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The Ablamap® System is used to analyze electrogram (EGM) signals and display results in a visual format for evaluation by a physician in order to assist in the diagnosis of complex cardiac arrhythmias.

The Ablacon Ablamap System is an electrophysiology mapping system used during electrophysiology procedures for assisting in the diagnosis of complex cardiac arrhythmias. The system consists of several hardware elements including an amplifier, cart, monitor, and a workstation with proprietary patented mapping software. Electrogram (EGM) signals are detected by 64-electrode mapping "basket" catheters which are input into, sampled, and amplified by the system's amplifier. The data is transmitted via fiber-optic cable from the amplifier to the workstation and processed by the system's mapping software with the results displayed on the monitor.

The system also accepts EGM data files recorded by EP amplifier recording systems from 64-electrode unipolar "basket" mapping catheters. The EGM data files are electrophysiology (EP) recordings that contain electrogram signals recorded by EP recording systems using 64-electrode "basket" mapping catheters. Compatible EP recording systems are the Boston Scientific LabSystem Pro™, the GE Healthcare CardioLab™ XT, and the St. Jude Medical WorkMate™ Claris System. The recorded EGM data files are saved onto the workstation and processed by the mapping software.

Compatible catheters are 64-electrode mapping "basket" catheters with the following dimensions: 50mm and 60mm sizes; an 8 spline x 8 electrode configuration with nominal electrode spacing of 0.354'' and 0.440" for 50mm and 60mm basket sizes respectively.

Through the software user interface, the user selects to record streamed EGM data from the Ablamap System signal amplifier that is saved to the workstation or the user selects an EGM data file recorded by an EP Recording System that has been saved to the workstation. The data file is processed by the Ablamap System software where the EGM signals are converted into electrographic flow® (EGF®) maps indicating flow consistency and direction of the action potential wave propagation during pre-defined time intervals. The resulting EGF® film maps display the flow with respect to the catheter electrodes and show the activity of sources of excitation where action potentials originate.

A Summary Map is displayed that is the graphical representation of the summation of the activity of EGF® sources from all segments of the EGM data file recording indicating the rate of occurrence i.e. prevalence of sources of EGF® with respect to the catheter electrodes.

These graphical maps are evaluated by the physician to assist in the diagnosis of complex cardiac arrhythmias during electrophysiology procedures.

The provided text, a 510(k) summary for the Ablamap® System, does not contain specific details about a clinical study involving human readers or comparative effectiveness for diagnostic performance. The document focuses on technological characteristics and engineering performance (verification and validation testing, usability testing) to demonstrate substantial equivalence to previously cleared devices.

Therefore, many of the requested details about a study proving the device meets acceptance criteria related to diagnostic performance cannot be extracted from this text. The acceptance criteria mentioned are general (e.g., "meets the specification requirements and performs as designed," "met the user needs and was found to be clinically acceptable").

However, I can extract the information that is present according to your numbered list:

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

Based on the provided text, a direct quantitative table of acceptance criteria and reported device performance for diagnostic accuracy in a clinical setting is not available. The performance discussions relate to engineering verification and validation.

2. Sample sized 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 text for any clinical performance test. The document mentions "Verification Testing," "Validation Testing," and "Usability Testing," which typically involve engineering and usability evaluations rather than large-scale clinical accuracy studies with patient data.

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. While "evaluators" are mentioned for validation testing ("found to be clinically acceptable by all evaluators"), their number or qualifications are not specified. This typically refers to internal evaluators, not independent experts establishing ground truth for diagnostic accuracy.

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

This information is not provided.

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:

A multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned in the provided text. The submission focuses on demonstrating substantial equivalence primarily through technological characteristics and engineering performance, rather than a direct comparison of human reader performance with and without AI assistance.

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

The text states the system "assists in the diagnosis of complex cardiac arrhythmias" and "display results in a visual format for evaluation by a physician." This implies a human-in-the-loop use case. While the software processes EGM signals into EGF® maps, a standalone performance assessment of the algorithm's diagnostic accuracy without human interpretation is not described in this document.

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

The specific type of ground truth for diagnostic accuracy is not specified in the provided text, as a clinical performance study demonstrating diagnostic accuracy is not detailed. The "ground truth" implicitly referred to in the context of engineering verification and validation would be the design specifications and user needs.

8. The sample size for the training set:

Information regarding a "training set" (implying a machine learning or AI model development) and its sample size is not provided. The device processes EGM data and converts it into "electrographic flow® (EGF®) maps" using a "proprietary algorithm" and "Optical Flow" as the computation method (page 5). This description does not explicitly detail a neural network or machine learning model that would require a distinct "training set" in the context of typical AI device submissions.

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

As no training set is described, information on how its ground truth was established is not provided.

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