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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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The NovaCross Microcatheter is intended to be used in conjunction with a steerable guidewire to access discrete regions of the coronary and peripheral vasculature and for guidewire exchange.

The NovaCross™ Microcatheter is a sterile, single-use, single lumen, over-the-wire, disposable percutaneous support catheter designed for use in conjunction with a steerable guidewire to access discrete regions of the coronary and peripheral vasculature for guidewire exchange.

The NovaCross™ Microcatheter consists of telescopic shaft. Over Tube, and a proximal Handle Body that allows for manual device manipulation and a means for flushing the catheter lumen. A key element of the device is a temporarily deployable and retractable distal Nitinol Scaffold, which is visible through fluoroscopy when deployed by the user, and expands to the width of the artery to provide an anchoring to aid the user in establishing greater support near the treatment site.

Subsequent to conventional guidewire placement, therapeutic devices such as atherectomy devices, PTCA catheters, and/or stents may be used to provide therapeutic benefit. The NovaCross™ Microcatheter by itself does not provide therapeutic benefit beyond simple facilitation of guidewire support. The NovaCross™ Microcatheter is similar in its design and it achieves its intended use by means of the same mechanisms as the predicate devices.

Here's a breakdown of the acceptance criteria and study information for the NovaCross Microcatheter:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not contain a specific table detailing acceptance criteria alongside exact numerical performance metrics for each criterion. Instead, it states that "All [mechanical] tests met the predefined acceptance criteria" and "The Test Item successfully achieved all performance criteria defined in the study protocol" for the animal study.

Here's an inferred table based on the information provided:

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

• Test Set Sample Size:

  • Animal Study: 6 pigs.
  • Mechanical Testing: Not specified, but implied to be sufficient for each distinct test.
  • Biocompatibility / Sterilization / Packaging / Shelf Life: Not specified, but implied to be sufficient for each distinct test.

• Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). However, the animal study is described as a "GLP animal study," indicating it was a prospective, controlled study conducted under Good Laboratory Practice regulations, typically for regulatory submission.

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

• Animal Study: The study involved evaluation of gross pathology and histopathology. While not explicitly stated how many experts or their specific qualifications (e.g., "veterinary pathologist with X years experience") were involved, the execution of a "GLP animal study" strongly implies that qualified veterinary professionals, including veterinarians, surgeons, and pathologists specialized in animal models, were involved in the assessment and establishment of ground truth for the animal tissue analysis.

• Other Testing (Mechanical, Biocompatibility, etc.): Ground truth for these tests is typically established by engineering specifications, international standards (e.g., ISO), and defined acceptance limits rather than expert consensus on individual cases.

4. Adjudication Method for the Test Set

• Animal Study: The text mentions "Pathology and histopathology analyses confirmed the results of the study." This suggests a formal pathological review process. However, the exact adjudication method (e.g., blinded review, multiple pathologists, consensus meeting) is not detailed.
• Other Testing: Adjudication methods are not applicable in the same way as clinical or image-based studies. Tests are pass/fail based on predefined criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic or screening devices to assess human reader performance with and without AI. The NovaCross Microcatheter is a medical device (microcatheter) used in interventional procedures, not an AI-powered 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. The device described is a physical medical instrument, not a software algorithm.

7. The Type of Ground Truth Used

• Biocompatibility: Established by standardized biological assays and compliance with ISO 10993-1.
• Sterilization, Packaging, Shelf Life: Established by adherence to ISO 11135-1 and company-defined stability/integrity protocols.
• Mechanical Testing: Established by engineering specifications and predefined acceptance criteria, often derived from industry standards or predicate device performance.
• Animal Study: "No discernible pathological adverse effects were detected, in terms of local and systemic effects" and "Pathology and histopathology analyses confirmed the results of the study." This indicates that pathology and histopathology (tissue analysis) served as the ground truth for safety and effectiveness in the animal model.

