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To facilitate the placement of balloon dilatation catheters during perculaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). The Asahi PTCA Guide Wires are not to be used in the cerebral blood vessel.

'I'he Asahi PTCA Guide Wire Confianza Pro is steerable guide wire with a maximum 0.014" and available in 180 cm and 300 cm length. The extension wire is diameter of connected to the end of the guide wire outside the body. The wire is constructed from a stainless steel core wire. The core wire and coil are soldered. The distal end of the guide wire has a radiopaque tip that is available straight and is made soft to easily bend with the vessel curve. The coating (hydrophilic and silicone) is applied to the distal portion of the wire guide wire. The proximal section of the guide wire is coated with PTFE.

This is a 510(k) premarket notification for a medical device, which typically relies on demonstrating substantial equivalence to a predicate device rather than presenting detailed clinical study data with acceptance criteria for device performance in the same way a PMA (Premarket Approval) application would.

Based on the provided text, the device in question is the Asahi PTCA Guide Wire Confianza Pro.

Here's an analysis of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a table of
specific, quantifiable acceptance criteria or detailed reported device performance for the Asahi PTCA Guide Wire Confianza Pro.

The document states:
"Bench and biocompatibility testing were conducted according to the recommendations from relevant FDA guidance to demonstrate that the Asahi PTCA Guide Wire Confianza Pro met the acceptance criteria and performed similarly to the predicate devices. No new safety or effectiveness issues were raised during the testing."

This indicates that:

• Acceptance Criteria: Existed, but are not explicitly listed in the provided summary. They were likely derived from relevant FDA guidance for guide wires.
• Reported Device Performance: The device "met the acceptance criteria and performed similarly to the predicate devices." No specific numerical performance metrics are provided. The "bench and biocompatibility testing" would have assessed physical properties (e.g., tensile strength, kink resistance, lubricity) and biological safety (e.g., cytotoxicity, sensitization), aiming to show equivalence to the predicate.

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

This information is not provided in the document. The text only mentions "bench and biocompatibility testing," which are typically laboratory-based tests of the device itself, not clinical tests on patient data. There is no indication of a "test set" of patient data in the context of clinical performance.

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

This information is not applicable/provided. Since no clinical test set with patient data is described, there's no mention of experts establishing ground truth for such a set.

4. Adjudication Method for the Test Set

This information is not applicable/provided. No clinical test set is described.

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

This information is not applicable/provided. The 510(k) summary focuses on substantial equivalence based on bench testing and biocompatibility, not on a clinical MRMC study. There is no mention of human readers or AI assistance.

6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance)

This information is not applicable/provided. This device is a physical medical device (guide wire), not a software algorithm. Therefore, "standalone performance" in the context of an algorithm is irrelevant.

7. Type of Ground Truth Used

This information is not applicable/provided in the context of clinical performance. For the bench testing, the "ground truth" would be established specifications and standards for guide wire performance (e.g., material properties, force measurements, kink resistance thresholds). For biocompatibility, it would be established ISO standards for biological evaluation of medical devices.

8. Sample Size for the Training Set

This information is not applicable/provided. As this is a physical device and not an AI/software product, there is no "training set."

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

This information is not applicable/provided. There is no training set for this type of device.

Overall Summary:

The provided document is a 510(k) summary, which aims to demonstrate that a new device is substantially equivalent to a legally marketed predicate device. This process primarily relies on comparing technological characteristics, materials, and intended use, supported by bench and biocompatibility testing. It does not typically involve the extensive clinical trials or human-reader studies that would provide the type of detailed performance data and acceptance criteria you've asked for, especially for AI or diagnostic devices. The acceptance criteria and performance data mentioned relate to the physical and biological characteristics of the guide wire itself, assessed in a lab setting, rather than its clinical performance in patients as measured by diagnostic accuracy, for example.

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