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This microcatheter is a medical device intended for angiography and/or infusion of various substances including diagnosis, embolization and treatment in the peripheral vasculature using an appropriate guide wire. The microcatheter is not intended for use in neurovasculature, coronary arteries and carotid arteries.

The ASAHI Veloute, ASAHI Veloute C3, ASAHI Tellus and ASAHI Tellus C3 Microcatheters are sterile single use devices designed for use in the peripheral vasculature. The ASAHI Veloute, ASAHI Veloute C3, ASAHI Tellus and ASAHI Tellus C3 consist of a catheter shaft that is reinforced with braid wires to enhance pushability and maintain patency of the inner lumen. A radiopaque marker is fixed on the distal end of the catheter shaft to facilitate location of the catheter during angiography. The distal portion of the catheter shaft is flexible and available in two shapes, straight and angled, to provide improved trackability in tortuous vessels. A hydrophilic coating is applied on the outer surface of the catheter to provide a smooth transition. In addition, accessories, including either a stylet, syringe and RHV (rotating hemostasis valve), or a stylet, syringe, inserter and hemostasis valve are available for use with the ASAHI Veloute, ASAHI Veloute C3, ASAHI Tellus and ASAHI Tellus C3.

The provided text describes a 510(k) premarket notification for various microcatheters (ASAHI Veloute, ASAHI Veloute C3, ASAHI Tellus, ASAHI Tellus C3). This document serves as a regulatory submission to demonstrate that a new device is substantially equivalent to a legally marketed predicate device, rather than a study proving the device meets acceptance criteria for an AI/ML medical device.

Therefore, the requested information regarding acceptance criteria, study design, expert involvement, and ground truth for an AI/ML-based device cannot be extracted from this document. The document primarily focuses on the mechanical, material, and biocompatibility performance of a physical medical device (microcatheter) and its substantial equivalence to existing devices.

However, I can extract the information related to the performance testing and acceptance criteria for the physical microcatheter device as detailed in the document.

Acceptance Criteria and Device Performance (for the physical microcatheter device)

The document details non-clinical laboratory testing and biocompatibility testing conducted to demonstrate the substantial equivalence of the ASAHI microcatheters.

1. Table of Acceptance Criteria and Reported Device Performance

Regarding the AI/ML-specific details (Items 2-9 from your prompt):

The provided document is a 510(k) summary for a physical medical device (microcatheter), not an AI/ML-driven software device. Therefore, information related to:

2. Sample size for test set and data provenance: Not applicable. Tests were bench/in-vitro and animal studies for device performance and biocompatibility.
3. Number of experts and qualifications for ground truth: Not applicable. Performance data is from physical tests. Biocompatibility standards are specific laboratory tests.
4. Adjudication method: Not applicable.
5. Multi Reader Multi Case (MRMC) comparative effectiveness study: Not applicable. This is for AI-assisted human reading.
6. Standalone (algorithm only) performance: Not applicable. This is a physical device.
7. Type of ground truth used: For non-clinical tests, the ground truth is the physical measurement and functional assessment against specified engineering criteria. For biocompatibility, it's defined by the specific ISO standards and their pass/fail criteria.
8. Sample size for training set: Not applicable (no AI/ML model training).
9. How ground truth for training set was established: Not applicable.

In conclusion, this document demonstrates the safety and effectiveness of a microcatheter through standard predicate comparison, non-clinical bench testing, and biocompatibility studies, which are typical requirements for such devices. It does not contain any information about an AI/ML component or its associated validation studies.

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The Anchor Dual Lumen Guidewire Catheter is intended for use in the peripheral, coronary, and neuro vasculature for the intravascular introduction of interventional devices.

The Anchor Dual Lumen Guidewire Catheter, model AQ8001, is a single use, sterile (EO), 8F, 110 cm (working length of 100 cm) biocompatible, flexible, radiopaque, dual lumen catheter with a 6F, C shaped tip. The shaft utilizes a braided wire design with multiple Pebax durometer extrusions reflowed over PTFE liner. The distal tip includes radiopaque marker bands for visibility under fluoroscopy. The larger lumen accommodates an 0.035" guidewire and other interventional devices; the smaller lumen allows a 0.014" guidewire to exit the catheter at the curve to provide stabilization of the catheter. The hub, with Luer fittings, is compatible with standard syringes and is leak proof. The hub is marked to identify the lumens.

The Aqure Medical, Inc. Anchor Dual Lumen Guidewire Catheter (K201076)

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not explicitly state numerical sample sizes for most of the tests. It typically refers to "All devices" or "Devices" met the criteria.

• Physician Simulated Use: Two physicians used "subject and predicate devices." The number of devices used by each physician is not specified.
• Functionality/Stabilization: "Subject and predicate devices were tested."
• Shelf Life Testing: "Devices were subjected to all testing post 6 month accelerated aging."
• Packaging Testing: Implies sufficient packages were tested to ensure compliance.
• Biocompatibility Tests: These tests follow ISO standards, which typically specify sample sizes for biological evaluations. The document does not provide the specific numbers of samples tested, but states that the tests were performed per the referenced ISO standards. For instance, the "4-Hour Thrombogenicity Study in Canine" would involve a number of animal subjects.

The data provenance is not explicitly stated in terms of country of origin or whether the studies were retrospective or prospective, beyond the fact that these were laboratory and simulated use studies conducted as part of the device's development and premarket notification. These are assumed to be prospective studies conducted specifically for this regulatory filing.

