatic Biliary System is as follows.
- Delivery system profile in the area of stent housing is 5 F for stent diameters ranging from 5-7 mm and 6F for stent diameters ranging from 8-10 mm.
- The stent will be delivered to the lesion site via the Rapid Exchange Stent Delivery System
- Guidewire Lumen - 0.014"
- Stent delivery system useable length - 135 mm
- Stent lengths - 20, 30 and 40 mm
- Stent diameters - 5, 6, 7, 8, 9, and 10 mm
The provided document is a 510(k) summary for a medical device called the "Precise™ Rx Nitinol Stent Transhepatic Biliary System." This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific acceptance criteria through a comparative effectiveness study or standalone performance evaluation.
Therefore, much of the requested information regarding acceptance criteria, specific study design details, ground truth establishment, expert involvement, and statistical measures like effect size or sample sizes for training/test sets is not available in this document. This submission focuses on demonstrating that the new device is as safe and effective as existing predicate devices through pre-clinical testing, rather than reporting on a clinical study with detailed performance metrics against predefined acceptance criteria.
However, I can extract the following information that is available:
1. Table of Acceptance Criteria and Reported Device Performance:
As this is a 510(k) submission based on substantial equivalence, there are no explicit "acceptance criteria" presented in the format of a table with specific performance metrics as would be found in a clinical trial report. Instead, the "performance" is demonstrated by showing "substantial equivalence" to predicate devices through pre-clinical testing. The document states:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate devices for safety and effectiveness. | Equivalence was confirmed through pre-clinical testing. |
| (No specific quantifiable acceptance criteria are provided in the document.) | (No specific quantifiable performance data is provided in the document.) |
2. Sample size used for the test set and the data provenance:
- Sample size for test set: Not applicable/Not provided. The document refers to "pre-clinical testing" without detailing specific sample sizes for a test set. This generally refers to bench testing rather than human subject data.
- Data provenance (country of origin, retrospective/prospective): Not applicable/Not provided. Pre-clinical testing is typically laboratory-based and does not involve patient data with specific provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not provided. This type of information is relevant for clinical studies involving expert adjudication, which is not described in this 510(k) summary.
4. Adjudication method for the test set:
- Not applicable/Not provided. Adjudication methods are typically used in clinical trials to establish ground truth from expert readings, which is not described here.
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, a multi-reader multi-case comparative effectiveness study was not done. This device is a physical medical device (stent), not an AI-powered diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical medical device (stent), not an algorithm.
7. The type of ground truth used:
- Not applicable/Not provided in the context of clinical outcomes. The "ground truth" for "pre-clinical testing" usually refers to engineering specifications and performance benchmarks met through laboratory tests (e.g., stent deployment characteristics, material integrity), rather than clinical outcomes or pathology.
8. The sample size for the training set:
- Not applicable/Not provided. This pertains to machine learning models, which is not relevant for this device.
9. How the ground truth for the training set was established:
- Not applicable/Not provided. This pertains to machine learning models, which is not relevant for this device.
In summary, the provided document is a 510(k) notification for a medical device (a stent) and establishes substantial equivalence through pre-clinical testing. It does not contain information about clinical acceptance criteria, detailed study designs for evaluating performance against such criteria, expert evaluations, or AI-related metrics because these are not typically required for this type of submission for this kind of device.
§ 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.