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The MAGiC Sweep™ EP Mapping Catheter is intended for intracardiac electrophysiological recording and/or stimulation for pacing in the heart.

The MAGiC Sweep™ EP Mapping Catheters are biocompatible, flexible, radiopaque fixed catheters that are 130cm in length and available in multiple electrode spacing configurations and multiple magnet spacings. They have magnets encapsulated in the device shaft to allow manipulation through the vasculature and placement by a physician controlled robotic magnetic navigation system. Each device consists of 19 electrodes plus one tip electrode and come in three (3) different electrode spacings. In addition there are twenty (20) different magnet spacings for each electrode spacing configuration. The catheters are 8F diameter tapering to 5F at the distal end of the device shaft. The variety of configurations facilitate the navigation of the device to specific areas of the heart and facilitate recording of intracardiac signals and/or stimulation in the atrial and ventricular regions of the heart during electrophysiology studies.

The MAGiC Sweep™ EP Mapping Catheter is designed to be positioned in various endocardial and intravascular sites utilizing the Stereotaxis magnetic navigation system (MNS) along with the Stereotaxis catheter advancement system (CAS). The MAGiC Sweep™ EP Mapping Catheter is designed for recording intracardiac signals when connected to a recording system and for cardiac stimulation when connected to a stimulation system.

The MAGiC Sweep™ EP Mapping Catheter is comprised of a Pebax catheter shaft, platinum-iridium ring electrodes, platinum-iridium electrode tip, Neodymium Boron Magnets attached to a safety cable, and Redel electrical connectors. The Neodymium Boron Magnets are encapsulated within the catheter shaft.

The provided 510(k) clearance letter and summary describe the acceptance criteria and the study that proves the device meets the acceptance criteria for the Stereotaxis MAGiC Sweep™ EP Mapping Catheter.

1. Table of Acceptance Criteria and Reported Device Performance

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Medline ReNewal Reprocessed Boston Scientific Dynamic XT Unidirectional Steerable Diagnostic Catheters are indicated for use to diagnose cardiac arrhythmia.

The Medline ReNewal Reprocessed Boston Scientific Dynamic XT Unidirectional Steerable Diagnostic Catheters are intended for temporary intracardiac sensing, recording, stimulation, and temporary pacing during the evaluation or cardiac arrhythmias. The steerable diagnostic electrode catheters are radiopaque, flexible, insulated catheters with a polymer shaft, each having a mechanical operating mechanism. In each catheter the polymer shaft connects to the catheter handle whereby the curve or loop is actuated by a single pull cable. The Dynamic XT Catheters have a plunger mechanism, which, when moved forward or back, results in curvature of the distal tip.

The provided FDA 510(k) clearance letter (K250772) pertains to a reprocessed medical device, specifically the Medline ReNewal Reprocessed Boston Scientific Dynamic XT Unidirectional Steerable Diagnostic Catheter. This document largely focuses on demonstrating substantial equivalence to a predicate device through comparison of technological characteristics and functional performance testing.

Crucially, the provided text does not contain information about acceptance criteria or a "study that proves the device meets the acceptance criteria" in the context of an AI/ML powered device, as assumed by the structured request. The clearance is for a physical medical device (a reprocessed catheter), not a software or AI/ML algorithm. Therefore, many of the requested categories (e.g., sample size for test/training sets, expert ground truth, MRMC studies, standalone algorithm performance) are not applicable to the information contained within this document.

The "Non-clinical Testing Summary" section describes the types of tests performed to demonstrate safety and effectiveness for a reprocessed physical device. These tests assess the physical and electrical properties of the catheter after reprocessing.

I will attempt to answer the applicable sections based on the information provided, and explicitly state when information is not available or not applicable due to the nature of the device.

Description of Acceptance Criteria and Study to Prove the Device Meets Acceptance Criteria for K250772

As noted above, this 510(k) clearance is for a reprocessed physical medical device (a catheter), not an AI/ML-powered device. Therefore, the "acceptance criteria" and "study" described herein are related to the physical, functional, and safety performance of the reprocessed catheter compared to the original, new device, rather than a statistical evaluation of an AI algorithm's diagnostic performance.

1. Table of Acceptance Criteria and Reported Device Performance

The FDA 510(k) summary (pages 6-8) describes the non-clinical testing performed to establish substantial equivalence. While explicit numerical acceptance criteria values are not provided in this public summary, the types of tests indicate the areas where the reprocessed device must perform equivalently to the predicate. The "reported device performance" is implied by the statement "found to be substantially equivalent to the predicate device based on the following tests."

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

• Sample Size: The document does not specify the exact number of reprocessed catheters (the "test set") used for each functional and safety test. For medical devices, particularly reprocessed ones, sample sizes are typically determined by statistical rationale to demonstrate equivalence or meet performance specifications, but these details are not in the summary.
• Data Provenance: This relates to the testing of the reprocessed device itself. The data would be prospective, as it involves testing reprocessed devices manufactured by Medline ReNewal. The country of origin for the data would be where Medline ReNewal conducts its testing, likely the USA given the FDA clearance.

