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The ASAHI Corsair Armet 18 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 18 is also intended to assist in the delivery of contract media into the peripheral vasculature.

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

This product consists of a distal tip, a shaft tube, a protector and a connector. The distal tip and distal side of shaft are coated with hydrophilic coating on the outer surface. The tip is radiopaque, and the distal end is clearly distinguished by the tip.

The provided document, a 510(k) summary for the ASAHI Corsair Armet 18, describes the device's acceptance criteria and the study (non-clinical testing) used to demonstrate its substantial equivalence to a predicate device.

It's important to note that this device is a Percutaneous Catheter, and its performance evaluation relies on non-clinical bench testing rather than clinical studies involving human patients or complex AI algorithms processing medical images. Therefore, some of the requested information (like sample size for test/training sets for AI, expert adjudication, MRMC studies, or specific ground truth methodologies for image-based AI) is not applicable or present in this context.

Here's a breakdown of the requested information based on the provided document:

Acceptance Criteria and Device Performance (Based on Non-Clinical Testing)

1. Table of Acceptance Criteria and Reported Device Performance

Note: The specific quantitative acceptance values for each test are not detailed in this summary but are implied to be established based on ISO10555-1 and/or internally validated procedures.

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

• Sample Size: The document repeatedly states "All ASAHI Corsair Armet 18 Microcatheter test samples" but does not specify the exact number of samples used for each test. This is typical for bench testing where a representative number of units are tested to ensure consistency and compliance.
• Data Provenance: The testing was "in vitro bench tests" performed on finished sterilized product. The applicant is ASAHI INTECC CO., LTD based in Japan, and the primary contact is in Tustin, California, USA. The testing itself would have been conducted in a laboratory, likely in-house or by a contracted lab. The data is retrospective in the sense that it's performed on manufactured devices for regulatory submission.

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

• Not applicable in this context. This device's evaluation is based on physical and mechanical performance characteristics of a medical device, not on diagnostic interpretations by human experts. The "ground truth" is defined by the objective measurement of physical properties against established engineering and medical device standards (ISO10555-1) and internal specifications.

4. Adjudication Method for the Test Set

• Not applicable in this context. Adjudication methods like 2+1 or 3+1 are used for human review processes, typically in medical imaging studies where there's subjectivity in interpretation. For bench testing, results are quantitative and directly measured against pre-defined criteria.

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

• No. An MRMC study is relevant for AI-powered diagnostic devices where human readers' performance with and without AI assistance is compared. This document is for a medical catheter, not an AI diagnostic system.

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 algorithm. Its "performance" is its ability to meet specified physical and mechanical criteria.

7. The Type of Ground Truth Used

• The ground truth is quantitative, objective physical and mechanical measurements against established international standards (ISO10555-1) and internally developed/validated acceptance criteria for various performance aspects (e.g., burst pressure, tensile strength, dimensions, kink resistance).

8. The Sample Size for the Training Set

• Not applicable. There is no "training set" in the context of this device's non-clinical evaluation, as it is not an AI/machine learning product. The device itself is manufactured, and specific samples from the manufacturing process are chosen for testing.

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

• Not applicable. As there is no training set for an AI algorithm, this question does not apply. The "ground truth" for evaluating the catheter's performance is derived from engineering principles, relevant ISO standards, and established medical device design specifications.

Summary of Approach:

The evaluation of the ASAHI Corsair Armet 18 relies entirely on non-clinical bench testing to demonstrate that its physical and mechanical performance characteristics are substantially equivalent to a legally marketed predicate device (ASAHI Corsair Armet, K161362). The "acceptance criteria" are the thresholds or ranges for various engineering and material properties that the device must meet to ensure safety and effectiveness as a percutaneous catheter. The "study" involves performing a series of standardized tests on a set of manufactured devices and confirming that all tested samples meet these pre-defined criteria.

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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 neurovasculature.

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. The primary change in this Special 510(k) involves a minor change in the shape of the distal tip.

The provided document is a 510(k) Summary for the ASAHI Corsair Armet. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving efficacy or safety through large-scale clinical trials. Therefore, the information typically requested in your prompt regarding acceptance criteria, study details, and expert involvement for diagnostic algorithm performance is not present in this document.

The document describes non-clinical (bench) testing performed to confirm the device's performance against pre-defined acceptance criteria, primarily related to its physical characteristics and functionality.

Here's a breakdown of the available information based on your request, with an emphasis on what is not provided due to the nature of this regulatory submission:

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

The document lists the types of non-clinical tests performed, but does not provide a specific table detailing the quantitative acceptance criteria for each test or the exact numerical performance values. It generally states that the device "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)

• Sample Size: Not specified for the non-clinical tests. These are typically bench tests conducted on a sufficient number of units to demonstrate consistency, but not usually reported with statistical sample sizes in a 510(k) summary.
• Data Provenance: The tests were "non clinical laboratory testing." No country of origin for the data is specified, but the applicant is Asahi Intecc Co., Ltd. from Japan, and the testing likely occurred internally or at a contracted lab.
• Retrospective or Prospective: These were bench tests, so the concept of retrospective or prospective (which applies to clinical data) is 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 information is not applicable to this type of non-clinical device testing. "Ground truth" established by human experts (like radiologists) pertains to diagnostic algorithms, not to the physical performance of a catheter. The ground truth for these tests is based on engineering specifications and measurement standards.

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

This information is not applicable as it relates to expert consensus on clinical or diagnostic data. For bench testing, results are typically analyzed against predefined, objective, and measurable 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

This information is not applicable. This device is a percutaneous catheter, not an AI-powered diagnostic tool. Therefore, MRMC studies and the effect of AI assistance on human readers are irrelevant to this submission.

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

This information is not applicable. This device is hardware (a catheter), not an algorithm or AI system.

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

For non-clinical testing, the "ground truth" implicitly refers to the engineering specifications and performance standards. For example, for "Force at Break," the ground truth would be a defined minimum force the device must withstand, determined by engineering principles and safety margins. For "Dimensions," the ground truth is the specified dimensional tolerances.

8. The sample size for the training set

This information is not applicable. There is no "training set" as this is not an AI/machine learning device.

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

This information is not applicable, as there is no training set for this type of medical device submission.

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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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