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The Charter™ Guidewires are intended for use in the coronary and peripheral vasculature.

The Navilyst Medical Guidewire is a disposable medical device designed for single use only. It consists of a PTFE coated 140cm or 180cm, 0.014" or 0.018" diameter stainless steel core wire, one end of which is reduced in diameter over a 43cm approx. segment in a progressive fashion through a centreless grinding operation. The profile of this reduced section affords the product a reduced area of stiffness and can be varied to produce various levels of support.

The distal part of the reduced section is covered with a 3cm, 0.010" platinum tungsten spring coil. This provides greater visibility on x-ray equipment. A 39cm approx. length of black / grey Estane 88A radiopaque heat shrink polymer tubing is applied over the tapered distal end of the wire and ground to form a constant outer diameter, OD, equivalent in diameter to the main core body. Coatings are placed on the device to improve the lubricity and ease in its advancement through the guide catheter and the blood vessel

The provided text describes the 510(k) application for the Navilyst Charter Guidewire, focusing on its substantial equivalence to predicate devices based on in vitro bench testing and biological safety evaluations. There is no mention of a diagnostic device, AI/ML algorithm, or clinical study involving human readers or ground truth established by experts.

Therefore, most of the requested information cannot be extracted from the given text.

Here is what can be inferred:

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

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

• Sample Size: Not specified for each test. The document states "Charter™ Guidewires (in its various configurations)" were tested, implying multiple units were used.
• Data Provenance: In vitro bench testing. The country of origin for the data is not specified, but the applicant is Brivant Ltd, Ireland. The testing was prospective for the Charter Guidewire.

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

Not applicable. No experts were used for establishing ground truth as this was an in vitro bench testing study for a medical device (guidewire), not a diagnostic algorithm.

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

Not applicable. No adjudication method was used as this was an in vitro bench testing study.

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 MRMC comparative effectiveness study was conducted. This document describes the approval of a medical device (guidewire), not a diagnostic AI.

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

Not applicable. This is not for an algorithm.

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

Not applicable. The "ground truth" for the bench tests would be the established engineering specifications and performance standards for guidewires, as referenced by the "FDAs guidance document "Coronary and Cerebrovascular Guidewire Guidance, Jan 1995" and the product specification.

8. The sample size for the training set

Not applicable. There is no training set mentioned, as this is not an AI/ML algorithm.

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

Not applicable. There is no training set mentioned.

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