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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 placement of 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 included with each sheath. This application addresses changes to the 12F FlexCath sheath tip and valve assembly.

The FlexCath Steerable Sheath & Dilator (K102176) is intended for percutaneous catheter introduction into the vasculature and chambers of the heart. The sheath's deflection facilitates catheter positioning. The predicate devices are K081049 - FlexCath Steerable Sheath & Dilator, Models 3FC10, 3FC12.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state specific sample sizes for each test in the test set. However, it mentions "representative finished sterilized samples" were used for in vivo, ex vivo animal testing, biocompatibility, and mechanical testing. The data provenance is primarily through a series of standardized tests (ISO, USP, AAMI TIR). The source of the animal models for in vivo testing is not specified, but the human cells for hemolysis testing and canine for thrombogenicity testing are mentioned. It is implicitly a prospective study since testing was performed on the modified device to demonstrate performance.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not applicable. This is a medical device, and the "ground truth" for performance is established through adherence to engineering standards and physical/biological test results, not expert interpretation of data.

4. Adjudication Method for the Test Set

Not applicable. This is a medical device, and the "adjudication" is based on meeting predefined technical and biological specifications outlined in the referenced standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done as this is a medical device and not an AI-assisted diagnostic tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, the device performance was evaluated in a standalone manner through various functional, mechanical, and biocompatibility tests. There is no "human-in-the-loop" aspect to these performance assessments, as they measure the intrinsic properties and behavior of the device itself.

7. The Type of Ground Truth Used

The ground truth used for this device's acceptance is based on an objective assessment of physical and biological properties against established industry standards and regulatory guidance. This includes:

• Engineering standards compliance: ISO 11070 for mechanical tests.
• Biocompatibility standards compliance: ISO 10993 series and USP 33 <661>.
• Effectiveness of sterilization: AAMI TIR28:2001.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI/algorithm-based system requiring a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As there is no training set, there is no ground truth established for one.

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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:

1. 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.
2. 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.
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 available in this document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not available in this document.
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 available in this document. This device is a steerable sheath, not an AI or software device that would assist human readers in interpretation.
6. 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.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not available in this document.
8. The sample size for the training set: Not applicable. This is a physical medical device, not an AI/ML algorithm requiring a training set.
9. How the ground truth for the training set was established: Not applicable. This is a physical medical device, not an AI/ML algorithm.

Ask a specific question about this device

The FlexCath™ Steerable Sheath & Dilator 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 text does not contain any information about acceptance criteria or a study proving device performance for the FlexCath™ Steerable Sheath & Dilator.

The document is a 510(k) summary, which is a premarket notification for a medical device seeking substantial equivalence to a predicate device. It primarily focuses on the device description, intended use, and a comparison of technological characteristics to predicate devices. There is no mention of clinical studies, performance endpoints, sample sizes, expert involvement, or statistical analyses that would typically be associated with proving device performance against acceptance criteria.

Therefore, I cannot populate the requested table or answer the specific questions because the information is not present in the provided text.

Ask a specific question about this device