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The product (FineCross M3) is intended to be percutaneously into blood vessels and support a guide wire while performing PCI (percutaneous coronary intervention). The product is also intended for injection of radiopaque contrast media for angiography. The product should not be used in cerebral and peripheral vessels.

FineCross M3 is a single use, ethylene oxide sterilized device that is intended to be percutaneously introduced into blood vessels and support a guide wire while performing PCI (percutaneous coronary intervention). The product is also intended for injection of radiopaque contrast media for angiography. FineCross M3 features a three-layer construction, which consists of a stainless steel mesh braid sandwiched between an outer layer of polyester elastomer and an inner layer of polytetrafluoroethylene. The outer surface of the catheter is coated with hydrophilic polymer.

Here's an analysis of the provided text regarding the acceptance criteria and study for the FineCross M3 device, structured to answer your specific questions.

1. Table of Acceptance Criteria and Reported Device Performance

The document provides a list of performance tests conducted on the FineCross M3 device. For each test, it states that "Performance testing met the predetermined acceptance criteria and is acceptable for clinical use throughout its shelf life." However, it does not provide specific numerical or qualitative values for the acceptance criteria, nor does it detail the specific reported device performance values for each test. Instead, it offers a general statement of compliance.

Biocompatibility Testing:

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

The document does not specify the sample sizes used for each of the performance or biocompatibility tests. It only states that tests were performed on "non-aged and accelerated aged samples" for performance testing (except Radio-detectability and Simulated Use Usability) and on "non-aged, sterile, whole device" and "accelerated-aged (2 years), sterile, whole device" for biocompatibility.

The data provenance is industrial (manufacturer-conducted testing) and likely combines both novel testing for this specific device and potentially established testing protocols based on industry standards. It is not patient or clinical data, so terms like "retrospective" or "prospective" are not applicable in this context. The country of origin for the manufacturing and testing is Japan (Ashitaka Factory of Terumo Corporation).

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

This document describes non-clinical performance and biocompatibility testing of a medical device (a microcatheter). It does not involve diagnostic interpretation or patient data where "ground truth" would typically be established by human experts like radiologists. Therefore, this information is not applicable to the provided document. The ground truth for these tests is based on objective, measurable physical and chemical properties and engineering standards.

4. Adjudication Method for the Test Set

As this document describes non-clinical performance and biocompatibility testing, an "adjudication method" in the context of expert consensus (like 2+1 or 3+1 for clinical interpretations) is not applicable. The results of these tests are determined by adherence to pre-defined scientific and engineering protocols and acceptance criteria.

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

There was no MRMC comparative effectiveness study and no AI component mentioned in this 510(k) submission. This K-submission is for a medical device (microcatheter), not an AI/software-as-a-medical-device.

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

This is not applicable as the device is a physical medical instrument (microcatheter), not an algorithm or AI system.

7. The Type of Ground Truth Used (expert concensus, pathology, outcomes data, etc)

For the performance tests, the "ground truth" is defined by engineering specifications, material science principles, and established industry standards. For example, the freedom from leakage is tested against a standard preventing fluid escape, and material biocompatibility is tested against ISO 10993 standards and FDA guidance. This is not a "ground truth" derived from expert consensus, pathology, or outcomes data in a clinical sense.

8. The Sample Size for the Training Set

There is no training set in this context. This is a physical medical device, not a machine learning model.

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

This is not applicable as there is no training set mentioned in the document.

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This product is intended to be used in conjunction with steerable guidewires in order to access discrete regions of the coronary arterial vasculature and peripheral vessels, to facilitate placement of guidewires and other interventional devices, for use during two guidewire procedures, and to subselectively infuse/deliver diagnostic or therapeutic agents. Not for use in the neurovasculature.

The ASAHI SASUKE® Dual Lumen Catheter is a sterile single use device designed for use in the arterial vasculature. The ASAHI SASUKE® is a catheter that has two lumens: an over-the-wire lumen that extends across the length of the catheter, and a rapid exchange lumen installed at the distal end. This product consists of a tip, shaft, protector and connector. The surface of the distal section of the shaft of this product is coated with hydrophilic coating. In addition, a radiopaque marker is provided between the tip and the shaft of the product, enabling the user to view the position of the tip under X-ray fluoroscopy. The device packaging includes a needle to flush the lumens prior to use.

