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The Medtronic ConfidaTM Brecker Guidewire is intended for use to introduce and position catheters during diagnostic and interventional procedures within the chambers of the heart, including transcatheter aortic valve implantation (TAVI).

The Medtronic ConfidaTM Brecker Guidewire was developed for use in diagnostic and interventional procedures including transcatheter aortic valve implantation (TAVI) procedures for the treatment of aortic valve disease. The Medtronic ConfidaTM Brecker Guidewire (model number GWBC30) is available in one size and is comprised of a stainless steel wire, 0.035" in diameter, and 260cm in length. The distal end of the Medtronic ConfidaTM Brecker Guidewire is comprised of a preformed 360° curved tip. The Medtronic ConfidaTM Brecker Guidewire is an external communicating device having limited contact (

This document is a 510(k) summary for the Medtronic Confida™ Brecker Guidewire (K181001), indicating its substantial equivalence to a predicate device. The purpose of this 510(k) is to notify the FDA of a change to the PTFE coating on the core wire section from a low Chromium VI PTFE coating to a Chromium VI-free PTFE coating.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states "All testing met the specified acceptance criteria," indicating successful compliance without explicitly detailing the specific quantitative or qualitative criteria for each test in this summary.

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

The document does not specify the exact sample sizes for each non-clinical test (e.g., number of guidewires tested for coating adhesion, number of animals for in vivo studies, or cell cultures for in vitro tests).

The data provenance is not explicitly stated in terms of country of origin of the data or whether the studies were retrospective or prospective, beyond the fact that they are non-clinical evaluations performed to demonstrate substantial equivalence.

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

This is a technical device evaluation rather than a study involving expert human interpretation or ground truth establishment in a clinical context (e.g., imaging interpretation). Therefore, information regarding "number of experts," "qualifications of experts," or "ground truth for the test set" as typically understood in AI/clinical studies is not applicable to this submission content. The "ground truth" here is the adherence to established scientific and regulatory safety and performance standards for medical devices, validated through the non-clinical tests listed.

4. Adjudication Method for the Test Set

As mentioned above, this is a non-clinical device evaluation. Therefore, an "adjudication method" in the context of expert consensus (e.g., 2+1, 3+1 for clinical interpretations) is not applicable. The "adjudication" is inherent in the laboratory testing and comparison against pre-defined acceptance criteria for each specific test.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI on human reader performance in interpreting medical images or data. The current submission is for a physical medical device (guidewire) and focuses on its material and performance characteristics through non-clinical testing.

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

This query is pertinent to AI algorithms. The Medtronic Confida™ Brecker Guidewire is a physical medical device, not an algorithm. Therefore, the concept of "standalone (algorithm only without human-in-the-loop performance)" is not applicable. The device's performance is standalone in the sense that its physical properties and biocompatibility are tested directly.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The "ground truth" for this device evaluation is established by validated non-clinical test methodologies and their pre-defined acceptance criteria, which are based on recognized standards (e.g., ISO, USP, ASTM) for biocompatibility and material performance of medical devices. The success of each test (e.g., passing a cytotoxicity assay) serves as its own ground truth for compliance.

8. The Sample Size for the Training Set

This submission pertains to a physical medical device and its non-clinical evaluation, not an AI algorithm requiring a training set. Therefore, the concept of "sample size for the training set" is not applicable.

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

As this document does not concern an AI algorithm, the question of "how the ground truth for the training set was established" is not applicable.

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