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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 Microcatheter 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. The Corsair Microcatheter is also intended to assist in the delivery of contrast media into the coronary, peripheral, and abdominal vasculatures.

The ASAHI Corsair 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 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 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 has a tapered shape and is designed to have increased flexibility towards the distal end. PTFE is applied to the inner lumen of the catheter 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.

This document describes a 510(k) premarket notification for the ASAHI Corsair Microcatheter. The notification aims to demonstrate substantial equivalence to a legally marketed predicate device (ASAHI Corsair Microcatheter, K083127). The information provided focuses on non-clinical testing and comparison to the predicate device, rather than a clinical study with detailed acceptance criteria and performance against those criteria in a typical AI/software context.

Here's an analysis of the provided text based on your request, with the understanding that this is a medical device submission focused on substantial equivalence through non-clinical testing:

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

The document does not explicitly state numerical acceptance criteria in a table format with corresponding performance results for each criterion in the way one might see for an AI/software device. Instead, it describes general performance categories and confirms they met "all acceptance criteria" or performed "similarly to the predicate."

• Acceptance Criteria (Implicit): Maintain torque durability, maintain coating integrity/peel strength, biocompatibility.
• Reported Device Performance:
  • Torque Durability: "maintained the torque durability within the acceptance criteria."
  • Coating Integrity/Peel Testing: "confirmed equivalent performance of the Subject device as compared to its predicate."
  • Biocompatibility: "supports that the modifications to the coating material continue to render the device biocompatible."
  • Overall: "The in vitro bench test demonstrated that the ASAHI Corsair Microcatheter met all acceptance criteria and performed similarly to the predicate devices."

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 describes "non clinical laboratory testing" and "in vitro bench test." It does not specify sample sizes for these tests. The data provenance is implied to be from the manufacturer's internal testing ("ASAHI Intecc Co., Ltd." in Japan, with branch offices globally). This is not a clinical study; therefore, terms like retrospective/prospective clinical data or country of origin for patient data are not applicable.

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 is not applicable as the device is a physical microcatheter, and the evaluation involves bench testing for mechanical and material properties, not interpretation of medical images or data by experts. Ground truth in this context would be defined by engineering specifications and biocompatibility standards.

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

Not applicable. This is a non-clinical bench study, not a clinical study requiring adjudication of expert interpretations.

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 (microcatheter), not an AI or software device. No MRMC study was conducted.

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.

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

The "ground truth" for the non-clinical testing would be defined by:

• Engineering specifications and standards: For torque durability and coating integrity/peel strength, the acceptance criteria are likely derived from internal specifications and/or industry standards for microcatheter performance.
• Biocompatibility standards: For biocompatibility, the ground truth refers to established international standards (e.g., ISO 10993 series) for evaluating biological responses to medical devices. The specific tests mentioned (cytotoxicity, sensitization, intracutaneous reactivity, systemic toxicity (acute), and hemocompatibility) are standard tests within these guidelines.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI or software device that undergoes "training."

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

Not applicable. As there is no training set for a physical device, this question is not relevant.

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The Asahi Corsair Microcatheter 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. The Corsair Microcatheter is also intended to assist in the delivery of contrast media into the coronary, peripheral and abdominal vasculatures.

The ASAHI Corsair Microcatheter consists of distal tip and a shaft tube that are inserted into a vascular connector for catheter control and infusion of contrast media. The Corsair has a radiopaque marker coil is imbedded into the inner layer of resin to facilitate the tip location during angiographic procedures. In addition, the device is coated with sodium hyaluronate on the outer surface of shaft tube to provide a smooth transition in blood vessel. The Distal tip of the Corsair has a tapered shape and is designed to have increased flexiblility towards distal side. PTFE is applied to the inner lumen of Catheter for the purpose of smooth transition and exchange of guidewire. The Microcatheter also reinforcement wires that are knitted between hypoblast and intercellular layer 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 provided text regarding the acceptance criteria and study details for the Asahi Corsair Microcatheter, focusing on the requested categories:

This submission is a 510(k) Pre-Market Notification, which is a regulatory pathway for medical devices seeking to demonstrate substantial equivalence to a previously legally marketed device (predicate device). In this context, the "acceptance criteria" are not performance metrics of an AI algorithm, but rather the regulatory requirements for showing that the new device is as safe and effective as existing ones.

The provided text describes a traditional medical device (microcatheter), not an AI/ML powered device. Therefore, many of the requested categories (e.g., AI assistance, standalone algorithm performance, training set details) are not applicable to this document.

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

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

• Not Applicable. This document describes a traditional medical device, not an AI/ML system evaluated on a "test set" of data. The performance was demonstrated through biocompatibility testing and mechanical/functional bench testing, which usually involves a set number of physical device units rather than a dataset of patient information. The number of devices used for these tests is not specified in this summary.

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)

• Not Applicable. As this is not an AI/ML system, there is no "ground truth" established by experts in the context of a test set for diagnostic accuracy. The evaluation revolves around the physical and material properties of the microcatheter.

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

• Not Applicable. There is no "adjudication method" described for a test set, as this is not an AI/ML system with diagnostic outputs that require expert consensus.

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 not an AI-assisted device. Therefore, no MRMC study or AI assistance effect size is relevant or reported.

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, not an AI algorithm.

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

• Not Applicable. For a physical device like a microcatheter, the "ground truth" used for evaluation is based on established engineering standards for mechanical performance, material science for biocompatibility, and regulatory criteria for safety and effectiveness compared to predicate devices. It's not about diagnostic accuracy.

8. The sample size for the training set

• Not Applicable. This is not an AI/ML system. There is no "training set" in the context of data for model development.

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

• Not Applicable. As no training set exists for an AI/ML model, there's no ground truth established in this context.

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