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The Reprocessed Supreme Diagnostic Electrophysiology Catheters can be used in the evaluation of a variety of cardiac arrhythmias from endocardial and intravascular sites.

The Reprocessed Supreme Diagnostic Electrophysiology Catheters are manufactured in various fixed curves and electrode spacing for electrophysiological mapping for the evaluation of a variety of cardiac arrhythmias from endocardial and intravascular sites.

The provided text describes a 510(k) premarket notification for Reprocessed Supreme Diagnostic Electrophysiology (EP) Catheters. This document focuses on demonstrating substantial equivalence to a predicate device, rather than a study proving performance against acceptance criteria in the typical sense of a human-in-the-loop or standalone AI performance study.

The "acceptance criteria" here refer to the various engineering and performance characteristics that the reprocessed catheters must meet to be considered safe and effective and substantially equivalent to the original, new devices and the predicate reprocessed devices. The "study" proving these criteria are met consists of a series of bench and laboratory tests.

Here's a breakdown based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample size for each bench and laboratory test. It generally refers to "bench and laboratory testing" conducted. The provenance of the data is implicitly from internal tests conducted by Innovative Health, LLC. This would be a retrospective analysis of the reprocessed devices' performance against set standards.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This type of information is generally not applicable to the testing of physical medical devices like catheters. The "ground truth" is established by engineering specifications, regulatory standards (e.g., for biocompatibility, sterility), and the performance characteristics of the predicate device. Expert involvement would be in the design and execution of the tests, and interpretation of results against objective criteria, rather than establishing a subjective "ground truth" from data.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like 2+1 or 3+1 are typically used for clinical evaluations or expert review of data (e.g., medical images) where there can be inter-rater variability. For physical device testing, the results are typically quantitative measurements that either meet or do not meet predefined criteria.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

Not applicable. An MRMC comparative effectiveness study is used for diagnostic systems, particularly AI-driven ones, to assess how human performance changes with AI assistance. This document describes the re-processing of a physical medical device, not a diagnostic AI tool.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. There is no AI algorithm involved in the function or reprocessing of these electrophysiology catheters. The device itself is a physical tool, not a software algorithm. The "standalone" performance here refers to the device's inherent function, which is assessed through the various functional and safety tests mentioned.

7. Type of Ground Truth Used

The ground truth used here consists of:

• Engineering Specifications: Defined parameters for dimensions, electrical properties, mechanical strength, etc., derived from the original device design and performance requirements.
• Regulatory Standards: Requirements for biocompatibility (e.g., ISO 10993), sterilization (e.g., ISO 11135, ISO 11137), cleaning validation, and electrical safety.
• Predicate Device Performance: The demonstrated performance of the legally marketed predicate devices (K151622 and K161769) sets the benchmark for substantial equivalence.

8. Sample Size for the Training Set

Not applicable. This is not a machine learning or AI device that requires a training set.

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

Not applicable, as there is no training set for this device.

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The Reprocessed Supreme Diagnostic Electrophysiology Catheters can be used in the evaluation of a variety of cardiac arrhythmias from endocardial and intravascular sites.

The Reprocessed Supreme Diagnostic Electrophysiology Catheters are manufactured in various fixed curves and electrode spacing for electrophysiological mapping for the evaluation of a variety of cardiac arrhythmias from endocardial and intravascular sites.

This document is a 510(k) Summary for Reprocessed Supreme Diagnostic Electrophysiology Catheters, outlining their substantial equivalence to predicate devices. It describes the device, its indications for use, and a summary of testing conducted to demonstrate safety and effectiveness.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the "Functional and Safety Testing" section. The document states that testing was conducted "to demonstrate performance (safety and effectiveness)". However, specific quantitative acceptance criteria or detailed reported device performance values are not provided in this summary document. The summary only lists the types of tests performed and generally states that the device is "as safe and effective as the predicate devices".

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

The document does not specify the sample sizes used for the functional and safety testing. It also does not explicitly state the provenance of the data (e.g., country of origin) or whether it was retrospective or prospective. It implies that "bench and laboratory testing" were conducted by Innovative Health, LLC.

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

This type of information is not provided in the document. The testing described focuses on physical and electrical device performance rather than interpretation of data by human experts for ground truth establishment.

4. Adjudication Method for the Test Set

This information is not applicable to the type of device and testing described. The tests are objective measurements of the device's physical and electrical properties.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of Human Readers Improve with AI vs without AI Assistance

This information is not applicable. The device is a reprocessed electrophysiology catheter, which is a physical medical device, not an AI or imaging diagnostic tool that would involve human readers or comparative effectiveness studies with AI assistance.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Study Was Done

This information is not applicable as the device is a physical medical device and not an algorithm or software.

7. The Type of Ground Truth Used

For the functional and safety testing, the "ground truth" would be the engineering and performance specifications for the original, new device, and relevant regulatory standards (e.g., for biocompatibility, sterility, electrical safety). The reprocessed devices are tested to ensure they meet these established specifications.

8. The Sample Size for the Training Set

This information is not applicable as this is a reprocessing of a physical medical device, not an AI or machine learning model that requires a training set.

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

This information is not applicable for the same reason as above.

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