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Affera Integrated Mapping System:
The Affera Integrated Mapping System is intended to be used cardiac electrophysiological mapping. The mapping system allows pacing and real-time visualization of compatible catheters as well as display of cardiac maps in multiple formats. The acquired patient signals, including body surface electrocardiograms and intracardiac electrograms, may also be recorded and displayed on the system's display screen.

Magnetic Localization Patch Kit:
Refer to the instructions for use accompanying the compatible electrophysiology catheter(s) used with the compatible mapping system for the specific indications for use.

Affera Integrated Mapping System:
The Affera Integrated Mapping System (integrated mapping system) is a computerized storage and display system with embedded software designed to present the user with information regarding the state and location of compatible catheters within the body. The integrated mapping system provides real-time visualization of compatible catheters as well as display of cardiac maps in multiple formats. The integrated mapping system uses magnetic localization technology similar to localization systems used in other EP mapping systems, with a magnetic field generator placed under the table and one or more passive electromagnetic sensors embedded in the catheter. In addition to magnetic-based tracking and navigation, the integrated mapping system provides optional capability for hybrid electromagnetic-impedance tracking and navigation, including the ability to visualize Medtronic and third-party therapeutic and diagnostic devices that do not contain electromagnetic location sensors.

The integrated mapping system collects and displays surface electrocardiogram (ECG) signals using commercially available body surface electrodes. Electrogram signals from electrodes on connected catheters can also be collected. Data derived from these signals can be overlayed on the reconstructed anatomy to display cardiac maps in multiple formats. The integrated mapping system can connect to electrophysiology (EP) catheter lab equipment such as external stimulators to deliver pacing stimuli through thirdparty intracardiac (IC) catheters. Internally generated pacing stimuli can also be routed directly from the integrated mapping system CIU.

The integrated mapping system can be used with compatible cardiac ablation systems for tracking and navigation of catheters during ablation procedures. When connected via a communication link to a compatible ablation system, the integrated mapping system displays ablation data such as temperature and power on the user interface.

Magnetic Localization Patch Kit:
The Magnetic Localization Patch Kit is an accessory device that includes 2 surface localization patches and is used with the Affera Integrated Mapping System for electromagneticbased tracking and navigation only. The patches are placed in fixed positions in contact with the patient's skin and provide a provide a stable mounting point for magnetic sensors within the intended connecting cable, which are used to provide information regarding patient position and movement during electromagnetic-based tracking and navigation procedures.

The provided FDA 510(k) summary for the Medtronic Affera Integrated Mapping System and Magnetic Localization Patch Kit does not contain information typically found in a study proving the device meets acceptance criteria for an AI/ML-driven medical device, such as detailed performance metrics (sensitivity, specificity, accuracy), sample sizes for test sets, establishment of ground truth by expert consensus, multi-reader multi-case studies, or standalone algorithm performance.

This document is a premarket notification for a hardware accessory (Magnetic Localization Patch Kit) and a comprehensive mapping system, not specifically for an AI/ML diagnostic or prognostic algorithm that would require the in-depth performance study details requested. The "Programmable diagnostic computer" classification refers to the broader functional capabilities of the mapping system, not necessarily an AI deep learning component.

The "Safety and Performance Data" section states: "Performance testing applicable to the subject device was completed to ensure it performs as intended per the product specifications and requirements. The following testing has been completed in support of the Magnetic Localization Patch Kit, and all acceptance criteria were met in accordance with appropriate standards:

• Design verification testing
• Design validation
• Pre-clinical animal testing
• Biocompatibility testing
• Packaging validation"

This indicates engineering and functional validation for a hardware component, not a clinical study to evaluate an AI's diagnostic performance for which the detailed criteria in the prompt would apply.

Therefore, it is not possible to extract the requested information (performance table, sample sizes, expert involvement, MRMC study, standalone performance, ground truth details, training set specifics) from the provided text, as this document does not describe such a study for an AI/ML component. The acceptance criteria mentioned ("all acceptance criteria were met") refer to the successful completion of the listed engineering and biological tests for the hardware, not diagnostic performance metrics for an AI.

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