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Hi-Torque guide wires are indicated to facilitate the placement of percutaneous devices during Percutaneous Transluminal Angioplasty (PTA) in peripheral arteries such as femoral, poplited anteries. This guide wire may also be used with compatible stent devices during therapeutic procedures.

The Hi-Torque Connect guidewire range are disposable medical devices designed for single use only. They consist of a PTFE coated 0.018" diameter stainless steel core wire, one end of which is reduced in diameter 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. Each of these 3 levels of support are provided in 3 different length options (145cm - 300cm)

The provided text is related to a 510(k) premarket notification for a medical device called "Hi Torque Connect Guidewire." This document focuses on demonstrating the substantial equivalence of a modified device to a previously cleared predicate device, rather than presenting a study of an AI algorithm's performance or a diagnostic device.

Therefore, many of the requested elements (like sample size for test/training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, or specific ground truth types) are not applicable to this type of regulatory submission, as it deals with a physical medical device and its mechanical/material properties.

However, I can extract the acceptance criteria and performance data related to the device's physical properties.

Here's an analysis based on the information provided:

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

The document states that a design change involved a new PTFE coating for the guidewire. The performance testing was conducted to demonstrate the equivalence of the modified design to the existing design and to ensure the new coating does not adversely affect performance.

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

• Sample Size: The document does not specify the exact sample sizes (number of guidewires or test repetitions) for each bench test. It generally refers to "bench tests" being carried out.
• Data Provenance: The tests were "In vitro bench tests." The company, Lake Region Medical Limited, is located in Ireland. Therefore, the testing was likely conducted in Ireland or by designated testing facilities on behalf of the Irish manufacturer. The data is prospective as it was generated specifically for this 510(k) submission.

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

This is not applicable. The "ground truth" here is the performance of the guidewire against established engineering and material specifications, and comparison to the predicate device. This is determined by quantitative bench testing, not expert interpretation.

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

This is not applicable as the tests are quantitative bench tests, not qualitative assessments 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 is not applicable. This is a physical medical device (guidewire), not an AI algorithm for diagnostic imaging or similar application.

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

This is not applicable. This is a physical medical device.

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

The "ground truth" for this medical device's performance is based on established engineering and material specifications, as well as the performance characteristics of the previously cleared predicate device (K112381, cleared Nov 3, 2011). The tests also referenced the FDA's guidance document "Coronary and Cerebrovascular Guidewire Guidance, Jan 1995". This is a combination of:
* Engineering Specifications: Defined product specifications for the guidewire's physical and mechanical properties.
* Predicate Device Performance: Performance data from a legally marketed device used as a benchmark for substantial equivalence.
* Regulatory Guidance: Adherence to recognized testing methods and performance expectations outlined in FDA guidance.

8. The sample size for the training set

This is not applicable. This is not an AI/machine learning device that requires a training set.

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

This is not applicable.

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