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

• N/A. This concept applies to diagnostic or AI/ML devices where a "ground truth" is established by human experts (e.g., radiologists interpreting images). For a reprocessed physical device, "ground truth" is established by objective engineering and safety standards (e.g., measuring dimensions against specifications, testing electrical resistance against a standard). The "experts" would be qualified engineers and technicians performing the tests.

4. Adjudication Method for the Test Set

• N/A. Adjudication (e.g., 2+1, 3+1 consensus) is used in studies with human readers interpreting data, often to resolve discrepancies in diagnoses or interpretations. This is not applicable to the direct physical and functional testing of a medical device like a catheter.

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

• N/A. This type of study is relevant for AI/ML-assisted diagnostic tools, not for a reprocessed physical device like this catheter. The clearance is based on the catheter's physical and functional equivalence to new catheters, not on improving human diagnostic accuracy.

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

• N/A. This refers to the performance of an AI/ML algorithm on its own. It is not applicable to a physical medical device.

7. The Type of Ground Truth Used

• For the physical and functional aspects of the reprocessed catheter, the "ground truth" is established by:
  • Engineering Specifications: The design and performance specifications of the original (predicate) new device. The reprocessed device must meet these same specifications.
  • Regulatory Standards: Relevant FDA and international standards for medical device safety and performance (e.g., electrical safety, biocompatibility, sterilization).
  • Objective Measurements: Direct measurements (e.g., dimensions, electrical properties, mechanical strength) and analytical tests (e.g., for residual contaminants).

8. The Sample Size for the Training Set

• N/A. "Training set" refers to data used to train an AI/ML algorithm. This is not applicable to a physical reprocessed medical device. The "training" for this device is the validation of the reprocessing procedure itself.

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

• N/A. Since there is no "training set" in the AI/ML sense, this question is not applicable. For a reprocessed device, the "ground truth" is inherent in the established manufacturing and safety standards that the reprocessing procedure must meet. The reprocessor (Medline ReNewal) developed and validated a controlled process (cleaning, inspection, testing, packaging, sterilization) to ensure that the reprocessed catheter performs equivalently to a new device.

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The VIKING Fixed Curve Diagnostic Catheter is indicated for use to diagnose cardiac arrhythmias.

The Viking Fixed Curve Diagnostic Catheters (also referred to as Viking Catheters) are intended for use in electrophysiology procedures to record, stimulate and pace in the diagnosis of cardiac arrhythmias.

The Viking Catheters receive electrical signals from the cardiac tissue, which are transmitted via the electrode wiring through the connector and cable to an amplifier, where the signals are displayed on an EP recording system for the physician to view and interpret in diagnosing cardiac arrhythmias. The physician inserts the diagnostic catheter into the vasculature percutaneously. To reach the right side of the heart, either the internal jugular vein, the subclavian veins, or the femoral veins can be accessed. To reach the left ventricle, the retrograde approach via the femoral artery can be used. In some cases, the radial artery may be used to access the targeted cardiac chamber. Using fluoroscopic guidance, the physician then navigates the diagnostic catheter to the target site using the catheter steering mechanism, as confirmed by the intracardiac electrograms and/or pacing threshold, confirming electrode to endocardium interface.

Viking Catheters are radiopaque, flexible, insulated catheters. The catheters have a polymer shaft that houses the electrical wiring that connects the electrodes to a connector at the proximal end of the catheter; each electrode wire is soldered into this connector. When the catheter is used, the connector is attached to a sterile cable that connects to the hospital recording and pacing equipment.

The Viking Catheters are offered pre-packaged sterile and are a single use product not to be reused, reprocessed, or resterilized. The method of sterilization is ethylene oxide (EO).

The provided FDA 510(k) clearance letter and summary for the VIKING™ Fixed Curve Diagnostic Catheter do not contain any information regarding acceptance criteria and studies demonstrating device performance in the context of an AI/algorithm-based diagnostic device.

The document describes a medical device, specifically a diagnostic catheter, and the FDA's determination of substantial equivalence to a predicate device. The performance data discussed relates to:

• Bioburden Testing: To confirm bioburden levels were not adversely affected.
• Design Verification Testing: To demonstrate adherence to product specifications at baseline and after accelerated aging (25 months/761 days).
• Packaging Verification Testing: To ensure packaging meets design input and maintains sterility.

These tests are standard for physical medical devices to ensure safety, sterility, functionality, and shelf-life, not for evaluating the diagnostic accuracy or effectiveness of an AI algorithm.

Therefore, I cannot provide the requested information for acceptance criteria and studies related to an AI diagnostic device because the provided text is for a physical diagnostic catheter and does not involve AI or algorithmic performance evaluation.

To directly answer your numbered points based only on the provided text, without making assumptions:

1. A table of acceptance criteria and the reported device performance: Not applicable for AI performance from this document. The document presents performance data for physical device characteristics (bioburden, design verification, packaging verification) to support substantial equivalence, but no specific acceptance criteria or reported values are detailed in the summary itself.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable for AI performance from this document. The document refers to "Design Verification Testing" and "Packaging Design Verification testing" but does not specify sample sizes or data provenance in the context of diagnostic accuracy.
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 for AI performance from this document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for AI performance from this document.
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, as this is a physical diagnostic catheter, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical diagnostic catheter, not an AI algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable for AI performance from this document. The "ground truth" for the catheter's physical performance would be its adherence to engineering specifications and international standards.
8. The sample size for the training set: Not applicable, as this is a physical diagnostic catheter, not an AI algorithm.
9. How the ground truth for the training set was established: Not applicable, as this is a physical diagnostic catheter, not an AI algorithm.

