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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 IntellaMap Orion High Resolution Mapping Catheter is indicated for electrophysiological mapping (recording or stimulating only) of the cardiac structures of the heart.

The Reprocessed IntellaMap Orion High Resolution Mapping Catheter is an 8.5F(ø 2.82 mm), 115 cm working length, 64-electrode steerable catheter. The basket-shaped distal reqion consists of 8 splines that comprise the electrode array. The proximal end has a handle that extends to a cable with a connector. The handle includes bi-directional articulation controls and a deployment slider that activates the electrode array into a basket shape once inside the heart. A flushing port extends from the back of the connector for connection to a continuous pressurized saline drip. The catheter is supplied with an 8.5F insertion sleeve for insertion through the hemostasis valve of an introducer sheath. A sensor in the catheter tip enables the position of the distal region of the catheter to be tracked in space when used with the Rhythmia Mapping System.

The provided text describes the regulatory clearance of a reprocessed medical device, the Reprocessed IntellaMap Orion High Resolution Mapping Catheter, and lists the types of functional and safety testing conducted to demonstrate its performance. However, it does not provide specific acceptance criteria or detailed results of a study designed to prove the device meets those criteria.

Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance, nor can I detail a study that proves the device meets specific acceptance criteria based on the information given. The document focuses on regulatory equivalence to a predicate device rather than presenting a performance study with detailed metrics against defined acceptance criteria.

Based on the provided text, here's what can be inferred regarding the request:

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

   • Acceptance Criteria: Not explicitly stated as quantifiable metrics. The document broadly indicates that the reprocessed device's performance (safety and effectiveness) needs to be demonstrated and that its purpose, design, materials, function, and intended use are "identical to the predicate device."
   • Reported Device Performance: No specific numerical performance metrics are reported in this document. The document lists the types of tests performed (e.g., Biocompatibility, Cleaning Validation, Functional testing, Electrical Safety Testing, Packaging Validation), but not their outcomes or criteria for success.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

   • This information is not provided. The document mentions "Bench and laboratory testing" but does not specify sample sizes or data provenance for these tests.

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):

   • This information is not provided. The testing described is primarily laboratory and bench testing, not clinical studies requiring expert ground truth establishment in the context of diagnostic interpretation.

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

   • This information is not applicable and not provided, as the testing described does not involve expert adjudication of a diagnostic output.

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 MRMC comparative effectiveness study is mentioned. This device is a physical medical instrument (catheter), not an AI diagnostic tool, so this type of study is not relevant to its clearance.

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

   • This is not applicable as the device is a physical medical instrument, not an algorithm.

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

   • For the functional and safety testing, "ground truth" would be established through engineering specifications, material standards, and validated testing methodologies (e.g., sterilization validation based on established microbial inactivation levels, biocompatibility based on ISO standards, electrical safety based on IEC standards). No expert consensus, pathology, or outcomes data is mentioned as a "ground truth" for these tests in this document.

8. The sample size for the training set:

   • This is not applicable. The device is a reprocessed physical instrument, not an AI model, so there is no "training set."

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

   • This is not applicable for the reasons stated above.

In summary, the provided document is a regulatory clearance letter focused on substantial equivalence based on a comparison to a predicate device and a list of performed functional and safety tests. It does not contain the detailed performance data, acceptance criteria, or study specifics that would be expected for an AI/diagnostic software clearance, or a clinical study on a novel device.

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The Reprocessed PentaRay Nav eco High-Density Mapping Catheter is indicated for multiple electrode electrophysiological mapping of cardiac structures in the heart, i.e. recording or stimulation only. The catheter is intended to obtain electrograms in the atrial and ventricular regions of the heart.

The catheter provides location information when used with the compatible Carto 3 EP Navigation Systems. (This catheter is not compatible with Carto 3 EP Navigation Systems prior to Version 3.x.)

The Reprocessed PentaRay Nav eco High-Density Mapping Catheter is designed to facilitate electrophysiological mapping of the heart with the Carto 3 EP Navigation System. It is designed for deployment in a heart chamber through an 8 F guiding sheath. This deflectable catheter consists of multiple 3F spines on its distal tip, each spine having multiple platinum electrodes that are used for stimulation and recording. A magnetic location sensor embedded in the deflectable tip transmits location information to the Carto 3 EP Navigation System. The catheter has two electrodes on the deflectable tip to provide for visualization of the tip when used with the Carto 3 EP Navigation System. Pushing forward on the catheter thumb knob deflects the tip; pulling back on the thumb knob straightens the tip. This device includes an irrigation lumen for connection to a source of continuous anticoagulant fluid.

This catheter interfaces with standard recording equipment and the Carto 3 EP Navigation System via interface cables with the appropriate connectors.

