(23 days)
The PowerFlex Extreme PTA balloon catheter is indicated for dilatation of stenoses in iliac, femoral, ilio-femoral, popliteal, infra-popliteal and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
The Cordis PowerFlex Extreme PTA balloon catheter is a dual lumen design with a distal inflatable balloon. Two radiopaque marker bands indicate the dilating section of the balloon and aid in the balloon placement.
The provided text does not contain specific acceptance criteria or a detailed study description with performance metrics for the POWERFLEXTM EXTREME PTA Catheter. Instead, it details its 510(k) premarket notification and substantial equivalence to a predicate device.
Here's an analysis based on the information provided, highlighting what is present and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance:
No specific "acceptance criteria" (e.g., a specific percentage of success, or a defined performance threshold for a particular metric) nor quantitative "reported device performance" are mentioned in the provided text. The document states:
"The safety and effectiveness of the Cordis PowerFlex Extreme PTA Balloon Catheter have been demonstrated via data collect from non-clinical design verification tests and analyses."
This indicates that internal design verification tests were conducted, but their specific criteria and results are not shared in this document.
2. Sample Size Used for the Test Set and Data Provenance:
No information is provided regarding:
- The sample size used for any test set (e.g., number of patients, number of arteries, number of fistulae, or number of devices tested in a clinical setting).
- The data provenance (e.g., country of origin, retrospective or prospective). The document only mentions "non-clinical design verification tests and analyses," implying laboratory or bench testing rather than clinical data.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
Not applicable. As no clinical study results or clinical ground truth are discussed, there's no mention of experts establishing ground truth. The "non-clinical design verification tests" would typically rely on engineering specifications and direct measurements rather than expert consensus on clinical findings.
4. Adjudication Method for the Test Set:
Not applicable. Since no clinical test set or subjective interpretations are discussed, there's no mention of an adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No. There is no mention of an MRMC study or any study comparing human readers with and without AI assistance. This device is a physical medical device (balloon catheter), not an AI-powered diagnostic tool.
6. Standalone Performance:
Yes, in a way. The "non-clinical design verification tests and analyses" describe the standalone performance of the device against its design specifications and safety requirements. However, specific metrics are not provided. The performance is assessed based on the device's physical and functional properties (e.g., balloon inflation, pressure resistance, catheter trackability, material biocompatibility), not an algorithm's output.
7. Type of Ground Truth Used:
For the "non-clinical design verification tests and analyses," the 'ground truth' would be engineering specifications, material standards, and validated test methods. For example, balloon burst pressure would be compared against a defined specification, or material biocompatibility against an established standard. It's not clinical pathology, outcomes data, or expert consensus in the typical sense.
8. Sample Size for the Training Set:
Not applicable. This is a physical medical device, not an AI/machine learning algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for this type of device.
Summary of available information related to performance:
The document primarily focuses on establishing "substantial equivalence" of the POWERFLEX EXTREME PTA Catheter to its predicate device, the Cordis PowerFlex Plus PTA Balloon Catheter. The "performance data" section states:
"The safety and effectiveness of the Cordis PowerFlex Extreme PTA Balloon Catheter have been demonstrated via data collect from non-clinical design verification tests and analyses."
This indicates that the device's performance was evaluated through bench testing and laboratory analyses to ensure it met design specifications and safety requirements, aligning with the performance of its predicate. However, detailed results, specific acceptance criteria (e.g., "burst pressure must be >X psi" or "insertion force must be
§ 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).