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The Lunderquist Fixed Core Wire Guides are intended to facilitate placement of devices used during diagnostic and interventional procedures.

The Lunderquist® Fixed Core Wire Guide, subject of this submission, is a Class II device according to 21 CFR §870.1330; product code DQX (Wire, Guide, Catheter). The subject device consists of a mandril design with a distal spring coil anchored over the distal portion of the mandril and a cannula anchored over the proximal portion of the mandril. The Lunderquist Fixed Core Wire Guide is available with an outside diameter of 0.038 inch and a length of 120 centimeters (cm). The tip portion of the subject device is straight. The Lunderquist® Fixed Core Wire Guide is a packaged, sterile device intended for single patient use.

The document provided describes the K181353 submission for the Lunderquist® Fixed Core Wire Guide. It is a Class II medical device, product code DQX (Wire, Guide, Catheter), intended to facilitate the placement of devices during diagnostic and interventional procedures. The submission outlines various performance tests conducted to demonstrate that the device met applicable design and performance requirements and supports substantial equivalence to its predicate device, the Mandril Wire Guides (K171997).

Here's the breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that for each of the performance tests, "The predetermined acceptance criteria were met." However, the specific quantitative acceptance criteria or the reported device performance values are not provided in the text. The document only confirms qualitative success in meeting these criteria.

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

The document does not specify the sample sizes used for any of the performance tests. It also does not mention data provenance in terms of country of origin or whether the studies were retrospective or prospective. These were laboratory-based performance tests, not clinical studies with patient data.

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

This information is not applicable and not provided in the document, as the studies described are laboratory-based device performance tests against pre-defined engineering and safety standards, not studies involving expert interpretation of medical images or clinical outcomes.

4. Adjudication Method for the Test Set

This information is not applicable and not provided in the document, as the studies described are laboratory-based device performance tests against pre-defined engineering and safety standards, not studies involving human judgment requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. The document describes laboratory performance tests of the device itself, not studies comparing human reader performance with or without AI assistance.

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

This concept is not applicable to the device described. The Lunderquist® Fixed Core Wire Guide is a physical medical instrument, not a software algorithm. Therefore, "standalone" algorithm performance is not a relevant metric. The tests performed are analogous to "standalone" performance of the physical device.

7. The Type of Ground Truth Used

The ground truth for these performance tests was based on established ISO and ASTM standards, as well as FDA guidance documents (e.g., ISO 10993-1:2009, ISO 11070:2014, ASTM F640-12, FDA Coronary and Cerebrovascular Guidance (1995)). This represents a "standard-based" ground truth, where the device's physical and mechanical properties are measured against predefined acceptable ranges or thresholds.

8. The Sample Size for the Training Set

This information is not applicable and not provided. The Lunderquist® Fixed Core Wire Guide is a physical medical device, not an AI/ML algorithm that requires a training set. The tests described are for verification and validation of the device's physical properties.

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

This information is not applicable and not provided, as the device is not an AI/ML algorithm requiring a training set with established ground truth.

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