(117 days)
This monitor is intended to be used for monitoring, storing, reviewing, recording, and generating alarms for multiple physiological parameters including ECG, respiration (RESP), temperature (TEMP), functional arterial oxygen saturation (SpO2), pulse rate (PR), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), expired CO2, cardiac output (C.O.) and anesthetic gas (AG)of adults, pediatrics and neonates in hospital environments.
This monitor is suitable for use in hospital environments including but not limited to OR, PACU, ICU and neonate intensive care room.
The elite V8 Patient Monitor can perform long-time continuous monitoring of multiple physiological parameters. Also, it is capable of storing, displaying, analyzing and controlling measurements, and it will indicate alarms in case of abnormities happen.
The elite V8 realizes the monitoring of physiological parameters by configuration with different parameter modules which include SpO2 (pulse oxygen saturation, pulse rate and SpO2 plethysmogram) with EDAN SpO2 module or Nellcor SPO2 module, NIBP (systolic pressure, diastolic pressure, mean pressure and pulse rate), TEMP, ECG, RESP, CO2, IBP, C.O. and AG.
The above is the maximum configuration for elite V8, the user may select different monitoring parameters in according with the requirement.
Elite V8 configures with 17-inch touch screen and build-in Lithium-ion battery. Besides, elite V8 supports software upgrade online and networking.
The provided document is a 510(k) Summary for a patient monitor and outlines the device's intended use and comparison to predicate devices. However, it does not contain specific acceptance criteria, study details, or performance data for the device. The document mostly focuses on regulatory classification, comparison to predicate devices, and a general statement of quality assurance measures.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and the reported device performance
- Sample sizes used for the test set and data provenance
- Number of experts used and their qualifications for ground truth
- Adjudication method
- MRMC comparative effectiveness study details or effect size
- 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 states:
"The elite V8 Patient Monitors have the following similarities to that which previously received 510(k) concurrence: have the same indications for use, use the similar operating principle, have the same or similar performance specifications."
And:
"Verification and validation testing was done on the Patient Monitor. This premarket notification submission demonstrates that Patient Monitor is substantially equivalent to the predicate device."
These statements indicate that specific performance data and detailed study information are not included in this particular 510(k) summary, but rather the device's equivalence to existing cleared devices is asserted based on similar design and presumed performance. To find the specific study details and acceptance criteria, one would typically need to refer to the full 510(k) submission or the referenced predicate device documentation, which are not part of the provided text.
§ 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.