Search Results

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.

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.

Ask a specific question about this device

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:

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.

Ask a specific question about this device