(146 days)
The purpose and function of the AXEO 3 patient monitor basic physiological parameters including
- · ECG waveform derived from 3 or 5 lead measurements
- · Heart Rate
- · NIBP (systolic, diastolic, and mean arterial pressure)
- · SpO2
- · Respiration
- · Temperature up to 2 channels (Dual Temperature)
The target population is for adult, neonate and pediatric patients. It may be used as bedside or portable monitor and be used in all hospitals and hospital-type facilities such as clinics and emergency room facilities. It is to be used under the direct supervision of a licensed healthcare practitioner.
This device is not intended for use as an apnea monitor.
Prescription Use: Federal law restricts this device to sale by or on the order of a physician.
The Axeo 3 Patient Monitor is a comprehensive monitoring system with up to 8 traces compiling, processing, and displaying data from up to six different parameters: ECG. Heart Rate. NIBP. SoO2. Respiration, and Temperature. It integrates parameter measuring modules, a display, and a recorder in one device, featuring compactness, light weight, and portability.
A built-in rechargeable battery facilitates off-AC-power transport of the patient providing at monitoring from a fully charged battery. The battery recharges when AC power is reconnected to the monitor.
The associated accessories include:
- ECG Cable
- . SpO2 Finger Probes
- . Blood Pressure Cuffs
- Temperature Probe ●
- . Power Supply with Power Cord
- . User's Manual
The provided text describes the Axeo 3 Patient Monitor, which is a physiological monitor. The document extensively details performance data, including compliance with various international standards for safety and performance related to its different functions (ECG, alarms, SpO2, NIBP, temperature, and battery).
Here's an analysis of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document provides a list of performance tests conducted and the standards of compliance. It doesn't explicitly state specific numerical acceptance criteria (e.g., "HR accuracy ±2 bpm") alongside reported device performance values. Instead, it refers to compliance with established international standards.
| Performance Test Category | Standard of Compliance |
|---|---|
| Safety and Performance (General) | AAMI/ANSI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text) |
| EMC Safety and Performance | IEC 60601-1-2 Edition 4.0 2014-02 |
| ECG Safety and Performance | IEC 60601-2-27 Edition 3.0 2011-03 |
| Alarm Systems Safety and Performance | IEC 60601-1-8: 2006 (Second Edition) + Am.1: 2012 for use in conjunction with IEC 60601-1: 2005 (Third Edition) + Am.1: 2012 |
| Multifunction Patient Monitoring Safety and Performance | IEC 60601-2-49 (Second Edition): 2011 |
| SpO2 Safety and Performance | ISO 80601-2-61 First edition 2011-04-01 |
| NIBP Safety and Performance | IEC 80601-2-30 Edition 1.1 2013-07 |
| Temperature Safety and Performance | ISO 80601-2-56:2009 (First Edition) for use in conjunction with IEC 60601-1:2005 (Third Edition) |
| Biocompatibility Testing | Accessories are "well characterized chemically and physically," have "long history of safe use," and "FDA cleared through the 510(k) Premarket Notification process and have been tested for biocompatibility." |
| Electrical Safety | IEC60601-1 standards |
| Electromagnetic Compatibility (EMC) | IEC60601-1-2 standard |
| Software Verification and Validation Testing | FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software in Medical devices" |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly mention the sample size used for performance testing (e.g., number of patients, number of readings). It states that "The Axeo 3 Patient Monitor underwent tests according to several different performance standards." These are likely bench tests and compliance tests rather than clinical studies with human subjects. The data provenance (country of origin, retrospective/prospective) is not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the document. The performance tests seem to be primarily against established technical standards and reference devices/simulators, rather than requiring expert adjudication of ground truth for novel diagnostic outputs.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not mention any adjudication method. This type of method is typically used in clinical studies for diagnostic devices, which does not appear to be the nature of the "performance data" described here.
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
An MRMC comparative effectiveness study was not done. The Axeo 3 Patient Monitor is a physiological monitoring device, not an AI-assisted diagnostic tool that would typically involve human readers interpreting outputs.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Yes, the performance testing described appears to be standalone (algorithm/device-only performance) against established standards and simulated inputs, not involving human interpretation or interaction as part of the core performance evaluation described. The document states "The Axeo 3 Patient Monitor underwent tests according to several different performance standards".
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the performance tests, the "ground truth" implicitly used is the established accuracy and performance specifications outlined in the referenced international standards (e.g., IEC, ISO, AAMI/ANSI). These standards dictate acceptable deviations from true physiological values or the proper functioning of alarms and measurements. For example, for NIBP, the ground truth would be a highly accurate reference blood pressure measurement device used in the testing.
8. The sample size for the training set
The document describes the Axeo 3 Patient Monitor as a device that measures and displays basic physiological parameters. It is not an AI/machine learning device that would typically involve a "training set" in the conventional sense. The "software verification and validation testing" mentioned refers to the quality assurance and reliability of the device's embedded software, not the training of a machine learning model. Therefore, "training set sample size" is not applicable.
9. How the ground truth for the training set was established
As the concept of a "training set" is not applicable to this device, the establishment of ground truth for it is also not applicable.
§ 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).