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The RithmID-SD Steerable Diagnostic Electrophysiology Catheter can be used in the evaluation of a variety of cardiac arrhythmias from endocardial and intravascular sites.

The RithmID-SD Steerable Diagnostic Electrophysiology Catheter are biocompatible, flexible, radiopaque electrophysiology catheters that are available in a variety of diameters, lengths, curve shapes, and electrode number and spacing configurations, with a high-torque shaft with an array of platinum iridium alloy electrodes at the distal tip that can be used for recording electrical signals. The catheter is designed to facilitate the electrophysiological mapping of the heart.

The RithmID-SD Steerable Diagnostic Electrophysiology Catheter consist of a handle, a shaft and a steerable diagnostic tip. The catheter is introduced through the sheath and into the femoral vein, from the inferior vena cava into the heart and coronary sinus. The RithmID-SD Steerable Diagnostic Electrophysiology Catheter are available in 6F in various curves, including B, D, Y, and R curves.

The provided text is a 510(k) summary for a medical device called the "RithmID-SD Steerable Diagnostic Electrophysiology Catheter". This document focuses on demonstrating substantial equivalence to predicate devices, primarily through bench testing, biocompatibility testing, and comparisons of technical characteristics.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly list acceptance criteria for each test in a separate column. Instead, for most tests, it states "All test samples met the acceptance criteria," indicating that the criteria were satisfied. The performance results are qualitative; for a few tests, comparative statements are made relative to the reference device.

Here's a compilation of the tests and their reported performance:

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The CardioNXT iMap™ 3D Mapping & Navigation System is intended for the display of compatible electrophysiology catheter position and cardiac electrical activity when used with the MultiLink CS Catheter during conventional electrophysiological procedures.

The MultiLink CS Catheter is used for electrogram recording and as a navigation reference during conventional electrophysiological procedures.

The CardioNXT iMap™ 3D Mapping and Navigation System (iMap™ System) is a catheter navigation and mapping system, capable of displaying the three-dimensional (3D) position of conventional electrophysiology catheters, as well as displaying cardiac electrical activity as waveform traces and as electroanatomical maps of the cardiac chamber. The contoured surfaces of these threedimensional maps are based on the anatomy of the patient's cardiac chamber. The iMap™ System utilizes electromagnetic tracking and impedance tracking to track conventional catheters and paint the surfaces of cardiac chambers in 3D to generate a patient-specific image of the heart, also called a geometry. The iMap System measures cardiac electrogram (EGM) information from navigated catheter electrodes throughout the heart and displays this information on the patient-specific geometry. The iMap System utilizes a Coronary Sinus(CS)catheter with both electromagnetic sensors and electrodes as a reference for its navigation coordinate system.

The provided text describes the CardioNXT iMap™ 3D Mapping & Navigation System, but it does not contain acceptance criteria and specific study results in the format requested. Instead, it lists various types of testing performed and concludes that the device meets performance specifications and is substantially equivalent to predicate devices.

Here's a breakdown of what is and isn't present, based on your request:

1. Table of Acceptance Criteria and Reported Device Performance:

• Not provided. The document states that bench testing demonstrates the system meets performance specifications, but it does not list those specifications or the quantitative results against them.

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

• Sample size for test set: Not explicitly stated. The document mentions a "GLP animal study" and "bench testing," but doesn't give specific numbers of animals or test items.
• Data provenance: "GLP animal study" implies prospective animal data. "Bench testing" would be laboratory-based. No mention of human data, retrospective or prospective, for performance evaluation against acceptance criteria.

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

• Not provided. The document mentions "usability testing demonstrating usability by licensed cardiac electrophysiologist physicians," but this is for usability, not for establishing ground truth for device performance metrics.

4. Adjudication Method:

• Not provided.

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

• Not performed/reported. The document does not mention an MRMC study or any effect sizes of human reader improvement with AI assistance.

6. Standalone Performance:

• A standalone performance study was likely done as part of the "bench testing demonstrating substantially equivalent safety, performance, and accuracy to predicate" and the "GLP animal study." However, the specific metrics and results of this standalone performance are not detailed in the provided text. The overall conclusion is that it meets specifications, but the specifics are absent.

7. Type of Ground Truth Used:

• For the "GLP animal study" and "bench testing," the ground truth would typically be established through direct measurements, established physiological parameters, or physical phantom models with known properties. However, the document does not explicitly specify the type of ground truth (e.g., direct measurement, histological analysis, etc.) for each performance metric evaluated.

8. Sample Size for the Training Set:

• Not provided. The document does not mention any "training set." The iMap™ System is described as a "programmable diagnostic computer" and a "mapping and navigation system," implying it might use algorithms, but no details on machine learning model training or associated datasets are given.

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

• Not applicable/Not provided. Since no training set is mentioned, the method for establishing its ground truth is also not mentioned.

In summary, the provided document focuses on regulatory clearance and substantial equivalence by listing various types of testing performed (bench, animal, electrical safety, biocompatibility, etc.) and concluding that the device meets requirements. However, it lacks the detailed quantitative acceptance criteria and specific study results that you requested to demonstrate how those criteria were met.

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Reprocessed Diagnostic Electrophysiology (EP) Catheters are intended for temporary intracardiac sensing, recording, stimulation, and electrophysiology mapping of cardiac structures. The reprocessed IBI AFocus 100 Steerable and the Inquiry TM Optima™ catheters are to be used to map the atrial regions of the heart. The reprocessed Inquiry™ fixed curve and steerable catheters are commonly placed at the high right atrium, right ventricular apex, and HIS bundle.

