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

The IntellaMap Orion™ High Resolution Mapping Catheter is intended for multiple electrode electrophysiology mapping of the heart and is intended for recording of electrograms and stimulation of cardiac tissue. The IntellaMap Orion™ High Resolution Mapping Catheter is a 8.5 French (2.8mm), 115 cm, bidirectional, 64 electrode, non-linear (basket shaped) diagnostic catheter. The catheter consists of a polymer handle, a polymer shaft and a platinum/iridium and polymer distal mapping section mounted with iridium electrodes ('electrode array'). The catheter contains a flushing port capable of providing continuous flushing into the electrode array. The catheter is supplied with an 8.5 French insertion sleeve for insertion through the hemostasis valve of an introducer sheath. The catheter is provided sterile and is for single use only. The IntellaMap Orion™ High Resolution Mapping Catheter simultaneously acquires 64 electrograms from the electrodes on its splines. The catheter is designed to enter the vasculature with a low profile (8.5F) through a percutaneous approach. The catheter can be maneuvered with the aid of a handle that controls bidirectional steering and array deployment.

The provided document is a 510(k) summary for the IntellaMap Orion High Resolution Mapping Catheter. It focuses on demonstrating substantial equivalence to a predicate device, primarily through non-clinical bench testing of a handle design modification. This type of regulatory submission does not typically include the detailed clinical study information requested in your prompt (e.g., acceptance criteria for diagnostic performance, human reader studies, ground truth establishment, sample sizes for training/test sets for AI devices).

This device is an "Electrode Recording Catheter," which is a medical instrument used for electrophysiological mapping of cardiac structures. It captures electrograms and can stimulate cardiac tissue. It is not an AI-powered diagnostic device in the sense of analyzing images or data to provide a diagnosis or improve human reader performance. Therefore, many of your requested points relate to AI/diagnostic device performance studies, which are not applicable to the information presented in this 510(k) summary.

However, I can extract the relevant information regarding the non-clinical performance described in the document.

Here's the information that can be extracted relevant to the performance criteria and study from the provided document:

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

Note: The document states "The verification testing confirmed that the new handle design met the product performance requirements of the predicate device." It does not specify the numerical or qualitative requirements themselves, only that they were met.

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. The document refers to "bench top testing," which implies laboratory-based tests rather than data from human subjects.

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 applicable/provided. The testing described is benchtop testing for a handle modification, not a diagnostic or AI performance study requiring expert ground truth establishment in a clinical context.

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

This information is not applicable/provided. Adjudication methods are typically for clinical studies involving interpretation, not for benchtop engineering verification.

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

This information is not applicable. This is not an AI-assisted diagnostic device, and no MRMC study is mentioned. The device is a physical catheter for electrophysiological mapping.

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

This information is not applicable. This is not an algorithm-only device. It's a medical instrument used by clinicians.

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

This information is not provided. For benchtop testing of a handle, ground truth would relate to engineering specifications and measurements, which are not detailed here.

8. The sample size for the training set

This information is not applicable/provided. "Training set" refers to data used for machine learning or AI model development, which is not relevant to this device's description.

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

This information is not applicable/provided. As above, "ground truth for training set" is for AI models, not a physical medical device like this catheter.

Summary of what is clear from the document:

• Device Type: IntellaMap Orion High Resolution Mapping Catheter (a physical medical instrument).
• Purpose: Electrophysiological mapping (recording or stimulating) of cardiac structures.
• Regulatory Submission Reason: Modification to the handle design of an already cleared device.
• Performance Study Type: Non-clinical benchtop testing.
• Key Finding: The new handle design met the product performance requirements of the predicate device.
• Conclusion: The modified device is considered substantially equivalent to its predicate.

The document does not describe the specific performance metrics or acceptance criteria for the electrophysiological mapping overall, nor does it delve into the clinical accuracy of the mapping capability, as the focus of this particular 510(k) was on a modification to a previously cleared device's handle.

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