(32 days)
The Cordis 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 Cordis Precise™ Rx Nitinol Stent Transhepatic Biliary System is as follows:
• Delivery system profile in the area of stent housing is .069" (1.75mm) for stent diameters ranging from 5 - 7mm and .079" (2.0mm) for stent diameters ranging from 8 - 10mm.
• The stent will be delivered to the stricture site via the Rapid Exchange Stent Delivery System
• Guidewire lumen - 0.014"
• Stent delivery system useable length - 135cm
• Stent length - 20, 30, and 40mm
• Stent diameters - 5, 6, 7, 8, 9, and 10mm
The provided text describes a 510(k) premarket notification for a medical device, the Cordis Precise™ Rx Nitinol Stent Transhepatic Biliary System. This type of submission focuses on demonstrating substantial equivalence to a predicate device already on the market, rather than conducting new clinical studies with detailed acceptance criteria for performance in the same way a de novo or PMA submission might.
Therefore, the requested information about acceptance criteria, study design, sample size, expert involvement, and ground truth establishment is not explicitly contained within the provided document. The 510(k) process primarily relies on demonstrating that the new device has "similar technological characteristics" and "is as safe and effective as" a legally marketed predicate device.
However, I can extract information related to the device description and what would typically be considered performance characteristics for such a device, and connect it to the concept of substantial equivalence as the "acceptance criteria" here.
Here's how I can address the request based on the provided text, while also noting the limitations:
1. A table of acceptance criteria and the reported device performance
Since this is a 510(k) submission, the "acceptance criteria" are generally that the new device is substantially equivalent to the predicate device in terms of intended use, technological characteristics, and safety/effectiveness. The "reported device performance" would be presented through a comparison to the predicate device.
| Acceptance Criteria (Implied by Substantial Equivalence to Predicate) | Reported Device Performance (Characteristics of the Cordis Precise™ Rx Nitinol Stent Transhepatic Biliary System) |
|---|---|
| Intended Use: Palliation of malignant neoplasms in the biliary tree. | Indications for Use: Intended for use in the palliation of malignant neoplasms in the biliary tree. (Matches predicate's likely indications). |
| Technological Characteristics: Similar materials, design, and dimensions enabling safe and effective deployment in the biliary tree. | Device Description: |
| • Delivery system profile: 0.069" (1.75mm) for 5-7mm stent diameters, 0.079" (2.0mm) for 8-10mm stent diameters. | |
| • Delivery method: Rapid Exchange Stent Delivery System. | |
| • Guidewire lumen: 0.014". | |
| • Stent delivery system usable length: 135cm. | |
| • Stent lengths: 20, 30, and 40mm. | |
| • Stent diameters: 5, 6, 7, 8, 9, and 10mm. | |
| • Biocompatibility: All materials are biocompatible (implied to be similar to predicate). | |
| Safety and Effectiveness: Demonstrate similar safety and efficacy profile as the predicate device. | Summary of Substantial Equivalence: "The Cordis Precise™ Rx Nitinol Stent Transhepatic Biliary System is substantially equivalent to the predicate device." (This is the primary "reported performance" for a 510(k)). The FDA letter confirms this and adds specific labeling limitations regarding contraindications and prominence of indications for use to ensure safe application. |
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 (N/A) / Not provided. A 510(k) submission typically does not involve a new clinical "test set" in the sense of a prospective clinical trial. The justification relies on comparison to a predicate device, which would have its own historical data. The document does not describe a new clinical study.
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)
N/A / Not provided. Since there's no new clinical test set described, there's no mention of experts establishing ground truth for a new study.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
N/A / Not provided. No new clinical test set is 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
N/A / Not provided. This device is a physical medical stent, not an AI-assisted diagnostic tool. Therefore, MRMC studies involving human readers and AI assistance are not relevant to this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
N/A / Not provided. As stated above, this is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
N/A / Not provided. For a 510(k) submission of a physical device like a stent, "ground truth" typically refers to the established performance characteristics and safety profile of the predicate device, which would have been determined through prior clinical studies, literature, and real-world experience (often including pathology or patient outcomes data from those predicate studies). The current document does not detail how the predicate's ground truth was established, as it assumes the predicate is well-understood.
8. The sample size for the training set
N/A / Not provided. There is no mention of a "training set" as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
N/A / Not provided. There is no training set for this 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.