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The ASAHI Treasure Floppy Peripheral Guide Wire is intended to facilitate the placement and exchange of diagnostic and therapeutic devices during intravascular procedures. This device is intended for peripheral vascular use only.

The ASAHI Treasure Floppy Peripheral Guide Wire is a steerable guide wire with a maximum diameter of 0.018 inches (0.45mm) and available in 190 cm and 300 cm length. The guide wire is constructed from a stainless steel core wire with a stainless steel and platinum-nickel coil. The coil part (distal end) of the guide wire is radiopaque to achieve visibility. The distal end of the coil part is a straight configuration and is easily bendable with the vessel curvature. A hydrophilic coating is applied to the coil part (distal portion) of the guide wire. The proximal section of the guide wire is coated with PTFE, and the PTFE in the proximal coating is available in two types - PTFE type I and type II.

The provided text describes a medical device, the ASAHI Treasure Floppy Peripheral Guide Wire, but it does not contain information about acceptance criteria or a study that specifically proves the device meets those criteria in the context of device performance metrics with numerical values, statistical analysis, or clinical outcomes.

Instead, the document focuses on demonstrating substantial equivalence to predicate devices through various bench testing and biocompatibility assessments.

Here's a breakdown of the requested information based on the provided text, highlighting what is present and what is absent:

1. Table of Acceptance Criteria and Reported Device Performance

• Tensile Strength
• Turns to Failure (Torque Strength)
• Torqueability (Torque Response)
• Tip Flexibility
• Coating Adhesion
• Slipping Ability of Guide Wire in PTA Balloon Catheter
• Particulate testing
  The document states: "Enclosed within this submission is performance data that demonstrates that the ASAHI Treasure Floppy Peripheral Guide Wire meets all predetermined performance criteria. ... This 510(k) notice includes mechanical and functional bench testing that demonstrates that the ASAHI Treasure Floppy Peripheral Guide Wire performs as intended." |
  | Biocompatibility Testing: | Not explicitly defined in numerical terms in the provided document. The implied acceptance criterion is that the device materials are "proven to be biocompatible" and are consistent with predicate devices. | Biocompatibility testing included:
• Systemic Toxicity Study
• In Vitro Hemolysis Study
• Intracutaneous Study
• Cytotoxicity Study
• Sensitization Study
• Pyrogen Study
• Plasma Recalcification Time Coagulation Study
• In Vivo Thromboresistance Study
• C3a Complement Activation Study
• SC5b-9 Complement Activation Study
  The document states: "All components that come in direct contact with the patient have a long history of use in medical devices and are proven to be biocompatible for use in the vasculature. Furthermore, this submission contains reference to predicate ASAHI devices that use the same materials as used in the subject device." Biocompatibility testing was "leveraged from predicate devices with identical materials and manufacturing process." |

Key takeaway for this section: The document states that the device meets predetermined performance criteria, but the actual, quantifiable acceptance criteria and the detailed numerical results showing how it meets them are not provided in this summary. The evaluation relies on demonstrating substantial equivalence to predicate devices.

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

• Sample Size (Test Set): Not specified. The document mentions "bench testing" and "shelf-life testing" but does not give the number of units tested for each parameter.
• Data Provenance: The studies were in vitro bench testing and shelf-life testing. The country of origin for the data is not specified, but the applicant is from Japan, and the US correspondent is in Santa Ana, CA. Given it's a 510(k) submission to the FDA, results would be expected to be presented to US regulatory standards. The testing is retrospective in the sense that it's performed on manufactured devices for regulatory submission, not a prospective clinical trial.

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

This information is not applicable as the studies described are bench tests and biocompatibility assessments, not studies involving human interpretation where medical experts establish ground truth.

4. Adjudication Method for the Test Set

This information is not applicable for the same reason as above.

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

• Was it done? No. This type of study (comparing human readers with and without AI assistance) is not mentioned or relevant for this type of device (guide wire).
• Effect Size: Not applicable.

6. Standalone (Algorithm Only) Performance Study

• Was it done? No. This is a physical medical device, not an AI algorithm.

7. Type of Ground Truth Used

• For mechanical/functional bench testing: The "ground truth" would be established by validated test methods and specifications (e.g., a certain force in Newtons for tensile strength, a certain number of turns for torque strength, etc.).
• For biocompatibility testing: The "ground truth" is established by standard ISO and FDA-recognized biological evaluation tests to determine the device's interaction with the biological system. In many cases, these are in vitro or in vivo (animal) studies, not human data.
• The document explicitly states that biocompatibility data was "leveraged from predicate devices with identical materials and manufacturing process," implying that the ground truth for biocompatibility was previously established for those materials.

8. Sample Size for the Training Set

This information is not applicable as this is not an AI/machine learning device that requires a training set.

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

This information is not applicable for the same reason as above.

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