(125 days)
The CS/3™ Arrythmia Workstation (ARRWS) is indicated for centralized monitoring, arrhythmia analysis and detection, waveform data storage and patient data storage in hospitalized patients connected to Datex-Engstrom monitors.
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I apologize, but the provided text is a 510(k) clearance letter from the FDA regarding the "CS/3™ Arrhythmia Workstation." This document confirms the device's substantial equivalence to a predicate device and outlines regulatory information.
However, this document does not contain any information about:
- Acceptance criteria
- Reported device performance
- Details of a study proving the device meets acceptance criteria
- Sample sizes (test or training set)
- Data provenance
- Number or qualifications of experts for ground truth
- Adjudication methods
- MRMC comparative effectiveness study
- Standalone algorithm performance
- Type of ground truth used
- How ground truth for training was established
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. The document is solely a regulatory clearance communication, not a performance study report.
§ 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.