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

• Physician Simulated Use: "Two physicians" were actively involved in judging the performance of the device in a simulated use model. Their specific qualifications (e.g., years of experience, specialty) are not detailed in this document.

For other performance tests like visual inspection, dimensional measurements, buckle, flexibility, torque, leakage, flow rate, tensile strength, and particulate tests, the "ground truth" is established by adherence to recognized national and international standards (e.g., ISO, ASTM) and the device's own internal specifications. The experts are implied to be qualified technical personnel carrying out these standardized tests.

4. Adjudication Method for the Test Set:

• Physician Simulated Use: The two physicians "deemed the performance of the subject device acceptable." This suggests a consensus or agreement among the two on the acceptability of the device's performance, but no formal adjudication method like 2+1 or 3+1 is described. For the objective metrics (e.g., retropulsion), direct measurement provided the "ground truth."
• For the vast majority of the other tests (e.g., visual, dimensions, mechanical, biocompatibility), the adjudication method is based on meeting the quantitative or qualitative criteria of the referenced ISO/ASTM standards or the device's internal specifications. There is no mention of a multi-observer adjudication process for these tests; rather, they are objective measurements or pass/fail assessments against established 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:

This information is not applicable to the Aqure Medical, Inc. Anchor Dual Lumen Guidewire Catheter. This device is a physical medical instrument (a guidewire catheter), not an artificial intelligence (AI) or software-as-a-medical-device (SaMD) product. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant.

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

This information is not applicable for the same reason as point 5. The device is not an algorithm or AI system.

7. The Type of Ground Truth Used:

The ground truth for most of the tests is established through a combination of:

• Objective Measurements: For aspects like dimensions, contrast flow rate, tensile strength, and some biocompatibility metrics (e.g., p-value for PTT).
• Pass/Fail Criteria based on Established Standards: Adherence to ISO, ASTM, and EN standards for physical, mechanical, chemical, and biological properties.
• Expert Opinion/Acceptability: For the physician simulated use, the "acceptable" performance was a qualitative judgment by the physicians.
• Comparative Performance to Predicate: For certain aspects like retropulsion and thrombogenicity, the performance was compared directly to predicate devices and found to be superior or equivalent, respectively.

8. The Sample Size for the Training Set:

This information is not applicable. As a physical medical device, there is no "training set" in the context of machine learning or AI. The term "training set" is generally used for data used to train AI algorithms. For a physical device, development typically involves prototypes, iterative design, and testing, but not a "training set" in the computational sense.

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

This question is not applicable for the same reason as point 8.

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The ASAHI Corsair Armet is intended to provide support to facilitate the placement of guide wires in the peripheral vasculature, and can be used to exchange one guide wire for another.

The ASAHI Corsair Armet is also intended to assist in the delivery of contrast media into the peripheral vasculature.

This device should not be used in coronary vasculature or neuro vasculature.

The ASAHI Corsair Armet consists of a distal tip, a shaft tube that is inserted into vasculature, a protector, and a connector for catheter control and infusion of contrast media. The device has a hydrophilic coating on the outer surface of distal tip and the shaft tube to provide a smooth transition in blood vessels. The distal tip of the Corsair Armet has a tapered shape. PTFE is applied to the inner lumen of the catheter for the purposes of a smooth transition and exchange of guidewires.

This document is a 510(k) summary for the ASAHI Corsair Armet. It focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study of the device's performance against specific clinical acceptance criteria in a human study. Therefore, much of the requested information (like sample size for test sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and training set details) is not applicable or provided in this type of regulatory submission.

However, I can extract the acceptance criteria and the summary of non-clinical performance data provided.

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Device Meets Acceptance Criteria:

A series of non-clinical laboratory bench tests were performed on the ASAHI Corsair Armet. These tests were designed to evaluate the physical and mechanical properties of the device against predefined acceptance criteria for each test parameter.

Missing Information (Not provided in this 510(k) Summary):

2. Sample size used for the test set and the data provenance: This document does not detail the specific sample size (number of devices tested) for each bench test, nor does it refer to human "test sets" or data provenance in terms of country of origin or retrospective/prospective nature, as this is pre-market non-clinical testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth in this context is based on engineering specifications and performance standards for medical devices, not expert human interpretation of clinical data.
4. Adjudication method for the test set: Not applicable. The results are objective measurements from bench tests against defined specifications.
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 device is a percutaneous catheter, not an AI-powered diagnostic or assistive technology for human interpretation.
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: For the non-clinical tests, the "ground truth" or reference was established by pre-defined engineering and performance specifications and standards relevant to percutaneous catheters.
8. The sample size for the training set: Not applicable. This is a physical device, not a machine learning model.
9. How the ground truth for the training set was established: Not applicable.

Summary from the Document:

The ASAHI Corsair Armet underwent non-clinical laboratory testing, which included evaluating its appearance/dimensions, corrosion resistance, force at break, liquid leakage under pressure, air leakage, leak and damage under high static pressure, radio-detectability, torque transmission, slide durability, kink resistance, and torque durability.

The document states: "The in vitro bench tests demonstrated that the ASAHI Corsair Armet met all acceptance criteria and performed similarly to the predicate devices. Performance data demonstrate that the device functions as intended, and is substantially equivalent to the predicate devices."

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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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