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ASAHI PTCA Guide Wires are intended to facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA), including use in crossing or assisting in crossing de novo coronary chronic total occlusions (CTO).
The ASAHI PTCA Guide Wires are not to be used in the neurovasculature.
This product is intended to provide support to facilitate the placement of guide wires in the coronary and peripheral vasculatures, and can be used to exchange one guide wire for another.
This product is also intended to assist in the delivery of contrast media into the coronary, peripheral and abdominal vasculatures, and to assist in crossing de novo coronary chronic total occlusions (CTO).
This device should not be used in neurovasculature.

The ASAHI® PTCA Guide Wires and ASAHI® Corsair® / ASAHI® Corsair® Pro Microcatheters covered by this submission are existing marketed devices. There have been no physical changes to the subject devices as compared to the currently marketed predicate devices except for a change in indication and related clinical information added to the labeling. The designs and performance of the guidewires are unchanged.
The ASAHI® PTCA Guide Wires consist of a core wire and a coil assembly. Depending on the model, the coil assembly could consist of an outer coil soldered to the core wire, or an inner coil and an outer coil, with or without a safety wire, soldered to the core wire. The distal portion of the coil is radiopaque so as to easily confirm its position under radioscopy. In addition, coatings are applied on the surface of ASAHI® PTCA Guide Wires. The coil and distal portion of the quidewire have a hydrophilic outer coating. The proximal portion of the guidewires are coated with PTFE. The ASAHI® PTCA Guide Wires are available in various lengths and tip shapes. The shorter length devices are designed for use with a commercially available Asahi Intecc extension wire.
The ASAHI Corsair / ASAHI Corsair Pro Microcatheter consists of a distal tip and a shaft tube that are inserted into a vascular connector for catheter control and infusion of contrast media. No accessories are part of this device. The ASAHI Corsair has a radiopaque marker coil that is imbedded into the inner layer of resin to facilitate the tip location during angiographic procedures. In addition, the devices have a hydrophilic coating on the outer surface of the shaft tube to provide a smooth transition in blood vessels. The distal tip of the ASAHI Corsair / ASAHI Corsair Pro has a tapered shape and is designed to have increased flexibility towards the distal end. PTFE is applied to the inner lumen of the catheters for the purposes of a smooth transition and exchange of guidewires.
The microcatheters also contain wires to reinforce the distal tip and shaft tube to allow the physician greater control of the device during interventional procedures.

Here's an analysis of the acceptance criteria and study detailed in the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: 163 subjects
• Data Provenance: Prospective, multi-center, single-arm study. The document does not specify the country of origin of the data, but the applicant's address is in Japan and the US office is in California.

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

The document does not explicitly state the number of experts used to establish ground truth or their specific qualifications (e.g., radiologist with X years of experience). However, the "absence of in-hospital MACE" (Major Adverse Cardiac Events) and "Successful re-canalization" metrics imply adjudication by medical professionals typically involved in cardiac care and angiography. The "Expert Consensus Document from the Society for Cardiovascular Angiography and Interventions (SCAI) published in 2013" is referenced for an alternative MI definition, suggesting expertise from this society would be relevant.

4. Adjudication Method for the Test Set

The document does not explicitly state an adjudication method like 2+1 or 3+1 for establishing ground truth. The MACE definition includes "cardiac death, target lesion revascularization, or postprocedural myocardial infarction (MI)," which would typically involve clinical review and diagnosis by treating physicians or a clinical events committee. The re-canalization success is based on "angiographic visualization," which would involve interpretation by interventional cardiologists.

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, an MRMC comparative effectiveness study involving AI assistance for human readers was not conducted or reported. This study evaluates the performance of medical devices (guide wires and microcatheters) directly in human subjects, not an AI-assisted diagnostic tool.

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

No, a standalone algorithm performance study was not done. This study is a clinical trial evaluating the performance of physical medical devices in a clinical setting with human operators, not an AI algorithm.

7. The Type of Ground Truth Used

The ground truth is based on clinical outcomes and angiographic visualization, as determined by medical professionals during and after the procedures. Specifically:

• Angiographic visualization of guide wire crossing the target lesion for "successful re-canalization."
• Clinical assessment for "in-hospital major adverse cardiac events (MACE)," which includes cardiac death, target lesion revascularization, and post-procedural myocardial infarction (MI), with two different definitions for MI cited.

8. The Sample Size for the Training Set

This document describes a clinical trial for physical medical devices. There is no mention of a training set as would be applicable to an AI model.

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

As this is not an AI model, there is no training set and therefore no ground truth established for it.

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