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The Reprocessed Advisor HD Grid Mapping Catheter, Sensor Enabled, is indicated for multiple electrode electrophysiological mapping of cardiac structures in the heart, i.e., recording or stimulation only. This catheter is intended to obtain electrograms in the atrial and ventricular regions of the heart.

The Reprocessed Advisor HD Grid Mapping Catheter, Sensor Enabled, is an irrigated 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 catheter, use the actuator to deflect the catheter in either direction. The catheter is compatible with St. Jude Medical (Abbott) visualization and 3D navigation systems.

This document is a 510(k) Premarket Notification from the FDA for a reprocessed medical device, specifically a Reprocessed Advisor HD Grid Mapping Catheter, Sensor Enabled. It details the device, its indications for use, and a summary of testing conducted to demonstrate substantial equivalence to predicate devices.

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states that the functional and safety testing was conducted "to demonstrate performance (safety and effectiveness)" and the conclusion is that the device is "substantially equivalent," implying that all these tests met their respective acceptance criteria. Specific quantitative acceptance criteria (e.g., "electrical continuity must be X ohms") are not detailed in this summary.

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

The document does not provide specific sample sizes for the functional and safety testing mentioned.
Therefore, the sample size for the test set is not specified.
The data provenance is from bench and laboratory testing conducted by Innovative Health, LLC. The country of origin of the data is implicitly the United States, as Innovative Health, LLC. is based in Scottsdale, Arizona, and is interacting with the U.S. FDA. The testing conducted is likely prospective in nature, as it was performed to support the 510(k) submission for the reprocessed device.

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

This document does not describe the establishment of a "ground truth" in the sense of expert consensus on diagnostic imaging or clinical findings, as it pertains to a physical medical device (a catheter) and its reprocessing. The "testing" involved demonstrating physical, electrical, and sterilization performance. Therefore, this section is not applicable in the context of this device and submission.

4. Adjudication Method for the Test Set

This section is not applicable as the tests performed are objective measurements (e.g., electrical continuity, dimensional verification) or validations (e.g., sterilization, cleaning), not subjective assessments requiring expert 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

This section is not applicable. The device is a physical medical instrument (a mapping catheter), not an AI-powered diagnostic tool. Therefore, an MRMC study related to human reader performance with or without AI assistance is irrelevant to this submission.

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

This section is not applicable. The device is a physical medical instrument (a mapping catheter), not a standalone algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the performance characteristics of this device is established by:

• Engineering specifications and standards: These define acceptable dimensional tolerances, electrical properties, and mechanical characteristics for a functional catheter.
• Biocompatibility standards: Defines acceptable levels of biological response to materials.
• Sterilization and cleaning validation protocols: These define validated processes to ensure sterility and cleanliness, often with established microbial reduction or residue limits.
• Predicate device performance: The reprocessed device is compared to the performance characteristics of the original cleared device and other predicate reprocessed devices to demonstrate substantial equivalence.

8. The Sample Size for the Training Set

This section is not applicable. There is no "training set" in the context of this device. The device is a physical product, not an algorithm that requires training data.

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

This section is not applicable for the same reasons as point 8.

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The Reprocessed Advisor HD Grid Mapping Catheter, Sensor Enabled, is indicated for multiple electrode electrophysiological mapping of cardiac structures in the heart, i.e., recording or stimulation only. This catheter is intended to obtain electrograms in the atrial and ventricular regions of the heart.

The Reprocessed Advisor HD Grid Mapping Catheter, Sensor Enabled, is an irrigated, 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 catheter, use the actuator to deflect the catheter in either direction. The catheter is compatible with St. Jude Medical (Abbott) visualization and 3D navigation systems.

The provided text describes the 510(k) premarket notification for a Reprocessed Advisor HD Grid Mapping Catheter, Sensor Enabled. It is important to note that this document is for a reprocessed medical device, meaning it is a device that has been previously used, cleaned, sterilized, and prepared for re-use. The testing conducted primarily focuses on ensuring the reprocessed device performs comparably to the original new device and meets safety standards, rather than testing new clinical efficacy.

Based on the provided information, I can extract the following details regarding acceptance criteria and studies:

1. Table of Acceptance Criteria and Reported Device Performance:

The document lists various functional and safety tests performed but does not explicitly state quantitative acceptance criteria or detailed numerical performance results for most of them. It generally states that testing was conducted "to demonstrate performance (safety and effectiveness)".

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

The document does not specify the sample sizes used for any of the functional and safety tests.

Regarding data provenance:

• The tests are described as "Bench and laboratory testing".
• The data is retrospective in the sense that it relies on demonstrating equivalence to an already marketed device (the predicate device). It's not a prospective clinical trial generating new outcome data directly on patients.
• The location of the testing is not explicitly stated, but it would have been conducted by Innovative Health, LLC, which is based in Scottsdale, Arizona, USA.

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

This information is not provided in the document. For a reprocessed device and the types of engineering and safety tests described, ground truth would typically be established by internal engineering specifications, regulatory standards, and comparison to the original device's performance, rather than expert clinical consensus on a test set.

4. Adjudication Method for the Test Set:

This information is not applicable/not provided. The studies described are bench and laboratory tests, not clinical studies requiring expert adjudication of results.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, an MRMC comparative effectiveness study was not done. The document describes bench and laboratory testing to ensure the safety and effectiveness of the reprocessed device itself, not a study assessing human reader performance with or without AI assistance.

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

No, this is not an AI/algorithm-based device. The device is a physical electrophysiology catheter. Therefore, "standalone algorithm performance" is not applicable. The core of the submission is about the reprocessing process and ensuring the physical device's performance after reprocessing.

7. The type of ground truth used:

For the functional and safety testing, the ground truth is primarily based on:

• Engineering specifications and standards: For dimensional, electrical, and mechanical tests.
• Regulatory standards: For biocompatibility, cleaning, sterilization, and electrical safety.
• Performance of the original predicate device: The reprocessed device is demonstrated to have "identical" purpose, design, materials, function, and intended use to the predicate device, implying its performance should match the original.

8. The Sample Size for the Training Set:

This is not applicable. This is a reprocessed 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 is not applicable. As there is no training set for an AI model.

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