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The ASAHI SION PTCA Guide Wire is intended to facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). The ASAHI SION PTCA Guide Wire is not to be used in the cerebral blood vessel.

The ASAHI SION PTCA Guide Wire is a steerable guide wire with a maximum diameter of 0.014 inches (0.36mm) and available in 180 cm and 300 cm lengths. The extension wire is connected to the end of the guide wire outside the body. The guide wire is constructed from a stainless steel core wire with platinum-nickel and stainless steel coils. The coil assembly consists of an inner coil and an outer coil, and there is a safety wire for which is soldered to the inner and outer coils and the core wire. The distal end of the guide wire has a radiopaque tip to achieve visibility, and is available in a straight configuration and can be made to bend easily with the vessel curve. A hydrophilic coating is applied to the distal portion of the guide wire. The proximal section of the quide wire is coated with PTFE.

The provided text describes the ASAHI SION PTCA Guide Wire, a medical device, and its regulatory clearance process, including performance data. However, it does not include detailed acceptance criteria or a specific study proving the device meets those criteria in the format requested for AI/ML devices.

The document states: "In vitro bench testing, including tensile strength, torque strength, torqueability, tip flexibility, coating adherence, catheter compatibility and integrity (particulate testing) etc were conducted on the ASAHI SION PTCA Guide Wire, This 510(k) notice includes mechanical and functional bench testing that demonstrates that the ASAHI SION PTCA Guide Wire performs.as intended." This indicates that performance testing was done, but the specifics of what constitutes "performing as intended" (i.e., the acceptance criteria) and the detailed results against those criteria are not provided.

Furthermore, the document does not describe an AI/ML device, a clinical study with human readers, or the establishment of ground truth by expert consensus or pathology, as typically would be expected for the detailed questions about an AI/ML study. It is a traditional medical device (guide wire) submission.

Therefore, I cannot populate most of the requested fields. I will fill in what can be inferred from the text and note where information is not available or not applicable.

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: The document states that "In vitro bench testing... were conducted... that demonstrates that the ASAHI SION PTCA Guide Wire performs as intended." However, the specific quantitative acceptance criteria (e.g., "tensile strength must be >X Newtons") and the exact measured values are not disclosed in this summary. The performance is described qualitatively as meeting its intended function and being substantially equivalent.

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

• Sample Size for Test Set: Not specified for each individual bench test. The document mentions "bench testing" without providing specific numbers of guide wires tested.
• Data Provenance: Not explicitly stated, but implies in-house laboratory testing ("In vitro bench testing... were conducted on the ASAHI SION PTCA Guide Wire"). No information on geographical origin of data or retrospective/prospective nature as this is not a clinical study.

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

• Not Applicable. This is not an AI/ML device that generates outputs requiring expert interpretation or ground truth establishment based on clinical data. The performance verification is through engineering bench tests against established physical and material properties.

4. Adjudication Method for the Test Set

• Not Applicable. See point 3.

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. This is not an AI/ML device.

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

• Not Applicable. This is not an AI/ML device.

7. The Type of Ground Truth Used

• Not Applicable/Engineering Specifications. For this type of traditional medical device, the "ground truth" for performance is defined by established engineering and material specifications, regulatory standards, and comparison to predicate devices, rather than expert consensus on clinical data or pathology outcomes.

8. The Sample Size for the Training Set

• Not Applicable. This is not an AI/ML device.

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

• Not Applicable. This is not an AI/ML device.

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