(27 days)
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:
- 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.
- 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.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable or provided.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable or provided.
- 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.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No, this is not an AI-driven device.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable or provided for an AI study.
- The sample size for the training set: Not applicable or provided as this is not an AI-driven device.
- How the ground truth for the training set was established: Not applicable or provided as this is not an AI-driven device.
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).