8. The Sample Size for the Training Set

Not applicable. This device is a physical medical device, not an AI or machine learning algorithm that requires a "training set" in the computational sense.

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

Not applicable for the reason stated above.

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The ASAHI FUBUKI 043 and ASAHI FUBUKI Guide Catheters are intended to be used to guide interventional devices for neurovascular therapy to a lesion or a procedural site for a percutaneous intravascular in the neurovasculature. This catheter is also intended to be used for injection of contrast media. Do not use this cather other than for use in the neurovasculature.

ASAHI FUBUKI 043 and ASAHI FUBUKI Guide Catheters consists of a guide catheter, available in the following sizes: ASAHI FUBUKI 043 (4.2 Fr), ASAHI FUBUKI 6Fr (6 Fr), ASAHI FUBUKI 7Fr (7 Fr), ASAHI FUBUKI 8Fr (8 Fr). The ASAHI FUBUKI Neurovascular Guide Catheter Dilator Kit consists of a Catheter and Dilator components, available in the following sizes: ASAHI FUBUKI Dilator Kit 4Fr (Catheter 6 Fr, Dilator Shaft 1.75 mm), ASAHI FUBUKI Dilator Kit 5Fr (Catheter 7 Fr, Dilator Shaft 2.00 mm), ASAHI FUBUKI Dilator Kit 6Fr (Catheter 8 Fr, Dilator Shaft 2.21 mm). The catheter consists of three main sections including a tube, a protector section, and a connector. The proximal part of the tube is covered by the protector and the connector is bonded to the proximal end of the tube. A soft tip is bonded to the distal end of the catheter. The inner lumen of the tube (excluding the connector portion) is lined with PTFE to facilitate movement of the guide wire and other devices. The tube is made of polymer resin and is reinforced by a stainless steel and tungsten braid wire. The outer surface of the tube is partially coated with a hydrophilic polymer.

The provided document discusses a 510(k) premarket notification for the "ASAHI FUBUKI 043 and ASAHI FUBUKI Guide Catheters." This is a regulatory submission to demonstrate that the new device is substantially equivalent to legally marketed predicate devices, not a study designed to prove the device meets acceptance criteria in the context of an AI/ML medical device.

The document describes non-clinical testing performed on the device to establish substantial equivalence to predicate devices, but it does not contain information regarding acceptance criteria for an AI/ML device, nor does it detail a study proving an AI/ML device meets such criteria.

Specifically, the document does not include:

• A table of acceptance criteria and reported device performance for an AI/ML device.
• Sample sizes for a test set or data provenance for an AI/ML model.
• The number or qualifications of experts used to establish ground truth for an AI/ML test set.
• Adjudication methods for an AI/ML test set.
• Information about a multi-reader multi-case (MRMC) comparative effectiveness study or related effect sizes for AI assistance.
• Details about a standalone (algorithm-only) performance study for an AI/ML device.
• The type of ground truth used for an AI/ML model (e.g., pathology, outcomes data).
• The sample size for a training set (relevant for AI/ML).
• How ground truth for a training set was established (relevant for AI/ML).

Instead, the document focuses on non-clinical laboratory testing to compare the new catheter device to existing predicate devices. The tests performed are related to the physical and mechanical properties of the catheter, as listed under "NON CLINICAL TESTING / PERFORMANCE DATA":

• Corrosion resistance
• Force at break
• Liquid leakage under pressure
• Air leakage into hub assembly during aspiration
• Leak and damage under high static pressure
• Radio-detectability
• Kink resistance
• Appearance/Dimensions
• Biocompatibility

The conclusion drawn is that the new catheter device is "substantially equivalent" to the predicate devices based on shared intended use, technological characteristics (components, design, materials, sterilization, shelf life, operating principles), and performance data demonstrating it functions as intended with a similar safety and effectiveness profile.

Therefore, I cannot provide the requested information as it pertains to AI/ML device acceptance criteria and study details because the provided text describes a 510(k) submission for a physical medical device (catheter), not an AI/ML-driven device.

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