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Guidewire is intended to be used in the coronary and/or peripheral vascular system to introduce and position catheters to desired anatomical location during diagnostic or interventional procedures.

The Guidewire are designed to facilitate the placement of interventional devices. The guidewire has two models. PTFE coating type and hydrophilic coating type. The two models have the different material for wire and coating. PTFE guidewire consists of stainless steel spring coil wire, inside core wire and a safety wire. The guidewire is placed inside a loop flush dispenser, also as a hoop. Hydrophilic guidewire consisits of nickel titanium alloys core wire with a jacket that has a hydrophilic coating. The guidewire is placed inside a spiral hoop. The Guidewire is radiopactitive under fluoroscopy. The wire will be offered in straight, angle, J-tip configuration . All guidewires are available in five nominal outer diameter of 0.025", 0.028", 0.032", 0.038"inches and nominal lengths of 100cm, 150cm, 180cm, and 260cm.

The provided document is a 510(k) summary for a guidewire device and specifically states that no clinical tests were performed (Section 8. Clinical Test: "It is not applicable"). Therefore, there is no study described that involves AI or human readers for diagnostic purposes. The acceptance criteria and testing detailed relate to the physical and biocompatibility performance of the guidewire itself.

Based on the provided text, here's a breakdown of the requested information, focusing on the non-clinical performance and a clear indication where information is not available or applicable:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that for each performance test, "The predetermined acceptance criteria was met." Specific numerical thresholds for these criteria are not provided in this summary.

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

The document does not specify the exact sample sizes for each test in the acceptance criteria, nor does it detail the provenance of any data beyond indicating "in-house standard" for some tests. It mentions testing on "non-aged and aged to 3 years sample," implying samples were physical guidewire units. This is a medical device, not a diagnostic AI product, so "data provenance" as it relates to patient data is not applicable here.

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

Not applicable. This device is a physical medical instrument (guidewire) and not a diagnostic tool requiring expert interpretation or ground truth establishment in the traditional sense of an AI study.

4. Adjudication method for the test set

Not applicable. There is no human interpretation or adjudication described for the performance tests of the guidewire.

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

No. The document explicitly states "Clinical Test: It is not applicable." This is a guidewire, not an AI-assisted diagnostic tool.

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

No. This is a guidewire, not an algorithm or AI product.

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

For the physical and biological tests of the guidewire, the "ground truth" or reference points are defined by the standards themselves (e.g., ISO, ASTM, FDA guidance, USP) and "in-house" specifications. These standards provide the objective criteria against which the device performance is measured.

8. The sample size for the training set

Not applicable. This is a physical medical device. There is no AI model requiring a training set.

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

Not applicable. There is no AI model requiring a training set or ground truth in that context.

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