(30 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.
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.
I apologize, but the provided text does not contain the detailed information necessary to answer your request regarding the acceptance criteria and the study that proves the device meets those criteria.
The document is an FDA 510(k) clearance letter and an accompanying 510(k) summary for the EnSite™ X EP System. While it states that "Design verification and validation activities were performed to ensure the EnSite X v1.1.1 software release is safe and effective" and lists some "Types of Testing Performed" (Software Verification, Preclinical Validation Testing, Installation Validation), it does not provide:
- A table of specific acceptance criteria and detailed device performance metrics. The document primarily focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a performance study with quantitative results against specific criteria.
- Sample sizes used for testing.
- Data provenance (country of origin, retrospective/prospective).
- Information on experts used for ground truth (number, qualifications).
- Adjudication methods.
- Details on Multi-Reader Multi-Case (MRMC) comparative effectiveness studies or effect sizes.
- Standalone performance data (algorithm only).
- Specific type of ground truth used (e.g., pathology, outcomes data).
- Sample size for the training set (as this is a software update for an existing system, deep learning training data might not be relevant in the same way as for a novel AI device).
- How ground truth for the training set was established.
The document states that the software updates include "Patch input signals switched from driven to undriven signals," "Composite signal respiration waveform," "Bio Impedance Scaling algorithm updates," "Respiration Gating algorithm updates," and "Metal distortion threshold changes," along with "Additional bug fixes." The testing described is general software verification and preclinical validation to ensure user requirements are met and risks are mitigated, rather than a clinical performance study with specific quantitative acceptance criteria.
§ 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).