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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 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 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 Khelix Diagnostic Electrophysiology Catheters are indicated for the electrical recording of endocardial structures. The loop versions of the catheters are intended for obtaining and recording electrograms from the atrial region of the heart.

Khelix Diagnostic Electrophysiology Catheters are a range of electrophysiology diagnostic cardiac catheters designed to facilitate electrophysiological mapping of the heart. The devices are intended for the electrical recording and/or stimulation of endocardial structures. The device consists of a catheter handle and catheter shaft containing an array of platinum-iridium electrodes for stimulation and recording. The subject device comes in a variety of models based on the distal catheter configuration including Steerable and Loop models. The device interfaces with standard electrophysiological recording equipment, such as ECG monitoring equipment, impedance based navigational equipment and cardiac stimulation equipment, via the Khelix Diagnostic Extension Cable (supplied separately). The device is available in different device models with several variants according to electrode configurations, curve types and loop diameters, as applicable. The subject catheters use 4 to 20 electrodes with variable spacing to provide for variation in physician preference. The catheter is intended to be used with the Khelix Diagnostic Extension Cable. The extension cable connects distally to the catheter (sterile field) and proximally to standard electrophysiology (EP) laboratory equipment such as heart signal monitors/records and stimulators (non-sterile field) via shielded tip pins. The Khelix Diagnostic Electrophysiology Catheter range is supplied sterile. The devices are sterilized using an ethylene oxide (EtO) sterilization process.

This K211327 510(k) summary is for a diagnostic electrophysiology catheter. As such, the acceptance criteria and study that proves the device meets the criteria are typically bench and laboratory tests rather than clinical studies requiring human-in-the-loop performance, expert consensus, or complex ground truth establishment like pathology or outcomes data. The document confirms this expectation.

Here's a breakdown of the information requested, based on the provided text:

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

The provided document doesn't detail specific quantitative acceptance criteria values beyond "Pass" for each test. It lists the tests performed and their methodologies.

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

The document does not specify the sample sizes used for each of the bench and laboratory tests. It states that "Bench and laboratory testing was conducted." The data provenance is derived from the manufacturer's own internal testing. The manufacturer is CathRx Ltd, located in Rydalmere NSW 2116, Australia, implying the testing was conducted in Australia. The testing is retrospective as it was done to support the 510(k) submission.

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

This type of testing (bench and laboratory) does not typically involve human experts establishing ground truth in the same way clinical studies do. The "ground truth" for these tests is established by adherence to recognized international and industry standards (e.g., ISO, ASTM, IEC). The expertise lies in the engineers, technicians, and quality professionals who conduct these tests and interpret the results against the defined standards. The document does not specify the number or qualifications of these individuals.

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

Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving interpretation of medical images or data by multiple readers. Since this device's performance was evaluated through bench and laboratory testing against established engineering and safety standards, no such adjudication method was employed.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No MRMC comparative effectiveness study was conducted. This device is an electrophysiology catheter, not an AI-assisted diagnostic tool for image interpretation. Therefore, the concept of human readers improving with AI assistance is not applicable to the scope of this 510(k) submission.

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

This refers to the performance of an algorithm without human intervention, usually in the context of AI/ML devices. Since the Khelix Diagnostic Electrophysiology Catheters are physical medical devices for electrical recording and stimulation, and not a software algorithm, this concept is not applicable. The device's "standalone" performance is assessed through its physical, electrical, and functional characteristics validated by the bench and laboratory tests.

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

The ground truth for these bench and laboratory tests is based on engineering specifications and established international/industry standards. For example:

• Sterilization: Defined by ISO 11135 (SAL of 10^-6).
• Biocompatibility: Defined by ISO 10993 and ASTM 756.
• Electrical Safety: Defined by IEC 60601 series.
• Functional Performance: Defined by ISO 10555-1 and internal workmanship standards.

There is no "expert consensus" on individual cases, pathology, or outcomes data used as ground truth for this type of device submission.

8. The sample size for the training set

This device does not involve a "training set" as it is not an AI/ML device that requires machine learning model training. Its design and manufacturing are based on established engineering principles.

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

As there is no training set for this device, the concept of establishing ground truth for it is not applicable.

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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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The Reprocessed Achieve Advance Mapping Diagnostic Electrophysiology Catheter is indicated for multiple electrode electrophysiological mapping of the cardiac structures of the heart, i.e. recording or stimulation only. The catheter is designed to obtain electrograms in the atrial regions of the heart.

