(15 days)
The VantageView™ System is indicated for use during electrophysiology procedures, and is intended to be used by healthcare professionals to integrate the video outputs from several commercially-available systems commonly used in a medical procedure laboratory into a single video display. Control of the video sources is accomplished using a touchpad device.
The VantageView System uses a 56 inch, high definition (HD), LCD display monitor that is able to integrate up to 8 video displays from up to 16 video sources. The video inputs are typically from common electrophysiology (EP) equipment used in an EP Lab (e.g. Fluoroscopy, the EP-WorkMate System, the EnSite Velocity System, MediGuide Technology, etc.) This technology creates one focused observation point for monitoring the selected displays simultaneously.
The provided text does not contain information about specific acceptance criteria or a study that evaluates the device's performance against such criteria in a quantitative manner (e.g., sensitivity, specificity, accuracy).
Instead, the document focuses on regulatory submission details for a 510(k) premarket notification for the VantageView System. It describes:
- Device Description: A 56-inch HD LCD monitor system that integrates video outputs from various electrophysiology (EP) equipment into a single display.
- Intended Use: To be used by healthcare professionals during electrophysiology procedures to integrate video outputs from multiple systems into a single display, with control via a touchpad.
- Non-Clinical Testing: Mentions "extensive testing" during development, including bench testing to confirm compliance with design requirements and safety/effectiveness, system verification testing, standard-based testing, simulated clinical testing, and Instructions for Use (IFU) validation. It also notes electrical safety testing according to IEC 60601-1 and 60601-1-1.
- Design Control Activities: States development followed St. Jude Medical's Quality System requirements and 21 CFR 820.30 design controls.
- Predicate Device: Cardio-View Manufactured by Carrot Medical-CurlView (K083321).
- FDA Clearance: A letter from the FDA confirming the device's substantial equivalence to a legally marketed predicate device.
Therefore, I cannot provide the requested information, which includes:
- Table of acceptance criteria and reported device performance: No specific performance metrics (e.g., accuracy, reliability, latency) or numerical acceptance criteria are listed.
- Sample size, data provenance, number of experts, adjudication method, MRMC study, standalone performance, or type of ground truth for a test set: These details are entirely absent, as the document does not describe a clinical or rigorous performance study with such components. The "simulated clinical testing" is mentioned but without any specifics on its methodology or results.
- Sample size for the training set or how ground truth was established for the training set: These details are also not present, as the document describes a medical device display system rather than an AI/ML diagnostic or assistive device that would typically involve training data.
The document describes a hardware and software integration system primarily focused on displaying information, and the testing outlined is geared towards demonstrating functional safety and compatibility rather than clinical diagnostic performance.
§ 870.2450 Medical cathode-ray tube display.
(a)
Identification. A medical cathode-ray tube display is a device designed primarily to display selected biological signals. This device often incorporates special display features unique to a specific biological signal.(b)
Classification. Class II (performance standards).