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The MRWire Guide Wire is intended to direct a catheter to the desired anatomical location in the vasculatory system during diagnostic or interventional procedures.

The MRWire Guide Wire is a sterile, disposable guide wire for the introduction and/or placement of diagnostic or interventional devices. The MRWire is constructed from a high strength core composite of glass fibers and polymers, protected by a high-strength aramid fiber mantle. The distal tip of the MRWire is marked with discrete ring markers for MRI visibility and comes in different configurations such as straight and angled. Additionally, the Pebax® tip extrusion, contains BaSO4 for X-Ray visibility.

Guide wires are supplied sterile and non-pyrogenic. The MRWire's diameter is 0.035" (0.89 mm).

The provided document is a 510(k) summary for the MRWire Guide Wire. It details the device, its intended use, and a comparison with a predicate device to demonstrate substantial equivalence. However, it does not describe a study involving an AI algorithm or human readers for diagnostic performance. Therefore, many of the requested fields, particularly those related to AI model evaluation, ground truth establishment, expert consensus, and MRMC studies, cannot be directly addressed from this document.

Here's an analysis of the provided text in relation to your request:

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

The document lists performance tests, implying certain acceptance criteria were met for each, but it does not quantitatively define these criteria or provide specific numerical results for each test. Instead, it offers a qualitative statement of substantial equivalence.

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

• Preclinical: Swine model, unspecified sample size. Data provenance: Department of Cardiology (Johns Hopkins Division of Medicine), USA (implied as Johns Hopkins is in the US). Prospective testing.
• Clinical: Patients with congenital heart disease, unspecified sample size. Data provenance: German Heart Centre in Munich (Germany). Prospective (ongoing Post-Market Clinical Follow-up study).

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 applicable. The document describes device performance testing, not an AI algorithm requiring expert-established ground truth for diagnostic accuracy. The "ground truth" here is the physical performance and safety of the device itself, observed by researchers and clinicians.

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

Not applicable. This is not an AI diagnostic study.

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 applicable. This is a medical device clearance document, not an AI performance study.

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

Not applicable. There is no AI algorithm discussed.

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

The "ground truth" for the device can be considered:

• Physical measurements (e.g., tensile strength, dimensions) compared against design specifications and industry standards.
• Direct observation of device maneuverability and visibility during preclinical (swine) and clinical use.
• Physiological stability of subjects during preclinical testing.
• Safety and effectiveness observations in clinical use.

8. The sample size for the training set

Not applicable. This is not an AI algorithm study. There is no training set mentioned.

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

Not applicable. There is no training set or AI algorithm discussed.

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