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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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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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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 Reprocessed Webster Duo-Decapolar Diagnostic EP Catheter is indicated for electrophysiological mapping of cardiac structures, i.e. stimulation and recording only. In addition, the Webster Duo-Decapolar catheter is designed to facilitate electrogram mapping in the atrial reqion of the heart and the coronary sinus.

The Reprocessed Webster Duo-Decapolar Diagnostic Electrophysiology (EP) Catheter has been designed for electrophysiological mapping of heart. The catheters have a hightorque shaft with a deflectable tip section containing an array of platinum electrodes that can be used for stimulation and recording.

The 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 thumbknob, the tip is deflected (curved). When the piston is pulled back, the tip straightens. The high-torque shaft allows the plan of the curved tip to be rotated to facilitate accurate positioning of the catheter tip at the desired site.

The provided text describes a 510(k) premarket notification for a Reprocessed Webster Duo-Decapolar Diagnostic EP Catheter. This submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving novel performance against clinical acceptance criteria with a study designed to evaluate such. As such, the information typically found in a clinical study report regarding acceptance criteria and performance against those criteria (especially for AI/software devices) is not present in this document.

Here's an analysis based on the document:

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

This document does not contain a table of acceptance criteria and reported device performance in the context of clinical efficacy or diagnostic accuracy. The testing described is primarily for functional and safety testing to demonstrate that the reprocessed device performs comparably to the original device.

The "acceptance criteria" here are implied by the battery of tests performed to ensure the reprocessed device is safe and effective and functions like the new device. These include:

• Biocompatibility: The reprocessed device must be biocompatible.
• Cleaning Validation: The cleaning process must effectively remove contaminants.
• Sterilization Validation: The sterilization process must render the device sterile.
• Functional Testing:
  • Visual Inspection: Device appearance must meet specifications.
  • Dimensional Verification: Dimensions must be within specified tolerances.
  • Electrical Continuity and Resistance: Electrical properties must be within specifications.
  • Simulated Use: The device must perform as expected under simulated use conditions.
  • Mechanical Characteristics: Mechanical properties (e.g., tip deflection) must be maintained.
• Electrical Safety Testing:
  • Dielectric and Current Leakage: Electrical safety must be within acceptable limits.
• Packaging Validation: Packaging must maintain device integrity and sterility.

The document states, "Bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness) of the Reprocessed Webster Duo-Decapolar Diagnostic EP Catheters." It then lists the above tests, implying that the device "met" the unstated acceptance criteria for each of these tests to conclude that it is "as safe and effective as the predicate devices."

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

The document does not detail the sample sizes for the functional and safety tests. Studies for reprocessed medical devices typically involve testing a representative sample size of reprocessed units. No information on data provenance (e.g., country of origin, retrospective/prospective) is provided, as these are lab-based performance tests, not clinical studies with patient data.

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

This information is not applicable and not provided. The testing described is laboratory-based mechanical, electrical, and material testing, not human-interpretation-based evaluation requiring expert ground truth establishment.

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

This is not applicable and not provided. Adjudication methods are relevant for studies involving human interpretation or clinical outcomes, which are not described here.

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 and no such study was done. This device is a reprocessed electrophysiology catheter, not an AI or software device.

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

This is not applicable as the device is not an algorithm or software.

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

The "ground truth" for the performance claims of this reprocessed device is the established performance specifications and accepted safety and efficacy profiles of the original, new Webster Duo-Decapolar Diagnostic EP Catheter (K101991), and the performance standards for the specific functional and safety tests (e.g., electrical resistance limits, sterilisation assurance levels, biocompatibility standards). The reprocessed device is deemed safe and effective if it meets these engineering and performance standards, thereby being substantially equivalent.

8. The sample size for the training set:

This is not applicable. There is no training set mentioned as this is not an AI/machine learning device.

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

This is not applicable. There is no training set.

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The cable is designed for use only with the Medronic Achieve family of mapping catheters. It is intended to provide the connection of the catheter to a standard ECG interface box.