The provided FDA 510(k) summary (K190785) describes the substantial equivalence of a reprocessed medical device (Reprocessed PentaRay Nav eco High-Density Mapping Catheter) to an original predicate device. It addresses device safety and effectiveness through various tests.

However, this document does not describe a study involving an AI/Machine Learning device or a diagnostic algorithm that would typically have acceptance criteria related to accuracy, sensitivity, specificity, or human-in-the-loop performance. The testing described focuses on the physical and functional integrity, sterility, and biocompatibility of the reprocessed catheter.

Therefore, many of the requested points related to AI/ML device performance (like sample size for test/training sets, expert ground truth, MRMC studies, effect size of AI assistance, standalone performance, etc.) are not applicable to the information provided in this 510(k) summary.

The acceptance criteria and "study" described herein pertain to the reprocessing of a physical medical device, not a diagnostic algorithm.

Here's an interpretation based on the provided document:

Acceptance Criteria and Study for Reprocessed PentaRay Nav eco High-Density Mapping Catheter

The "study" described in the 510(k) summary for the Reprocessed PentaRay Nav eco High-Density Mapping Catheter (K190785) is not a study of an AI/Machine Learning diagnostic algorithm. Instead, it is a demonstration of the substantial equivalence of a reprocessed medical device to its original predicate device, focusing on its safety and effectiveness after reprocessing.

The acceptance criteria are implied by the battery of functional, safety, and performance tests conducted to ensure the reprocessed device performs as intended and is as safe and effective as the new device.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a formal table of quantitative acceptance criteria with numerical performance targets for an AI/ML diagnostic system. Instead, the acceptance criteria are implicitly linked to the successful completion and passing of the various tests for the reprocessed catheter, ensuring it meets the original device's specifications and performance.

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

• Sample Size: The document does not specify the exact number of reprocessed catheters used for each of the functional and safety tests. This information is typically detailed in the study reports submitted to the FDA but is summarized and not fully elaborated in the 510(k) summary. Given these are physical device tests, a statistically representative sample of reprocessed units would have been tested for each protocol.
• Data Provenance: The tests are performed "Bench and laboratory testing" by Innovative Health, LLC. This is likely internal testing conducted in a controlled laboratory environment.
  • Country of Origin: United States (based on the company and FDA filing location).
  • Retrospective or Prospective: These are prospective tests performed on reprocessed devices to validate the reprocessing procedure and the device's performance post-reprocessing.

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

• Not Applicable: This pertains to the validation of a reprocessed physical device, not an AI/ML algorithm requiring expert interpretation for ground truth. Ground truth for these tests would be established by objective measurements against engineering specifications (e.g., electrical resistance values, dimensional tolerances, sterilization test results).

4. Adjudication Method for the Test Set

• Not Applicable: Adjudication methods like "2+1" or "3+1" are typical for diagnostic imaging studies where multiple readers interpret cases and a consensus or tie-breaking mechanism is needed to establish ground truth. For the physical device testing described, the "ground truth" is determined by objective measurement against established engineering and safety standards.

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

• No: An MRMC comparative effectiveness study is not relevant here as the device is not a diagnostic imaging aid or an AI algorithm intended for human-in-the-loop performance evaluation. The study is about the safety and function of a reprocessed catheter.

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

• Not Applicable: This is not an algorithm. The "standalone" performance relates to the catheter's ability to perform its intended function (mapping, recording, stimulation) independently when used with compatible equipment. The "Functional testing" and "Electrical Safety Testing" sections would cover aspects of this.

7. The Type of Ground Truth Used

• Engineering Specifications and Standardized Test Results: The "ground truth" for the reprocessed catheter's performance and safety is derived from:
  • Predicate Device Specifications: The performance and safety parameters of the original, legally marketed predicate device (PentaRay NAV eco High-Density Mapping Catheter, K123837).
  • Industry Standards: Compliance with relevant national and international standards (e.g., ISO for biocompatibility, sterilization, packaging; IEC for electrical safety).
  • Defined Pass/Fail Criteria: Each test (e.g., electrical continuity, leak test, visual inspection) would have pre-defined quantitative or qualitative acceptance criteria.

8. The Sample Size for the Training Set

• Not Applicable: This device is not an AI/ML algorithm that requires a "training set." The reprocessing procedure itself is the "process" being validated, and its parameters are established through rigorous engineering and validation studies, not machine learning.

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

• Not Applicable: As there is no AI/ML training set, this question is irrelevant to the provided document. The "ground truth" for developing the reprocessing procedure (if one were to draw a very loose analogy) would be the established performance and safety of the new device, which the reprocessed device must match.

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