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This guide wire is intended to be used in the neuro vasculature to facilitate the placement and exchange of therapeutic devices such as cerebral catheters during intravascular therapy. This guide wire is intended for use only in the neuro vasculature.

The ASAHI CHIKAI Black 14 Soft Tip neurovascular guide wire is a steerable guide wire with a maximum diameter of 0.014 inches (0.36mm) and length of 200cm. The quide 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 the coil assembly is soldered to the core wire. The coil assembly construction is similar to that of the 510(k) cleared ASAHI CHIKAI black neurovascular guide wire (K141751). The distal end of the guide wire has a radiopaque tip to achieve visibility. A hydrophilic coating is applied to the distal portion of the guidewire. This change introduces a soft tip version of the round curve tip configuration.

The acceptance criteria and study proving the device meets them are described for the ASAHI Neurovascular Guide Wire: ASAHI CHIKAI Black 14 Soft Tip, a catheter guide wire used in neurovasculature.

Here's the breakdown of the information requested:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance:

• The document states "All test articles met established acceptance criteria" for Tensile Strength, Torque Strength, Torqueability, and Tip Flexibility tests, and "Test results on all test articles confirmed guide wire performance" for the Bench (Simulated) Testing. However, the exact sample size ("N") for the test set is not explicitly specified in the provided text. It refers to "all test articles" without quantifying them.
• Data provenance (country of origin, retrospective/prospective): Not explicitly stated in the provided text. The applicant is ASAHI INTECC CO., LTD. in Japan, so the testing was likely conducted by or for them. The nature of these bench tests suggests they are prospective (i.e., conducted specifically for this submission).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• This information is not applicable in the context of this device and these tests. The tests are purely performance-based bench tests comparing the physical properties and functional performance of the device against predefined specifications and predicate devices. There is no "ground truth" established by human experts in the way it would be for, say, an AI diagnostic algorithm.

4. Adjudication method for the test set:

• This information is not applicable for these types of bench tests. Adjudication methods like 2+1 or 3+1 are typically used for subjectively interpreted data or ground truth establishment by multiple human readers, which is not the case here. The results are objective measurements of physical properties.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly mentioned or indicated in the provided text. This type of study is more relevant for diagnostic devices that involve human interpretation of images or data, where AI might assist. The device described is a physical guide wire.

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

• Not applicable. This device is a physical medical instrument (a guide wire), not an algorithm or AI system. Therefore, the concept of "standalone performance" for an algorithm does not apply.

7. The type of ground truth used:

• The "ground truth" for the performance tests relies on pre-established specifications and comparative performance to predicate devices and industry standards (FDA guidance document). For example:
  • Tensile strength is measured against "ASAHI's established tensile strength specifications."
  • Bench testing evaluates whether the guide wire "reached target area and microcatheter was successfully advanced."
  • The overall conclusion states, "Performance data demonstrate that the device functions as intended, and has a safety and effectiveness profile that is similar to the predicate device."
• There's no external "gold standard" ground truth like pathology or outcomes data mentioned for these specific physical performance tests.

8. The sample size for the training set:

• Not applicable. This device is a physical medical instrument, not a machine learning model that requires a training set.

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

• Not applicable. As it's not an AI/ML device, there's no training set or associated ground truth establishment process.

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