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The JOSTENT SelfX is intended for use in the palliation of malignant strictures in the biliary tree.

The JOSTENT SelfX Biliary Stent consists of a self-expanding Nitinol stent mounted on a catheter delivery system. The stent will be available in lengths of 44 and 68 mm and diameters of 6, 8, and 10 mm. The delivery system has a usable length of 75 cm and is compatible with 0.035" diameter guidewires and 7F introducers.

The provided text describes a 510(k) summary for the JOSTENT® SelfX Biliary Stent, which is a medical device. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than conducting a de novo study with strict acceptance criteria and performance metrics against a defined ground truth.

Therefore, many of the requested elements for a study proving acceptance criteria are not directly applicable or available in this document. The submission is primarily based on performance data from bench and biocompatibility testing to show equivalence, rather than a clinical study evaluating specific performance criteria against a ground truth.

Here's an attempt to address your request based on the available information, noting where information is not present in the document.

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) submission for substantial equivalence, formal "acceptance criteria" for clinical performance as might be seen in a de novo clinical trial are not explicitly stated in this summary. The "performance data" mentioned refers to bench and biocompatibility testing. The "reported device performance" is essentially the finding of substantial equivalence based on these tests and comparison to predicate devices.

2. Sample size used for the test set and the data provenance

• Sample Size: Not applicable/not provided for a "test set" in the context of clinical performance. The document refers to "bench and biocompatibility testing," which would have their own sample sizes for material and mechanical tests, but these are not specified.
• Data Provenance: Not applicable for clinical data. Bench and biocompatibility testing data would typically be generated in a lab setting, details of which are not provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• This is not applicable as there is no clinical "test set" for which ground truth was established by experts in this 510(k) summary. The submission relies on equivalence to devices already accepted as safe and effective.

4. Adjudication method for the test set

• Not applicable, as no clinical test set requiring expert adjudication 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

• Not applicable. This device is a physical stent system, not an AI-assisted diagnostic tool, so an MRMC study related to AI assistance would not be relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable. This device is a physical stent system, not a software algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Not applicable for a clinical ground truth. The "ground truth" for this 510(k) relies on the established safety and effectiveness of the predicate devices and the demonstration of equivalence through non-clinical (bench and biocompatibility) data.

8. The sample size for the training set

• Not applicable. There is no "training set" in the context of an AI/algorithm. For the bench and biocompatibility testing, specific sample sizes would have been used for different tests (e.g., number of stents tested for radial force, number of samples for material characterization), but these details are not provided in the summary.

9. How the ground truth for the training set was established

• Not applicable. As there is no training set for an AI/algorithm, there is no corresponding ground truth to be established.

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The Fox PTA Catheter is intended for dilatation of lesions in the femoral, renal, iliac, popliteal, peroneal, and profunda arteries and native or synthetic arteriovenous dialysis fistulae.

The JOSTENT® Fox PTA Catheter consists of a double lumen catheter with a balloon located at the distal tip. The catheter will be available with balloon diameters of 3.0 - 12.0 mm and balloon lengths of 20 - 80 mm. The catheter will be available in lengths of 75 and 135 cm. The catheter is compatible with 0.035" diameter guidewires.

The provided document describes a JOMED Fox PTA Catheter, a Peripheral Transluminal Angioplasty Catheter. The submission is a 510(k) premarket notification, which means the device claims substantial equivalence to legally marketed predicate devices, rather than seeking approval through a Premarket Approval (PMA) application that would typically require extensive clinical trials.

Therefore, the information you're requesting regarding acceptance criteria and performance studies, particularly in the context of AI and human readers, is not present in this document. This document focuses on demonstrating substantial equivalence through bench, biocompatibility, and design control activities, which are typical for Class II medical devices like a PTA catheter.

Here's why the document doesn't contain the requested information:

• Type of Device: A Peripheral Transluminal Angioplasty Catheter is a physical medical device used for dilatation. It is not an AI/ML-driven diagnostic or assistive tool.
• Regulatory Pathway (510(k)): The 510(k) pathway for medical devices emphasizes substantial equivalence to existing devices. This usually involves demonstrating that the new device has the same intended use, technological characteristics, and performs as safely and effectively as a predicate device, often through non-clinical testing (bench, biocompatibility, design control). Extensive clinical studies, especially those involving AI performance comparisons with human readers, are not typically required for a 510(k) submission unless there are significant technological differences or new indications for use that raise new questions of safety or effectiveness.
• Date: The document is dated 2002, long before the widespread development and regulatory considerations for AI/ML in medical devices.

Based on the provided text, I cannot extract the information required for your questions about acceptance criteria and study details related to AI performance. The document states:

• Acceptance Criteria/Performance Data: "Bench, biocompatibility, and design control activities demonstrate the safety and effectiveness of the Fox PTA Catheter."
• Study Details: There are no details on sample size, data provenance, expert panels, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment because these types of studies are not relevant to demonstrating substantial equivalence for this type of physical device under the 510(k) pathway as described.

To directly answer your request based on the lack of this information in the provided text:

1. A table of acceptance criteria and the reported device performance: Not explicitly provided in a quantifiable table as requested for AI performance. The general acceptance criteria are that the device demonstrates safety and effectiveness through bench, biocompatibility, and design control activities, and is substantially equivalent to predicate devices.
2. Sample size used for the test set and the data provenance: Not applicable or provided as no clinical trial data of this nature were presented.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable or provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable or provided.
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, an MRMC study was not done as this is not an AI-driven device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No, this is not an AI-driven device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable or provided for an AI study.
8. The sample size for the training set: Not applicable or provided as this is not an AI-driven device.
9. How the ground truth for the training set was established: Not applicable or provided as this is not an AI-driven device.

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