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

The Reprocessed Dynamic Tip 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 describes a 510(k) premarket notification for a reprocessed medical device, specifically, Reprocessed Dynamic Tip Steerable Diagnostic Electrophysiology Catheters. The core of a 510(k) submission is to demonstrate that the new device is substantially equivalent to a legally marketed predicate device. This typically involves showing that the device has the same intended use and similar technological characteristics, or that any differences do not raise new questions of safety and effectiveness.

For a reprocessed device, the substantiation often focuses on demonstrating that the reprocessing does not compromise the device's safety and effectiveness compared to new devices or already reprocessed predicate devices. The "study" mentioned in this context is a series of bench and laboratory tests rather than a clinical study.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria with corresponding performance metrics like a standalone AI performance evaluation would. Instead, it lists the types of testing performed to demonstrate that the reprocessed devices are "as safe and effective as the predicate devices." The "reported device performance" is essentially that the device passed these tests, implying they met internal or established industry standards for reprocessed devices.

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

The document does not specify the exact sample sizes used for each of the listed functional and safety tests (e.g., how many reprocessed catheters were tested for biocompatibility, cleaning, or functional checks). It only states that "Bench and laboratory testing was conducted."

• Sample Size for Test Set: Not explicitly stated in the provided document.
• Data Provenance: The testing was conducted in a laboratory setting by Innovative Health, LLC. The data is thus prospective, generated specifically for this submission. The "country of origin" would be the US, where Innovative Health is located.

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

This type of information is typically relevant for studies involving human interpretation or clinical endpoints, such as medical imaging AI. For this reprocessed device, the "ground truth" is established through engineering and laboratory standards.

• No "experts" in the sense of clinical reviewers (e.g., radiologists) were used to establish a ground truth for a test set. The ground truth for functional and safety testing is based on established engineering specifications, material science, and regulatory standards for medical devices and reprocessing. The "observers" would be the engineers and technicians performing the tests.

4. Adjudication Method for the Test Set

Not applicable in this context. Adjudication methods (like 2+1, 3+1) are used to resolve disagreements among human reviewers when establishing a clinical ground truth. For bench and laboratory testing, results are typically objective measurements against predefined specifications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Improvement with AI vs. Without AI Assistance

Not applicable. This is not an AI-assisted diagnostic or therapeutic device. It is a reprocessed electrophysiology catheter.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable. This is not an algorithm, but a physical medical device.

7. The Type of Ground Truth Used

The "ground truth" for this reprocessed device's performance is based on engineering specifications, material safety standards, and established regulatory requirements for medical device reprocessing. This includes demonstrating:

• That the device is biocompatible after reprocessing.
• That it can be effectively cleaned and sterilized.
• That its functional and mechanical characteristics (e.g., electrical continuity, steerability, dimensions) remain within acceptable limits, comparable to the original new device specification or predicate device.
• That electrical safety is maintained.

8. The Sample Size for the Training Set

Not applicable. There is no training set in the context of a reprocessed medical device's physical and functional testing. Training sets are relevant for machine learning algorithms.

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

Not applicable for the same reason as above.

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Bard Electrophysiology's fixed curve diagnostic electrode catheters are intended for temporary intracardiac sensing, recording, stimulation and temporary pacing during the evaluation of cardiac arrhythmias.

The Viking Diagnostic Electrode Catheter is a closed lumen, nonsteerable device. Typical of electrode recording catheters currently sold, the Viking catheter will be offered in 6F diameter with 2-10 electrodes with a variety of inter-electrode spacings and curve styles.

Here's an analysis of the provided 510(k) summary regarding the Viking Diagnostic Electrode Catheter, structured according to your request:

Acceptance Criteria and Device Performance for the Viking Diagnostic Electrode Catheter

The 510(k) summary for the Viking Diagnostic Electrode Catheter indicates that its acceptance criteria were established based on the "Electrode Recording Catheter Preliminary Guidance, Data to be Submitted to the Food and Drug Administration in Support of Premarket Notifications" (March, 1995 Draft Version). The study demonstrating the device meets these criteria involved comprehensive bench testing and biocompatibility assessments.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for the Test Set and Data Provenance

• Sample Size for Test Set: The document does not specify a numerical sample size for the test set of Viking Diagnostic Electrode Catheters or the predicate devices used for comparative testing. It refers generally to "the Viking catheter" and "the Cordis Webster catheter and/or a Bard Woven electrode catheter."
• Data Provenance: The data appears to be from prospective bench testing conducted specifically for this 510(k) submission. There is no mention of retrospective data, clinical trials, or country of origin for patient data. This is a pre-market submission, so it relies on engineering and laboratory testing.

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

• Number of Experts: Not applicable. This submission relies on objective engineering and performance testing data, not subjective expert judgment, to establish "ground truth."
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. The "ground truth" for the performance testing was objective measurements against predetermined standards and comparisons to predicate devices. There wouldn't be an adjudication process in the sense of reconciling divergent expert opinions.

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

• MRMC Study Done: No. This submission is for a medical device (electrode catheter) that performs physical measurements and functions, not for an AI diagnostic tool that requires human interpretation of outputs. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant or described.
• Effect Size of Human Readers Improvement with AI vs. Without AI Assistance: Not applicable.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Standalone Study Done: Yes, in a sense. The entirely of the performance testing described is "standalone" in that it evaluates the physical characteristics and functional performance of the catheter itself in a laboratory setting, without human intervention in its diagnostic output interpretation for a patient. The "algorithm" here would be the physical design and manufacturing of the catheter, and its performance was assessed independently.

7. Type of Ground Truth Used

• Type of Ground Truth: The ground truth used for performance evaluation was based on objective engineering specifications, established performance standards for electrode recording catheters (from the 1995 FDA guidance), and comparative performance results against legally marketed predicate devices. For biocompatibility, the ground truth was meeting established biocompatibility standards.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. Training sets are relevant for machine learning or AI models. This submission describes a physical medical device. The "training" in this context would be the design and development iterations of the catheter, which are not quantified as a "training set."

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

• How Ground Truth for Training Set Was Established: Not applicable. As mentioned above, there isn't a "training set" in the context of an AI algorithm. The device's design and engineering would have been informed by existing knowledge of cardiac electrophysiology, material science, and the performance characteristics of previous catheters, but this isn't "ground truth" derived for a training dataset.

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