(182 days)
The Witt Biomedical Central Station Monitor and Advanced Patient Care Monitoring Units are designed to provide continuous monitoring of patient physiological parameters, generate alarms (both visual and audible), alerting operator to anomalous occurrences and facilitate timely responses. The Witt Biomedical Central Station Monitor and/or Advanced Patient Care Monitoring unit are intended for use in hospital environments including surgical intensive care, respiratory intensive care, coronary care, post anesthesia recovery, operating room, medical intensive care, pediatrics intensive care and patient holding areas of health care facilities. The Witt Biomedical Central Station Monitor and Advanced Patient Care Monitoring Unit offers a thorough display of monitoring parameters which use proven algorithms and are displayed in a logical, easily understood format that requires only familiarity to the users of any Witt Biomedical system.
The Witt Biomedical Central Station Monitor and Advanced Patient Care Monitoring Units are intended to be used by trained hospital personnel with training on the operation of this equipment.
Witt Biomedical Corporation Central Station with Advanced Patient Care Monitoring System.
I am sorry, but the provided text does not contain the necessary information to answer your request regarding the acceptance criteria and study details for the Witt Biomedical Corporation Central Station with Advanced Patient Care Monitoring System.
The document is a 510(k) clearance letter from the FDA, which confirms that the device is substantially equivalent to a predicate device and can be marketed. It includes the device name, indications for use, and regulatory classification but does not detail the specific performance acceptance criteria, study design, sample sizes, ground truth establishment, or expert qualifications that would be found in a clinical study report or performance evaluation.
Therefore, I cannot provide a table of acceptance criteria, reported device performance, sample sizes, data provenance, number of experts, adjudication methods, MRMC study results, standalone performance, type of ground truth used, or training set details based on this document.
§ 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.