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The Lunderquist Extra Stiff Double Curved Exchange Wire Guide is intended for complex diagnostic and interventional procedures where increased body, flexibility, and low surface friction of the wire guide are needed.

The Lunderquist Extra Stiff Double Curved Exchange Wire Guide has an outer diameter of .035 inches and is 260 cm long. The Lunderquist is a TFE-coated stainless steel wire guide with a double curved tip design, and a tapered, soft proximal end to ease device introduction. The double curved distal tip has 4 cm of tip flexibility.

This document is a 510(k) summary for a medical device (Lunderquist Extra Stiff Double Curved Exchange Wire Guide), not a study report for an AI/ML powered device. Therefore, much of the requested information regarding acceptance criteria for AI performance, sample size for test/training sets, expert qualifications, adjudication methods, or MRMC studies, is not applicable and cannot be extracted from the provided text.

However, I can extract the information related to the physical device's performance testing.

Here's a breakdown based on the provided text, addressing the applicable points:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that the device was subjected to specific tests, but it does not explicitly define quantitative acceptance criteria or provide numerical performance results. It only states that the results "provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its use as a guide wire."

2. Sample size used for the test set and the data provenance

• Sample Size: Not specified. The document indicates that tests were performed but does not quantify the number of units or test repetitions.
• Data Provenance: Not applicable in the context of clinical data. These are engineering/physical tests of the device itself, likely performed in Cook's internal labs.

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

• Not applicable. This is not a study involving human-interpreted ground truth for diagnostics. The "ground truth" here is the physical performance of the device against engineering specifications.

4. Adjudication method for the test set

• Not applicable. This is not a study involving human-interpreted ground truth for diagnostics.

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

• Not applicable. This is a 510(k) summary for a physical medical device, not an AI/ML powered device.

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

• Not applicable. This is a 510(k) summary for a physical medical device, not an AI/ML powered device.

7. The type of ground truth used

• Type of Ground Truth: Engineering specifications and performance standards for guide wires. The tests (4-Point Bend, Flexing/Straightening Force, Tensile Testing) are designed to assess the physical integrity and functional characteristics expected of such a device.

8. The sample size for the training set

• Not applicable. This is a 510(k) summary for a physical medical device, not an AI/ML powered device.

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

• Not applicable. This is a 510(k) summary for a physical medical device, not an AI/ML powered device.

In summary, the provided document details the submission for a medical device (a guide wire) and its engineering-based performance testing but does not contain information relevant to AI/ML device evaluation criteria.

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