(220 days)
The pager is intended for the annunciation of events to provide zone information that is secondary to the primary care provided. It provides specific information within a zone and alerts or draws an identified individual's attention to a defined patient condition in a timely manner. Primary care via the central station, telemetry system, or patient bedside monitor remains unchanged by the addition of a pager.
This device is commonly known as a pager and an alarm display unit.
This document is a 510(k) summary for a pager and alarm display unit, submitted in 1996. It explicitly states that performance standards have not yet been established for this device.
Therefore, based on the provided text, it's not possible to define specific acceptance criteria, provide a table of performance, or describe a study that proves the device meets such criteria because:
- No specific acceptance criteria are listed. The document states that the device is "unclassified" and that "performance standards have not yet been established."
- No detailed study is described. The document merely states "Validation test results indicate that the pager meets the requirements of its intended use" without providing any details about the methodology, sample size, or specific metrics used.
In a modern context for a medical device with an AI component, the requested information would be crucial. However, for this 1996 pager submission, the regulatory requirements and the nature of the device (a simple communication tool) were significantly different.
Therefore, I cannot provide the requested information for this specific device as it is not present in the provided 510(k) summary.
§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.