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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 PV Diagnostic Electrode Catheter is a closed lumen, steerable device. Typical of electrode recording catheters currently sold, the Orbiter PV catheter will be offered in 7.5F diameter (7F shaft with a 5F tip) with 1-24 electrodes with a variety of inter-electrode spacings. The distal curve is capable of forming a 360-degree loop.

The provided text describes a 510(k) premarket notification for the Orbiter PV Diagnostic Electrode Catheter. This type of regulatory submission primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than conducting a de novo clinical study with specific acceptance criteria and performance metrics typically seen for novel medical devices or AI-driven systems.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, and ground truth establishment is not explicitly present in the provided document, as it pertains to a regulatory clearance based on substantial equivalence to predicate devices, not a standalone performance study as would be required for a novel device or an AI/ML algorithm.

However, I can infer some aspects based on the nature of the submission:

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

• Acceptance Criteria: For a 510(k) submission, the primary "acceptance criterion" is demonstrating substantial equivalence to predicate devices in terms of intended use, technological characteristics, and safety and effectiveness. There are no specific quantitative performance metrics listed for the Orbiter PV itself in this summary that would typically be seen for AI/ML performance.
• Reported Device Performance: The document states that the Orbiter PV Diagnostic Electrode Catheter is "typical of electrode recording catheters currently sold" and will be offered with similar specifications (7.5F diameter, 1-24 electrodes, variety of inter-electrode spacings, 360-degree loop capability). This implies that its performance is expected to be comparable to these existing devices.

Since the submission is for substantial equivalence to predicate devices, a table like the one requested, with specific quantitative performance metrics and acceptance criteria, is not included in the provided text. The "performance data summary" section refers to technological characteristics and references predicate devices.

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

• Not applicable/Not provided: This information is typically for de novo studies evaluating a device's performance against specific endpoints. For a 510(k) based on substantial equivalence, a formal "test set" with a specified sample size for clinical validation is generally not required unless new clinical questions arise. The regulatory review focuses on whether the new device is as safe and effective as the predicate.

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

• Not applicable/Not provided: As no specific "test set" for performance evaluation is detailed, there's no mention of experts establishing a ground truth.

4. Adjudication method for the test set:

• Not applicable/Not provided: Without a test set and experts, there is no adjudication method described.

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: This device is an electrode catheter used for intracardiac sensing, recording, stimulation, and pacing. It is not an AI-assisted diagnostic imaging device, so an MRMC study comparing human readers with and without AI assistance is not relevant or described.

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

• Not applicable: The device is a physical catheter, not an algorithm. Therefore, a standalone algorithm performance study is not relevant.

7. The type of ground truth used:

• Not applicable/Not provided: As discussed, no formal performance study requiring ground truth establishment is detailed in this 510(k) summary. The ground truth for regulatory clearance in this context is the established safety and effectiveness of the predicate devices.

8. The sample size for the training set:

• Not applicable/Not provided: This device is not an AI/ML algorithm, so there is no "training set."

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

• Not applicable/Not provided: As above, this is not an AI/ML device.

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