In summary, the provided FDA document pertains to the clearance of a physical medical device (a catheter) and does not involve the evaluation of an AI algorithm or its diagnostic performance.

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ViewFlex™ Xtra ICE Catheter
The 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.

ViewFlex™ Eco Reprocessed ICE Catheter
The ViewFlex™ Eco Reprocessed Catheter is indicated for use in adult and adolescent pediatric patients to visualize cardiac structures, blood flow and other devices within the heart.

Advisor™ HD Grid Mapping Catheter, Sensor Enabled™
The 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.

Advisor™ HD Grid X Mapping Catheter, Sensor Enabled™
The Advisor™ HD Grid X 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.

Agilis™ NxT Steerable Introducer
The Agilis™ NxT Steerable Introducer is indicated for the introduction of various cardiovascular catheters into the heart, including the left side of the heart, during the treatment of cardiac arrhythmias.

Agilis™ NxT Steerable Introducer Dual-Reach™
The Agilis™ NxT Steerable Introducer Dual-Reach™ is indicated for the introduction of various cardiovascular catheters into the heart, including the left side of the heart, during the treatment of cardiac arrhythmias.

The Agilis™ NxT Steerable Introducer Dual-Reach™ is a sterile, single-use device that con-sists of a dilator and steerable introducer, which is designed to provide flexible catheter positioning in the cardiac anatomy. The inner diameter of the steerable introducer is 13F. The steerable introducer includes a hemostasis valve to minimize blood loss during catheter intro-duction and/or exchange. It has a sideport with three-way stopcock for air or blood aspiration, fluid infusion, blood sampling, and pressure monitoring. The handle is equipped with a rotating collar to deflect the tip clockwise ≥180° and counterclockwise ≥90°. The steerable introducer features distal vent holes to facilitate aspiration and minimize cavitation and a radiopaque tip marker to improve fluoroscopic visualization.

This FDA 510(k) clearance letter (K251211) and its accompanying 510(k) summary pertain to a change in workflow for several existing cardiovascular catheters, specifically allowing for a "Zero/Low Fluoroscopy Workflow."

The key phrase here is "Special 510(k) – Zero/Low Fluoroscopy Workflow". This type of submission is for modifications to a previously cleared device that do not significantly alter its fundamental technology or intended use, but rather introduce a change in how it's used or processed.

Crucially, this submission does NOT describe a new AI/software device that requires extensive performance testing against acceptance criteria in the manner you've outlined for AI/ML devices. Instead, it's about demonstrating that existing devices, when used with a new, less-fluoroscopy-dependent workflow, remain as safe and effective as before.

Therefore, many of the questions you've asked regarding acceptance criteria, study details, ground truth, and expert adjudication are not applicable to the information provided in this 510(k) document. The document explicitly states:

• "Bench-testing was not necessary to validate the Clinical Workflow modifications."
• "Substantial Equivalence of the subject devices to the predicate devices using the zero/low fluoroscopy workflow has been supported through a summary of clinical data across multiple studies in which investigators used alternative visualization methods."

This indicates that the "study" proving the device (or rather, the new workflow) meets acceptance criteria is a summary of existing clinical data where alternative visualization methods were already employed, rather than a prospective, controlled study of a new AI algorithm.

Based on the provided document, here's what can be answered:

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

• Acceptance Criteria: The implicit acceptance criterion is that the devices, when used with "zero/low fluoroscopy workflow," maintain substantial equivalence to their predicate devices in terms of safety and effectiveness. This means they must continue to perform as intended for visualizing cardiac structures, blood flow, mapping, or introducing catheters.
• Reported Device Performance: The document states that "Substantial Equivalence... has been supported through a summary of clinical data across multiple studies in which investigators used alternative visualization methods." This implies that the performance (e.g., adequate visualization, successful mapping, successful catheter introduction) was maintained. Specific quantitative metrics of performance (e.g., accuracy, sensitivity, specificity, or inter-reader agreement for a diagnostic AI) are not provided or applicable here as this is not an AI/ML diagnostic clearance.

2. Sample size used for the test set and the data provenance:

• Sample Size: Not specified. The document refers to "a summary of clinical data across multiple studies." This suggests an aggregation of results from existing (likely retrospective) patient data where alternative visualization techniques (allowing for "zero/low fluoroscopy") were already utilized clinically. It's not a new, single, prospectively designed test set for an AI algorithm.
• Data Provenance: Not specified regarding country of origin or specific patient demographics. It is implied to be clinical data collected from studies where these types of procedures were performed using alternative visualization. The data would be retrospective as it's a "summary of clinical data" that already exists.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable in the context of this 510(k). Ground truth in an AI/ML context typically refers to adjudicated labels for images or signals. Here, the "ground truth" is inferred from standard clinical practice and outcomes in the historical data summarized. There's no mention of a specific expert panel for new ground truth establishment for a diagnostic AI.

