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The Flexor® Radial Hydrophilic Introducer Access Set is intended to introduce diagnostic and interventional devices in radial artery access procedures.

The Flexor® Radial Hydrophilic Introducer Access Set is an introducer set, supplied with an introducer sheath, dilator, wire guide and access needle. The introducers are available in whole French sizes from 4.0 through 7.0 French and in lengths of 7, 13 and 23 centimeters. The sets are compatible with the supplied 0.018" wire guide. The sets are supplied sterile and intended for one-time use.

This document describes a 510(k) premarket notification for the "Flexor® Radial Hydrophilic Introducer Access Set" and its substantial equivalence to a predicate device. However, it does not contain a detailed study with specific acceptance criteria and performance data in the format requested.

The document states that the Flexor® Radial Hydrophilic Introducer Access Set met applicable design and performance requirements and that predetermined acceptance criteria were met for acute performance, check-flo valve leakage, and biocompatibility. However, it does not provide the specific numerical acceptance criteria or the reported device performance metrics.

Therefore, I cannot fulfill the request for a table of acceptance criteria and reported device performance, nor can I provide information about sample sizes for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, types of ground truth, training set sample size, or how training set ground truth was established, as this information is not present in the provided text.

The closest information available is:

• Device: Flexor® Radial Hydrophilic Introducer Access Set
• Intended Use: To introduce diagnostic and interventional devices in radial artery access procedures.
• Predicate Device: Flexor® Radial Hydrophilic Introducer Access Set (cleared under 510(k) number K132592).
• Reason for new submission: Modification of the check-flo valve in response to physician feedback.
• Tests performed:
  • Acute Performance
  • Check-Flo valve liquid leakage testing
  • Biocompatibility testing (cytotoxicity, sensitization, intracutaneous reactivity, systemic toxicity, pyrogen, hemocompatibility, complement activation, partial thromboplastin time, and thromboresistance in conformance with ISO 10993-1:2009).
• Outcome of tests: Predetermined acceptance criteria were met for all tests, supporting a determination of substantial equivalence.

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The Flexor® Radial Hydrophilic Introducer Access Set is introduce diagnostic and interventional devices in radial arterv access procedures.

The Flexor Radial Hydrophilic Introducer Access Set is comprised of an introducer sheath, a dilator, a wire guide, and an access needle.

This document describes the Cook, Inc. Flexor® Radial Hydrophilic Introducer Access Set (K132592). It details the testing conducted to demonstrate substantial equivalence to predicate devices, focusing on the quality and performance of the device components.

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance:

The provided document details various performance and laboratory tests. However, it does not specify sample sizes for each test set, nor does it mention data provenance (e.g., country of origin, retrospective or prospective data). These tests appear to be bench and laboratory-based assessments of the device's physical and biological properties.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided in the document. The tests described are primarily engineering and laboratory evaluations, not clinical studies requiring expert ground truth establishment in the traditional sense (e.g., for image interpretation).

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

This information is not applicable or not provided. The listed tests are objective, quantifiable physical and biological tests, not subjective interpretations requiring adjudication.

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 document describes a medical device (introducer access set), not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study assessing human reader improvement with AI assistance is not relevant and was not conducted.

6. If a standalone (i.e., algorithm only without human-in-the loop performance) was done:

No. This document describes a physical medical device. The concept of "standalone algorithm only" performance is not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" for the tests performed is based on established engineering standards (e.g., BS EN ISO 11070:1999, EN ISO 9626:1995), biocompatibility standards (e.g., ISO 10993-1:2009), and internal predetermined acceptance criteria derived from the device's intended use and design specifications. These are objective measures rather than expert consensus, pathology, or outcomes data.

8. The sample size for the training set:

This refers to a training set for machine learning or AI models. Since this is a physical medical device and not an AI/ML product, there is no "training set" in this context.

9. How the ground truth for the training set was established:

As there is no training set for an AI/ML model, this question is not applicable.

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