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The Reprocessed ClosureFast RF Catheter is intended for endovascular coagulation of blood vessels in patients with superficial vein reflux.

The Reprocessed ClosureFast RF Catheter relies on the delivery of radiofrequency (RF) energy via an intravascular catheter that delivers temperature controlled heat to a predetermined length of superficial vessel. The ClosureFast RF Catheter is a sterile device with a 7cm radiofrequency heating element, a molded handle with start/stop switch, a flexible shaft and an integrated instrument cable, and is designed for use with the ClosureRFG (RF) Generator.

This document is a 510(k) summary for a reprocessed medical device, the Reprocessed ClosureFast Radiofrequency (RF) Catheter, and does not describe a study involving AI or machine learning.

Therefore, I cannot provide information on the following points:

• A table of acceptance criteria and the reported device performance (no AI performance metrics are discussed).
• Sample size used for the test set and data provenance.
• Number of experts used to establish ground truth and their qualifications.
• Adjudication method for the test set.
• Multi-Reader Multi-Case (MRMC) comparative effectiveness study (not applicable).
• Standalone (algorithm only) performance (not applicable).
• Type of ground truth used.
• Sample size for the training set.
• How the ground truth for the training set was established.

However, I can extract information related to the device's performance data and acceptance criteria as described in this 510(k) summary:

1. Acceptance Criteria and Device Performance:

The document states that the Reprocessed ClosureFast RF Catheter was tested to demonstrate appropriate functional characteristics and that process validation testing was performed to validate the cleaning process in line with AAMI TIR 30:2011 requirements. The manufacturing process includes visual and validated functional testing of all products.

While specific numerical acceptance criteria (e.g., minimum tensile strength, maximum leakage current, etc.) for functional characteristics are not detailed in this summary, the implicit acceptance criterion is that the reprocessed device performs identically and safely to the new predicate device.

2. Study Description:

The summary refers to bench top verification testing and process validation testing as the studies conducted. These are not clinical trials, but rather engineering and quality control studies.

• Bench Top Verification Testing: This type of testing involves evaluating the device's functional performance in a laboratory setting. It would assess physical and electrical properties relevant to the device's intended use.
• Process Validation Testing: Specifically mentions validating the cleaning process in line with AAMI TIR 30:2011 requirements. AAMI TIR 30:2011 provides guidance on processing reusable medical devices in health care settings.

Summary of what's provided in the document regarding the "study":

• Study Goal: Demonstrate appropriate functional characteristics and validate the cleaning process to ensure the reprocessed device is safe, effective, and substantially equivalent to the predicate device.
• Type of Study: Bench top verification testing and process validation testing.
• "Test Set" / Samples Used: "Representative samples of Reprocessed ClosureFast RF Catheters." (Specific number of samples not provided).
• Data Provenance: Not explicitly stated, but assumed to be internal laboratory testing by the manufacturer (Covidien) in Mansfield, MA, USA. This is an internal, prospective testing of reprocessed devices.
• Ground Truth: For the "functional characteristics," the ground truth is likely the performance specifications of the original predicate device (ClosureFast RF Catheter K061373). For the cleaning process, the ground truth is adherence to the standards outlined in AAMI TIR 30:2011.

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The ClosureFAST™ Radiofrequency Catheter is intended for endovascular coagulation of blood vessels in patients with superficial vein reflux.

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.

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

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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