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

• Not applicable. This is not a study requiring adjudication of diagnostic outputs by multiple readers.

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. This is not an AI-assisted diagnostic device. The workflow change is about using alternative non-fluoroscopic imaging modalities (e.g., intracardiac echocardiography, electro-anatomical mapping systems), not about AI improving human reader performance.

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

• No. This is not an AI algorithm. The predicate devices are physical catheters.

7. The type of ground truth used:

• The "ground truth" is inferred from clinical outcomes and established clinical practice using the devices with alternative visualization methods in real-world scenarios. It's not a specific, adjudicated dataset for an AI algorithm. The performance of the devices (such as successful navigation, visualization, and mapping) under the "zero/low fluoroscopy" workflow is assumed to be equivalent to their performance under full fluoroscopy, as demonstrated by prior clinical use where such methods were employed.

8. The sample size for the training set:

• Not applicable. There is no AI model being trained discussed in this document.

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

• Not applicable. No training set for an AI model.

In summary:

This 510(k) is for a workflow modification for existing medical devices (catheters), not for an AI/ML diagnostic or assistive software. Therefore, the detailed data performance evaluation typically required for AI models against specific acceptance criteria (as requested in your template) is not presented or relevant in this clearance letter. The "proof" relies on the concept of substantial equivalence to previously cleared predicate devices, supported by a summary of existing clinical data that used alternative visualization methods, implying that the devices function safely and effectively even with reduced fluoroscopy.

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Medline ReNewal Reprocessed Abbott Inquiry Steerable Diagnostic Catheters can be used for electrogram recording and cardiac stimulation during diagnostic electrophysiologic studies. The catheters are commonly placed in the high right atrium, right ventricular apex, and the HIS bundle.

The Medline ReNewal Reprocessed Inquiry Steerable Diagnostic Electrophysiology Catheters are flexible, insulated catheters constructed of thermoplastic elastomer material and noble metal electrodes. The tip of the steerable catheters may be manipulated with the control mechanism located in the handle of the proximal end of the catheter.

The provided text is a 510(k) Premarket Notification from the FDA regarding a reprocessed medical device: the Medline ReNewal Reprocessed Abbott Inquiry Steerable Diagnostic Catheter. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the safety and effectiveness of a novel device through extensive clinical studies with specific acceptance criteria as you would see for an AI/ML powered device.

Therefore, the document does not contain the information requested regarding acceptance criteria, study details, sample sizes for training/test sets, expert adjudication, MRMC studies, standalone algorithm performance, or ground truth establishment in the context of an AI/ML device.

Instead, the document details physical and functional performance testing to ensure the reprocessed device is equivalent to the original predicate devices. This typically involves:

• Table of Acceptance Criteria and Reported Device Performance: This document does not present a formal table of acceptance criteria and reported device performance in the way one would for an AI/ML algorithm. Instead, it states that "The functional characteristics of the subject device have been evaluated and found to be substantially equivalent to the predicate device based on the following tests." The tests listed are:

  • Visual inspection
  • Dimensional measurement
  • Electrical safety
  • Mechanical characteristics (continuity, isolation, resistance)
  • Corrosion resistance
  • Cleaning validation
  • Biocompatibility
  • Packaging and shelf life validation
  • Sterilization validation
  • Product stability
    The acceptance criterion for these tests is that the reprocessed device performs comparably to the new, original predicate devices.

• Sample size used for the test set and the data provenance: The document does not specify exact sample sizes for each of the non-clinical tests listed. It indicates the tests were performed on the reprocessed devices. The "data provenance" is implied to be from Medline ReNewal's internal testing of their reprocessed catheters. This is not medical imaging data from patients.

• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. For reprocessed medical devices, "ground truth" relates to engineering specifications and performance standards established by the original manufacturer and industry standards, rather than expert human interpretation of medical data.

• Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Adjudication methods are typically associated with human interpretation of complex data (like medical images) to establish ground truth, which is not the type of data or evaluation performed for this device.

• 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 a physical medical device, not an AI-powered diagnostic tool. MRMC studies are for AI/ML devices to assess human reader performance with and without AI assistance.

• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device, not an algorithm.

• The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Ground truth for this device would be based on engineering specifications, material properties, functional performance benchmarks (e.g., electrical resistance within a specified range, mechanical integrity under stress, sterility), and established safety standards. It does not involve medical, pathological, or outcomes data in the way an AI/ML diagnostic would.

• The sample size for the training set: Not applicable. This is not an AI/ML device, so there is no "training set."

• How the ground truth for the training set was established: Not applicable. As there is no training set.

In summary, the provided document is a 510(k) clearance letter for a reprocessed physical medical device, not an AI/ML enabled device. Therefore, the questions related to AI/ML model evaluation (training/test sets, ground truth methodology, expert adjudication, MRMC studies) are not relevant to this submission. The "study" proving the device meets acceptance criteria refers to a series of non-clinical, bench-top functional and material property tests to ensure the reprocessed device performs equivalently to its new predicate.