The Reprocessed Achieve Advance Mapping Diagnostic Electrophysiology Catheter is an intra-cardiac electrophysiology (EP) recording catheter and can be used for cardiac stimulation during electrophysiology studies. The distal mapping section of the mapping catheter is a circular loop with eight or ten evenly spaced electrodes to map electrical conduction between the left atrium and the pulmonary veins.

The reprocessed mapping catheter is compatible for use with, and may be used to support and position, all catheters in the Medtronic Arctic Front CryoAblation Catheter family. Refer to the applicable Medtronic Arctic Front Technical Manual for additional instructions for use.

The reprocessed mapping catheter should only be used with the Medtronic catheter connecting cable (Model 2ACHC), which interfaces with standard electrophysiology recording equipment. For cable instructions, see the Medtronic 2ACHC catheter connecting cable instructions for use.

Only the catheter is the subject of this submission. Any other related equipment is not included in the scope of this submission.

I am sorry, but the provided text does not contain the information required to answer your request regarding the acceptance criteria and study details for an AI-powered medical device. The document is an FDA 510(k) clearance letter for a reprocessed diagnostic electrophysiology catheter, not an AI device.

Therefore, I cannot provide:

1. A table of acceptance criteria and reported device performance.
2. Sample size and data provenance for a test set.
3. Number and qualifications of experts for ground truth.
4. Adjudication method for the test set.
5. Information on a multi-reader, multi-case (MRMC) comparative effectiveness study or human reader improvement with AI.
6. Information on standalone algorithm performance.
7. The type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

This document focuses on the substantial equivalence of a reprocessed medical device to its predicate, primarily through bench and laboratory testing demonstrating functional, safety, and sterilization aspects. It does not involve AI or machine learning performance evaluations.

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

The Reprocessed Reflexion Spiral Bi-Directional Variable Radius Electrophysiology Mapping Catheter (hereinafter Reflexion Spiral catheter) is a flexible, bi-directional, variable radius loop electrophysiology catheter constructed of a polymer shaft that incorporates platinum electrodes. The Reflexion Spiral catheter has a loop and a proximal handle that contains a shaft actuator mechanism for varying the bi-directional (90°/180° minimum) distal portion of the shaft, a loop actuator mechanism for varying the loop diameter from approximately 25 mm to approximately 15 mm, and an electrical connector.

This document describes the validation of a reprocessed medical device, specifically the "Reprocessed Reflexion Spiral Bi-Directional Variable Radius Electrophysiology Catheter" (K191170). The acceptance criteria and the study proving the device meets these criteria are based on comparing the reprocessed device to its predicate devices through a series of functional and safety tests.

It's important to note that this is a 510(k) submission for a reprocessed device, not a novel AI/software medical device. Therefore, the concepts of "AI assistance," "human readers," "ground truth establishment by experts," "multi-reader multi-case (MRMC) studies," and "training/test sets with specific sample sizes for AI models" are not applicable in their conventional sense. The "study" here is a series of bench and laboratory tests demonstrating that the reprocessed device performs comparably and safely to the original, legally marketed predicate devices.

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

The acceptance criteria for this reprocessed device are based on demonstrating that its performance is equivalent to the predicate devices and that it meets safety standards after reprocessing. The reported device performance aims to show this equivalence.

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

The document does not specify exact sample sizes for each specific test (e.g., how many catheters were subjected to each functional test). However, the overall approach of a 510(k) for reprocessed single-use devices involves rigorous testing on a statistically relevant number of reprocessed units to ensure consistency and equivalence.

• Sample Size: Not explicitly stated as a number (e.g., 100 devices). Instead, it states "Bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness) of Reprocessed Reflexion Spiral catheter." This implies a sufficient sample size was tested to establish the required equivalence and safety.
• Data Provenance: The testing was conducted by Innovative Health, LLC. The testing is assumed to be prospective as it's part of the premarket notification process for a specific reprocessed device iteration. The testing would have occurred in a controlled laboratory/bench setting in the USA (where Innovative Health is located).

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

This concept is not directly applicable to a reprocessed medical device's performance validation in the way it applies to an AI/software device. The "ground truth" here is the established performance and safety profile of the original, legally marketed predicate device.

• "Experts": The "experts" are the engineers, scientists, and quality assurance personnel at Innovative Health who conducted and validated the tests, and implicitly, the FDA reviewers who assessed the submission. Their qualifications would include expertise in medical device testing, reprocessing, materials science, electrical engineering, etc.
• Establishment of "Ground Truth": The "ground truth" (i.e., acceptable performance) for the reprocessed device is its ability to meet or exceed the performance and safety characteristics of the predicate device, as demonstrated through the specified functional and safety tests. There isn't a "consensus" of external clinical experts on images or data; rather, it's a technical demonstration of equivalence.

