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The HI-TORQUE Guide Wire is intended for general intravascular use to aid in the selective placement of interventional devices and implantable coronary venous leads in the coronary and/or peripheral vasculature during diagnostic and/or therapeutic procedures.

The HI-TORQUE Guide Wires are steerable guide wires available in a nominal diameter of 0.14".

The provided text describes a 510(k) submission for HI-TORQUE Guide Wires, seeking to expand their indications for use. It primarily focuses on demonstrating substantial equivalence to existing devices rather than presenting a novel device requiring extensive performance acceptance criteria and a dedicated study to prove those criteria.

Here's an analysis based on the provided text, addressing your questions where possible:

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

The submission does not explicitly state formal quantitative acceptance criteria for the expanded indication. Instead, it relies on demonstrating equivalence to predicate devices and showing acceptable performance in in vivo animal and human clinical studies for the specific new intended use (placement of coronary venous pace/sense leads).

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

• Animal Study: The sample size is not specified. The text only mentions "Animal studies were conducted." Data provenance is not specified, but typically animal studies for medical devices are conducted in controlled environments.
• Human Clinical Testing Data: The sample size is not specified. The text states, "HI-TORQUE Guide Wires were evaluated in a clinical investigation." The data provenance is not specified, but it was a clinical investigation, implying a prospective study design.

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)

This information is not provided in the document. Given that this is a 510(k) for an expanded indication and not a de novo device, the focus is on safety and effectiveness as demonstrated through the in vivo studies, rather than a diagnostic device requiring expert interpretation of results to establish ground truth.

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

This information is not provided. As explained above, the nature of this submission (expanded indication for a guide wire) does not typically involve a complex adjudication process for establishing a "ground truth" in the way a diagnostic algorithm might. The evaluation likely focused on procedural success, adverse events, and device performance metrics.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic devices, which is not what the HI-TORQUE Guide Wire is. The device is a physical medical instrument whose performance is assessed through its direct application in procedures.

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

No, a standalone algorithm-only performance study was not done. The HI-TORQUE Guide Wire is a physical medical device, not a software algorithm. Its performance is intrinsically linked to its use by a human operator (e.g., a cardiologist).

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

For the human clinical testing, the "ground truth" would likely be successful placement of the compatible coronary venous pace/sense lead and absence of significant adverse events. This would be determined by the treating physician and potentially confirmed through post-procedure imaging or clinical follow-up (outcomes data related to the procedure's success and safety).

8. The sample size for the training set

The concept of a "training set" is not applicable to this device. Training sets are used in machine learning for AI algorithms. This submission concerns a physical medical device.

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

Not applicable, as there is no training set for a physical medical device.

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The ACS HI-TORQUE RULER™ Guide Wire is intended to facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA), or percutaneous transluminal angioplasty (PTA). The wire is also intended to facilitate the placement of equipment, such as compatible stent devices, during other diagnostic and therapeutic intravascular procedures. It should not be used with atherectomy devices. It is not intended for use in the cerebral vasculature.

The ACS HI-TORQUE RULER™ Guide Wire is a steerable guide wire intended to facilitate placement of balloon dilatation catheters during Percutaneous Transluminal Coronary Angioplasty (PTCA) and Percutaneous Transluminal Angioplasty (PTA), and other diagnostic and therapeutic intravascular procedures. It is not intended for use in the cerebral vasculature or for use with atherectomy devices.

The proximal and distal portions of the guide wire are constructed from a core assembly. A series of tapers, which reduce the diameter of the core wire distally, yields the desired tip flexibility. The distal 30 centimeters proximal to the tip of the ACS HI-TOROUE RULER™ Guide Wire are coated with Microglide® while the remaining portion is coated with polytetrafluoroethylene (PTFE). Both coatings are intended to reduce friction for improved movement of the wire within the catheter. The platinum alloy coils provide the physicians with a radiopaque tip.

This document describes the safety and effectiveness of the ACS HI-TORQUE RULER™ Guide Wire. The device is found substantially equivalent to predicate devices. The submission focuses on bench testing, biocompatibility testing, and animal testing to demonstrate performance.

Here's an analysis of the provided information, framed by your requested categories:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a submission for a medical device (guide wire) and not an AI/software device, the "acceptance criteria" are not framed in terms of precision, recall, or other machine learning metrics. Instead, they are related to physical and biological performance attributes of the guide wire. The "reported device performance" are the results of the specific tests conducted.

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

• Test Set Sample Size (for Bench and Biocompatibility): Not specified in terms of number of units tested for each individual test. The document generally states "These tests demonstrated..." without providing specific counts.
• Test Set Sample Size (for Animal Testing): "two subsequent animal studies" were performed. The number of animals or procedures within those studies is not specified.
• Data Provenance: The tests are likely performed by the manufacturer (Guidant Corporation / Advanced Cardiovascular Systems) in a laboratory setting. The country of origin for the data is not explicitly stated, but given the company's location (Santa Clara, California) and submission to the FDA, it's highly probable the data was generated in the United States. The testing is prospective for the specific device being submitted, as it was conducted specifically to gather data for this submission.

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

This type of information is generally not applicable to a physical device submission like this.

• For Biocompatibility: Expert interpretation of test results would be performed by toxicologists, biologists, or lab personnel following established standards (e.g., ISO 10993). The number and qualifications of these experts are not provided.
• For Bench Testing: Engineers and material scientists would interpret the results against pre-defined engineering specifications. The number and qualifications are not provided.
• For Animal Testing: Veterinarians and possibly interventional cardiologists/radiologists (or equivalent in animal models) would assess clinical performance. The number and qualifications are not provided.

4. Adjudication Method for the Test Set

This is not applicable in the context of device performance testing as described. Adjudication methods (like 2+1) are typically used for establishing ground truth in medical image analysis or clinical endpoint assessment with multiple human readers. Here, the "ground truth" is defined by objective physical/chemical measurements or observed biological reactions.

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 section is not applicable. This submission is for a physical medical device (guide wire), not an AI/software device, and therefore no MRMC studies or AI assistance are part of its evaluation.

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

This section is not applicable. This is a physical device, not an algorithm.

7. The Type of Ground Truth Used

• For Biocompatibility: The "ground truth" is established by adherence to recognized biocompatibility standards and test methodologies (e.g., ISO 10993 series), which define what constitutes "non-cytotoxic," "non-hemolytic," "pass," etc. These are objective measures against established biological thresholds.
• For Bench Testing: The "ground truth" is established by engineering specifications and industry standards. For example, a pull test result is compared against a minimum tensile strength requirement, or a torque response is objectively measured.
• For Animal Testing: The "ground truth" is established through direct observation of the device's function and biological response in vivo, assessed by veterinary and medical professionals, following pre-defined endpoints for "acceptable clinical performance." This likely involves qualitative and quantitative assessments during the animal procedures.

8. The Sample Size for the Training Set

This section is not applicable as this is a physical device submission, not an AI/machine learning model submission. There is no "training set" in this context.

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

This section is not applicable as there is no training set.

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