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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.

Device Description

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.

AI/ML Overview

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

Acceptance Criteria Category	Specific Criteria (Inferred from Text)	Reported Device Performance
Functional Equivalence	Indication Statements	"The uses of these devices are the same...for electrophysiological mapping of cardiac structures."
	Technological Characteristics (Design, Materials)	"The only technological difference is in electrode width," which was "within the range of those of the predicate devices." "Differences in materials are minor, such as the use of different colorants."
Bench Testing	All required characteristics of electrode recording catheters	"The Viking catheter was found to meet all testing acceptance criteria."
	Comparative performance with predicate devices	"Equivalent to, better than, or between the performances of the Cordis Webster and Bard Woven electrode catheters."
Biocompatibility	General biocompatibility requirements	"The Viking catheter passed all tests of biocompatibility."
Clinical Acceptability	Overall safety and performance	"Determined to be clinically acceptable in every case."

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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