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The Fidus Rhyder Diagnostic Catheter is intended to simultaneously pace and record monophasic action potentials (MAPs) from the endocardial surface of the heart. The combined capabilities of this catheter obviate the need to insert a separate catheter for stimulation in MAP studies.

The Fidus Rhyder Diagnostic Catheter is a flexible catheter with two pairs of electrodes at the distal tip. One pair of electrodes consisting of tip (active) and side (indifferent) electrodes is used for recording ECG signals. The second pair of electrodes, located adjacent to the catheter's tip, are used for pacing. The Rhyder Diagnostic Catheter is available with three distal tip designs.

The provided text does not include information on acceptance criteria for device performance, nor does it describe a study specifically designed to prove that the device meets such criteria in terms of clinical effectiveness or diagnostic accuracy.

The document discusses bench testing and biocompatibility testing to support substantial equivalence to predicate devices, focusing on physical and material characteristics, rather than performance in the context of its indicated use (simultaneous pacing and recording monophasic action potentials (MAPs)).

Therefore, I cannot populate the requested table and answer many of the questions as the information is not present in the provided text.

Here's a breakdown of what can be extracted and what cannot:

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

• Cannot be provided. The document lists types of bench tests (thermal cycling, impedance, tensile, etc.) but does not specify acceptance criteria (e.g., "tensile strength must be > X Newtons") nor does it report the specific results of these tests (e.g., "tensile strength was Y Newtons"). The primary conclusion is that these tests "support the substantial equivalence claims."

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

• Cannot be provided. The text only mentions "bench testing" and "biocompatibility testing." The sample sizes for these engineering tests are not specified, nor is there any concept of "data provenance" as this refers to clinical/patient data, which was not used in the described tests.

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)

• Not applicable. This question pertains to studies involving human interpretation or clinical diagnosis, which were not described. The "ground truth" for bench tests would be engineering specifications or reference materials, not expert consensus.

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

• Not applicable. See point 3.

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

• Cannot be provided. This is a diagnostic AI-specific question and the device described is a physical medical catheter, not an AI diagnostic tool.

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

• Not applicable. See point 5.

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

• Cannot be provided definitively for all tests. For bench tests, ground truth would typically be established by international standards, engineering specifications, or validated reference measurement systems. For biocompatibility, it would be established by relevant ISO standards and test guidelines for material safety.

8. The sample size for the training set

• Not applicable. The concept of a "training set" applies to machine learning algorithms. This document describes a physical medical device.

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

• Not applicable. See point 8.

In summary, the provided document focuses on demonstrating the physical and material safety and equivalency of the Rhyder Diagnostic Catheter to existing predicate devices through bench and biocompatibility testing. It does not contain information about clinical performance, diagnostic accuracy, or any studies involving human subjects or AI algorithms that would generate the kind of data requested in your prompt.

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