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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 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 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 provided text is a 510(k) Summary for a Reprocessed ViewFlex Xtra ICE Diagnostic Ultrasound Catheter. It focuses on the substantial equivalence of the reprocessed device to its predicate devices, rather than a clinical study evaluating diagnostic performance against specific acceptance criteria. Therefore, much of the requested information regarding acceptance criteria for a diagnostic study, sample sizes for test/training sets, expert involvement, and comparative effectiveness studies cannot be found in this document.

However, I can extract information related to the device's functional and safety testing, which serves as a form of "acceptance criteria" for demonstrating the reprocessed device's safety and effectiveness compared to the original and previously reprocessed versions.

Here's a breakdown of what can be inferred and what is explicitly stated:

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

The document does not present specific quantitative acceptance criteria or numerical performance results for diagnostic accuracy (e.g., sensitivity, specificity, AUC) because it's a submission for reprocessing an existing diagnostic device and demonstrating its functional equivalence, not evaluating its diagnostic capability from scratch. The "performance" here refers to the functional and safety aspects of the reprocessed device.

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 for any of the functional or safety tests. The summary indicates "bench and laboratory testing" was conducted.
• Data Provenance: Not specified. Given it's laboratory and bench testing, it's likely internal data from Innovative Health, LLC.
• Retrospective or Prospective: These terms are generally applied to clinical studies involving patient data. For bench/lab testing, it's typically prospective testing of reprocessed devices.

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/Not specified. This information pertains to studies evaluating diagnostic accuracy, which is not the focus of this submission. The "ground truth" here would be objective measurements and standards from engineering and microbiology for functional and safety testing.

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

• Not applicable/Not specified. No expert adjudication process for diagnostic interpretations is discussed.

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, an MRMC comparative effectiveness study was not conducted or described. This type of study is relevant for AI-assisted diagnostic devices, which this reprocessed ultrasound catheter is not.

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

• Not applicable. This is not an AI algorithm.

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

For the functional and safety testing, the "ground truth" would be established by:

• Industry standards for biocompatibility (e.g., ISO 10993).
• Microbiological testing standards for cleaning and sterilization effectiveness.
• Engineering specifications and performance metrics of the original device for functional and mechanical characteristics.
• Electrical safety standards.

8. The sample size for the training set

• Not applicable. This document does not describe an AI/machine learning model that would require a training set.

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

• Not applicable, as no training set for an AI model is described.

In summary: This document is a 510(k) submission for a reprocessed medical device, focusing on demonstrating the functional and safety equivalence of the reprocessed device to its original predicate. It does not contain information about studies evaluating the diagnostic performance (e.g., sensitivity, specificity) of the ultrasound catheter, which is what the provided questions are primarily geared towards. The "acceptance criteria" here are related to ensuring the device remains safe and performs as intended after reprocessing, rather than its diagnostic accuracy.

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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 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 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.

I am sorry, but the provided text does not contain information about the acceptance criteria or a study proving that the device meets those criteria. The document is an FDA 510(k) clearance letter and summary for a reprocessed medical device (Reprocessed ViewFlex Xtra ICE Diagnostic Ultrasound Catheter).

The document outlines:

• The device's trade name, regulation number, and classification.
• The FDA's decision of substantial equivalence to a predicate device.
• The indications for use for the reprocessed catheter.
• A description of the reprocessed device and its technological characteristics.
• A list of functional and safety testing conducted (e.g., biocompatibility, cleaning validation, functional testing, mechanical characteristics, electrical safety testing, packaging validation).

However, it does not provide:

1. A table of specific acceptance criteria (e.g., performance metrics like sensitivity, specificity, accuracy) and reported device performance against those criteria.
2. Details about a specific study designed to "prove the device meets acceptance criteria," especially in the context of diagnostic performance involving a test set, ground truth, or expert interpretations. The testing mentioned is for the physical and functional integrity of the reprocessed device to ensure it performs comparably to the original, not to establish diagnostic performance for an AI/algorithm.
3. Information regarding sample sizes for test sets, data provenance, number or qualifications of experts, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth types for diagnostic evaluation.
4. Sample size for the training set or how ground truth was established for a training set, as this is not an AI/algorithm-based device.

The "studies" mentioned (biocompatibility, cleaning validation, functional testing, etc.) are bench and laboratory tests to demonstrate the safety and effectiveness of the reprocessing process and the reprocessed device's physical/functional integrity, not diagnostic performance.

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