(27 days)
The purpose and function of the OMNI 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 patient monitor is a comprehensive monitoring system with three or six 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 patient 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.
This 510(k) submission describes the Infinium Omni Patient Monitor, a device that measures various physiological parameters. The submission focuses on demonstrating substantial equivalence to a predicate device (Infinium OMNI II Patient Monitor, K103737) rather than providing a detailed clinical study demonstrating specific performance against acceptance criteria with associated numerical results.
Therefore, the requested information elements related to specific performance metrics, sample sizes, expert involvement, and ground truth for a clinical study are not explicitly present in the provided text. The submission relies on non-clinical data (electrical safety tests and software validation) and a comparison of technological characteristics to the predicate.
Here's an analysis of the provided information based on your request, highlighting what is present and what is not:
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided text, the submission does not contain specific acceptance criteria with corresponding numerical performance results for physiological measurements in the way a clinical study would typically present them. Instead, it relies on demonstrating compliance with recognized standards.
| Acceptance Criteria Category | Reported Device Performance / Assessment Method |
|---|---|
| Electrical Safety | "The Omni Patient monitor underwent several electrical safety tests to verify safety and effectiveness." |
| Compliance with: |
- ANSI/AAMI EC13:2002 Cardiac Monitors, Heart rate meters and alarms
- IEC 60601-1-2:2007 Medical electrical equipment - Part 1-2: General requirements for safety -Collateral standard: Electromagnetic compatibility - Requirements and tests
- ISO 9919:2005 Medical electrical equipment - particular requirements for the basic safety and essential performance of pulse oximeters.
- IEC 60601-2-27: (2005-08), Medical electrical equipment -- Part 2-27: Particular requirements for the safety, including essential performance, of electrocardiographic monitoring equipment.
- AAMI/ANSI SP10:2002 Manual, electronic or automated sphygmomanometers. (Cardiovascular) |
| Software Validation | "Software Validation" was performed. |
| Functional Equivalence | The device has the "same intended use and similar technological characteristics" as the predicate (Infinium OMNI II Patient Monitor K103737). Differences noted are physical (size, weight) and display characteristics (3-6 traces vs. 4, 6 or 8 traces). |
2. Sample size used for the test set and the data provenance
- Not explicitly stated. The submission focuses on non-clinical testing and comparison to a predicate, not a clinical test set with patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. There is no mention of a clinical test set requiring expert ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. There is no clinical test set mentioned that would require adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No. This is a patient physiological monitor, not an AI-assisted diagnostic device for human readers. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- While the device functions as a "standalone" monitor in the sense it provides measurements, the submission does not detail standalone algorithmic performance against a defined ground truth or reference standard in the context of, for example, diagnostic algorithms. The performance is assessed by compliance with electrical safety and performance standards for each measured parameter.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For the electrical safety and performance tests, the "ground truth" is often established by adherence to defined test protocols and reference measurements established by the specified standards (e.g., a known voltage/current for electrical safety, a calibrated pressure source for NIBP, a known oxygen saturation for SpO2, and a known heart rate for ECG testing). This is not "expert consensus" or "pathology" in the typical sense for clinical performance.
8. The sample size for the training set
- Not applicable. This submission does not describe a machine learning or AI algorithm that would require a training set.
9. How the ground truth for the training set was established
- Not applicable. No training set is mentioned.
§ 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).