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Intended to facilitate the delivery of catheter-based interventional devices during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). This guide wire may be used with compatible stent devices during therapeutic procedures. The guide wire may be used to reach and cross a target lesion, provide a pathway within the vessel structure, facilitate the substitution of one diagnostic or interventional device for another, and to distinguish the vasculature.

The Hi-Torque Vektor Guide Wire is a 0.014" (0.36 mm) diameter steerable guide wire available in several lengths and has a shapeable distal tip. Refer to the product label for product specifications (e.g. wire length, diameter and length of tip radiopacity).

The Hi-Torque Vektor Guide Wires have a modified proximal end that permits the attachment of the DOC Guide Wire Extension. Refer to the product label for Guide Wire Extension system compatibility. Joining the guide wire extension to the guide wire facilitates the exchange of one interventional device for another, while maintaining guide wire position in the anatomy. After the interventional device exchange has been completed, the extension can be detached and the guide wire can be used in its original capacity.

Brachial and femoral markers located on the proximal segment of the 0.014" (0.36 mm) Hi-Torque Vektor guide wire aid in gauging guide wire position relative to the guiding catheter tip when using bare wire technique. These Hi-Torque Vektor guide wires are compatible with guiding catheters that are at least 90 cm (brachial) or 100 cm (femoral) long.

When wet, a hydrophilic coating increases the lubricity of the Hi-Torque Vektor guide wire surface. This coating contains highly purified hyaluronic acid (HA).

Principles of Operation: The Hi-Torque Vektor guidewire is operated manually by a manual process.

The provided document describes the predicate device comparison and performance testing for the "Hi-Torque Vektor Guidewire Family" to demonstrate substantial equivalence to its predicate devices, rather than a study proving the device meets general acceptance criteria in the context of AI/ML performance evaluation. The document is for a traditional medical device (a guidewire) and not an AI/ML powered device. Therefore, many of the requested criteria related to AI/ML performance (e.g., sample size for test set, expert qualifications for ground truth, MRMC study, effect size of AI assistance, standalone performance, training set size) are not applicable or extractable from this document.

However, I can extract information related to the acceptance criteria and performance of the device based on the provided text, focusing on the bench testing conducted to demonstrate equivalence.

Here's a summary of the applicable information:

1. A table of acceptance criteria and the reported device performance

The document states that "The results from these performance evaluations demonstrated that the Hi-Torque Vektor Guidewire range met the acceptance criteria defined in the product specification and performed comparably to the predicate device(s)."

The acceptance criteria themselves (e.g., specific values for tensile strength, torque strength) are not explicitly detailed in the provided text. Instead, the performance is reported in relation to the predicate devices and internal product specifications. The table below outlines the tested parameters and the reported performance relative to the predicate devices.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document describes in vitro bench tests. No specific sample sizes for each test are provided, nor is information on data provenance in terms of country of origin or retrospective/prospective nature, as these are not relevant for bench testing of a physical device.

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

This question is not applicable. Ground truth for these physical performance tests (e.g., tensile strength, lubricity) is established by standardized test methods and instrumentation, not by expert consensus or clinical assessment.

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

This question is not applicable, as ground truth is based on objective physical measurements and established test methods, not subjective assessment 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

This question is not applicable. The device is a guidewire, a physical medical device, not an AI/ML-powered diagnostic or assistive tool. "Human readers" and "AI assistance" are not relevant to this submission.

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

This question is not applicable, as the device is a guidewire and does not involve algorithms or AI.

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

The ground truth for the performance evaluations (bench tests) is based on the results generated by standardized in vitro test methods and comparison to predefined product specifications and the performance of "legally marketed predicate devices."

8. The sample size for the training set

This question is not applicable, as the device does not involve machine learning or a training set.

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

This question is not applicable, as the device does not involve machine learning or a training set.

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The HydraView Polymer Guidewires are intended for use in the coronary and peripheral vasculature to facilitate the selective placement of interventional devices with compatible guidewire lumen and compatible coronary venous leads.

The HydraView Guidewire is a disposable medical device designed for single use only. It consists of a PTFE coated 190cm, 0.014" diameter stainless steel core wire, one end of which is reduced in diameter over a 30cm approx. segment in a progressive fashion through a centreless grinding operation. The profile of this reduced section affords the product a reduced area of stiffness and is varied to produce 3 unique levels of support; ES, DS and EDS.

