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The TechDevice Guidewire facilitates placement and exchange of catheters and other instruments in the alimentary tract. This device is not indicated for neuro or cardiac use.

The Guidewire is constructed of a stainless steel core wire and a stainless steel or platinum coil welded/brazed in place over the core wire. The coll may cover the entire core wire or just the floppy distal portion. The exposed core wire and or the coil may be uncoated stainless steel or coated with a PTFE spray or a PTFE jacket. Platinum iridium marker bands may be placed under the coil to aid in visualization. Exit markers may be printed on the proximal section of the guidewire to aid the physician in determining the depth of insertion.

This 510(k) summary describes a medical device called the TechDevice Guidewire. The device is intended to facilitate the placement and exchange of catheters and other instruments in the alimentary tract, but not for neuro or cardiac use. The submission states that substantial equivalence was based on a comparison of labeling, physical and performance design characteristics to predicate devices, as well as the results of comparative bench testing.

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

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance

The document does not specify the sample sizes used for the comparative bench testing (test set sizes). It also does not mention the country of origin of the data or whether the data was retrospective or prospective. It only states "comparative bench testing."

3. Number of Experts and Qualifications

This information is not provided in the document. Bench testing typically does not involve human expert review in the same way clinical studies do.

4. Adjudication Method

This information is not provided in the document. Adjudication methods are typically associated with clinical studies involving human interpretation, not bench testing.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC study was done. The document describes bench testing of physical and performance characteristics, not a clinical study involving human readers or AI.

6. Standalone (Algorithm Only) Performance

Not applicable. This device is a physical guidewire, not an algorithm or software. The performance described is for the physical device itself.

7. Type of Ground Truth Used

The ground truth for the performance tests would be the established engineering standards or specifications for each of the measured characteristics (Tensile Strength, Torque Strength, Torqueability, Tip Flexibility, Coating Integrity). The document implies that the "ground truth" was the performance of the predicate devices. The phrase "comparative bench testing" suggests that the TechDevice Guidewire's performance was compared directly against the predicate devices for these characteristics.

8. Sample Size for the Training Set

Not applicable. This device is a physical guidewire, not an AI or software device that uses a training set. The "training" in the context of device development would refer to the design and engineering process, not a data-driven training set.

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

Not applicable, as there is no "training set" in the context of this device. The design and manufacturing process would be guided by engineering principles and comparison to predicate devices, rather than a data-driven ground truth.

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The HI-TORQUE IRON MAN™ 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). The wire is also intended to facilitate the placement of equipment, such as atherectomy and compatible stent devices, during other diagnostic and therapeutic intravascular procedures. It is not intended for use in the cerebral vasculature.

The proximal and distal portions of the guide wire are constructed from a core assembly. A series of tapers and flats, which reduce the diameter of the core wire distally, vields the desired tip flexibility. The distal 12 to 15 centimeters proximal to the tip of the ACS HI-TOROUE IRON MAN™ 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.

The provided document describes a medical device, the ACS HI-TORQUE IRON MAN™ Guide Wire, and its substantial equivalence to predicate devices, rather than a study evaluating its performance against specific acceptance criteria in the context of an AI-powered device. Therefore, a direct response to your prompt with specific acceptance criteria, reported device performance in those terms, and details about training/test sets, ground truth, and human expert involvement is not applicable based on the given text.

The document discusses the following:

• Substantial Equivalence: The primary assertion is that the ACS HI-TORQUE IRON MAN™ Guide Wire is substantially equivalent to existing predicate devices (ACS Hi-Torque Extra S'Port™ Guide Wire and Boston Scientific Corporation .014" Platinum Plus™ Guide Wire) in terms of intended use, materials, and design.
• Testing Data:
  • Biocompatibility: Relies on data from the predicate device as the materials are identical.
  • In vivo Testing: Two animal studies compared the new guide wire's performance to predicate wires when used with specific catheters and stent delivery systems. The conclusion was that it performed "as well as or better than" the predicate wires in most parameters.
  • Bench Testing: Evaluated:
    • Tensile strength of the distal tip (pull test) – "adequate"
    • Torsional strength of the distal tip (turns-to-failure test) – "adequate"
    • Rotational accuracy (correlation between proximal and distal rotation) – "adequate torque response"
    • Tip flexibility – "equivalent to that of the predicate and is acceptable"

Therefore, I cannot populate the table or answer the specific questions about AI/algorithm performance. The document describes a traditional medical device submission focused on demonstrating equivalence through mechanical and animal testing, not an AI/ML device with established acceptance criteria based on diagnostic performance metrics like sensitivity, specificity, accuracy, or human reader improvement.

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