(133 days)
The SmartLinx Vitals Plus Patient Monitoring System is intended for monitoring and alarming of physiologic parameters, including non-invasive blood pressure (systolic, diastolic, and mean arterial pressure), pulse rate, functional arterial oxygen saturation (SpO2), and temperature, on adult, pediatric, and neonatal patients in hospital environments when used by clinical physicians or appropriate medical staff under the direction of physicians.
The SmartLinx Vitals Plus Patient Monitoring System operates on top of the SmartLinx Medical Device Information System (MDIS) to present patient information to the clinical user for active monitoring purposes at the point of care. SmartLinx Vitals Plus consists of the following components: SmartLinx Vitals Plus Application, SmartLinx Vitals Plus NIBP Module, Masimo uSpO2 Pulse Oximetry Cable, Exergen TAT-5000S Thermometer, Covidien FILAC 3000 Thermometer, SmartLinx Vitals Plus Alarm Hub, SmartLinx Neuron 2 Mobile Platform, and SmartLinx Early Warning Scoring System.
The provided text does not contain enough information about acceptance criteria or a study proving that the device meets specific performance metrics. It primarily focuses on the device's substantial equivalence to predicate devices and adherence to recognized safety and performance standards.
The document discusses:
- Device Description: What the device is and its components.
- New Functionality: The additions to the SmartLinx Vitals Plus Application, such as Intervals Mode for NIBP, physiological alarms, continuous SpO2 monitoring features, and integration of the Covidien FILAC 3000 Thermometer.
- Comparison to Predicate Devices: Tables detailing technical characteristics and their differences, and a discussion of why these differences do not raise new questions of safety or effectiveness.
- Safety and Performance Testing: A list of FDA recognized standards that the device complies with (e.g., for general safety, EMC, usability, alarms, software, NIBP, temperature, SpO2, battery, patient monitoring).
- Clinical Studies: A clear statement that clinical studies were not required to support substantial equivalence.
Therefore, I cannot extract the specifically requested information about acceptance criteria, detailed device performance, sample sizes for test/training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, or standalone performance, because this information is not present in the provided text.
The document states:
- "Extensive performance testing ensures that the SmartLinx Vitals Plus Patient Monitoring System performs as well as the indicated predicate devices and meets all of its functional requirements and performance specifications."
- "The subject of this premarket submission, the SmartLinx Vitals Plus Patient Monitoring System, did not require clinical studies to support substantial equivalence."
This indicates that while performance testing was done against specifications, the specific details of those tests, the acceptance criteria used, and the quantitative results are not included in this summary document.
§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).