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ANGIOGUARD XP and ANGIOGUARD RX Emboli Capture Guidewire devices are indicated for use as a guidewire and embolic protection system to contain and remove embolic material (thrombus/debris) while performing carotid artery angioplasty and stenting procedures in carotid arteries. The diameter of the site of filter basket placement should be from 3mm to 7.5mm.

Both the subject and predicate ANGIOGUARD XP Emboli Capture Guidewire and ANGIOGUARD RX Emboli Capture Guidewire devices consists of a guidewire with integrated emboli filter basket at the distal end. The devices function as an interventional guidewire and distal protection device during delivery and placement of stents and interventional devices in carotid procedures. The guidewire is delivered via an OTW (overthe-wire) or RX (rapid-exchange) deployment sheath and is captured via an OTW or RX capture sheath. The ANGIOGUARD XP Emboli Capture Guidewire and ANGIOGUARD RX Emboli Capture Guidewire devices have a filter basket at the distal end that is deployed prior to the stenting procedure. When deployed, the filter basket opens in an umbrella-like fashion, allowing passive hemo-filtration with subsequent emboli capture. At the end of the procedure, the filter is collapsed and retrieved.

The provided document is a 510(k) premarket notification decision letter from the FDA regarding the ANGIOGUARD XP Emboli Capture Guidewire and ANGIOGUARD RX Emboli Capture Guidewire. This document determines substantial equivalence to a predicate device, but it does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of device performance related to a diagnostic or therapeutic algorithm.

Instead, it focuses on the substantial equivalence of an updated version of a medical device (the ANGIOGUARD XP/RX Emboli Capture Guidewire) to a previously cleared predicate device. The changes are limited to a material change for the Deployment and Capture Sheath components.

The "Performance Data" section (Page 4-5) lists the types of tests performed to demonstrate that the new material meets the same requirements as the previous material and that the device's performance and functionality remain substantially equivalent. However, these are not "acceptance criteria" in the sense of performance metrics for an AI algorithm or a diagnostic test with corresponding study results. They are engineering and biocompatibility tests to ensure the safety and effectiveness of the physical device after a material change.

Therefore, for the requested information:

1. A table of acceptance criteria and the reported device performance: Not available in the provided document in the context of a diagnostic or therapeutic performance study. The document focuses on showing that a material change to an existing device maintains equivalence to its predicate. The "performance data" listed are physical and biological tests, not performance metrics like sensitivity, specificity, etc., with associated target levels and results.

2. Sample size used for the test set and the data provenance: Not applicable. There is no "test set" in the context of an algorithm or diagnostic study. The tests mentioned (e.g., biocompatibility) involve laboratory samples or animal models, not human patient data in the way a diagnostic study would.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth establishment for a diagnostic test is described.

4. Adjudication method: Not applicable.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable. This is a physical device, not an AI or diagnostic algorithm improving human reader performance.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.

7. The type of ground truth used: Not applicable.

8. The sample size for the training set: Not applicable. There is no training set mentioned, as this is a physical device submission, not an AI algorithm submission.

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

In summary, the provided FDA letter confirms the substantial equivalence of a physical medical device following a material change. It does not describe a study involving acceptance criteria for diagnostic/therapeutic performance, nor does it involve AI or algorithmic performance evaluation.

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The ANGIOGUARD™ XP Emboli Capture Guidewire is indicated for use as a guidewire and embolic protection system to contain and remove embolic material (thrombus/debris) while performing carotid artery angioplasty and stenting procedures in carotid arteries. The diameter of the artery at the site of filter basket placement should be from 3mm to 7.5 mm.

The ANGIOGUARD™ RX Emboli Capture Guidewire is indicated for use as a guidewire and embolic protection system to contain and remove embolic material (thrombus/debris) while performing carotid artery angioplasty and stenting procedures in carotid arteries. The diameter of the artery at the site of filter basket placement should be from 3mm to 7.5 mm.

Both subject and predicate ANGIOGUARD XP and RX devices consist of a guidewire with integrated emboli filter basket at the distal end. The devices function as an interventional guidewire and distal protection device during delivery and placement of stents and interventional devices in carotid procedures. The guidewire is delivered via an OTW (over-the-wire) or RX (rapid-exchange) deployment sheath and is captured via an OTW or RX capture sheath. ANGIOGUARD devices have a fitter basket at the distal end that is deployed prior to the stenting procedure. When deployed, the filter basket opens in an umbrella-like fashion, allowing passive hemo-filtration with subsequent emboli capture. At the end of the procedure, the filter is collapsed and retrieved.

The Cordis Corporation ANGIOGUARD XP & RX Emboli Capture Guidewires are embolic protection guidewires used during carotid artery angioplasty and stenting procedures. The device's primary function is to contain and remove embolic material (thrombus/debris). This 510(k) notification is for a special 510(k) due to a change in the adhesive material used to adhere radiopaque markers to the filter basket struts.

Here's an analysis of the acceptance criteria and study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document describes "Design verification activities" rather than a clinical human trial needing a test set with specific sample sizes. The testing involved:

• Deployment and Capture Testing: This would likely involve in vitro or bench testing. No specific sample size is provided.
• Visual Inspections: No specific sample size is provided.
• Bioburden Testing: No specific sample size is provided.
• Endotoxin Testing: No specific sample size is provided.
• EtO Residual Testing: No specific sample size is provided.
• Biocompatibility Testing: Conducted per ISO 10993-1. This is a series of tests, and the "sample size" would relate to the number of test articles and controls used in each specific biological evaluation (e.g., cytotoxicity, sensitization, irritation). No specific detailed numbers are given in this summary.

The data provenance is not explicitly stated as retrospective or prospective in the context of human data. Given the "Special 510(k)" for a material change, the focus is on bench testing and laboratory evaluations to confirm the new adhesive does not alter the device's fundamental performance or safety.

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

Not applicable. This submission is for a material change to an already cleared device, relying on design verification activities (bench testing, lab tests) rather than a clinical test set requiring expert ground truth establishment for a diagnostic or imaging device.

4. Adjudication Method for the Test Set:

Not applicable. Since the evaluation consists of design verification activities (bench and lab testing), there is no "adjudication method" in the sense of expert review for clinical data.

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 an embolic protection guidewire, a physical medical device, not an AI software. Therefore, an MRMC study related to AI assistance is irrelevant.

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 or AI software.

7. The Type of Ground Truth Used:

For the design verification activities:

• Technical Specifications/Device Inputs: The "ground truth" for the tests described (Deployment and Capture Testing, Visual Inspections, Bioburden, Endotoxin, EtO residual testing, biocompatibility testing) is adherence to predefined engineering specifications, performance standards, and regulatory standards (e.g., ISO 10993-1). The summary states "Results demonstrated that design outputs continue to meet device inputs."

8. The Sample Size for the Training Set:

Not applicable. This is a change to a physical medical device, not a machine learning model requiring a training set.

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

Not applicable. No training set was used.

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