(190 days)
For monitoring hospital patient's respiration (CO2, O2, N2O and respiration rate) ventilation (airway pressure, volume and flow) and gas exchange status (Oxygen Consumption VO2, Carbon (an way production VCO2, Respiratory Quotient RQ, and Energy Expenditure, EE). The system is intended for use by qualified medical personnel only.
Not Found
The provided text is a Fragment of a 510(k) summary letter from the FDA to Datex Engstrom, Inc. regarding their CS/3™ Compact Airway Module, M-COVX. This document primarily focuses on the FDA's decision of substantial equivalence and does not contain detailed information about acceptance criteria or specific study results to prove a device meets those criteria.
Therefore, I cannot provide the requested information about acceptance criteria and the study that proves the device meets them based on the text provided. The document does not include:
- A table of acceptance criteria and reported device performance.
- Sample sizes or data provenance for a test set.
- Number and qualifications of experts for ground truth.
- Adjudication methods.
- Information about MRMC comparative effectiveness studies.
- Results of standalone algorithm performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
The document is a regulatory approval letter, not a technical 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.