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The Reprocessed IntellaMap Orion High Resolution Mapping Catheter is indicated for electrophysiological mapping (recording or stimulating only) of the cardiac structures of the heart.

The Reprocessed IntellaMap Orion High Resolution Mapping Catheter is an 8.5F(ø 2.82 mm), 115 cm working length, 64-electrode steerable catheter. The basket-shaped distal reqion consists of 8 splines that comprise the electrode array. The proximal end has a handle that extends to a cable with a connector. The handle includes bi-directional articulation controls and a deployment slider that activates the electrode array into a basket shape once inside the heart. A flushing port extends from the back of the connector for connection to a continuous pressurized saline drip. The catheter is supplied with an 8.5F insertion sleeve for insertion through the hemostasis valve of an introducer sheath. A sensor in the catheter tip enables the position of the distal region of the catheter to be tracked in space when used with the Rhythmia Mapping System.

The provided text describes the regulatory clearance of a reprocessed medical device, the Reprocessed IntellaMap Orion High Resolution Mapping Catheter, and lists the types of functional and safety testing conducted to demonstrate its performance. However, it does not provide specific acceptance criteria or detailed results of a study designed to prove the device meets those criteria.

Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance, nor can I detail a study that proves the device meets specific acceptance criteria based on the information given. The document focuses on regulatory equivalence to a predicate device rather than presenting a performance study with detailed metrics against defined acceptance criteria.

Based on the provided text, here's what can be inferred regarding the request:

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

   • Acceptance Criteria: Not explicitly stated as quantifiable metrics. The document broadly indicates that the reprocessed device's performance (safety and effectiveness) needs to be demonstrated and that its purpose, design, materials, function, and intended use are "identical to the predicate device."
   • Reported Device Performance: No specific numerical performance metrics are reported in this document. The document lists the types of tests performed (e.g., Biocompatibility, Cleaning Validation, Functional testing, Electrical Safety Testing, Packaging Validation), but not their outcomes or criteria for success.

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. The document mentions "Bench and laboratory testing" but does not specify sample sizes or data provenance for these 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):

   • This information is not provided. The testing described is primarily laboratory and bench testing, not clinical studies requiring expert ground truth establishment in the context of diagnostic interpretation.

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

   • This information is not applicable and not provided, as the testing described does not involve expert adjudication of a diagnostic output.

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 MRMC comparative effectiveness study is mentioned. This device is a physical medical instrument (catheter), not an AI diagnostic tool, so this type of study is not relevant to its clearance.

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

   • This is not applicable as the device is a physical medical instrument, not an algorithm.

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

   • For the functional and safety testing, "ground truth" would be established through engineering specifications, material standards, and validated testing methodologies (e.g., sterilization validation based on established microbial inactivation levels, biocompatibility based on ISO standards, electrical safety based on IEC standards). No expert consensus, pathology, or outcomes data is mentioned as a "ground truth" for these tests in this document.

8. The sample size for the training set:

   • This is not applicable. The device is a reprocessed physical instrument, not an AI model, so there is no "training set."

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

   • This is not applicable for the reasons stated above.

In summary, the provided document is a regulatory clearance letter focused on substantial equivalence based on a comparison to a predicate device and a list of performed functional and safety tests. It does not contain the detailed performance data, acceptance criteria, or study specifics that would be expected for an AI/diagnostic software clearance, or a clinical study on a novel device.

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