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

The Charter™ Guidewire is a disposable medical device designed for single use only. It consists of a PTFE coated 140cm, 180cm, or 300cm 0.014", 0.016" 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 a 510(k) application for the Charter™ Guidewire. This is a medical device, not an AI/ML powered device, therefore the criteria for AI/ML powered devices cannot be fully satisfied by the provided information.

However, I can extract the acceptance criteria and the study type conducted based on the available text.

Here's a breakdown of the requested information based on the provided document:

Acceptance Criteria and Device Performance

Study Information (Based on a medical device, not an AI/ML framework):

1. Sample size used for the test set and the data provenance:

   • The study involved in vitro bench testing.
   • The sample size for these tests is indicated as "n" (which is not a specific number but typically implies a sufficient number for statistical validity in bench testing).
   • The documentation does not specify provenance like country of origin for the "data" as it pertains to physical device testing, not patient data. It is a prospective bench test conducted by the manufacturer to assess device properties.

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

   • This question is not applicable to this type of device and study. "Ground truth" in the context of AI/ML or diagnostic studies refers to a verified diagnosis or outcome. For a physical medical device like a guidewire, the "ground truth" is established by direct measurement and adherence to engineering specifications and performance standards through well-defined bench test methodologies.

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

   • This is not applicable. Adjudication refers to resolving disagreements between human readers or between an AI and human readers in diagnostic tasks. The bench tests described are objective measurements against defined acceptance criteria.

4. 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, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices (especially those involving image interpretation by human readers, often assisted by AI). The Charter™ Guidewire is a physical interventional device, not a diagnostic one.

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

   • N/A. This refers to AI algorithm performance. The Charter™ Guidewire is a physical device, and its "performance" is measured by its physical and mechanical properties described in the bench tests, not by an algorithm.

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

   • The "ground truth" for this device's performance is based on pre-defined product specifications and industry standards for guidewire performance, as outlined in the "In vitro bench testing" section, specifically referencing the "FDAs guidance document 'Coronary and Cerebrovascular Guidewire Guidance, Jan 1995'". The device's performance is measured against these objective, quantifiable criteria.

7. The sample size for the training set:

   • This is not applicable. There is no "training set" in the context of a physical medical device's performance testing. Training sets are used to develop and train AI/ML models.

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

   • This is not applicable as there is no training set for this type of device.

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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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