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The AcQMap System is intended for use in patients for whom electrophysiology procedures have been prescribed.

When used with the AcQMap Catheters, the AcQMap 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 or voltage-based maps of complex arrhythmias that may be difficult to identify using conventional mapping systems alone.

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When used with the specified Patient Electrodes, the AcQMap System is intended to display the position of AcQMap Catheters and conventional electrophysiology (EP) catheters in the heart.

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When used with conventional electrophysiology catheters, the AcQMap 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, Model 900100 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, Model 900100 ("AcQMap System Model, 900100") 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 System hardware consists of three functional subsystems:

• . Ultrasound imaging,
• . ECG and EGM recording; and
• o Impedance based electrode Localization.

The AcQMap System, Model 900100 is used in conjunction with the associated AcQMap 3D Imaging and Mapping Catheter (cleared under K170819). The AcQMap System provides:

• . 3-D cardiac chamber reconstruction - Contact and non-contact (ultrasound),
• . Three-dimensional position of the AcQMap Catheter and conventional electrophysiology catheters,
• o 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 System, Model 900100 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 modified AcQMap System allows physicians to perform traditional contact mapping activities, including establishing a coordinate system, localizing conventional electrophysiology catheters relative to one another within the coording 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 arrythmia without deploying the AcQMap Catheter.

The provided text is a 510(k) premarket notification for the AcQMap® High Resolution Imaging and Mapping System, Model 900100. It focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than presenting a detailed de novo clinical study with specific acceptance criteria and performance data for a new AI/ML algorithm.

Therefore, much of the requested information regarding acceptance criteria, multi-reader multi-case studies, and specific performance metrics of an AI model cannot be extracted directly from this document. This document primarily discusses the safety and effectiveness of a medical device (hardware/software system) for cardiac imaging and mapping, not an AI/ML algorithm requiring rigorous clinical validation for its own performance.

However, I can extract information related to the device's validation and the high-level assessment of its performance.

Here's what can be gathered, with limitations noted:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not present specific quantitative acceptance criteria or performance metrics in a tabular format as would be expected for an AI/ML algorithm's clinical validation study (e.g., sensitivity, specificity, AUC). Instead, it states that "the collective results of the nonclinical testing... demonstrate that the proposed device does not raise different questions of safety or effectiveness when compared to the predicate device" and that the clinical study "demonstrated that the AcQMap System is safe and effective for its intended use."

The document focuses on "functional and performance characteristics" of the system as compared to its predicate, rather than an AI's accuracy against a ground truth.

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