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The Reprocessed Advisor FL Circular Mapping Catheter is a sensor-enabled steerable electrophysiology catheter used for recording intracardiac signals and cardiac stimulation during diagnostic electrophysiology studies. The catheter can be used to map the atrial regions of the heart.

The catheter is used with the EnSite Precision System to combine and display magnetic processed patient positioning and navigation mapping information. The catheter is used with the MediGuide Technology system to enable real-time positioning and navigation. The MediGuide Technology system is indicated for use as an adjunct to fluoroscopy.

The Reprocessed Advisor FL Circular Mapping Catheter, Sensor Enabled, is a steerable, flexible, insulated electrophysiology catheter constructed of thermoplastic elastomer material and noble metal electrodes. The shaft curvature is manipulated by the control mechanism located on the handle at the catheter's proximal end. To adjust the curve on the bi-directional catheter, use the actuator to deflect the catheter in either direction. The distal loop is oriented counter-clockwise as viewed from the handle.

This document is a 510(k) Premarket Notification from the FDA regarding a reprocessed medical device, specifically a Reprocessed Advisor FL, Sensor Enabled, Circular Mapping Catheter. As such, it details the safety and functionality testing to establish substantial equivalence to a predicate device, rather than providing the kind of detailed clinical study results (like MRMC studies for AI/software devices or specific performance metrics with acceptance criteria) that would be common for novel, performance-driven devices.

Therefore, many of the requested criteria for a study proving a device meets acceptance criteria (especially those related to AI model evaluation like test sets, ground truth establishment by experts, MRMC studies, effect size of human improvement with AI, standalone AI performance) are not applicable to this type of regulatory submission and device.

However, I can extract the information relevant to the safety and functional performance tests conducted for this reprocessed catheter.

Here's a breakdown of what can be extracted or inferred from the provided text, and what cannot:

Information Extracted/Inferred:

1. A table of acceptance criteria and the reported device performance:
The document lists various functional and safety tests, implying that the reprocessed device met established acceptance criteria for each to demonstrate substantial equivalence. However, the specific quantitative acceptance criteria and detailed reported performance values for each test are not provided in this summary. The summary states: "Bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness) of Reprocessed Catheter." and "Innovative Health concludes that the Reprocessed Catheter is as safe and effective as the predicate devices described herein." This implies the acceptance criteria were met.

The types of tests conducted (which would have associated acceptance criteria) include:

2. Sample size used for the test set and the data provenance:
The document mentions "Bench and laboratory testing" but does not specify the sample size for these tests. Data provenance is implied to be from Innovative Health's internal testing. It's a retrospective evaluation of their reprocessing procedures and the resulting devices. Country of origin for data is not explicitly stated but would be the USA, where Innovative Health is located.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This concept is not applicable here. Ground truth in this context refers to the physical and functional properties of the catheter, established by engineering specifications and direct measurement/testing, not expert interpretation of diagnostic data.

4. Adjudication method for the test set:
Not applicable. Testing involves direct measurement and objective assessment against specifications, not subjective interpretation requiring adjudication.

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 not an AI/software device that assists human readers. It's a reprocessed physical medical device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an AI algorithm. Its "standalone" performance means its functional and safety characteristics as a physical device.

7. The type of ground truth used:
For the various tests (e.g., dimensional, electrical, mechanical, biological safety), the "ground truth" would be engineering specifications, industry standards (e.g., ISO for biocompatibility, sterility), and established performance characteristics of the original predicate device.

8. The sample size for the training set:
Not applicable. This device does not use a "training set" in the context of machine learning or AI.

9. How the ground truth for the training set was established:
Not applicable.

Summary of what is possible to provide based on the document:

This submission focuses on demonstrating that the reprocessed physical device maintains the same safety and effectiveness as the original, legally marketed predicate device. The "acceptance criteria" are implied by the successful completion of a battery of rigorous functional and safety tests (biocompatibility, cleaning, sterilization, electrical, mechanical, visual, packaging, simulated use). The "study" involves these various bench and laboratory tests. The "ground truth" for these tests are the established engineering specifications and performance parameters of the original device and relevant industry standards. There is no mention of clinical studies involving human patients or complex data interpretation by experts, as would be common for AI/software devices.

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