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The WIRION® is indicated for use as an embolic protection system to contain and remove embolic material (thrombus/ debris) while performing atherectomy in calcified lesions of the lower extremities. The diameter of the vessel at the site of filter basket placement should be between 3.5mm to 6.0mm. WIRION® may be used with commercially available 0.014" guide wires.

WIRION® is a temporary Embolic Protection System (EPS), filtering distal to the intervention site. The system is a rapid exchange, pre-crimped filter that can be used with any commercially available 0.014" guide wires.

I am sorry, but the provided text from the FDA 510(k) K210282 letter and summary for the WIRION® Embolic Protection System does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria in the context of an AI-based or statistical classification system.

The document is a traditional 510(k) submission for a physical medical device (an embolic protection system), not a software or AI-driven diagnostic device that would typically involve acceptance criteria related to sensitivity, specificity, or reader studies.

The "Functional and Safety Testing" section mentions:

• Biocompatibility testing
• Simulated use
• Bond and torque strength testing
• Package testing

These are standard engineering and safety tests for a physical medical device, not performance metrics for an AI algorithm.

Therefore, I cannot extract the requested information (table of acceptance criteria, sample sizes, expert involvement, MRMC study details, etc.) from the provided text because it is not relevant to the type of device described in the document.

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The WIRION™ is indicated for use as an embolic protection system to contain and remove embolic material (thrombus/ debris) while performing atherectomy in calcified lesions of the lower extremities. The diameter of the vessel at the site of filter basket placement should be between 3.5mm to 6.0mm. WIRION™ may be used with commercially available 0.014" guide wires.

WIRION™ is a temporary Embolic Protection System (EPS), filtering distal to the intervention site. The system is a rapid exchange, pre-crimped filter that can be used with any commercially available 0.014" guide wires.

This document is for an embolic protection system (WIRION™), a medical device, and not an AI/ML powered device. Therefore, many of the requested criteria (e.g., acceptance criteria for an AI algorithm, expert ground truth establishment, MRMC study, training/test set sample sizes, data provenance) are not applicable to this 510(k) submission.

The core of this 510(k) submission is that the WIRION™ device is identical to a previously cleared predicate device (K180023). This means the manufacturer is asserting substantial equivalence based on the device being literally the same as one already on the market, rather than needing to prove performance through new clinical or algorithm-specific studies.

Here's how to address the request based on the provided document:

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

Since this is a substantial equivalence claim based on identity to a predicate device, there are no specific performance acceptance criteria or reported performance data for this specific submission. The acceptance is predicated on the prior clearance of the identical device.

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

• Not Applicable. No new test set or data provenance details are provided because the device is stated to be identical to a previously cleared predicate.

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. No ground truth establishment by experts for a test set was required for this submission.

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

• Not Applicable. No adjudication method for a test set was required for this submission.

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/ML device, and no MRMC comparative effectiveness study was performed or required.

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

• Not Applicable. This is not an algorithm, so no standalone performance evaluation was done.

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

• Not Applicable. No new ground truth types were used or established for this submission, as it relies on the predicate device's prior clearance. The previous clearance would have relied on data and performance demonstrations appropriate for a mechanical medical device, likely including preclinical testing and/or clinical data that established safety and effectiveness.

8. The sample size for the training set

• Not Applicable. This is not an AI/ML device, so there is no "training set."

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

• Not Applicable. No ground truth for a "training set" was established.

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WIRION™ is indicated for use as an embolic protection system (EPS) to contain and remove embolic material (thrombus/ debris) while performing angioplasty and stenting in the carotid arteries and atherectomy in calcified lesions of the lower extremities (LE) arteries.

The diameter of the vessel at the site of filter basket placement should be between 3.5mm to 6.0mm. WIRION™ may be used with commercially available 0.014" guide wires.

WIRION™ is a embolic protection system comprised of an independent Filter Unit that can be delivered, locked and deployed on commercially marketed guide wires, according to physician preference, anywhere on the wire. The WIRION™ is a rapid exchange system for single use by a single operator. The WIRION™ is identical to the FDA cleared (K143570) WIRION device indicated for use in carotid artery stenting (CAS) procedures.

The document describes the acceptance criteria and study findings for the WIRION™ Embolic Protection System (EPS).

Here's the breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: 103 patients were enrolled in the WISE LE clinical study.
• Data Provenance: The study was a prospective clinical study (referred to as "WISE LE clinical study") conducted to support the expanded indication of the WIRION™ EPS. The country of origin is not explicitly stated in the provided text, but it is implied to be multinational given the FDA submission context.

