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The Inquiry™ AFocusII™ Diagnostic Catheter is a steerable electrophysiology catheter used for recording intracardiac signals and cardiac stimulation during diagnostic electrophysiological studies. The Inquiry™ AFocusII™ Diagnostic Catheters are to be used to map the atrial regions of the heart.

The Inquiry™ AFocusII™ Diagnostic Catheter is a flexible, radiopaque catheter with a variable number of electrodes with the first electrode located at the distal tip and the other band electrodes following at predetermined distances. A connecting cable is used to connect the catheter to electrogram devices. The catheter has a distal double loop in a plane perpendicular to the catheter body. The circumferential shape or loop allows the electrophysiologist to record the potentials of cardiac structures without changing the position of the catheter. The catheter shaft is steerable by manipulating the handle. The placement of the electrodes around the entire circumference of the distal loop also assists the electrophysiologist during fluoroscopy with visualization. The distal loop shape is easily straightened with the thumb and forefinger to facilitate insertion into sheaths and introducers. Once the catheter is extended beyond the sheath, the catheter resumes its pre-formed shape. The device is supplied sterile and is intended for single use only.

The provided text describes a medical device, the Inquiry™ AFocusII™ Diagnostic Catheter, and its clearance process, but it does not contain information about specific acceptance criteria or a study designed to prove the device meets those criteria, as one would expect for an AI/ML device.

This document is a 510(k) summary for a traditional medical device (catheter), not an AI/ML diagnostic tool. Therefore, many of the requested elements (like sample size for test set, number of experts, MRMC studies, standalone performance, ground truth for training data) are not applicable or
not present in this type of submission.

The "Brief summary of nonclinical tests and results" section in the document states:
"The bench testing for the Inquiry™ AFocusII™ Diagnostic Catheter was based on the The belieft tosument "Electrode Recording Catheter Preliminary Guidance, Draft Version'', March 1995. Test results indicate reliable performance when the device is used version , March 1999 Instructions for Use. The catheter does not raise new issues of safety, effectiveness, or performance of the product."

This indicates that:

• Acceptance Criteria: Were likely derived from the "Electrode Recording Catheter Preliminary Guidance, Draft Version'', March 1995. These guidance documents typically specify performance metrics for parameters like electrical characteristics, mechanical integrity, biocompatibility, and sterilization for catheters. Specific numerical acceptance criteria are not provided in this summary.
• Study: Bench testing was performed. The nature of this testing would involve physical and electrical measurements of the catheter's components and overall function.
• Reported Device Performance: "Test results indicate reliable performance when the device is used version , March 1999 Instructions for Use." No specific numerical results are provided in this summary.

Therefore, many parts of your request cannot be answered directly from the provided text because it pertains to a different type of medical device submission (a physical catheter, not an AI/ML software).

Here's how to address your questions based on the available information:

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

*Note: Specific numerical criteria and results are not provided in this summary.*

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
* This information is not provided in the document. For bench testing of a physical device like a catheter, the "test set" would typically refer to the number of catheters subjected to various engineering tests (e.g., durability, electrical impedance, steerability). Data provenance (country of origin, retrospective/prospective) is not applicable in the typical sense for this type of bench testing.

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 as this is not an AI/ML diagnostic device requiring expert interpretation for ground truth. The "ground truth" for a catheter would be its measured physical and electrical properties compared against engineering specifications.

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

   • This is not applicable for bench testing of a medical catheter.

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, an MRMC study was not done. This is not an AI-assisted diagnostic device.

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

   • No, this is not applicable. This is a physical medical device, not an algorithm.

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

   • The "ground truth" for this device would be its engineering specifications and performance benchmarks as established by the "Electrode Recording Catheter Preliminary Guidance." It is not based on clinical "ground truth" like pathology or expert consensus related to diagnostic accuracy.

8. The sample size for the training set

   • This is not applicable as this is not an AI/ML device that requires a training set.

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

   • This is not applicable as this is not an AI/ML device that requires a training set or ground truth establishment in that context.

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