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The Reprocessed Electrophysiology Diagnostic Catheters are intended for temporary use during electrophysiology studies for intracardiac sensing, recording, stimulation and temporary pacing during the evaluation of cardiac arrhythmias; and for electrophysiologic mapping of cardiac structures during these evaluations.

The device consists of a reprocessed catheter that has a high-torque shaft with a handle at the proximal end, and may or may not be steerable. These catheters have an outer diameter of 4F to 8F, a length ranging from 60 to 160 cm, with 2-20 platinum, radiopaque electrodes along the tip shaft and a variety of inter-electrode spacings and curve styles at the tip. The tip generally is deflectable. Specific cables, as recommended by the original manufacturer, connect to the handle and interface between the catheter and an external stimulator and/or an electrophysiologic recorder. It should be noted that this submission pertains to the catheter only. It does not include any other components in a system such as, connector cables, external stimulators, or electrophysiologic recorders.

This is not an AI/ML device, and therefore the criteria listed in parts 1-9 do not apply. This is a reprocessed medical device (electrophysiology diagnostic catheters) that functions identically to original manufacturer devices. The 510(k) summary focuses on demonstrating that the reprocessed device is substantially equivalent to predicate devices in terms of functional design, materials, indications for use, and construction.

Here's an analysis of the provided text, addressing the requested information where applicable for a non-AI/ML device:

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

For this reprocessed device, the "acceptance criteria" are essentially demonstrating substantial equivalence to the original, predicate devices. The performance is measured against these established characteristics rather than novel AI/ML metrics.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify a "test set" in the context of an AI/ML model. Instead, it refers to "Representative samples of reprocessed electrophysiology diagnostic catheters" used for design testing. The sample size is not quantified.

• Sample Size: Not specified beyond "Representative samples."
• Data Provenance: Not explicitly stated, however, the testing would be conducted internally by SterilMed, Inc. (Minneapolis, MN, USA) on their reprocessed devices. This would be prospective for the reprocessed devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable to this type of device. "Ground truth" in the context of this device would refer to the established performance characteristics and safety profiles of the original predicate devices, as well as the successful validation of reprocessing steps (cleaning, sterilization). These are typically established through engineering standards, clinical trials of the original devices, and scientific validation methods, not expert consensus on interpretations like in AI/ML.

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

Not applicable. Adjudication is a term relevant to resolving discrepancies in expert interpretations, typically in AI/ML or clinical trial settings where subjective assessment is involved. The testing described for this device (functional and safety) involves objective measurements and validation protocols.

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 not an AI-assisted diagnostic device, and therefore MRMC studies are irrelevant.

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

Not applicable. This is not an algorithm.

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

The "ground truth" for this reprocessed device is established by:

• Predicate Device Specifications: The known functional, material, and performance specifications of the original, legally marketed electrophysiology diagnostic catheters.
• Engineering Standards & Bench Testing: Objective measurements and tests (e.g., electrical conductivity, mechanical integrity, sterility assays) to ensure the reprocessed device meets these predefined specifications.
• Process Validation: Scientific evidence that the cleaning, sterilization, and packaging processes consistently achieve their intended outcomes without degrading the device.

8. The sample size for the training set

Not applicable. There is no "training set" as this is not an AI/ML device.

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

Not applicable. There is no "training set" for this device.

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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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