(86 days)
The Cordis 4F Nylex Angiographic Catheters are intended for the delivery of radiopaque contrast medium to selected sites in the vasculature.
The catheter is a 4F diameter single lumen catheter with a radiopaque tip.
This document describes a premarket notification (510(k)) for a medical device: the Cordis 4F Nylex Angiographic Catheter Modification.
Based on the provided text, the device is a simple, low-risk peripheral angiographic catheter. The submission focuses on biocompatibility and substantial equivalence to previously marketed devices. There is no mention of an AI component, an algorithm, or any performance metrics that would require a study with acceptance criteria in the manner you've described for AI/diagnostic systems.
Therefore, I cannot provide the information requested in your prompt regarding acceptance criteria and a study that proves the device meets them, as those concepts are not applicable to this particular device and its 510(k) submission as presented.
Here's why each of your requested points is not present or applicable:
- 1. A table of acceptance criteria and the reported device performance: This document states: "Performance standards have not been established by the FDA under section 514 of the Food, Drug and Cosmetic Act." For this type of device, substantial equivalence is typically demonstrated through comparison to a predicate device's design, materials, and intended use, rather than through quantitative performance metrics with specific acceptance criteria like accuracy for an AI system.
- 2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): No such test set or data is mentioned, as there's no algorithm or diagnostic performance being evaluated.
- 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.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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 is not an AI device.
- 6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an algorithm.
- 7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable.
- 8. The sample size for the training set: Not applicable.
- 9. How the ground truth for the training set was established: Not applicable.
The "study" mentioned for this device is the successful performance of biocompatibility tests per ISO 10993-1, which is a standard for evaluating the biological effects of medical devices. This confirms the safety of the materials used, rather than a performance study in the context you've outlined.
In summary, the provided text describes a traditional medical device (catheter) undergoing a 510(k) submission, not an AI or diagnostic device that would involve the type of performance studies and acceptance criteria you've specified.
§ 870.1200 Diagnostic intravascular catheter.
(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).