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

• The ground truth for the primary endpoint (MAE) was established by an independent Clinical Events Committee (CEC).
• The number of experts within the CEC is not specified.
• Their specific qualifications are not explicitly stated, beyond being an "independent Clinical Events Committee." It is generally understood that such committees are comprised of medical professionals relevant to the study area (e.g., cardiologists, interventional radiologists).

4. Adjudication Method for the Test Set:

• The adjudication method for Major Adverse Events (MAE) was done by an independent Clinical Events Committee (CEC). This suggests a consensus-based review by multiple experts, rather than a simple 2+1 or 3+1 rule which usually refers to isolated expert reads.

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 MRMC comparative effectiveness study was done. This study is for a medical device (embolic protection system), not an AI-based diagnostic or assistive software.

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

• Not applicable. The WIRION™ is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used:

• For the primary endpoint (MAE), the ground truth was established based on clinical outcomes data adjudicated by an independent Clinical Events Committee (CEC). This involved assessing serious adverse events such as death, acute myocardial infarction, thrombosis, pseudo-aneurysm, dissection, distal embolism, unplanned amputation, or clinically-driven target vessel revascularization.
• For other endpoints like device, clinical, and technical success, the ground truth was based on procedural observations and clinical outcomes.

8. The Sample Size for the Training Set:

• Not applicable in the context of this device. The WIRION™ is a physical medical device, not an AI/machine learning system that requires a "training set" in the conventional sense. The "WISE LE clinical study" served as the primary clinical validation (test set) for the expanded indication.

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

• Not applicable as there is no "training set" for an AI algorithm. The device's design and previous versions were based on engineering principles and prior clinical experience. The previous K143570 clearance also involved clinical data, which could be considered foundational, but not a "training set" for an AI model.

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The WIRION™ is indicated for use as an embolic protection system to contain and remove embolic material (thrombus/ debris) while performing angioplasty and stenting procedures in carotid arteries.

The diameter of the vessel at the site of filter basket placement should be between 3.5 mm to 6.0 mm. WIRION™ may be used with commercially available 0.014" guide wires.

WIRION™ is a embolic protection System comprised of an independent Filter Unit that can be delivered, locked and deployed on commercially marketed guide wires, according to physician preference, anywhere on the wire. The WIRION™ is a rapid exchange system for single use by a single operator.

Here's a breakdown of the acceptance criteria and the study details for the WIRION™ Embolic Protection System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document explicitly states that "All tests met their predetermined acceptance criteria," but it does not provide a specific table of these criteria. Instead, it details the observed performance of the primary and secondary endpoints in the clinical study.

Study Details:

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

• Sample Size: 120 patients
• Data Provenance: Clinical studies. The text does not explicitly state the country of origin but implies a multicenter study, and it mentions "historic control" which suggests a comparison to existing data from potentially various sources. The study was prospective, open label, and single arm.

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

The document does not provide details on the number or specific qualifications of experts used to establish ground truth for the clinical study. MACCE (Major Adverse Cardiac and Cerebrovascular Events) rates and other clinical endpoints are typically determined by clinical outcomes and adjudicated by study investigators or independent clinical events committees, but the specific structure is not described here.

4. Adjudication Method for the Test Set

The document does not explicitly state the adjudication method (e.g., 2+1, 3+1). Clinical trials typically use independent adjudication committees for primary endpoints like MACCE, but this detail is not provided.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

No, an MRMC comparative effectiveness study involving human readers with and without AI assistance was not conducted or mentioned. This device is an embolic protection system (a physical medical device), not an AI-powered diagnostic tool.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

No, a standalone algorithm performance study was not done. This is a physical medical device. The performance refers to its function within the human body during a medical procedure, not an algorithm's output.

7. The Type of Ground Truth Used

The ground truth for the clinical study was based on outcomes data (MACCE rates, device success, clinical success, angiographic success, procedural success, complications) observed in human patients during the study.

8. The Sample Size for the Training Set

The document does not mention a "training set" in the context of an algorithm or AI. This is a physical medical device, not a software algorithm that would require a training set. The clinical study described involved 120 patients.

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

As there is no "training set" for an algorithm mentioned, this question is not applicable. For the clinical study, the ground truth was established by clinical observation and assessment of patient outcomes.

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