4. Adjudication method for the test set

Not applicable in the context of an AI/software device's test set. The "adjudication" is essentially the detailed review and approval process by the FDA, based on the submitted test data.

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 device is an electrophysiology catheter, not an AI software intended to assist human readers (e.g., radiologists interpreting images).

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

Not applicable. This is a physical, reprocessed medical device, not a standalone algorithm. Its performance is inherent to the device itself.

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

The "ground truth" is primarily based on the established performance specifications and safety profiles of the predicate devices. This is demonstrated through:

• Bench Testing Data: Direct measurements of physical, electrical, and mechanical properties.
• Laboratory Testing Data: Validation of cleaning, sterilization, and biocompatibility processes.
• "Simulated Use" Data: Performance under controlled, simulated clinical conditions.

There is no "expert consensus" on clinical interpretations or "pathology/outcomes data" being used as ground truth for this type of device's 510(k) clearance in the way it would be for a diagnostic AI.

8. The sample size for the training set

Not applicable. This is a reprocessed physical device, not an AI model requiring a training set.

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

Not applicable. This is a reprocessed physical device, not an AI model.

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

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

The provided document is a 510(k) premarket notification letter and summary for a Reprocessed Livewire Steerable Diagnostic Electrophysiology Catheter. This document describes the device's technical characteristics, predicate devices, and the testing performed to demonstrate its safety and effectiveness.

Crucially, this document pertains to a medical device that is reprocessed (reused after cleaning and sterilization), not an AI/ML-enabled medical device. Therefore, the information requested in your prompt regarding acceptance criteria, study methodologies (e.g., MRMC studies, standalone AI performance), ground truth establishment, expert adjudication, and sample sizes for AI training/test sets is not applicable to this specific document.

The document focuses on demonstrating substantial equivalence to a predicate device through:

• Technological Characteristics: Stating that the reprocessed device has identical purpose, design, materials, function, and intended use as the predicate devices, with no changes to claims, clinical applications, patient population, performance specifications, or method of operation.
• Functional and Safety Testing: A list of bench and laboratory tests performed, including biocompatibility, cleaning validation, sterilization validation, functional testing (visual inspection, dimensional verification, electrical continuity and resistance, simulated use, mechanical characteristics), electrical safety testing (dielectric and current leakage), and packaging validation.

Since this is not an AI/ML device, I cannot fill in the requested table and study information as it's designed for AI/ML performance evaluation. The "acceptance criteria" for this device would be its ability to meet the performance and safety standards of the predicate device after reprocessing, as demonstrated by the functional and safety testing listed.

In summary, based on the provided text, I cannot describe acceptance criteria and study proving device meets acceptance criteria related to AI/ML performance, because the document is about a reprocessed medical catheter, not an AI/ML device.

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The Diagnostic Fixed Electrophysiology Catheter and Diagnostic Electrophysiology Cable are intended for electrogram recording and pacing during diagnostic electrophysiology studies.

The Diagnostic Fixed Electrophysiology Catheter is a sterile, single-use 2F diagnostic catheter with multiple electrodes and a fixed distal curve. The catheter is intended to be placed in the heart percutaneously for the purpose of temporary cardiac pacing and electrophysiology studies of the heart, such as the coronary sinus and atrioventricular annulus. The catheter is connected to separately cleared diagnostic electrophysiology equipment via an accessory, the Diagnostic Electrophysiology Cable. The cable is supplied sterile and is reusable.

The provided document is a 510(k) summary for a medical device (Diagnostic Fixed Electrophysiology Catheter and Diagnostic Electrophysiology Cable) and primarily focuses on proving substantial equivalence to a predicate device. It does not contain the kind of detailed information about acceptance criteria, specific performance metrics, sample sizes for test/training sets, expert qualifications, or adjudication methods that would be relevant for an AI-powered diagnostic device's performance study.

The performance testing section (page 5) lists various non-clinical verifications and validations (Biocompatibility, Mechanical, Electrical, Bench, Cleaning/Re-Sterilization, Reuse, Animal Studies, Packaging). These are standard tests for the safety and functionality of an electrophysiology catheter and cable, not for evaluating the diagnostic accuracy of an AI algorithm.

Therefore, I cannot extract the requested information regarding acceptance criteria and performance study details for an AI device from this document. The document confirms that "The Diagnostic Fixed Electrophysiology Catheter and accessory cable met all requirements as specified by the test protocols," but these protocols are about device safety and fundamental physical/electrical performance, not diagnostic accuracy of an AI.

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