The Medline ReNewal Reprocessed Medtronic Achieve Catheter Connecting Cable is licensed for single use only. It connects the catheter and console to provide a path of electrical transmission from the proximal end of an Achieve mapping catheter to standard shielded ECG pins that connect to standard EP pacing and recording equipment. The cable is designed to only be used with the Medtronic Achieve family of mapping catheters

The provided text describes a 510(k) premarket notification for a reprocessed medical device, the "Medline ReNewal Reprocessed Medtronic Achieve Catheter Connecting Cable (2ACHC)". It is fundamentally a comparison to a predicate device, arguing for substantial equivalence through non-clinical testing.

However, the information provided does not contain details about acceptance criteria or a study proving device performance against such criteria in the context of an AI/algorithm-driven medical device.

The document is a regulatory approval letter and a 510(k) summary for a reprocessed physical medical device (a cable), not an AI/software as a medical device (SaMD). Therefore, it does not include:

• Acceptance criteria for an AI/algorithm's performance (e.g., sensitivity, specificity, AUC).
• Details about a test set (sample size, provenance).
• Information on expert ground truth establishment (number of experts, qualifications, adjudication methods).
• Any multi-reader multi-case (MRMC) comparative effectiveness study.
• Stand-alone algorithm performance.
• Ground truth type for AI/algorithm evaluation.
• Training set details for an AI model.

The "Non-clinical Testing Summary" section describes the tests performed for this reprocessed physical device:

• Functional performance: simulated use and artificial soiling; visual inspection; continuity, isolation and resistance device functionality; Electrical Safety current leakage and hipot
• Cleaning Validation
• Sterilization Validation bioburden testing
• Packaging and shelf life validation
• Product stability

These are standard engineering and safety tests for a physical medical device, not performance evaluations for an AI/software.

Therefore, based on the provided text, it is not possible to answer the detailed questions about acceptance criteria and study design for an AI/algorithm-driven medical device. The document simply isn't about that kind of device.

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The Medline ReNewal Reprocessed St. Jude Medical Livewire Steerable Electrophysiology Catheter can be used in the evaluation of a variety of cardiac arrhythmias from endocardial and intravascular sites.

The Medline ReNewal Reprocessed St. Jude Medical Livewire Steerable Electrophysiology Catheter is a flexible electrode catheter constructed of a polyurethane insulation/shaft and incorporates platinum electrodes. The active tip may be manipulated by a remote means located at the proximal end of the catheter.

Here's an analysis of the provided text, focusing on the acceptance criteria and the study proving the device meets them:

Disclaimer: The provided text is a 510(k) summary for a reprocessed medical device. These summaries typically focus on demonstrating substantial equivalence to a predicate device through non-clinical testing rather than conducting new clinical trials for effectiveness in the way an AI/ML algorithm might. Therefore, many of the requested points related to AI/ML clinical studies (e.g., MRMC studies, ground truth establishment for training sets) are not directly applicable or explicitly stated in this type of document. I will address the points as best as possible given the information provided.

Device: Medline ReNewal Reprocessed St. Jude Medical Livewire Steerable Electrophysiology Catheter

The document demonstrates that the reprocessed device is substantially equivalent to the predicate device, St. Jude Medical MediGuide Enabled Livewire Steerable Electrophysiology Catheter (K151622). The acceptance criteria are primarily defined by successful completion of various non-clinical performance, safety, and reprocessing validation tests, ensuring the reprocessed device maintains the same technological characteristics and performance as the original predicate device.

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not explicitly state the specific sample sizes for each non-clinical test. It lists the types of tests performed. For reprocessed devices, the "test set" would typically involve multiple units of the reprocessed devices subjected to each of the listed functional, cleaning, biocompatibility, and sterilization tests.

• Sample Size: Not explicitly stated for each test. It would be an industry standard sample size for each specific test (e.g., a certain number of devices for tensile strength, a certain number for biocompatibility assays).
• Data Provenance: Retrospective (reprocessed existing devices from St. Jude Medical) and prospective (testing performed on these reprocessed devices). The "country of origin of the data" is not specified, but the submission is to the U.S. FDA, implying compliance with U.S. regulatory standards and potentially testing done within the U.S. or by labs recognized by U.S. standards.

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

This point is not applicable here. This submission is for a reprocessed electrophysiology catheter, which is a hardware device, not an AI/ML diagnostic or image analysis algorithm. Therefore, there is no "ground truth" in the clinical AI sense (e.g., expert labels on images) to be established by experts for an AI test set. The "ground truth" for this device is based on physical and biological testing against established engineering and safety standards.

