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The AcQMap High Resolution Imaging and Mapping System is intended for use in patients for whom electrophysiology procedures have been prescribed. When used with the AcQMap High Resolution Imaging and Mapping System is intended to be used to reconstruct the selected chamber from ultrasound data for purposes of visualizing the chamber anatomy and displaying electrical impulses as either charge density-based maps of complex arrhythmias that may be difficult to identify using conventional mapping systems alone. AND When used with the specified Patient Electrodes, the AcQMap High Resolution Imaging System is intended to display the position of AcQMap Catheters and conventional electrophysiology (EP) catheters in the heart. OR When used with conventional electrophysiology catheters, the AcQMap High Resolution Imaging and Mapping System provides information about the electrical activity of the heart and about catheter location during the procedure.

The AcQMap High Resolution Imaging and Mapping System operates outside of the sterile field and consists of the AcQMap Console, the AcQMap Workstation and the AcQMap Auxiliary Interface Box. The AcQMap High Resolution Imaging and Mapping System is a diagnostic recording system. This computer-based system is intended for use in the Electrophysiology (EP) Lab, and it is capable of imaging, navigation, and mapping of the atrial chambers of the heart. The AcQMap High Resolution Imaging and Mapping System hardware consists of three functional subsystems: Ultrasound imaging, ECG and EGM recording; and Impedance based electrode Localization. The AcQMap High Resolution Imaging and Mapping System is used in conjunction with the associated AcQMap 3D Imaging and Mapping Catheter models 900003 and 900009 (cleared under K201341). The AcQMap High Resolution Imaging and Mapping System provides: 3-D cardiac chamber reconstruction - Contact and non-contact (ultrasound), Three-dimensional position of the AcQMap Catheter and conventional electrophysiology catheters, Cardiac electrical activity as waveform traces, Contact LAT and voltage amplitude maps Remapping of the chamber at any time during the procedure; and Dynamic, three-dimensional, charge density maps overlaid on the cardiac chamber reconstruction to show chamber-wide electrical activation. The AcQMap High Resolution Imaging and Mapping System is intended to create a surface reconstruction of the cardiac chamber as well as an electrical map of the substrate. The surface reconstruction and electrical map are then used by physicians to identify the source(s) of the arrhythmia. Additionally, the AcQMap High Resolution Imaging and Mapping System allows physicians to perform traditional contact mapping activities, including establishing a coordinate system, localizing conventional electrophysiology catheters relative to one another within the coordinate system, recording contact electrograms, and initiating a procedure without the AcQMap Catheter present. Based on the information captured in the contact electrograms, the physician may decide to treat an arrhythmia without deploying the AcQMap Catheter. The modifications to the AcQMap High Resolution Imaging and Mapping System include software modification and the addition of new accessories to support compatibility with the AcQBlate Force Sensing Ablation System.

The provided text includes general information about the device's classification, indications for use, and a comparison to a predicate device. However, it does not contain specific acceptance criteria, reported device performance data, or detailed information about the study design elements you requested for a comparative effectiveness study or standalone performance evaluation.

Here's what can be extracted and what is missing based on your request:

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

The document does not specify quantitative acceptance criteria or reported device performance in a table format. It states that "The modified AcQMap High Resolution Imaging and Mapping System was tested to verify that the device meets the established performance specifications" and "The collective results of the testing demonstrate that the design of the modified AcQMap High Resolution Imaging and Mapping System meets its established performance specifications necessary for performance during its intended use." However, it does not detail what these specific performance specifications or criteria are, nor does it present the results against them.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Test set sample size: For the original AcQMap High Resolution Imaging and Mapping System (K170948), the clinical study included 84 patients. This study's results are incorporated by reference for the modified device.
• Data provenance: The clinical study (DDRAMATIC-SVT) was a prospective, non-randomized, open-label study conducted at eight clinical sites outside the U.S.
  • Country of origin: Outside the U.S.
  • Retrospective or prospective: Prospective.

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 in the document. The document mentions "physicians" using the system to identify arrhythmia sources but does not detail the number or qualifications of experts for establishing ground truth in the clinical study.

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

This information is not provided in the document.

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

• MRMC comparative effectiveness study: The document describes a clinical study "DDRAMATIC-SVT", which demonstrated the substantial equivalence of the original AcQMap system. However, this study did not evaluate human readers with AI assistance versus without AI assistance. The AcQMap system itself (which includes imaging and mapping capabilities) is the device being assessed, not an AI assisting human readers with interpreting external data.
• Effect size: Therefore, no information on the effect size of human reader improvement with AI assistance is provided, as this type of study was not conducted or reported.

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

The document describes the AcQMap High Resolution Imaging and Mapping System as a diagnostic recording system intended for use in an Electrophysiology (EP) Lab, used by physicians. It generates 3-D reconstructions, electrical maps, and displays electrical impulses. The description strongly implies it's a tool for physicians, not a standalone AI algorithm producing diagnoses without human interpretation. Therefore, a standalone (algorithm-only) performance study as you describe would likely not be directly applicable, and no such study is reported in the provided text. The performance assessed is of the system as a whole, which operates in the context of clinical procedures.

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

This information is not explicitly stated. The system is intended to help physicians "identify the source(s) of the arrhythmia" and provides "information about the electrical activity of the heart." While this implies clinical assessment by physicians based on the system's output and potentially other diagnostic tools, the specific method for establishing the definitive "ground truth" for arrhythmias in the study (e.g., confirmed by a separate gold standard, follow-up outcomes, expert consensus) is not detailed.

8. The sample size for the training set

The document describes a modified device being compared to a predicate device (K222209). The necessary clinical testing for the original AcQMap High Resolution Imaging and Mapping System (K170948) is incorporated by reference. There is no mention of a "training set" in the context of AI/machine learning in this document, as the device is not presented as an AI-driven diagnostic algorithm that requires a separate training set. It's a system for imaging and mapping.

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

As there is no mention of a "training set" for an AI algorithm in this context, this information is not applicable/not provided.

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