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The Medline ReNewal Reprocessed Biosense Webster CS Catheter is indicated for electrophysiological mapping of cardiac structures, i.e., stimulation and recording only. The catheter is designed for use in the coronary sinus.

The reprocessed catheters are diagnostic bi-directional 7F deflectable mapping electrophysiology EP catheters. The devices have the ability to map electrical activity within the Coronary Sinus (CS) through electrodes along the catheters' pre-shaped tip. The catheters have a braided bi-directional tip section that provides the user with two 180° opposed single plane curves (available curves are DF and FJ). The tip is deflected with a Rocker Lever, and the high torque shaft permits the tip's plane to rotate to ease accurate positioning of the catheter tip at the desired site. The Medline ReNewal Reprocessed Biosense Webster Webster CS Catheter with EZ Steer Technology and Auto ID are equipped with an Electronically Erasable Programmable Read Only Memory (EEPROM) that is used to store unique catheter identification information.

The provided document is a 510(k) premarket notification from the FDA for a reprocessed medical device: "Medline ReNewal Reprocessed Biosense Webster CS Catheter with EZ Steer Technology and Medline ReNewal Reprocessed Biosense Webster Webster CS Catheter with EZ Steer Technology and Auto ID".

This document is not about an AI/ML medical device. It's about a reprocessed catheter and demonstrates substantial equivalence to existing predicate devices based on non-clinical performance data. Therefore, the specific questions related to AI/ML device acceptance criteria, study methodologies (like MRMC, standalone performance, training sets, expert consensus for ground truth), and effect sizes of AI assistance are not applicable to this document.

The document discusses "non-clinical testing" and "functional performance studies" for the reprocessed catheters to demonstrate their equivalence to new, original equipment manufacturer (OEM) catheters.

Here's an attempt to extract the relevant information from the provided text, while noting the limitations regarding the AI/ML specific questions:

Acceptance Criteria and Device Performance (based on non-clinical testing for a reprocessed device):

The document does not provide a table of precise quantitative acceptance criteria with corresponding performance metrics for the reprocessed catheter in the way one would expect for an AI/ML device's diagnostic performance. Instead, it states that the functional characteristics of the subject device (reprocessed catheter) have been evaluated and found to be substantially equivalent to the predicate device. This substantial equivalence is based on various non-clinical tests.

The types of non-clinical tests performed and implicitly, the areas where acceptance criteria would have been applied (though not explicitly listed with values), include:

The evidence for "proof" that the device meets "acceptance criteria" is the FDA's determination of substantial equivalence (SE) to legally marketed predicate devices. This SE determination is based on the provided non-clinical testing data which, by inference, met the internal acceptance criteria set by Medline ReNewal and deemed sufficient by the FDA for establishing SE.

Regarding the AI/ML specific questions:

1. A table of acceptance criteria and the reported device performance: As explained above, for this reprocessed medical device, specific quantitative metrics are not provided in the summary. The acceptance is based on demonstrating substantial equivalence through various functional, mechanical, cleaning, biocompatibility, and sterilization tests.

2. Sample sizes used for the test set and the data provenance: The document mentions "non-clinical testing data" and "functional performance studies" but does not specify the sample sizes (e.g., number of catheters tested) or the provenance (country of origin, retrospective/prospective) of this data. It is inherently laboratory/bench testing data, not clinical data from patients.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This is not applicable. For a reprocessed physical device, "ground truth" would be established through laboratory methods and validated testing protocols against known engineering and biological standards, not through human expert consensus in the medical imaging sense.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, as no expert adjudication of diagnostic outputs occurred.

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 a reprocessed physical catheter, not an AI/ML diagnostic algorithm.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical device, not an AI algorithm. Its "standalone" performance would refer to its physical properties and functionality outside of human use, as evaluated through the non-clinical tests.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable in the context of diagnostic "ground truth" for AI. For this device, "ground truth" refers to the established performance and safety specifications of the original predicate device, against which the reprocessed device's performance is compared through physical and chemical testing.

8. The sample size for the training set: Not applicable. This is a reprocessed physical medical device, not an AI/ML algorithm that undergoes "training."

9. How the ground truth for the training set was established: Not applicable. No training set or ground truth in the AI/ML context exists for this device.

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EP.XT, Dynamic Tip, and Dynamic XT Unidirectional Steerable Diagnostic Catheters are indicated for use to diagnose cardiac arrhythmia.

The unidirectional steerable diagnostic catheters acquire electrical signals from the cardiac tissue, which are transmitted via the electrode wiring through the connector and cable to an amplifier, where the signals are displayed on an EP recording system for the physician to view and interpret in diagnosing cardiac arrhythmias. The physician inserts the diagnostic catheter(s) percutaneously via either the anterior approach using the internal jugular vein or the subclavian vein or via the femoral vein or for a retrograde approach, via the femoral artery. In some cases, the radial artery may be used to access the targeted cardiac chamber. Using fluoroscopic guidance, the physician then navigates the diagnostic catheter to the target site using the catheter steering mechanism as confirmed by the intracardiac electrograms and/or pacing threshold, confirming electrode to endocardium interface.

