(13 days)
The M2376A DeviceLink System is indicated for use in data collection and clinical information management either directly or through networks with independent bedside devices.
The M2376A is not intended for monitoring purposes, nor is the M2376A intended to control any of the clinical devices (independent bedside devices / information systems) it is connected to.
The M2376A DeviceLink System receives digital data produced by external devices through device specific cables, converts that data into the HL7 format and transmits that information to any networked Clinical Information System.
The provided text is a 510(k) summary for the M2376A DeviceLink System. It primarily focuses on regulatory information, device description, and indications for use. It does not contain information regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment for a performance study.
Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them based on the provided input. The document is a regulatory submission for market clearance, not a technical performance study report.
The DeviceLink System is described as a device that "receives digital data produced by external devices through device specific cables, converts that data into the HL7 format and transmits that information to any networked Clinical Information System." Its function is for electronic data collection and clinical information management, and it is explicitly stated that it is "not intended for monitoring purposes, nor is the M2376A intended to control any of the clinical devices (independent bedside devices / information systems) it is connected to." This suggests its primary function is data transfer and formatting, rather than generating clinical insights or diagnoses that would typically require validation against medical performance metrics.
§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).