The provided text is a 510(k) summary for the HydraView Polymer Guidewire and contains information about its equivalence to predicate devices based on non-clinical performance testing. It is not a study proving a device meets acceptance criteria related to an AI algorithm or diagnostic performance. Therefore, I cannot extract the specific information requested in your prompt regarding AI performance, human readers, ground truth establishment, or sample sizes for AI training/test sets.

However, I can extract information related to the non-clinical performance testing for the HydraView Polymer Guidewire, which serves as the "study" in this context to demonstrate substantial equivalence to its predicate devices.

Here's an interpretation of the available information in the context of your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that in-vitro bench tests were carried out to demonstrate equivalence. While explicit acceptance criteria and specific numerical reported performance values are not detailed in this summary, the following table lists the tests performed, implying that the acceptance criterion for each was "comparable to predicate devices" or "conformance to requirements for intended use." The reported performance is that the device met these implied criteria.

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

This document describes bench testing of a medical device, not an AI algorithm. Therefore, "test set" and "data provenance" in the context of clinical data are not applicable. The evaluations were in-vitro (bench tests). The sample sizes for each specific bench test (e.g., number of guidewires tested for tensile strength) are not provided in this summary.

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

This information is for AI algorithm validation, which is not described here. For mechanical device testing, "ground truth" is typically established by engineering specifications, validated test methods, and comparison against established predicate device performance. Experts would be involved in designing and executing the tests and interpreting the engineering data, but their "number" and "qualifications" in the sense of clinical ground truth establishment are not relevant or provided.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

This is for clinical data adjudication in AI studies and is not applicable to the bench testing described.

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

This is for AI algorithm clinical studies and is not applicable to the bench testing described.

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

This is for AI algorithm performance and is not applicable to the bench testing described.

7. The Type of Ground Truth Used

For this device, the "ground truth" is based on:

• Engineering Specifications and Performance Standards: The tests were conducted "with reference to the FDA's guidance document 'Coronary and Cerebrovascular Guidewire Guidance, Jan 1995'."
• Predicate Device Performance: The primary comparison for demonstrating substantial equivalence was against the performance of the Streamer Guidewire and Charter Guidewire (predicate devices). This means the established, safe, and effective performance of the predicate devices served as the benchmark.

8. The Sample Size for the Training Set

This is for AI algorithms and is not applicable to the bench testing described.

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

This is for AI algorithms and is not applicable to the bench testing described.

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The Brivant guide wires are intended for use in the coronary and peripheral vasculature.

The Brivant Guidewire is a disposable medical device designed for single use only. It consists of a 0.014" or 0.018" diameter stainless steel core wire, one end of which is reduced in diameter over the distal coil segment in a progressive fashion. The Brivant Guidewire is produced in lengths of 175, 195 and 300cm and is available in either silicone or hydrophilic coatings. The profile of the reduced section is varied to provide a range of products of mixed stiffness.

The provided document describes a 510(k) premarket notification for the "Brivant Guidewire," a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel effectiveness through clinical trials or studies analyzing AI performance. Therefore, the information requested regarding acceptance criteria, device performance tables, sample sizes for test/training sets, expert qualifications, ground truth methods, MRMC studies, and standalone AI performance is not applicable to this submission.

The document states that "Performance testing involving the following testing has been completed tensile strength, torque strength, torque response, coating performance, radiopacity, packaging qualification (including accelerated aging), sterilization, tip flexibility, catheter compatibility testing and biocompatibility testing in compliance with ISO 10993-1 has been successfully completed. The successful tests demonstrated the Brivant Guidewires consistently performed within their design parameters, are safe and effective and perform as well as the predicate devices."

This indicates that internal engineering and bench testing was conducted to ensure the device met its design specifications and relevant safety standards, allowing it to perform "as well as the predicate devices" in terms of functional effectiveness. However, no specific acceptance criteria thresholds or reported performance values from these tests are detailed in the summary. The "study" here refers to this suite of non-clinical performance and safety tests, not a clinical trial involving human patients or an AI performance evaluation.

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