The steerable diagnostic electrode catheters are radiopaque, flexible, insulated catheters with a polymer shaft, each having a mechanical operating mechanism. In each catheter the polymer shaft connects to the catheter handle whereby the curve or loop is actuated by a single pull cable. The EP+XT Catheter has a white rotating handle mechanism which provides curve actuation of the distal tip. The Dynamic Tip and Dynamic XT Catheters have a plunger mechanism, which, when moved forward or back, results in curvature of the distal tip.

The EP•XT, Dynamic Tip, and Dynamic XT Catheters are offered pre-packaged sterile and are a single use product not to be reused, reprocessed, or resterilized. The method of sterilization is ethylene oxide (EO).

This document describes the FDA's decision to clear Boston Scientific's EP.XT, Dynamic Tip, and Dynamic XT Unidirectional Steerable Diagnostic Catheters for marketing based on a determination of substantial equivalence to predicate devices. This clearance is not based on a study proving the device meets specific performance criteria for diagnostic accuracy in the same way an AI/ML diagnostic would be; rather, it relates to the device's physical and functional characteristics and its ability to acquire electrical signals.

Therefore, the requested information (acceptance criteria and study details related to diagnostic performance, human reader improvement with AI, ground truth, expert adjudication, etc.) is not applicable to this 510(k) submission. This is a clearance for a physical medical device (catheter) used to acquire data, not a software-based diagnostic algorithm.

Here's a breakdown based on the provided document, addressing what is relevant and noting what is not:

1. Acceptance Criteria and Reported Device Performance

The "acceptance criteria" here are based on the device's physical and functional performance, sterilization, and packaging, demonstrating it is substantially equivalent to a predicate device. There are no diagnostic performance metrics (e.g., sensitivity, specificity, AUC) reported because this is not a diagnostic algorithm.

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

N/A. This 510(k) summary does not describe a clinical study for diagnostic performance with a test set of patient data. The "test set" for this device would refer to units of the manufactured catheters themselves undergoing engineering and bench testing. The document states "Design verification testing was performed on the EP.XT, Dynamic Tip, and Dynamic XT Catheters," implying a sample of the manufactured devices were tested, but specific numbers are not provided in this summary.

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

N/A. This is not a diagnostic algorithm requiring expert-established ground truth on patient data. The ground truth for this device's performance relates to engineering specifications and international standards (e.g., ISO 11607-1 for packaging, ISO 11737-1 for bioburden).

4. Adjudication Method for the Test Set

N/A. Not applicable to a physical device's engineering and performance testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. An MRMC study is relevant for evaluating the impact of AI on human reader performance for diagnostic tasks. This device is a diagnostic tool that acquires electrical signals, not an AI-powered diagnostic system.

6. If a Standalone Performance Study Was Done

No, not in the context of an algorithm's diagnostic performance. The "performance data" described (Bioburden, Design Verification, Packaging Verification) are standalone tests of the device's physical and functional attributes against engineering specifications and regulatory standards.

7. The Type of Ground Truth Used

The "ground truth" for this device's clearance is based on:

• Engineering Specifications: The design inputs and performance requirements set by Boston Scientific for the catheters.
• International Standards: E.g., ISO 11737-1 for bioburden, ISO 11607-1 for packaging, and likely other ISO standards for biocompatibility and electrical safety (though not explicitly listed in the summary).
• Predicate Device Performance: The primary "ground truth" for 510(k) clearance is that the new device performs "substantially equivalent" to legally marketed predicate devices, meaning it has similar technological characteristics and the same intended use.

8. The Sample Size for the Training Set

N/A. This is not an AI/ML device that requires a training set of data.

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

N/A. Not applicable as there is no training set for an AI/ML algorithm.

In summary: The provided document is a 510(k) clearance letter for a medical device (catheter) based on substantial equivalence. It does not contain information about acceptance criteria or studies related to the diagnostic accuracy of an AI/ML algorithm, nor does it describe human-in-the-loop performance studies. The "performance data" refers to the physical and functional characteristics of the catheter itself, not its diagnostic accuracy in interpreting patient data.

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The Reprocessed DECANAV™ Electrophysiology Catheter is indicated for electrophysiological mapping of cardiac structures i.e., recording and stimulation, in the Coronary Sinus. In addition, the Reprocessed DECANAV™ Catheter is used with compatible Carto® 3 EP Navigation Systems to provide catheter tip location information.

The Reprocessed WEBSTER® Duo-Decapolar Electrophysiology Catheter is indicated for electrophysiological mapping of cardiac structures, i.e., stimulation and recording only. In addition, the Reprocessed WEBSTER® Duo-Decapolar Catheter is designed to facilitate electrogram mapping in the atrial region of the heart and coronary sinus.

