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Intended to facilitate the delivery of catheter-based interventional devices during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). This guide wire may be used with compatible stent devices during therapeutic procedures. The guide wire may be used to reach and cross a target lesion, provide a pathway within the vessel structure, facilitate the substitution of one diagnostic or interventional device for another, and to distinguish the vasculature. This guide wire may also be used to cross or assist in crossing de novo chronic total coronary occlusions (CTO).

The HI-TOROUE PROGRESS Guide Wire (K091825, cleared Sept. 25, 2009) is an existing family of guide wires, designed to provide improved torque response and crossing while maintaining tactile feedback in stenotic vessels. The subject wire is a core to tip design, where the core material runs through the entire length of the wire. This family of guide wires has a maximum diameter of 0.0140" with a stainless steel core and is provided in 190cm extendable and 300cm exchange lengths. The distal core segment of the PROGRESS guide wire family is offered in 5 configurations: PROGRESS 40. PROGRESS 80, PROGRESS 120, PROGRESS 140T and PROGRESS 200T. Each configuration is identical in design except for those design features that impact tip stiffness.

The HI-TOROUE PILOT Guide Wire (K030549/K101116, originally cleared Mav 14, 2003) is an existing family of guide wires constructed using a 304V stainless steel core. HI-TORQUE PILOT Guide Wires have a maximum diameter of 0.0140" and are available in 190cm extendable lengths and a 300 cm exchange length. There are three HI-TORQUE PILOT™ Guide Wire designs with varying tip stiffness (i.e., HI-TORQUE PILOT™ 50, HI-TORQUE PILOT™ 150, and HI-TOROUE PILOT™ 200 Guide Wires). The distal segment of the guide wire includes a series of tapered grinds and a flat section, which reduce the diameter and stiffness of the distal core, thus yielding the desired flexibility and performance.

Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Device Performance Study

The study, named "EXPERT CTO Guidewire Clinical Trial," was a prospective, multi-center, single-arm study designed to assess the safety and effectiveness of the HI-TORQUE (HT) PROGRESS and HT PILOT guide wires in recanalization of chronic total occlusions (CTO).

1. Table of Acceptance Criteria and Reported Device Performance

Breakdown of individual criteria for successful recanalization:

Note: The primary endpoint focused on successful recanalization using any guide wire (which included the study guidewires), achieving a lower one-sided 95% CI above the 62.5% performance goal. An alternate analysis using a different MACE definition also confirmed the success, and a separate analysis for study guidewires only for specific components (like successful placement and MACE) was performed but not for the overall primary endpoint.

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

• Sample Size for the Test Set: 138 subjects were enrolled for the guidewire portion of the study.
• Data Provenance: The study was a "prospective, multi-center, single-arm study." The text does not specify the country of origin, but generally, multi-center studies for US regulatory submissions typically involve sites in the US and potentially other regions. The study is prospective.

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

The document does not explicitly state the "number of experts" used to establish ground truth for the test set. However, it describes a clinical trial where "Successful guide wire crossing was defined as confirmation of the presence of a guide wire in the distal true lumen." This confirmation would typically be performed by interventional cardiologists involved in the procedures and potentially reviewed by an independent clinical events committee (though not explicitly stated for this specific detail).

The text mentions the study objectives for the EXPERT CTO clinical trial: "assess the safety and effectiveness of the HI-TORQUE (HT) PROGRESS and HT. PILOT guide wires in recanalization of chronic total occlusions". The "successful recanalization" and "absence of in-hospital MACE" (Major Adverse Cardiac Events) are clinical outcomes reported.

Given the nature of the trial, the ground truth for success (e.g., successful guide wire crossing, absence of MACE) would have been established by the treating physicians (interventional cardiologists) and possibly an independent clinical events committee, as is standard for clinical trials. The qualifications of these experts would be based on their medical licensure and experience in interventional cardiology.

4. Adjudication Method for the Test Set

The document does not explicitly describe an adjudication method like 2+1 or 3+1. For clinical trials involving endpoints like MACE, an independent Clinical Events Committee (CEC) is typically used to adjudicate events to ensure consistency and minimize bias. However, this specific detail is not provided in the summary. The endpoints (successful guide wire crossing, absence of MACE) are clinical observations made during or after the procedure.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This study focuses on the device's performance directly in patients, not on how human readers (e.g., radiologists interpreting images) improve with or without AI assistance. The device in question is a guide wire, which is a physical tool used in interventional procedures, not an AI diagnostic software.

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

Not applicable. The device is a physical medical device (guide wire), not an algorithm or AI software. Therefore, the concept of "standalone" performance for an algorithm does not apply. The study evaluates the performance of the physical guide wire when used by a human physician in a clinical setting.

7. The Type of Ground Truth Used

The ground truth used is clinical outcomes data from a prospective human clinical trial.

• Successful recanalization of the CTO: Defined by two components:
  • Confirmation of placement of any guide wire in the distal true lumen.
  • Absence of in-hospital MACE (Major Adverse Cardiac Events).
• Confirmation of guide wire in distal true lumen: This would be assessed by the interventional cardiologist during the procedure, likely using angiography.
• Absence of in-hospital MACE: MACE events (e.g., MI, death, stroke) are serious clinical outcomes, typically recorded from hospital records and often adjudicated by an independent CEC in clinical trials. The study uses both ARC MI definition and per protocol MI definition for MACE.

8. The Sample Size for the Training Set

Not applicable. This study describes a clinical trial evaluating a physical medical device, not an AI algorithm. Therefore, there is no "training set" in the context of machine learning. The 138 subjects are part of the test set for evaluating the device's clinical performance.

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

Not applicable. As stated above, this is a clinical trial for a physical device, so there is no training set for an AI algorithm.

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