(74 days)
The FlexCath® Steerable Sheath is intended for percutaneous catheter introduction into the vasculature and into the chambers of the heart. The Sheath deflection facilitates catheter positioning.
The FlexCath® Steerable Sheath is a deflectable catheter introducer used to facilitate placing a catheter through the skin into the artery or vein.
It is comprised of the following two (2) main sections: the shaft and the handle. A dilator is also part of the package.
The provided document is a 510(k) summary for the CryoCath Technologies Inc. FlexCath® Steerable Sheath & Dilator. This type of regulatory submission is for medical devices and focuses on demonstrating substantial equivalence to a legally marketed predicate device.
Based on the nature of this document, it describes the device and its intended use, and states that substantial equivalence has been demonstrated through bench testing and biocompatibility testing where dimensional and material differences existed. It does not contain information about clinical studies with acceptance criteria, human reader performance, or ground truth establishment in the way typically associated with AI/software devices.
Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth from this document. The document states:
- "Information submitted in this Special 510k for the FlexCath® Steerable Sheath and Dilator is substantially equivalent to the predicate devices listed."
- "Where dimensional and material differences exist between the proposed device and the predicate devices, bench testing and biocompatibility testing demonstrated that these differences do not adversely affect safety and effectiveness."
This indicates that the "performance testing" referenced was likely bench testing and biocompatibility testing, and not a clinical study involving the detailed metrics you've asked for.
Therefore, here's a direct response to your points based only on the provided text:
- A table of acceptance criteria and the reported device performance: Not available in this document. The document states substantial equivalence was demonstrated through bench and biocompatibility testing, not clinical performance metrics.
- Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not available in this document. The document refers to bench and biocompatibility testing, not a test set of data.
- 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 available in this document.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not available in this document.
- 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 available in this document. This device is a steerable sheath, not an AI or software device that would assist human readers in interpretation.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not available in this document. This device is a physical medical device, not an algorithm.
- The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not available in this document.
- The sample size for the training set: Not applicable. This is a physical medical device, not an AI/ML algorithm requiring a training set.
- How the ground truth for the training set was established: Not applicable. This is a physical medical device, not an AI/ML algorithm.
§ 870.1280 Steerable catheter.
(a)
Identification. A steerable catheter is a catheter used for diagnostic and monitoring purposes whose movements are directed by a steering control unit.(b)
Classification. Class II (performance standards).