The Reprocessed DECANAV™ Catheter is a sterile, single patient use device designed to be used with the CARTO® 3 EP Navigation System (a magnetic field location technology) to facilitate electrophysiological mapping of the heart. The catheter has a high torque shaft with a deflectable tip section containing an array of platinum/iridium electrodes that can be used for stimulation and recording of cardiac electrical signals. The Reprocessed DECANAV™ Catheter has a single proximal electrode that can be used for unipolar recording signals. The Reprocessed DECANAV™ Catheter tip deflection is controlled by a proximal hand piece that features a thumb operated sliding piston and is offered in curve types D and F. Pushing the thumb knob forward causes the catheter tip to bend (curve); when the knob is pulled back, the tip straightens. The plane of the curved tip can be rotated during use. The Reprocessed DECANAV™ Catheter interfaces with standard recording equipment and CARTO® 3 EP Navigation System equipment via interface cables with the appropriate connectors.

The Reprocessed WEBSTER® Duo-Decapolar Catheter (DDP) is a sterile, single patient use device designed to facilitate electrophysiological mapping of the heart. The catheter has a high-torque shaft with a deflectable tip section containing an array of platinum electrodes that can be used for stimulation and recording. Tip deflection is controlled at the proximal end by a tubular handpiece in which a piston slides. When the piston is pushed forward with the thumb knob, the tip is deflected (curved). When the piston is pulled back, the tip straightens. The high torque shaft allows the plane of the curved tip to be rotated to facilitate accurate positioning of the catheter tip at the desired site. The catheter interfaces with standard recording equipment via interface cables with the appropriate connectors.

The provided text describes the 510(k) summary for reprocessed electrophysiology catheters, which are medical devices, not AI/ML-enabled software. Therefore, the questions related to AI/ML device performance, such as sample size for test sets (data provenance), number of experts, adjudication methods, MRMC comparative effectiveness studies, standalone performance, and training set information (sample size, ground truth establishment), are not applicable to this document.

The document discusses acceptance criteria and device performance in the context of demonstrating substantial equivalence for reprocessed medical devices to their predicate devices.

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

The document lists several tests performed to demonstrate appropriate functional characteristics and substantial equivalence to predicate devices. It states that "Performance testing shows the Reprocessed DECANAV™ and Reprocessed WEBSTER® Duo-Decapolar Electrophysiology Catheters perform as originally intended." and "Results demonstrated substantial equivalence to the predicate devices."

Specific acceptance criteria (e.g., numerical thresholds for compliance) are not explicitly detailed in this summary. However, the types of tests conducted serve as the basis for determining if the reprocessed devices meet acceptable performance comparable to the original predicate devices.

2. Sample size used for the test set and the data provenance

The document states: "Representative samples of reprocessed devices were tested to demonstrate appropriate functional characteristics." It does not specify the exact sample size for each test or the total test set.

• Data provenance: Not explicitly stated, but the testing was conducted by Sterilmed, Inc. or its contractors in the context of their reprocessing efforts. This would be considered internal data from the reprocessing process. The data is retrospective in the sense that it evaluates the reprocessed devices after manufacturing, but the tests themselves are prospective studies on those samples.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This question is not applicable. The device is a reprocessed electrophysiology catheter. Performance is assessed through engineering and biocompatibility tests against established specifications and comparison to the original (OEM) device, not through expert human review of interpretative data like medical images.

4. Adjudication method for the test set

This question is not applicable, as the performance evaluation relies on objective engineering and biological test results, not expert human interpretation or adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

This question is not applicable. MRMC studies are typically used to evaluate the diagnostic accuracy of imaging systems or AI algorithms by comparing performance with and without an AI assist. This document is for a reprocessed medical device.

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

This question is not applicable. This is not an AI/ML-enabled device.

7. The type of ground truth used

The "ground truth" for the performance of these reprocessed catheters is established by:

• Engineering specifications and performance characteristics of the original equipment manufacturer (OEM) predicate devices. The reprocessed devices are tested to ensure they meet these specifications.
• Compliance with recognized standards for medical device reprocessing, safety, and performance (e.g., ISO 10993 for biocompatibility, ASTM standards for packaging and shelf-life, and internal functional performance criteria designed to mimic intended use).
• Visual inspection for physical integrity.

Essentially, the ground truth is the performance and safety profile of the new, original predicate device.

8. The sample size for the training set

This question is not applicable. This is not an AI/ML-enabled device, so there is no training set in the context of machine learning.

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

This question is not applicable, as there is no training set for an AI/ML algorithm.

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The Medline ReNewal Reprocessed St. Jude Medical Response Electrophysiology Catheters and Supreme Electrophysiology Catheters can be used in the evaluation of a variety of cardiac arrhythmia from endocardial and intravascular sites.

Medline ReNewal Reprocessed St. Jude Medical Supreme and Response Electrophysiology Catheters are commonly placed at the high right atrium, right ventricular apex and His bundle, and in the coronary sinus, and are used for electrogram recording and cardiac stimulation during diagnostic electrophysiology studies. The Medline ReNewal Reprocessed St. Jude Medical Supreme and Response Electrophysiology Catheters are fixed electrode catheters constructed of a polyurethane insulation/shaft and incorporate platinum electrodes. Each device is marked and tracked and will be taken out of service once the maximum number of cycles has been reached.

The provided text describes a 510(k) premarket notification for reprocessed electrophysiology catheters, specifically the Medline ReNewal Reprocessed St. Jude Medical Response Electrophysiology Catheter and Supreme Electrophysiology Catheter.

