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The Reprocessed Achieve Advance Mapping Diagnostic Electrophysiology Catheter is indicated for multiple electrode electrophysiological mapping of the cardiac structures of the heart, i.e. recording or stimulation only. The catheter is designed to obtain electrograms in the atrial regions of the heart.

The Reprocessed Achieve Advance Mapping Diagnostic Electrophysiology Catheter is an intra-cardiac electrophysiology (EP) recording catheter and can be used for cardiac stimulation during electrophysiology studies. The distal mapping section of the mapping catheter is a circular loop with eight or ten evenly spaced electrodes to map electrical conduction between the left atrium and the pulmonary veins.

The reprocessed mapping catheter is compatible for use with, and may be used to support and position, all catheters in the Medtronic Arctic Front CryoAblation Catheter family. Refer to the applicable Medtronic Arctic Front Technical Manual for additional instructions for use.

The reprocessed mapping catheter should only be used with the Medtronic catheter connecting cable (Model 2ACHC), which interfaces with standard electrophysiology recording equipment. For cable instructions, see the Medtronic 2ACHC catheter connecting cable instructions for use.

Only the catheter is the subject of this submission. Any other related equipment is not included in the scope of this submission.

I am sorry, but the provided text does not contain the information required to answer your request regarding the acceptance criteria and study details for an AI-powered medical device. The document is an FDA 510(k) clearance letter for a reprocessed diagnostic electrophysiology catheter, not an AI device.

Therefore, I cannot provide:

1. A table of acceptance criteria and reported device performance.
2. Sample size and data provenance for a test set.
3. Number and qualifications of experts for ground truth.
4. Adjudication method for the test set.
5. Information on a multi-reader, multi-case (MRMC) comparative effectiveness study or human reader improvement with AI.
6. Information on standalone algorithm performance.
7. The type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

This document focuses on the substantial equivalence of a reprocessed medical device to its predicate, primarily through bench and laboratory testing demonstrating functional, safety, and sterilization aspects. It does not involve AI or machine learning performance evaluations.

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