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The ViewFlex™ Xtra Reprocessed ICE Catheter is indicated for use in adult and adolescent pediatric patients to visualize cardiac structures, blood flow and other devices within the heart.

The ViewFlex™ Xtra Reprocessed ICE Catheter is a temporary intracardiac ultrasound catheter intended for use in patients to accurately visualize cardiac structures, blood flow and other devices within the heart when connected to a compatible intracardiac ultrasound console via the compatible ViewFlex™ Catheter Interface Module. Examples of the types of other devices that can be visualized include, and are not limited to, intracardiac catheters, septal occluders, delivery wires, delivery sheaths, sizing balloons and transseptal needles. The use of these images is limited to visualization with no direct or indirect diagnostic use. The ViewFlex™ Xtra Reprocessed ICE Catheter has a useable length of 90 cm, with a 9 French (F) shaft with an ultrasound transducer. A 10F introducer is recommended for use with this catheter for insertion into the femoral or jugular veins. The catheter tip has four-directional deflection allowing for Left-Right and Posterior-Anterior deflection, with an angle of at least 120 degrees in each direction. The ViewFlex™ Xtra Reprocessed ICE Catheter is compatible with the ViewMate™ Z, ViewMate™ and Philips CX50 ultrasound consoles. The ViewFlex™ Xtra Reprocessed Reprocess Catheter has been reprocessed by Abbott one (1) time. Each catheter includes marking on the proximal handle and connector that identify the catheter status. Device is taken out of service after reaching the maximum number of reprocessing cycles. Abbott restricts its reprocessing to exclude devices previously reprocessed by other reprocessors.

Please specify which information from the document is necessary to fulfill the request. The document is about the FDA 510(k) clearance for a reprocessed medical device, the "ViewFlex™ Xtra Reprocessed ICE Catheter." It describes the device, its intended use, and the testing performed to demonstrate substantial equivalence to a predicate device.

However, the document does not contain the kind of information typically associated with complex AI/ML device studies that require:

• A table of acceptance criteria and reported device performance for an AI/ML algorithm.
• Sample sizes for test sets, data provenance, ground truth establishment by experts, or adjudication methods for AI/ML performance.
• Details on multi-reader multi-case (MRMC) studies or effect sizes of human reader improvement with AI assistance.
• Stand-alone (algorithm-only) performance metrics.
• Training set details for AI/ML models.

The study described in this document focuses on the reprocessing of a medical device and its continued safety and effectiveness after being reprocessed once. The "functional and safety testing" mentioned refers to engineering and manufacturing performance verification (e.g., cleaning validation, biocompatibility, sterilization, design validation/verification, packaging verification) to ensure the reprocessed device performs comparably to the new device and meets established specifications. It's not a study about an AI/ML algorithm's performance in a diagnostic context.

Therefore, I cannot provide the requested information (1-9) as it pertains to an AI/ML device study, because the provided document does not describe such a study.

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The Reprocessed ViewFlex™ Xtra ICE Catheter is indicated for use in adult and adolescent pediatric patients to visualize cardiac structures, blood flow and other devices within the heart.

The Reprocessed ViewFlex Xtra ICE Catheter is a temporary intracardiac ultrasound catheter intended for use in patients to visualize cardiac structures and blood flow within the heart. The Reprocessed ViewFlex Xtra ICE Catheter is inserted into the heart via intravascular access. The Reprocessed ViewFlex Xtra ICE Catheter shaft is a 9 French catheter with a useable length of 90 cm. The shaft is compatible with a 10 French or larger introducer for insertion into the femoral or jugular veins. The catheter tip is a 64- element linear phased array transducer housed in silicone. The distal portion of the shaft is deflectable in four directions allowing for leftto-right and anterior-to-posterior deflection. The handle of the catheter has two deflection mechanisms that correspond with movement of the distal shaft in the four planes of movement. The Reprocessed ViewFlex Xtra Ice Catheter is compatible with ViewMate Z or ViewMate and Philips CX50 ultrasound consoles via the use of a compatible ViewFlex Catheter interface module.

The provided text is a 510(k) summary for a reprocessed medical device, specifically a Reprocessed ViewFlex Xtra ICE Catheter. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study of the device's performance against detailed acceptance criteria for a new AI or diagnostic device.

Therefore, many of the requested elements (e.g., sample size for test/training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, type of ground truth for training) are not applicable to this document as it describes a reprocessed catheter and not a new diagnostic algorithm or AI system.

However, I can extract the relevant information regarding performance testing that was conducted to demonstrate the reprocessed device's safety and effectiveness.

Here's a breakdown of what can be extracted, and where limitations exist based on the document:

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

The document describes the types of tests performed to demonstrate that the reprocessed device performs "as originally intended" and is "effectively identical" to the predicate. It does not provide specific quantitative acceptance criteria or detailed numerical performance results for these tests. The conclusion states the device is "at least as safe and effective as the predicate device," implying it met internal standards for each test.

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. The document states "Each individual device is tested for appropriate function" during reprocessing, and that bench and laboratory testing was conducted. This implies testing on a statistically relevant sample of reprocessed devices, but the exact number isn't given.
• Data Provenance: Not applicable in the context of this device and the types of tests described. These are laboratory/bench tests, not clinical data sets from patients.

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. This document describes engineering and laboratory testing for a reprocessed catheter, not a diagnostic algorithm that requires expert ground truth for interpretation.

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

• Not applicable. Adjudication methods are used for interpreting clinical data, particularly in a reader study or when establishing ground truth from multiple experts. This is not relevant for bench testing of a catheter.

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 a reprocessed catheter, not an AI or diagnostic imaging device. No MRMC study was mentioned or would be relevant for this type of submission.

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

• Not applicable. There is no algorithm; this is a physical medical device.

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

• Not applicable. The "ground truth" for these engineering tests would be established by validated test methods, adherence to specifications, and comparison to the original device's performance, as measured by calibrated equipment and documented procedures. For instance, the ground truth for electrical safety is adherence to established electrical safety standards.

8. The sample size for the training set:

• Not applicable. This is a reprocessed physical device, not an AI model requiring a training set.

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

• Not applicable. As above, no training set for an AI model is involved.

Summary of the Study:

The study described is a series of bench and laboratory tests designed to confirm that the Reprocessed ViewFlex Xtra ICE Catheter is safe and effective and performs "as originally intended," thereby demonstrating substantial equivalence to the predicate device.

The tests included:

• Biocompatibility
• Validation of Reprocessing
• Sterilization Validation
• Functional Performance Tests
• Acoustic Testing
• Electrical Safety Testing
• Electromagnetic Compatibility Testing
• Packaging Validation

The specific detailed results or quantitative acceptance criteria for each test are not provided in this summary document, only the general statement that the testing "demonstrates that Reprocessed ViewFlex device perform as originally intended" and that the device is "at least as safe and effective as the predicate device." The study essentially aims to prove that the reprocessing process does not negatively impact the device's original validated performance and safety characteristics.

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