4. Adjudication Method for the Test Set:

Not applicable in the context of an AI/ML algorithm's clinical performance. The "adjudication" for this type of device is the assessment of test results against predefined acceptance criteria (e.g., pass/fail for functional tests, within limits for chemical residuals, absence of adverse effects for biocompatibility).

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 medical device, not an AI-assisted diagnostic tool. No MRMC study was performed as it is irrelevant to the substantial equivalence of a physical catheter.

6. 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.

7. The Type of Ground Truth Used:

The "ground truth" for this device's performance relies on a combination of:

• Engineering Specifications: Performance parameters (e.g., tensile strength, electrical properties) are measured against established engineering standards and the specifications of the original predicate device.
• Biological/Chemical Standards: Residual limits for cleaning agents, sterility assurance levels, and biocompatibility endpoints are evaluated against recognized biological and chemical safety standards (e.g., ISO standards for biocompatibility).
• Predicate Device Performance: The original, new St. Jude Medical Livewire catheter establishes the benchmark for "ground truth" performance and safety, to which the reprocessed device must demonstrate substantial equivalence.

8. The Sample Size for the Training Set:

Not applicable. This is a medical device, not an AI/ML algorithm. There is no concept of a "training set" in the context of this 510(k) submission.

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

Not applicable, as there is no training set for a physical medical device.

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The reprocessed cable provides an electrical connection between the IntellaMap Orion Mapping Catheter and the Signal Station of the Rhythmia Mapping System. The reprocessed Umbilical Cable is intended to be used with an Orion Mapping Catheter during electrophysiology procedures, electroanatomical mapping, intracardiac stimulation (pacing) and/or recording of electrical potentials.

The reprocessed umbilical cable is an insulated, multi-conductor cable that us 200 cm (6.6 ft) in length with multi-pin connectors at each end.

The provided document is a 510(k) summary for a Reprocessed Umbilical Cable, not an AI/medical imaging device. As such, it does not contain the information required to answer the prompt, which is specifically looking for details about the acceptance criteria and study proving performance for an AI device.

The document describes the reprocessing of a physical medical cable and includes information on:

• The device description and its intended use (providing an electrical connection between a mapping catheter and a signal station).
• Bench and laboratory testing performed for safety and effectiveness, such as cleaning validation, sterilization validation, visual inspection, dimensional verification, electrical continuity testing, HiPOT testing, and packaging validation.
• The reprocessed cable's substantial equivalence to a predicate device.

It does not contain any information about:

• Acceptance criteria related to AI performance metrics (e.g., sensitivity, specificity, AUC).
• Sample sizes for test sets or training sets for an algorithm.
• Data provenance for AI training/testing data.
• Expert involvement in establishing ground truth for AI.
• Adjudication methods for AI ground truth.
• MRMC studies or human reader improvement with AI assistance.
• Standalone algorithm performance.
• Ground truth types like pathology or outcomes data for AI.

Therefore, I cannot fulfill the request as the source document does not pertain to an AI device.

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The Reprocessed Dynamic Tip and Dynamic XT Steerable Diagnostic EP Catheters are intended for temporary intracardiac sensing, recording, stimulation and temporary pacing during the evaluation of cardiac arrhythmias.

The Reprocessed Dynamic Tip and Dynamic XT Steerable Diagnostic Electrophysiology (EP) Catheters are radiopaque, flexible, insulated catheters with a polymer shaft. The catheters have a plunger mechanism, which, when moved forward or back, results in curvature of the distal tip.

The provided text does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria. The document is a 510(k) premarket notification clearance letter from the FDA for reprocessed electrophysiology catheters. It focuses on demonstrating substantial equivalence to predicate devices rather than proving specific performance metrics through a study with acceptance criteria.

The "Functional and Safety Testing" section (page 5-6) lists the types of tests conducted (e.g., Biocompatibility, Cleaning Validation, Functional Testing, Electrical Safety Testing, Shelf-life Validation), but it does not provide:

• A table of acceptance criteria and reported device performance.
• Details about sample sizes, data provenance, ground truth establishment, or expert involvement for any specific performance study.
• Information on MRMC comparative effectiveness studies or standalone algorithm performance.

Therefore, I cannot fulfill your request for that specific information based on the text provided.

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