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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 total occlusions (CTO).

This device should not be used in neurovasculature.

The ASAHI Corsair Pro® XS consists of a distal tip and a shaft tube that are inserted into a vascular connector for catheter control and infusion of contrast media. The device has 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 Pro® XS has a tapered shape and is designed to have increased flexibility towards the distal end. The inner lumen of the catheter is PTFE for the purposes of a smooth transition and exchange of guidewires.

The microcatheter also contains wires to reinforce the distal tip and shaft tube to allow the physician greater control of the device during interventional procedures.

As compared to the predicate device, the primary change presented in this 510(k) involves a minor change in the dimensions of the tip and catheter shaft and the structure of inner layer (rope coil) of the catheter shaft.

I am sorry, but the provided text does not contain the acceptance criteria and study details for an AI-powered medical device.

The document is a 510(k) Pre-market Notification for a medical device called "ASAHI Corsair Pro® XS", which is described as a percutaneous catheter used to facilitate the placement of guide wires and assist in the delivery of contrast media.

The document discusses non-clinical testing and biocompatibility testing for this physical device to demonstrate its substantial equivalence to a predicate device. It does not mention any AI component, software, or algorithm that would require the kind of acceptance criteria, study design, and performance metrics typically associated with AI/ML medical devices.

Therefore, I cannot provide the requested information based on the given context.

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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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The ASAHI Corsair Pro is intended to provide support to facilitate the placement of guide wires in the coronary and peripheral vasculature, and can be used to exchange one guide wire for another. The ASAHI Corsair Pro is also intended to assist in the delivery of contrast media into the coronary, peripheral, and abdominal vasculature. This device should not be used in neurovasculature.

The ASAHI Corsair Pro consists of a distal tip and a shaft tube that are inserted into a vascular connector for catheter control and infusion of contrast media. The device has a hydrophilic coating on the outer surface of the shaft tube to provide a smooth transition in blood vessels. The distal tip of the Corsair Pro has a tapered shape and is designed to have increased flexibility towards the distal end. The inner lumen of the catheter is PTFE for the purposes of a smooth transition and exchange of guidewires. The microcatheter also contains wires to reinforce the distal tip and shaft tube to allow the physician greater control of the device during interventional procedures.

The provided text describes the ASAHI Corsair Pro, a percutaneous catheter, and its substantial equivalence to predicate devices (ASAHI Corsair Microcatheter K151103, K083127). The document outlines the testing performed to demonstrate that the device meets acceptance criteria.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. A table of acceptance criteria and the reported device performance

The document states that "The in vitro bench tests demonstrated that the ASAHI Corsair Pro met all acceptance criteria." However, specific numerical acceptance criteria for each test (e.g., "Force at Break > X N") are not explicitly provided in this document. The table below lists the tests performed and the general statement of performance.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify the sample sizes used for any of the non-clinical tests.
The data provenance is from in vitro bench tests conducted by ASAHI Intecc Co., Ltd. The company is based in Nagoya, Aichi, Japan, with various branch offices and research facilities globally. The specific location where these tests were performed is not detailed. The tests are prospective in nature, as they are conducted on the new device to demonstrate its performance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This section is not applicable as the study described is a series of non-clinical, in vitro bench tests. These tests assess physical and mechanical properties of the device against predefined engineering specifications, not clinical outcomes requiring expert interpretation or ground truth establishment in a medical context.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This section is not applicable as the described study involves non-clinical bench testing. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or studies involving expert review of medical images or data to establish a ground truth or resolve discrepancies.

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

This section is not applicable. The provided document pertains to the regulatory submission for a medical device (a microcatheter), and the studies described are non-clinical bench tests. It is not an AI-based diagnostic device, and therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant to this content.

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

This section is not applicable. The device is a physical medical instrument (microcatheter), not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the non-clinical bench tests, the "ground truth" refers to predefined engineering specifications and performance standards. The device's performance in each test is measured and compared against these established criteria, which are derived from industry standards, regulatory requirements, and the performance characteristics of the predicate device. There is no biological or clinical "ground truth" derived from expert consensus, pathology, or outcomes data in this context.

8. The sample size for the training set

This section is not applicable. The document describes non-clinical testing of a physical medical device, not a machine learning model or algorithm that typically requires a training set.

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

This section is not applicable for the same reasons as #8.

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