(113 days)
The EnSite™ X EP System is a suggested diagnostic tool in patients for whom electrophysiology studies have been indicated.
The EnSite™ X EP System provides information about the electrical activity of the heart and displays catheter location during conventional electrophysiological (EP) procedures.
EnSite™ X EP System Contact Force Software License:
When used with the TactiSys™ Quartz Equipment, the EnSite™ X EP System Contact Force Module is intended to provide visualization of force information from compatible catheters.
EnSite™ X EP System Surface Electrode Kit:
The EnSite™ X EP Surface Electrode Kit is indicated for use with the EnSite™ X EP System in accordance with the EnSite™ X EP System indications for use.
The EnSite™ X EP System is a catheter navigation and mapping system. A catheter navigation and mapping system is capable of displaying the 3-dimensional (3-D) position of conventional and Sensor Enabled™ (SE) electrophysiology catheters, as well as displaying cardiac electrical activity as waveform traces and as three-dimensional (3D) isopotential and isochronal maps of the cardiac chamber.
The contoured surfaces of the 3D maps are based on the anatomy of the patient's own cardiac chamber. The system creates a model by collecting and labeling the anatomic locations within the chamber. A surface is created by moving a selected catheter to locations within a cardiac structure. As the catheter moves, points are collected at and between all electrodes on the catheter. A surface is wrapped around the outermost points.
The provided text does not contain details about acceptance criteria or a study proving the device meets those criteria for the EnSite™ X EP System's AI software.
The document is a 510(k) summary for the EnSite™ X EP System, specifically for version 2.0. It primarily focuses on demonstrating substantial equivalence to a predicate device (EnSite™ X v1.1.1). While it mentions "software was revised to include the following updates" which sound like new features (e.g., "Displays activation time based on the Near Field Detection Method," "Displays peak frequency maps," "Automatically assesses activation times for outliers using the Outlier Filter"), it does not provide any specific quantitative acceptance criteria or detailed study results related to the performance of these new software features or any embedded AI/algorithmic components.
The "Non-Clinical Testing Summary" broadly states that "Design verification activities were performed and met their respective acceptance criteria to ensure that the devices in scope of this submission are safe and effective." It lists types of testing performed such as "Software Verification at unit, software and system level," "Performance Testing of updated feature functionality," and "Preclinical studies to evaluate substantial equivalence," and "Preclinical Validation Testing to confirm the system could meet user requirements and its intended use after modifications." However, it does not elaborate on the specific acceptance criteria for these tests, nor does it provide any data (e.g., accuracy, sensitivity, specificity, or inter-reader agreement statistics) to demonstrate how these criteria were met.
Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, as the necessary information is not present in the provided document. The document primarily focuses on regulatory approval based on "substantial equivalence" rather than a detailed performance study of specific AI algorithm metrics.
§ 870.1425 Programmable diagnostic computer.
(a)
Identification. A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.(b)
Classification. Class II (performance standards).