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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 Reflexion Spiral™ catheter can be used for recording intracardiac signals and for cardiac stimulation during electrophysiology studies. The Reflexion Spiral™ catheter is to be used to map the atrial regions of the heart.

The St. Jude Medical (SJM) Reflexion Spiral™ Variable Radius Catheter (Reflexion Spiral catheter) is a flexible, asymmetric, bi-directional, radiopaque variable radius loop electrophysiology catheter constructed of a polymer shaft that incorporates platinum electrodes.

The Reflexion Spiral catheter has a proximal handle (ComfortGrip™) that contains: 1) A shaft actuator mechanism for varying the asymmetrical sweep (90° sweep) and curl (180° curl) of the distal portion of the shaft. 2) A loop actuator mechanism for varying the loop diameter from approximately 25mm to approximately 15mm. 3) An electrical connector fitted into the proximal end of the handle.

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

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document does not explicitly state specific acceptance criteria in terms of numerical performance targets. Instead, it relies on demonstrating equivalence to a predicate device. The performance is described in a comparative manner rather than against pre-defined numerical thresholds.

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

• Sample Size for Test Set: The document does not specify a patient or clinical sample size for the test set. The testing described is primarily non-clinical (bench and animal data).
• Data Provenance: The data comes from bench testing and animal studies conducted by St. Jude Medical. No information on country of origin of data or whether it was retrospective or prospective is provided for the non-clinical tests.

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

• Number of Experts: This information is not provided in the document.
• Qualifications of Experts: This information is not provided in the document.

Given that the studies were primarily non-clinical (bench and animal), "ground truth" would likely refer to engineering specifications or physiological measurements in the animal model, rather than expert interpretation of clinical data.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set:

• Adjudication Method: Not applicable/Not mentioned. Since the studies were non-clinical (bench and animal) and no expert review of clinical cases is described, there would be no need for a human adjudication method for establishing ground truth as would be relevant in a clinical imaging or diagnostic study.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:

• MRMC Study: No, an MRMC comparative effectiveness study was not done. The device in question is a physical medical catheter, not an AI-assisted diagnostic tool for human readers. Therefore, the concept of human readers improving with AI assistance is not relevant to this submission.

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

• Standalone Performance: Not applicable/Not done in the context of an algorithm. The device is a physical catheter, not an algorithm. The "standalone performance" was demonstrated through bench testing and animal data to show its functional capabilities and safety, independent of human interpretive assistance (as it's a tool for direct physiological measurement/stimulation).

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):

• Ground Truth Type: For the non-clinical tests, the "ground truth" would be established by:
  • Engineering Specifications: For bench testing of loop radius control, sweep/curl positioning, and electrical characteristics.
  • Physiological Measurements/Observation: In animal studies, to ensure the catheter can record intracardiac signals and provide cardiac stimulation as intended, and to assess biocompatibility and safety.
  • Compliance with Standards: Meeting the requirements outlined in FDA Guidance and ISO 10555-1.

8. The Sample Size for the Training Set:

• Sample Size for Training Set: Not applicable. As this is a physical medical device and not an AI/machine learning model, there is no "training set."

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

• Ground Truth for Training Set Establishment: Not applicable. There is no training set for this device.

Summary of Study and Device Performance:

The study described for the Reflexion Spiral™ Variable Radius Catheter is a non-clinical study primarily consisting of:

• Bench Testing: To evaluate functional performance aspects like loop radius control and sweep/curl positioning, comparing them to the predicate device.
• Animal Data: Likely to assess in-vivo performance, safety, and biocompatibility.

The purpose of these studies was to demonstrate substantial equivalence to a currently marketed predicate device (Irvine Biomedical, Inc., (IBI) Inquiry™ Optima™ Steerable Electrophysiology Catheter K042775) and conformance to relevant industry standards (FDA Guidance and ISO 10555-1). The document asserts that the device achieves functional equivalence to the predicate and does not introduce new safety or effectiveness concerns, thereby meeting the requirements for 510(k) clearance by the FDA.

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