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The Merit Hydrophilic Guide Wire is intended to be used in the peripheral vascular system to facilitate the placement of devices during diagnostic and interventional procedures.

The Merit Hydrophilic Guide Wire consists of a jacketed core wire with a hydrophilic coating applied to the jacket. The wire will be offered in straight, angled, standard and stiff configurations, in various lengths.

The provided text describes a 510(k) premarket notification for the "Merit Hydrophilic Guide Wire." This document is a regulatory submission demonstrating substantial equivalence to a predicate device, not a study proving the device meets specific acceptance criteria in the sense of a clinical or academic study reporting performance metrics like sensitivity, specificity, or reader improvement with AI.

Instead, the document details a series of engineering and biocompatibility tests conducted to show that the new device (Merit Hydrophilic Guide Wire with a "Benzene Free" coating material) performs comparably to its predicate device (Merit Hydrophilic Guide Wire with the previous coating material) and meets established industry standards and FDA guidance.

Therefore, many of the requested items related to "AI performance," "ground truth," "expert adjudication," and "effect size of human readers with AI assistance" are not applicable to this type of device submission.

Here's an analysis based on the provided text, focusing on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that a "battery of testing was conducted in accordance with protocols based on requirements outlined in guidance's and industry standards and these were shown to meet the acceptance criteria that were determined to demonstrate substantial equivalence." However, it does not provide the specific numerical acceptance criteria or quantitative performance results for each test. It only lists the types of tests performed and states that all tests were "successfully completed" and "met the predetermined acceptance criteria."

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

• Test Set Sample Size: The document mentions that "Most of the performance testing was performed on the 0.018" and 0.038" diameter wires only, as these represent the minimum and maximum wire diameters within the cleared device range... The exception to this is Biocompatibility, where the 0.035" OD variant of the wire was chosen for testing." The exact number of units tested for each specific test is not provided.
• Data Provenance: The tests are conducted internally by Merit Medical Systems, Inc. (or related entities). This is a manufactured product, so the "data provenance" refers to the results of in-vitro and potentially in-vivo (for biocompatibility, such as the canine thrombolysis study) testing. The document does not specify the country of origin for the testing facilities, but the company itself has addresses in the US and Ireland. The testing is prospective in the sense that it's performed specifically for this submission.

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

Not applicable. This is a medical device engineering and biocompatibility assessment, not an AI performance study requiring expert ground truth for interpretation of medical images or data. The "ground truth" here is established by the standardized test methods themselves and their predefined pass/fail criteria.

4. Adjudication Method for the Test Set

Not applicable. There is no expert adjudication in this type of testing. The results are physical/chemical measurements or biological responses against established criteria.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This is not an AI device, and therefore no MRMC study was performed comparing human readers with and without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. This is not an AI algorithm. The device, a guide wire, is used directly by a human clinician.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance validation is:

• Engineering Standards and Specifications: Adherence to defined physical, mechanical, and functional specifications established by industry standards (e.g., ISO, ASTM) and FDA guidance for guide wires.
• Biocompatibility Standards: Compliance with established biological safety standards (e.g., ISO 10993 series) for medical devices.
• Comparative Performance to Predicate: Demonstrating that the subject device performs comparably to the legally marketed predicate device (K141295) in various performance attributes.

8. The Sample Size for the Training Set

Not applicable. This is not an AI algorithm, so there is no training set in the machine learning sense.

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

Not applicable, as there is no AI training set.

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