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The Cordis ATW Marker Wire Steerable Guidewires are intended for use in angiographic procedures to introduce and position catheters and interventional devices within the coronary and peripheral vasculature. In addition, the Cordis ATW Marker Wire Steerable Guidewires are intended to facilitate the alignment of interventional devices and function as a measurement tool.

The device description of the ATW Marker Wire Steerable Guidewire is as follows.
• Stainless Steel Corewire,
• Radiopaque platinum / nickel coilwire,
• Radiopaque Marker Bands with optional spacing (See package labeling), and
• PTFE coating on shaft.

The provided document is a 510(k) summary for the "ATW Marker Wire Steerable Guidewire." This is a premarket notification for a medical device seeking clearance based on substantial equivalence to predicate devices, rather than a study demonstrating the device meets specific acceptance criteria based on performance testing against defined metrics.

Therefore, most of the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment is not present in this type of submission.

Here's what can be extracted based on the provided text:

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

The document does not explicitly define quantitative acceptance criteria or report performance metrics in the way a clinical study would. Instead, it asserts substantial equivalence to predicate devices. The "Summary of Substantial Equivalence" states: "The ATW Marker Wire Steerable Guidewires are substantially equivalent to the previously cleared ST Steerable Guidewire, Wizdom Marker Wire, and Stabilizer Marker Wire Steerable Guidewires."

The shared characteristics that support this equivalence are:

• Intended Use: "The Cordis ATW Marker Wire Steerable Guidewires are intended for use in angiographic procedures to introduce and position catheters and interventional devices within the coronary and peripheral vasculature. In addition, the Cordis ATW Marker Wire Steerable Guidewires are intended to facilitate the alignment of interventional devices and function as a measurement tool." This is directly compared to the intended use of predicate devices (though not explicitly detailed in this excerpt).
• Device Description:
  • Stainless Steel Corewire
  • Radiopaque platinum / nickel coilwire
  • Radiopaque Marker Bands with optional spacing
  • PTFE coating on shaft
• Biocompatibility: "All materials used in the ATW Marker Wire Steerable Guidewires are biocompatible."

The implication is that because these characteristics are similar to predicate devices, the new device will perform acceptably without needing to meet new, specific performance acceptance criteria.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. This is a 510(k) submission based on substantial equivalence, not a clinical trial or performance study with a test set of data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. No test set or ground truth in this context.

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

Not applicable. No test set 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

Not applicable. This device is a steerable guidewire, not an AI-powered diagnostic tool, and no MRMC study is mentioned.

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

Not applicable. This device is a physical medical instrument, not an algorithm.

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

Not applicable. Ground truth is not established in this type of submission; clearance is based on comparison to existing, cleared devices.

8. The sample size for the training set

Not applicable. This is not an AI/algorithm where a training set would be used.

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

Not applicable. No training set.

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