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The Lunderquist Wire Guide and the Lunderquist DC Wire Guide are intended for complex diagnostic and interventional procedures where increased body, flexibility, and low surface friction of the wire guide are needed.

The Lunderquist Wire Guide is a PTFE-coated stainless steel wire guide with an outer diameter of .035 inches and comes in 90 to 300 cm lengths. For lengths 260-300 cm , a radiopaque gold coil is provided on the flexible distal tip. The distal tip has 4 or 7 cm of flexibility comes straight or as a J-curve with a 3 or 7.5 mm radius.

The Lunderquist DC Wire Guide is a PTFE-coated stainless steel wire guide with an outer diameter of .035 inches and comes in 260-300 cm lengths. A radiopaque gold coil is provided on the flexible distal tip. The Lunderquist DC Wire Guide is a PTFE-coated stainless steel wire guide with a double curved tip design. The double curved distal tip has 4 cm of tip flexibility.

The provided document, K061670, is a 510(k) summary for the Lunderquist Wire Guide and Lunderquist DC Wire Guide. It describes the device, its intended use, and the tests performed to demonstrate substantial equivalence to predicate devices. However, it does not include a detailed study with specific acceptance criteria and reported device performance in the format requested. The document primarily focuses on demonstrating that the device is "similar" to existing predicate devices in terms of materials, construction, and indications for use, and that it has undergone general performance tests.

Therefore, much of the requested information regarding specific acceptance criteria, detailed study results, sample sizes, expert involvement, and ground truth establishment, as typically found in clinical efficacy studies, is not present in this 510(k) summary.

Here's a breakdown of what can and cannot be extracted from the document:

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

Rationale: The document states that the devices were "subjected to the following tests to assure reliable design and performance under the specified testing parameters." However, it does not provide specific quantitative acceptance criteria for each test or detailed numerical results. It only offers a general statement that the results "provide reasonable assurance that the devices have been designed and tested to assure conformance to the requirements for their use as guide wires."

2. Sample sizes used for the test set and the data provenance:

• Sample Size for Test Set: Not specified. The document does not provide details on the number of units tested for each type of test.
• Data Provenance: Not specified. The document does not mention the country of origin of the data or whether the tests were retrospective or prospective. Given the nature of bench testing, it would inherently be prospective in a lab setting.

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

• Number of Experts: Not applicable. The tests performed are engineering and material characteristic tests (e.g., tensile, flexibility, corrosion). These types of tests do not typically involve human expert adjudication for establishing a "ground truth" in the way a clinical study analyzing medical images or patient outcomes would. The "ground truth" for these tests is determined by the physical properties of the materials and device.
• Qualifications of Experts: Not applicable.

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

• Adjudication Method: Not applicable. As mentioned above, the tests are primarily objective engineering performance tests, not subjective assessments requiring expert 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:

• MRMC Study: No. This document describes a medical device (wire guide), not an AI diagnostic or assistance system. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant or described.
• Effect Size: Not applicable.

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

• Standalone Performance: Not applicable. This is a physical medical device, not an algorithm, so the concept of standalone algorithmic performance is not relevant.

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

• Type of Ground Truth: The "ground truth" for these tests would be the established engineering specifications and material properties against which the device's performance is measured. For example, for tensile testing, the ground truth would be the expected tensile strength for the materials used. This is not established by expert consensus, pathology, or outcomes data, but by established engineering standards and material science.

8. The sample size for the training set:

• Sample Size for Training Set: Not applicable. As this is not an AI/machine learning device, there is no "training set."

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

• Ground Truth for Training Set: Not applicable, as there is no training set.

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