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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 18 soft tip neurovascular guide wire is a steerable quide wire with a maximum diameter of 0.018 inches (0.45mm) 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 18 neurovascular guide wire (K141751). The distal end of the quide wire has a radiopaque tip to achieve visibility. A hydrophilic coating is applied to the distal portion of the guidewire. Like the predicates, the ASAHI CHIKAI black 18 soft tip is packaged with accessories: a torque device, shaping device, and inserter. This change introduces a soft tip version of the round curve tip configuration.

This document describes the premarket notification (510(k)) for the ASAHI Neurovascular Guide Wire: ASAHI CHIKAI black 18 soft tip. The core of the document focuses on demonstrating substantial equivalence to a predicate device (ASAHI CHIKAI black 18, K141751) through non-clinical performance testing. This is a medical device, not an AI/ML model, so the typical AI/ML acceptance criteria and study designs (like MRMC, training/test sets, expert consensus for ground truth) are not applicable in this context.

However, I can extract the information relevant to device performance acceptance criteria and proof based on the provided text, re-framing it to fit the spirit of your request for "acceptance criteria and the study that proves the device meets the acceptance criteria" for a medical device.

Here's the breakdown:

Understanding the Device and Context:

• Device Name: ASAHI Neurovascular Guide Wire: ASAHI CHIKAI black 18 soft tip
• Device Type: Catheter Guide Wire (Class II)
• Intended Use: To be used in the neuro vasculature to facilitate the placement and exchange of therapeutic devices such as cerebral catheters during intravascular therapy.
• Purpose of Submission: Demonstrate substantial equivalence to a predicate device (ASAHI CHIKAI black 18, K141751) due to a minor modification (introduction of a soft tip version). This is a device modification, not a brand new AI/ML model being deployed.

Acceptance Criteria and Device Performance (Adapted for Medical Device Testing):

Since this is a physical medical device, the "acceptance criteria" are based on engineering specifications and performance benchmarks established from the predicate device and internal standards, rather than metrics like sensitivity/specificity for an AI model.

1. Table of Acceptance Criteria and Reported Device Performance

• Evaluation of predicate devices
• ASAHI's established tensile strength specifications | All test articles met established acceptance criteria. |
  | Torque Strength | Torque strength before failure (distal tip stationary, proximal end rotated). Determined by:
• Evaluation of predicate devices
• ASAHI's established torque strength specifications | All test articles met established acceptance criteria. |
  | Torqueability | Torque response at the distal end (proximal end rotated). Determined by:
• Evaluation of predicate devices
• ASAHI's established torqueability specifications | All test articles met the acceptance criteria. |
  | Tip Flexibility | Force to deflect the guide wire. Determined by:
• Evaluation of predicate devices
• ASAHI's established tip flexibility specifications | All test articles met established Tip Flexibility acceptance criteria. |
  | Simulated Use Testing | Successful navigation to target area and successful advancement of microcatheter over guidewire to target site (in a simulated model). Determined by:
• Evaluation of predicate devices
• ASAHI's established simulated use specifications | Test results on all test articles confirmed guide wire performance. Guidewire reached target area and microcatheter was successfully advanced over guidewire to target site. |

Overall Conclusion on Performance: "The in vitro performance tests demonstrated that the ASAHI CHIKAI black 18 soft tip met all acceptance criteria and performed similarly to the predicate device. Performance data demonstrate that the device functions as intended, and has a safety and effectiveness profile that is similar to the predicate device."

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

• Sample Size: The document repeatedly uses the phrase "All test articles" or "Test results on all test articles." While a specific numerical sample size (e.g., N=X units for each test) is not explicitly stated, it implies that a predefined number of units were manufactured and tested for each performance characteristic.
• Data Provenance: This is not a clinical study involving patient data, but rather in-vitro performance testing of a physical device. Therefore, concepts like country of origin of data or retrospective/prospective do not apply. The tests were conducted according to the FDA's "Coronary and Cerebrovascular Guidewire Guidance."

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

• This is not applicable as this is not an AI/ML study requiring expert annotation for ground truth. The "ground truth" here is the physical performance of the device against predefined engineering specifications and the performance of the predicate device. The "experts" are the engineers and technicians conducting the tests and the designers establishing the specifications.

4. Adjudication Method for the Test Set

• Not applicable. This is not a study requiring human adjudication of classifications or interpretations. Performance is measured against objective, quantifiable metrics (e.g., force, torque, successful navigation).

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

• Not applicable. This is a physical medical device, not an AI system assisting human readers. Therefore, an MRMC study is not relevant.

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

• Not applicable. This is a physical medical device, not an algorithm. The performance tests ("Non Clinical testing / Performance Data") effectively serve as a "standalone" assessment of the device's physical properties and functionality.

7. The Type of Ground Truth Used

• The "ground truth" for this device's performance is established by:
  • Engineering Specifications: Pre-defined quantifiable ranges for physical properties (e.g., tensile strength, torque strength).
  • Predicate Device Performance: Performance data from the previously cleared ASAHI CHIKAI black 18 guidewire (K141751) serves as a benchmark for "similarity."
  • Clinical Experience: ASAHI's established specifications are also based on clinical experience with similar devices.
  • FDA Guidance: Adherence to recommendations in the FDA guidance document: "Coronary and Cerebrovascular Guidewire Guidance."

8. The Sample Size for the Training Set

• Not applicable. As a physical medical device, there is no "training set" in the AI/ML sense. The "training" for the device design and manufacturing processes comes from decades of engineering knowledge, materials science, and previous device iterations (like the predicate device).

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

• Not applicable for the same reasons as point 8. The "ground truth" for developing the device itself resides in the established scientific and engineering principles, material properties, and performance benchmarks derived from prior device development and regulatory clearances.

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