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The ClosureFAST™ Radiofrequency Catheter is provided sterile, and is a single-use, disposable device. It has a 3cm radiofrequency heating element, a flexible shaft, and an integrated instrument cable. It is designed for use with the VNUS RFG2 Generator, cleared under 510(k) K040638.

AI/ML Overview

The provided text describes a 510(k) submission for the ClosureFAST™ Radiofrequency Catheter, focusing on its substantial equivalence to a predicate device. It primarily concerns regulatory approval based on design and material similarity, rather than extensive clinical performance studies comparing it to a human baseline or establishing detailed performance criteria.

Therefore, many of the requested elements for an AI/device performance study (like detailed acceptance criteria, ground truth specifics, expert qualifications, MRMC studies, and sample sizes for training/test sets) are not present in this regulatory document.

However, I can extract the available information and indicate where the requested data is not provided.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (Implicitly from "substantial equivalence")	Reported Device Performance
Intended Use	Identical to predicate device	Identical to predicate device
Technology Characteristics	Identical to predicate device's fundamental scientific technology	Identical to predicate device's fundamental scientific technology
Material Composition	Identical to predicate device materials	Identical to predicate device materials
Design Specifications	Meet established design parameters for the modified 3cm heating element	Testing demonstrates compliance with design specifications
Catheter Compatibility	Demonstrate compatibility with other components (e.g., VNUS RFG2 Generator)	Testing demonstrates catheter compatibility
Overall Performance	Substantially equivalent performance to the legally marketed predicate device	Results from testing demonstrate substantial equivalence

Explanation of "Acceptance Criteria": In the context of a 510(k) for a device modification, the primary "acceptance criterion" is often demonstrating substantial equivalence to a predicate device. This means showing that the modified device is as safe and effective as the legally marketed predicate. The performance data presented focuses on comparing the new device to the predicate rather than defining independent, quantitative clinical thresholds of performance like sensitivity/specificity for diagnostic AI.

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

Sample Size for Test Set: Not specified. The document states "Testing was performed on the proposed ClosureFast to compare it to the predicate device." This likely refers to bench testing and engineering verification/validation, not a clinical test set with human patients.
Data Provenance: Not specified. The testing is described generally as "Design Verification and Validation." Given the nature of device modifications, this testing would typically be controlled laboratory and engineering tests conducted by the manufacturer, not necessarily involving human patient data from a specific country or collected retrospectively/prospectively in a clinical study.

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

This information is not applicable and not provided. The ground truth for this type of device (a radiofrequency catheter) is established through engineering principles, material science, and functional testing to ensure it meets design specifications and performs its intended physical action (coagulation). It does not involve expert reader consensus on diagnostic images or patient outcomes in the way an AI diagnostic device would.

4. Adjudication Method for the Test Set

This information is not applicable and not provided. Adjudication methods (like 2+1, 3+1) are used in studies where human readers are interpreting data or making clinical judgments that need to be reconciled to form a ground truth. For this device's testing, the "ground truth" would be objective measurements and engineering standards.

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, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic or assistive devices that impact human decision-making. The ClosureFAST™ Radiofrequency Catheter is a surgical tool, not a diagnostic AI.

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

This information is not applicable. The device is a surgical catheter; it does not operate as a standalone algorithm. Its performance is inherent to its physical function and design.

7. The Type of Ground Truth Used

The ground truth for this device's performance is based on engineering benchmarks, material specifications, and functional measurements (e.g., radiofrequency energy delivery, coagulation effectiveness in a controlled environment, structural integrity, dimensions). This is not a "ground truth" in the clinical sense (like pathology, expert consensus, or outcomes data).

8. The Sample Size for the Training Set

This information is not applicable and not provided. The ClosureFAST™ Radiofrequency Catheter is a physical medical device, not an AI model that undergoes a "training" process with a dataset.

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

This information is not applicable and not provided, as there is no "training set" for this type of device.

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