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PCI Guide Wires are intended to facilitate the placement of balloon dilatation catheters during percutaneous coronary intervention (PCI) and percutaneous transluminal angioplasty (PTA), including use in crossing de novo coronary chronic total occlusions (CTO).

The PCI Guide Wires are not to be used in the neurovasculature.

The ASAHI PCI Guide Wire ASAHI CONFIANZA PRO 8-20 (Hereafter "ASAHI CONFIANZA PRO 8-20") is a steerable guide wire with a maximum diameter of 0.014 inches (0.36mm) and available in 190cm, 235cm and 300cm length. The extension wire is connected to the end of the guide wire outside the body for 190cm and 235cm wire. The guide wire is constructed from a stainless-steel core wire with a platinum-nickel coil. The coil is soldered to the core wire. The coil has radiopacity to achieve visibility and can be made to bend easily with the vessel curve. A hydrophilic coating is applied to the distal portion of the guide wire.

Here's an analysis of the provided text regarding the acceptance criteria and study for the device:

Device: ASAHI PCI Guide Wire ASAHI CONFIANZA PRO 8-20

The information provided describes a guide wire, not an AI/ML powered device, so several of the requested sections (MRMC study, standalone AI performance, ground truth for training set, training sample size) are not applicable. The document focuses on demonstrating substantial equivalence to a predicate device through non-clinical bench testing.

1. Table of Acceptance Criteria and Reported Device Performance

The document states that the ASAHI CONFIANZA PRO 8-20 met all acceptance criteria. However, it does not explicitly list the specific numerical acceptance criteria for each test. It only lists the types of tests performed. Without the specific thresholds for "Tensile Strength," "Torque Strength," etc., a detailed table with specific acceptance criteria is not possible from the provided text.

Here's a table based on the types of tests and the general conclusion:

Note: The document explicitly states: "The in vitro bench tests demonstrated that the ASAHI CONFIANZA PRO 8-20 met all acceptance criteria and performed similarly to the predicate devices." This is the highest level of detail provided regarding performance.

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

The document only states that "in vitro bench tests" were conducted. It does not specify:

• The exact sample size (e.g., number of guidewires tested for each parameter).
• The data provenance (e.g., country of origin for the data).
• Whether the study was retrospective or prospective, although bench testing is typically prospective by nature.

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

This section is not applicable as the study described is non-clinical bench testing, not a clinical study involving experts establishing ground truth for diagnostic or prognostic purposes. The "ground truth" here is determined by objective physical measurements against defined performance specifications.

4. Adjudication Method for the Test Set

This section is not applicable for non-clinical bench testing. Adjudication methods (like 2+1 or 3+1) are used to resolve discrepancies among multiple human readers or evaluators in clinical studies. For bench testing, results are typically objective measurements.

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. The device is a physical medical device (guidewire), not an AI-powered diagnostic or therapeutic tool for which an MRMC study would be relevant.

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

This section is not applicable. The device is a physical medical device (guidewire), not an algorithm or AI system.

7. The Type of Ground Truth Used

For this physical device, the "ground truth" for the non-clinical testing is based on pre-defined engineering specifications and performance benchmarks established for similar medical devices (the predicate device and industry standards/guidance documents). The tests measure physical and mechanical properties against these objective standards.

8. The Sample Size for the Training Set

This section is not applicable. As a physical guidewire, there is no "training set" in the context of machine learning. The device design and manufacturing processes are developed through engineering and materials science principles, not machine learning training.

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

This section is not applicable for the reasons mentioned in point 8.

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