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

The Orbiter ST extension cable is indicated for use during electrophysiology studies in conjunction with the appropriate electrode catheter. This cable may be reused subject to the cleaning and sterilization restrictions herein.

The Orbiter ST Diagnostic Electrode Catheter is a closed lumen, steerable device. Typical of electrode recording catheters currently sold, the Orbiter ST catheter will be offered in 7F diameter with 2-20 electrodes with a variety of inter-electrode spacings and curve styles.

An accessory to the Orbiter ST Diagnostic Electrode Catheter, the Orbiter ST Extension Cable will be sold separately.

The provided K992373 document is a 510(k) summary for the Orbiter ST Diagnostic Electrode Catheter and Orbiter ST Extension Cable. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving novel effectiveness. Therefore, the document primarily discusses performance testing against specified requirements rather than a clinical study comparing device performance against a gold standard or human readers.

Here's an analysis of the provided information, framed by your request, and identifying where the document does not contain the requested details:

Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

The document states that the Orbiter ST catheter underwent "performance testing" to demonstrate its safety and effectiveness, and that it met all testing acceptance criteria. However, the specific quantitative acceptance criteria for each test are not detailed in this summary document. The document refers to "Appendix 2" for detailed protocols and results, which is not provided.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The specific quantitative acceptance criteria and detailed performance results are not present in the provided 510(k) summary. These would typically be found in the appendices (Appendix 2, for performance testing). The document only states that the device "meets the requirements of the specified performance testing" and "was found to meet all testing acceptance criteria and was therefore acceptable."

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

• Sample Size for Test Set: Not specified in the provided summary. The summary refers to "in vitro bench testing" and "performance testing" but does not give the number of devices or units tested.
• Data Provenance: The testing was "in vitro bench testing," meaning it was conducted in a laboratory setting. The country of origin for the testing itself is not explicitly stated, but the submitter (C.R. Bard, Inc.) is based in Massachusetts, USA. The data is prospective, meaning the tests were performed specifically for this submission.

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

This information is not applicable to this type of submission or the reported testing. The "ground truth" for in vitro bench testing is typically based on established engineering principles, regulatory standards, and material science, rather than expert clinical consensus. For example, a test for tensile strength would compare the device's performance against a pre-defined strength requirement, not against an expert's opinion.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods (like 2+1, 3+1) are used to resolve discrepancies in expert ground truth establishment, which is not the nature of the reported in-vitro performance testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This 510(k) submission is for a medical device (electrode catheter) and its accessory, not for an AI or diagnostic imaging algorithm that requires human interpretation. Therefore, a study to assess the improvement of human readers with AI assistance is irrelevant and was not performed.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone algorithm performance study was not done. This device is a physical electrode catheter and an extension cable, not a software algorithm.

7. The Type of Ground Truth Used

For the reported performance and biocompatibility testing, the "ground truth" was based on:

• Established Scientific Methods and Standards: The document states that "Tests were chosen and developed based on the 1995 Draft Guidance and through previous experience with the Viking catheter 510(k)." This implies that the 'ground truth' for whether the device performed adequately was defined by these regulatory guidelines and historical performance benchmarks for similar devices.
• Biocompatibility Standards: The biocompatibility testing results demonstrated that the materials are "nontoxic and biocompatible," which refers to compliance with recognized biological safety standards.
• Engineering Specifications: Implicitly, the performance tests would have measured various physical and electrical properties against pre-defined engineering specifications and safety margins.

8. The Sample Size for the Training Set

Not applicable. This device is a hardware medical device, not a machine learning algorithm, so there is no "training set."

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

Not applicable. As there is no training set for a machine learning algorithm, there is no ground truth to be established for it.

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