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The Back-Up Meier Steerable Guidewire facilitates catheter placement and exchange during diagnostic or interventional procedures including AAA endovascular graft procedures.

The proposed Back-Up Meier Steerable Guidewires are intended to facilitate catheter placement and exchange during diagnostic or interventional procedures including AAA endovascular graft procedures. The Back-Up Meier Steerable Guidewires are sterile, single-use wirres and are available in different tip shapes with overall wire lengths of 185cm - 300cm. The distal segment of the wire is radiopaque to aid in visualization of the device under fluoroscopy.

The provided text describes a medical device, the "Back-Up Meier Steerable Guidewire," and its 510(k) premarket notification to the FDA. The document focuses on establishing substantial equivalence to a predicate device and does not involve a study with acceptance criteria and device performance as typically understood for AI/ML-based medical devices.

Therefore, many of the requested categories are not applicable to this submission.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: Not explicitly stated in terms of quantitative performance metrics for a study. The "criteria" for this 510(k) submission are related to demonstrating substantial equivalence through bench testing and biocompatibility.

• Reported Device Performance: The document states: "Bench testing and biocompatibility testing were performed to support a determination of substantial equivalence. The results of these tests provide reasonable assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use. No new safety or performance issues were raised during the testing regimen."

  This is a qualitative statement about the outcomes of the tests, not specific performance metrics (e.g., accuracy, sensitivity, specificity) against predefined numerical acceptance criteria.

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

• Sample Size: Not applicable. The submission refers to "bench testing" and "biocompatibility testing," which typically involve a set number of devices or material samples for physical, mechanical, and biological evaluations, not a "test set" of patient data as implied by the question.
• Data Provenance: Not applicable, as there is no patient data involved in this type of submission for this device.

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

• Not applicable. There is no "ground truth" derived from expert consensus on patient data presented in this submission. The evaluation is based on engineering and biological test standards.

4. Adjudication Method for the Test Set:

• Not applicable for the reasons stated above.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

• No. This type of study is not relevant for a guidewire device and its 510(k) submission.

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

• No. This is not an AI/ML algorithm or software device.

7. The Type of Ground Truth Used:

• Not applicable. The "ground truth" for the performance of a guidewire is compliance with established engineering and biocompatibility standards, not clinical outcomes data in the context of an AI/ML algorithm.

8. The Sample Size for the Training Set:

• Not applicable. There is no AI/ML model being trained.

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

• Not applicable for the reasons stated above.

Conclusion based on the provided text:

The submission for the Back-Up Meier Steerable Guidewire is a 510(k) premarket notification demonstrating substantial equivalence to a predicate device. The "study" referenced refers to bench testing and biocompatibility testing to show the device meets requirements for its intended use. This is a much different type of evaluation than what is typically performed for AI/ML devices, and therefore, many of the requested details about acceptance criteria, data sets, and expert evaluations are not present in this document. The FDA's letter (K020283) confirms that the device was found substantially equivalent to the predicate device based on the information provided, which included these tests.

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