(96 days)
The Scio and MultiGas/MultiGas+ modules sample breathing gases from adults and pediatrics. The gas modules continuously measure the content of CO2, N2O, O2 and one of the anesthetic agents, Halothane, Isoflurane, Sevoflurane and Desflurane in any mixture and communicates real time and derived gas information to the INFINITY monitors.
With etCO2 the monitors can measure end tidal carbon dioxide, inspired carbon dioxide, and respiration rate in either mainstream or side-stream measurement mode; and with etCO2+Respiratory Mechanics, spirometry and carbon dioxide can be monitored. The monitors can interface with specific third party devices via an MIB protocol converter.
The devices are intended to be used in the environment where patient care is provided by Healthcare Professionals, i.e. Physicians, Nurses, and Technicians, who will determine when use of the device is indicated, based upon their professional assessment of the patient's medical condition.
The devices are intended to be used on Adult, Pediatric and Neonatal populations, with the exception of the parameter Cardiac Output, ST Segment Analysis, and arrhythmia which are intended for use in the adult and pediatric populations only; and tcpO2 which is to be used in the neonatal population only when the patient is not under gas anesthesia.
The intent of this 510(k) is to describe modifications for the Infinity Delta and Kappa series monitors (Delta, Delta XL, Kappa,, Vista XL, Gamma X XL, and Kappa XLT), including Pacer Fusion mode and Age-Based MAC. Kappa XLT now supports the BisX and tpO2 pods, and FiO2.
The provided text is a 510(k) summary and FDA clearance letter for the Dräger Infinity Delta and Kappa series monitors. It does not include the detailed information required to describe the acceptance criteria and the study that proves the device meets those criteria for software-driven AI/ML medical devices.
The document discusses modifications to an existing physiological monitor (Pacer Fusion mode and Age-Based MAC) and supports the BisX and tpO2 pods, and FiO2 for the Kappa XLT. It mentions "Verification and validation testing performed indicates that the VF6 modifications described are as safe and effective as previous versions and have not altered the fundamental technology of the device(s)," but it does not provide specifics on this testing in terms of acceptance criteria, sample sizes, ground truth, or expert involvement typically associated with AI/ML device studies.
Therefore, I cannot provide the requested information based on the given input. The categories in your request (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance, training set size) are characteristic of studies for AI/ML devices, which are not detailed in this 2006 510(k) summary for a physiological monitor.
§ 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.