(14 days)
The Conquest™ PTA Balloon Dilatation Catheter is recommended for use in Percutaneous Transluminal Angioplasty of the femoral, iliac, and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also recommended for post-dilatation of stent grafts in the peripheral vasculature. This catheter is not for use in coronary arteries.
The Conquest™ PTA Balloon Dilatation Catheter is composed of a coaxial lumen catheter. One lumen accommodates a guidewire for catheter tracking and the second provides a channel for balloon inflation/deflation. A composite balloon is mounted onto the distal tip of the catheter. During use, the balloon position in the vessel is identified by two radiopaque platinum iridium marker bands that indicate the working length of the balloon and aid in placement.
The provided text describes the regulatory clearance of the Conquest™ PTA Balloon Dilatation Catheter and its substantial equivalence to predicate devices. However, it does not contain specific details about a study conducted to demonstrate the device meets acceptance criteria.
Instead, the document states:
"The subject device, the Conquest™ PTA Balloon Dilatation Catheter, met all the predetermined acceptance criteria of design verification and validation as specified by applicable standards, guidance, test protocols and/or customer inputs."
This indicates that internal design verification and validation activities were performed, but the document does not provide the specifics of these studies in the format requested. Therefore, most of the requested information cannot be extracted from the given text.
Here is what can be inferred or stated based on the provided document:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly detailed in specific measurable terms. The document vaguely refers to "predetermined acceptance criteria of design verification and validation as specified by applicable standards, guidance, test protocols and/or customer inputs."
- Reported Device Performance: Not explicitly detailed. The document only concludes that the device, "met all the predetermined acceptance criteria."
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not provided. The document does not describe a clinical study or a specific "test set" in the context of data used for performance claims. It only mentions design verification and validation.
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)
- Not applicable/Not provided. Ground truth establishment by experts is typically relevant for studies involving the interpretation of medical images or diagnostic outputs. This document concerns a medical device (balloon catheter) and its mechanical and functional specifications, not an AI or diagnostic imaging device requiring expert ground truth in this context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not provided. Adjudication methods are relevant for expert consensus in diagnostic studies.
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. This is a medical device (catheter) clearance, not an AI-assisted diagnostic or imaging device. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant or described.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not provided. Given the nature of the device (PTA Balloon Dilatation Catheter), "ground truth" would likely relate to engineering specifications, material properties, mechanical performance (e.g., burst pressure, inflation/deflation times, guidewire compatibility), biocompatibility, and sterilization effectiveness. These would be assessed through various engineering tests and possibly preclinical animal studies, but the specifics are not detailed in this summary.
8. The sample size for the training set
- Not applicable. The document describes a medical device, not a machine learning model.
9. How the ground truth for the training set was established
- Not applicable. The document describes a medical device, not a machine learning model.
§ 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).