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For use in angiographic procedures to introduce and position catheters and interventional devices within the coronary and peripheral vasculature.

These steerable guidewires have a nominal diameter of 0.014" and nominal lengths of 180 cm and 300 cm. The wire is configured with a radiopaque gold cup at the distal end and an embedded magnet used with a navigation system to navigate the wire through vasculature. The distal tip can either be straight or angled. A hydrophilic coating covers the distal portion of the wire and a PTFE coating covers the proximal end of the wire.

This document describes a 510(k) premarket notification for a medical device, specifically the Titan™ Guidewire. Such submissions typically focus on demonstrating substantial equivalence to a predicate device, rather than providing detailed studies with specific acceptance criteria and performance metrics for a new, innovative device's clinical efficacy. Therefore, a direct answer to your request, formatted as a table of acceptance criteria and reported device performance with all the specified details, is not fully extractable from the provided text.

The document states that "all verification and validation activities resulted in the ability to demonstrate that the predetermined acceptance criteria were met." However, it does not explicitly list these acceptance criteria or the specific quantitative results for the Titan™ Guidewire. Instead, it relies on demonstrating equivalence to predicate devices through "Qualification Testing" (Non-Clinical Tests and Biocompatibility Testing).

Here's what can be inferred and explicitly stated from the provided text based on your request, with significant limitations due to the nature of the submission:

1. Table of Acceptance Criteria and Reported Device Performance

As mentioned, explicit, quantified acceptance criteria and specific performance results for the Titan™ Guidewire itself are not provided in this 510(k) summary. The document focuses on demonstrating that the device is "substantially equivalent" to predicate devices, implying that its performance meets the established safety and effectiveness profiles of those predicates.

The text does state that:

• "Test pieces were Stereotaxis performed tooling to established specific inspection criteria requirements for visual/tactile, dimensional and mechanical attributes."
• "The requirements for visual/tactile, functionality and performance results of these guidewires are comparable to the currently marketed devices."
• "All non-clinical test embedded magnet being assemmal equivalence to the predicate devices." (Likely a typo, meant to convey "all non-clinical tests re-affirmed substantial equivalence").

In lieu of a specific table, the "acceptance criteria" can be broadly interpreted as meeting the performance and safety profiles of the predicate devices. No specific numerical values for these criteria are given.

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

• Test Set Sample Size: Not specified. The document mentions "test pieces" for non-clinical testing but does not provide details on the number of units tested.
• Data Provenance: The testing described (visual/tactile, dimensional, mechanical attributes, biocompatibility) are non-clinical (bench) tests. The document does not refer to clinical test sets with patient data.

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

• Not applicable. The "ground truth" concept usually applies to clinical studies where experts evaluate outcomes. For these non-clinical tests, the "ground truth" would be established by the testing methodology and the specification requirements themselves, not by expert consensus in a clinical context.

4. Adjudication method for the test set

• Not applicable. This applies to clinical studies or assessments requiring human interpretation. The non-clinical tests would have pass/fail criteria based on specifications.

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. This is a 510(k) submission for a guidewire, which is a physical medical device, not an AI-powered diagnostic or assistive tool. MRMC studies are not relevant here.

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

• No. This is a physical medical device. The concept of "standalone algorithm performance" is not applicable.

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

• For the non-clinical tests, the "ground truth" was based on engineering specifications and established test methods designed to ensure the device's physical attributes, functionality, and biocompatibility are comparable to predicate devices. There is no mention of clinical ground truth (e.g., pathology, outcomes data) for the Titan™ Guidewire itself in this submission document beyond relying on the predicate device's established safety and efficacy.

8. The sample size for the training set

• Not applicable. There is no "training set" as this is a physical medical device, not a machine learning model.

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

• Not applicable. See point 8.

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