(162 days)
The purpose and function of the OMNI II Patient monitor is to monitor ECG, heart rate, NIBP (systolic, diastolic, and mean arterial pressures), SpO2, respiration, and temperature, for adult, neonate and pediatric patients. It may be used as a bedside or portable monitor and be used in all hospitals and hospital type facilities such as clinics and emergency room facilities.
The OMNI II monitor is a comprehensive monitoring system with four, six or eight traces compiling, processing, analyzing and displaying data from up to eight different patient parameters. It integrates parameter measuring modules, display and recorder in one device, featuring in compactness, lightweight and portability. Built-in battery facilitates transportation of patient. The OMNI II monitor can be powered by an internal battery pack that provides 1 hour of monitoring from fully charged batteries. The batteries are continuously recharged when AC power is connected to the monitor.
The Infinium Omni II Patient Monitor is a physiological monitoring system that measures ECG, heart rate, NIBP, SpO2, respiration, and temperature for adult, neonate, and pediatric patients. It is intended for use as a bedside or portable monitor in various hospital-type facilities.
Here's an analysis of its acceptance criteria and the supporting study:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text doesn't specify numerical acceptance criteria for the device's performance (e.g., accuracy ranges for NIBP, SpO2, etc.). Instead, the device's performance is demonstrated by its compliance with recognized industry standards for safety and effectiveness.
| Acceptance Criteria (Demonstrated by Compliance with Standards) | Reported Device Performance (Compliance) |
|---|---|
| Electrical Safety & Cardiac Monitoring: Ensure safe electrical operation and accurate cardiac rhythm and heart rate monitoring. | Complies with ANSI/AAMI EC13:2002 (Cardiac Monitors, Heart rate meters and alarms) and IEC 60601-2-27: (2005-08) (Medical electrical equipment - Part 2-27: Particular requirements for the safety, including essential performance, of electrocardiographic monitoring equipment). |
| Electromagnetic Compatibility (EMC): Ensure the device functions correctly in its intended electromagnetic environment without causing or being susceptible to undue electromagnetic interference. | Complies with IEC 60601-1-2:2007 (Medical electrical equipment - Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests). |
| Pulse Oximetry Performance: Ensure accurate and reliable measurement of blood oxygen saturation. | Complies with ISO 9919:2005 (Medical electrical equipment - particular requirements for the basic safety and essential performance of pulse oximeters). |
| NIBP (Non-Invasive Blood Pressure) Performance: Ensure accurate and reliable measurement of non-invasive blood pressure. | Complies with AAMI/ANSI SP10:2002 (Manual, electronic or automated sphygmomanometers). |
| Software Validation: Ensure the software operates as intended and meets its specified requirements. | Software Validation was conducted. (Specific details of validation methods or results are not provided beyond the statement that it was performed.) |
| Overall Safety and Effectiveness: The device is safe and effective for its intended use. | Based on the conclusions of all listed tests, it is determined that the Omni II patient monitor is safe and effective. |
2. Sample Size Used for the Test Set and Data Provenance
The provided summary does not specify sample sizes for any test sets related to clinical performance data. The performance testing mentioned is primarily focused on compliance with recognized electrical safety and performance standards. These standards often have their own specific testing protocols, which may involve various samples or simulated environments, but details are not provided within this document.
The document does not mention any patient data or clinical data provenance. The testing appears to be primarily bench testing and software validation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
This information is not applicable or not provided in the given document. The "ground truth" for compliance with electrical safety and performance standards typically relies on standardized test methods and calibrated equipment rather than expert human evaluation to establish a clinical ground truth.
4. Adjudication Method for the Test Set
This information is not applicable or not provided as the performance testing described doesn't involve subjective expert review or adjudication of results. The tests are based on objective measurements against established standard requirements.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC comparative effectiveness study was not done or is not mentioned in this document. This type of study is typically performed for AI or diagnostic imaging devices to evaluate the impact of the device on human reader performance. The Omni II Patient Monitor is a physiological monitoring device, and its safety and effectiveness are established through compliance with technical standards, not typically through MRMC studies.
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)
A standalone performance study, as typically understood for an AI algorithm without human intervention, was not performed or described in this document. The device itself is a physiological monitor that provides data for clinicians; it's not an AI analysis tool in the described context. Its "performance" is demonstrated by its adherence to the technical specifications outlined in the standards.
7. The Type of Ground Truth Used
The "ground truth" for the performance testing of the Omni II Patient Monitor is established by meeting the requirements and parameters defined in the referenced industry standards. For example, an NIBP measurement system is considered "accurate" if its readings fall within the specified error margins when compared to a reference standard, as outlined in AAMI/ANSI SP10:2002. Similarly, the performance of the pulse oximeter is validated against the requirements of ISO 9919:2005, which typically includes comparison against co-oximetry reference values or simulated physiological conditions.
8. The Sample Size for the Training Set
This information is not applicable or not provided. Physiological monitors like the Omni II typically rely on established measurement principles and software algorithms, not machine learning models that require a "training set" of data in the AI sense.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable or not provided for the same reason as point 8. The device's functionality is based on established engineering principles and validation against industry standards, not on a machine learning training paradigm.
§ 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).