The provided document describes a medical device, the ASAHI SASUKE®, and its 510(k) premarket notification for substantial equivalence to existing predicate devices. The document highlights the device's indications for use, description, and a comparison with predicate devices, along with non-clinical testing performed.

However, the document does not contain the level of detail requested for a comprehensive description of acceptance criteria and a study proving the device meets those criteria in the context of an AI/ML powered device. The ASAHI SASUKE® is a physical medical device (a catheter), and the information provided pertains to its mechanical and biological performance, not an AI/ML algorithm's performance.

Specifically, the document does not provide:

• A table of acceptance criteria and reported device performance in the context of an AI/ML device (e.g., sensitivity, specificity, AUC).
• Sample sizes used for a test set (in the context of AI/ML validation) or data provenance.
• Number of experts, their qualifications, or adjudication methods for establishing ground truth for an AI/ML model.
• Information about a multi-reader multi-case (MRMC) comparative effectiveness study for AI assistance.
• Details about a standalone AI algorithm performance study.
• The type of ground truth used for AI/ML development.
• Sample size for a training set or how ground truth was established for training (as these are not relevant for a physical catheter).

Instead, the document details non-clinical laboratory testing for a physical catheter. The "Non Clinical testing / Performance Data" section lists various bench tests, and states:

"The in vitro bench tests demonstrated that the ASAHI SASUKE® met all acceptance criteria. Performance data demonstrate that the device functions as intended, and is substantially equivalent to the predicate and reference devices."

The listed tests include:

• Appearance/Dimensions
• Corrosion Resistance
• Force at Break
• Liquid Leakage under Pressure
• Air Leakage
• Radio-Detectability
• Slide Durability
• Kink Resistance
• Particulate and Coating Integrity testing

It also mentions Biocompatibility testing in accordance with ISO 10993, including:

• Cytotoxicity
• Intracutaneous
• Sensitization
• Systemic Toxicity
• USP Pyrogen
• Hemolysis
• Sc5b-9 Complement Activation
• In Vivo Thrombogenicity
• Partial Thromboplastin Time
• Platelet and Leukocyte Binding

Conclusion from the Document:
The ASAHI SASUKE® has the same intended use and indications, and the same or similar technological characteristics (design, materials, sterilization method, performance, and operating principles) as the predicate and reference devices. Performance data from these non-clinical tests successfully demonstrated that the device functions as intended and is substantially equivalent to the predicate and reference devices.

Summary based on the document's content (not an AI/ML study):

1. Table of acceptance criteria and reported device performance: Not provided in a tabular format with specific numerical criteria or performance metrics beyond a general statement that "met all acceptance criteria" and "demonstrate that the device functions as intended."

   • Acceptance Criteria (General): Catheter meets specified mechanical, physical, and biological properties for safe and effective use (e.g., no liquid/air leakage, sufficient force at break, kink resistance, radiodetectability, biocompatibility).
   • Reported Device Performance: "The in vitro bench tests demonstrated that the ASAHI SASUKE® met all acceptance criteria." and "Performance data demonstrate that the device functions as intended, and is substantially equivalent to the predicate and reference devices."

2. Sample size used for the test set and data provenance: Not applicable in the context of AI/ML. The tests are benchtop performance tests of physical properties.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for catheter performance is typically based on engineering specifications and standardized test methods.

4. Adjudication method for the test set: Not applicable.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done: No.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: No.

7. The type of ground truth used: Not applicable in the context of discerning AI output. For the physical device, the "ground truth" would be established engineering and biological standards for catheter performance.

8. The sample size for the training set: Not applicable.

9. How the ground truth for the training set was established: Not applicable.

In essence, the provided text describes the regulatory clearance for a traditional medical device (catheter) based on non-clinical bench testing and biocompatibility assessments, rather than an AI/ML powered device requiring extensive clinical validation or sophisticated ground truth establishment for algorithm performance.

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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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