The Reprocessed Diagnostic Electrophysiology (EP) Catheters are specially designed electrode catheters that transmit electrical impulses and can be positioned for endocardial recording or stimulation. Diagnostic EP catheters incorporate a hand piece, a flexible shaft and a distal tip section containing diagnostic electrodes. The distal tip of deflectable catheters can be deflected into a curve by manipulating the hand piece. Specific to the Inquiry™ Optima™, Optima™ Plus steerable electrophysiology catheters: The catheter incorporates both a deflectable shaft steering mechanism and a distal end with a variable loop diameter, which allows selection of diameters within a specific range. The distal shaft may be deflected by pushing and pulling the thumb control and the distal loop diameter may be expanded or contracted by turning the rotating knob. Specific to the AFocus™ steerable and the Inquiry™ fixed curve and steerable electrophysiology catheters: The catheters are flexible and insulated catheters constructed of noble metal electrodes and thermoplastic elastomer material. The control mechanism located in the handle at the proximal end of the catheter manipulates the tip of the steerable catheters. The distal tip on the AFocus™ catheter has been designed to expedite the collection of electrogram recordings of a circumferential area.

The provided text describes a 510(k) summary for "Reprocessed Electrophysiology Catheters" by Stryker Sustainability Solutions. It details the device, its intended use, and the performance data submitted to demonstrate substantial equivalence to predicate devices.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

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

The document does not explicitly list quantitative acceptance criteria in a numerical table format for device performance. Instead, it states that "Performance testing demonstrates that Reprocessed Electrophysiology Catheters perform as originally intended." This implies that the acceptance criterion is that the reprocessed devices function equivalently to the original, new devices. The reported performance is that this equivalence has been demonstrated through various tests.

The performance data listed includes:

• Biocompatibility
• Validation of reprocessing
• Sterilization Validation
• Function test(s)
• Packaging Validation

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

The document does not specify the sample size used for the test set for any of the performance tests (Biocompatibility, Reprocessing Validation, Sterilization Validation, Function Tests, Packaging Validation). It also does not mention the country of origin of the data or whether the studies were retrospective or prospective.

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 in the document. The type of device (reprocessed catheters) and the nature of the tests (biocompatibility, sterilization, function) suggest that ground truth would likely be established through standardized laboratory methods and measurements, rather than human expert interpretation of images or clinical outcomes.

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

This information is not applicable and is not provided in the document. Adjudication methods are typically used in clinical studies involving human interpretation or subjective endpoints. The tests described are primarily objective bench and laboratory tests.

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 is not applicable to the device described. The device is a reprocessed electrophysiology catheter, and the studies mentioned are bench and laboratory tests. There is no AI component, no human readers involved in interpreting results in the way an MRMC study would assess, and therefore no effect size relating to AI assistance.

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 reprocessed medical instrument, not an algorithm or AI system.

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

For the performance tests mentioned (Biocompatibility, Validation of reprocessing, Sterilization Validation, Function test(s), Packaging Validation), the ground truth would be established by:

• Biocompatibility: Adherence to ISO standards (e.g., ISO 10993) and established toxicological profiles.
• Validation of reprocessing: Verification that the reprocessing steps (cleaning, disinfection, inspection) meet predefined criteria to render the device clinically safe and functional. This would involve testing for residual soil, microbial load, and material integrity.
• Sterilization Validation: Demonstrating a specified sterility assurance level (SAL), typically 10^-6, through established sterilization methodologies (e.g., ethylene oxide or steam sterilization validation protocols).
• Function test(s): Comparison of critical performance parameters (e.g., electrical conductivity, steerability, mechanical integrity, electrode adhesion) of the reprocessed device against predetermined specifications (often based on the original new device's specifications).
• Packaging Validation: Ensuring package integrity and maintenance of sterility through simulated shipping and environmental challenges (e.g., according to ISO 11607).

These forms of ground truth are based on objective, measurable criteria and established scientific standards, rather than expert consensus on subjective findings, pathology, or long-term outcomes data.

8. The sample size for the training set:

This is not applicable. The device is not an AI/ML algorithm that requires a training set.

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

This is not applicable. The device is not an AI/ML algorithm that requires a training set.

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The IBI Luma-Cath™ Steerable Electrophysiology Catheters are 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 Irvine Biomedical, Inc. Luma-Cath™ Steerable Electrophysiology Catheter System is a multiple-electrode electrophysiology recording catheter and its connecting cable. The diameter of the catheter is between 6 and 8 French. The diameter of the electrodes is between 6 and 8 French. There is a lumen with nominal internal diameter of 0.036 inch.

The provided text does not contain information regarding detailed acceptance criteria, a specific study proving device performance against those criteria, or the methodology typically associated with such studies (like sample sizes, expert qualifications, ground truth establishment, or comparative effectiveness studies).

The text is a summary of safety and effectiveness for a 510(k) submission, confirming the device's substantial equivalence to predicate devices and its compliance with general controls. It focuses on biocompatibility, performance tests (without detailing them or their outcomes), manufacturing quality, and regulatory approval.

Therefore, I cannot fulfill your request for the specific points listed (Table of acceptance criteria, sample sizes, expert qualifications, ground truth, MRMC study, standalone performance, training set details) because this information is not present in the provided document.

The document indicates:

• Device: Luma-Cath™ Steerable Electrophysiology Catheter System
• Purpose: Electrophysiology recording and cardiac stimulation during diagnostic electrophysiologic studies.
• Safety and Effectiveness Claim: Based on biocompatibility, passed unnamed performance tests, manufacturing process following GMP, and substantial equivalence to predicate devices.
• Predicate Device: K961924 for accessory cables (though this is for the cables, not the catheter itself, which is stated to have patient contact materials "the same as the predicate devices").
• Regulatory Conclusion: Device is "substantially equivalent" to legally marketed predicate devices.

Without specific performance metrics and a study design, I cannot populate the requested table or answer the detailed questions about the study's execution.

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