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The TruePath CTO Device is indicated to facilitate the intra-luminal placement of conventional guidewires beyond peripheral artery chronic total occlusions.
The device is contraindicated for use in carotid arteries.
The TruePath Extension Wire is designed to extend the TruePath CTO Device so that a catheter can be exchanged for another catheter.

The TruePath CTO Device is a sterile, disposable, steerable, 0.018" OD Guidewire with an Active Tip for penetrating chronic total occlusions and is used with a sterile, disposable battery-operated Control Unit during a single patient procedure. The TruePath CTO system consists of the TruePath CTO Device, Control Unit, Shaping Tool, and the TruePath Extension Wire.
The TruePath CTO Device consists of a distal 0.018"guidewire assembly and a Motor Housing with a Connector Cable to the Control Unit. The TruePath CTO Device has a 165 cm working length with a hydrophilic coating. The distal tip is shapeable and the cone shaped portion is diamond coated. The distal 3 cm of the guidewire is radiopaque.
The Control Unit, when activated, allows current to flow to the motor to turn the driveshaft, located within the stationary hollow outer shaft. The active tip at the most distal end of the guidewire assembly rotates at approximately 13,000 RPMs under no load conditions. In active mode the TruePath guidewire assembly creates a pathway through the lesion via mechanical rotation. In the passive mode the guidewire assembly functions as guidewire.
The shaping tool is an accessory provided with the TruePath CTO Device to shape the tip if desired. The TruePath Extension Wire can be attached to the TruePath guidewire assembly to create an extended guidewire that can be used to exchange a catheter without moving the TruePath CTO Device from the artery.

The provided text describes a 510(k) premarket notification for the TruePath™ CTO Device. The submission focuses on demonstrating substantial equivalence to a predicate device through comparison of technological characteristics and performance data from bench testing.

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

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

The document does not explicitly state acceptance criteria in quantitative terms (e.g., minimum pass rates, specific thresholds). Instead, it lists the types of performance tests conducted and generally states that the "results of these tests provide reasonable assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use." It concludes that "No new safety or performance issues were raised during the testing."

Therefore, the table will reflect the types of tests performed and the qualitative outcome reported.

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

The document states that "Bench testing was performed" and lists several in-vitro performance tests. It does not specify the sample size for these tests. The data provenance is in-vitro (bench testing), meaning it was conducted in a lab setting, not on human subjects. There is no information regarding the country of origin.

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

This information is not provided in the document. The study described is bench testing, not a clinical study involving human assessment or ground truth established by experts in a diagnostic context.

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

This information is not applicable/not provided. The study described is bench testing, which does not involve adjudication by experts in the way clinical studies often do for establishing ground truth.

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

There was no MRMC comparative effectiveness study done. This device is a mechanical medical device (a guidewire for CTOs), not an AI-powered diagnostic tool. Therefore, the concept of "human readers improving with AI assistance" is not relevant to this submission.

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

This question is not applicable. The device is a physical guidewire; there is no "algorithm" or standalone performance in the sense of an AI or software device. The bench testing evaluated the physical performance of the device.

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

The concept of "ground truth" as it applies to diagnostic accuracy from expert consensus, pathology, or outcomes data is not applicable to this submission. The "ground truth" in this context refers to the defined specifications and performance requirements for the mechanical characteristics of the device, against which the bench test results were evaluated.

8. The sample size for the training set

There is no training set mentioned in the document. This device is a mechanical guidewire and its performance was evaluated through bench testing against established engineering parameters, not through a machine learning approach requiring a training set.

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

Since there is no training set for this type of device submission, this question is not applicable.

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