However, the document does not contain the detailed information necessary to complete the requested table and answer questions 2 through 9 regarding acceptance criteria, study data, sample sizes, ground truth establishment, or expert involvement for a medical device that uses an algorithm or AI.

The document is a regulatory submission for reprocessed physical medical devices (catheters), not a study of an algorithmic or AI-based diagnostic/detection device. The "Non-clinical Testing Summary" section discusses functional performance, mechanical characteristics, corrosion resistance, cleaning, biocompatibility, packaging, shelf-life, and sterilization validation, which are typical for reprocessed physical medical devices.

Therefore, I cannot extract the requested information as the context of the document does not align with the type of study and acceptance criteria you are asking about (i.e., for an AI/algorithm-based device).

To summarize, the relevant information you requested is not present in the provided text because the document is about reprocessed physical medical devices, not an AI or algorithm-driven device.

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The Nordica PV Cryo Mapping Catheter is indicated for multiple electrophysiological mapping of cardiac structures (i.e., recording and stimulation only). The Nordica PV Cryo Mapping Catheter is designed to obtain electrograms in the atrial regions of the heart.

The Nordica PV Cryo Mapping Catheter is a 3F sterile, single use, multi-electrode, diagnostic catheter designed to map cardiac signals during ablation procedures. The catheter is provided with a fixed loop diameter of 15mm or 20mm with either 5 or 4 evenly spaced, radiopaque pairs of electrodes. The proximal end of the catheter contains an electrical connection for the EP electrical cable that integrates with electrophysiology lab recording systems. Once deployed in the vasculature through the central lumen of a catheter, a circular or spiral shape is established such that the electrodes contact the endocardial surface. This allows for recording, pacing, and interrogation of electrical conduction between the left atrium and the pulmonary veins.

The provided text describes the submission for a 510(k) premarket notification for the "Nordica PV Cryo Mapping Catheter" and focuses on demonstrating substantial equivalence to a predicate device.

Crucially, this document focuses on the safety and performance of a medical device (a catheter) through various engineering, sterilization, biocompatibility, and animal studies. It explicitly states: "This section is not applicable as the subject and predicate devices do not contain any software components or utilize software for their intended use." and "Human Clinical Performance Testing: Clinical testing was not required to demonstrate substantial equivalence to the predicate device."

Therefore, the request for acceptance criteria and a study proving a device meets the acceptance criteria in the context of AI/software performance, human readers, ground truth, and training/test sets is not applicable to this document.

The document details the following types of testing for the physical medical device:

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

The document provides a "Table 1: Comparison of Technological Characteristics with the Predicate Device" which implicitly serves as a comparison of the subject device's features against the predicate's known characteristics, thereby establishing the "acceptance criteria" through equivalence. The "reported device performance" is then demonstrated through various specific tests.

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

• Test set for Biocompatibility: "All tested subject devices met the acceptance criteria for each biological endpoint test". The exact number of devices tested for each biological endpoint (e.g., ISO MEM Elution, Hemolysis, etc.) is not specified, but it implies a sufficient sample size was used for each test to provide robust results.
• Test set for Benchtop Studies: "The results of benchtop testing demonstrated the design outputs of the subject device met the design input acceptance criteria required to demonstrate substantial equivalence with the predicate device." Similarly, exact sample sizes for each benchtop test (e.g., buckle force, catheter deflection, etc.) are not provided.
• Pre-Clinical GLP Animal Study: A "chronic GLP animal study" was performed on a "canine animal model". The exact sample size (number of animals) is not specified.
• Data Provenance: The document does not specify the country of origin for the data or whether the studies were retrospective or prospective, beyond stating it was a "chronic GLP animal study" which implies a prospective, controlled study in a laboratory setting. All testing appears to be internal (Synaptic Medical Corporation) or contracted to ISO/ASTM compliant labs.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This is not applicable as the studies are engineering, biological, and animal model evaluations, not human-read AI evaluations.

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

Not applicable.

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.

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

Not applicable. The device has no software components or AI.

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

For the various tests, the "ground truth" is defined by the established scientific and engineering standards and methods:

• Biocompatibility: Defined by the acceptance criteria of ISO 10993 series standards (e.g., no cytotoxicity, no hemolysis, no sensitization, no pyrogenicity, etc.).
• Sterilization: Defined by ISO 11135:2014+A1:2019 (achieving SAL of 10^-6 or better) and EN ISO 10993-7:2008 + A1:2022 (residual limits).
• Shelf-Life: Defined by ASTM F1980-21 for accelerated aging and specific packaging integrity tests (ASTM F2096-11(2019), ASTM F88/F88M-21).
• Benchtop Performance: Defined by ISO 10555-1:2013/AMD 1:2017 and internal "design input acceptance criteria" for various physical properties (e.g., buckle force, tensile strength, electrical continuity).
• Pre-Clinical GLP Animal Study: Evaluation of "chronic safety, performance, and usability" in a canine model, presumably against pre-defined physiological endpoints and observational criteria.

8. The sample size for the training set

Not applicable, as this device does not involve AI/machine learning.

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

Not applicable, as this device does not involve AI/machine learning.

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