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Intended to facilitate the delivery of catheter-based interventional devices during Percutaneous transluminal angioplasty (PTA) and Percutaneous transluminal coronary angioplasty (PTCA). This guide wire may also be used with compatible stent devices.

This device is designed and intended for ONE-TIME USE ONLY. Do not resterilize and / or reuse.

The HI-TORQUE VersaTurn Guide Wire Family includes steerable guide wires offered in several configurations by various support levels, tip offerings, hydrophilic coating lengths, tip shapes and guide wire lengths.

The HI-TORQUE VersaTurn Guide Wire Family will be available with a range of tip offerings and coating lengths. These features are listed as follows:

• 4 tip offerings: Extra Floppy (EF),Floppy (F), Soft (S), Complex (C) ●
• 3 support levels: HT VersaTurn Ultraflex, HT VersaTurn Flex, HT VersaTurn ●
• 2 coating lengths: Fully Coated (HC), Uncoated Tip (pHC) ●
• 2 tip shapes: Straight, Pre-shaped J ●
• 2 lengths: 190 cm, 300cm o

The HI-TORQUE VersaTurn Guide Wire Family has a maximum diameter of 0.0142" or 0.0145" depending on the support level and is compatible with devices designed for use with 0.014" guide wires. The HI-TORQUE VersaTurn Guide Wire Family includes a shaping tool, which is clipped on to the outer packaging coil after the final assembled product has been inserted into the packaging coil. This accessory is to aid the physician in shaping the distal portion of the guide wire, if desired.

The provided text describes a 510(k) premarket notification for a medical device, specifically the HI-TORQUE® VersaTurn Guide Wire Family. The document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving a device's superior performance against acceptance criteria in a clinical or AI-driven context.

Therefore, much of the requested information regarding AI performance, expert adjudication, ground truth, and multi-reader multi-case studies is not applicable to this document. This is a conventional medical device submission, not an AI software submission.

However, I can extract the relevant information about the acceptance criteria and the study that "proves the device meets the acceptance criteria" in the context of this traditional medical device:

Here's the information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document indicates "in vitro bench testing" was conducted. It does not specify the exact sample sizes for each test. The data provenance is internal laboratory testing ("in vitro bench testing"). The terms "retrospective" or "prospective" are not applicable to this type of bench testing.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

This is not applicable. For physical device bench testing, "ground truth" is typically established by engineering specifications, validated test methods, and industry standards, not by human experts adjudicating on data.

4. Adjudication Method for the Test Set

This is not applicable. Adjudication methods like "2+1" or "3+1" are relevant to clinical studies or AI algorithm ground truth establishment, not to physical bench testing.

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

This is not applicable. This is a submission for a physical medical guide wire, not an AI-driven device or software for interpretation.

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

This is not applicable. This is a physical medical device.

7. The Type of Ground Truth Used

For the in vitro bench testing, the "ground truth" (or reference standard) would be the established engineering specifications, performance standards, and validated test methods for guide wires.

8. The Sample Size for the Training Set

This is not applicable. There is no "training set" in the context of this physical device's bench testing.

9. How the Ground Truth for the Training Set Was Established

This is not applicable for the same reason as above.

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