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The MaxO2 ME+p is an oxygen monitor with integrated pressure monitoring intended for continuous monitoring of the concentration of oxygen and pressure being delivered to patients ranging from newborns to adults. It can be used in the hospital and sub-acute settings. The MaxO2 ME+p is not intended as a life-supporting device or life sustaining device.

Device Description

The MaxO2 ME +p is a battery powered oxygen and pressure monitor in a single assembly. The oxygen monitor measures the oxygen concentration from a gas source, displays these measured concentrations, and provides user selectable high and low oxygen alarms. It also the user to monitor pressure simultaneously and provides user selectable high and low pressure alarms.

AI/ML Overview

The MaxO2 ME+p device is an oxygen monitor with integrated pressure monitoring. The acceptance criteria and supporting study details are as follows:

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document compares the MaxO2 ME+p (proposed device) to two predicate devices: Maxtec - MaxO2 ME (K153659) for oxygen monitoring and Caradyne - Criterion 40 (K992101) for pressure monitoring.

Attribute	Acceptance Criteria (Predicate MaxO2 ME)	Reported Device Performance (MaxO2 ME+p)	Acceptance Criteria (Predicate Criterion 40)	Reported Device Performance (MaxO2 ME+p)
Oxygen Monitoring
Oxygen % Range	0.0 to 100%	0.0 to 100%	N/A	N/A (for pressure comparison)
Oxygen Resolution	0.1%	0.1%	N/A	N/A
Accuracy and Linearity	±1% of full scale at constant temperature, RH and pressure when calibrated at fill scale	±1% of full scale at constant temperature, RH and pressure when calibrated at fill scale	N/A	N/A
Total Accuracy (Oxygen)	±3% Actual oxygen level over full operating temperature range	±3% Actual oxygen level over full operating temperature range	N/A	N/A
Response Time	90% of final value in approx. 15 seconds at 23°C	90% of final value in approx. 15 seconds at 23°C	N/A	N/A
Low Oxygen Alarm Range	15%-99% (>1% lower than high alarm)	15%-99% (>1% lower than high alarm)	N/A	N/A
High Oxygen Alarm Range	16%-99% (>1% higher than low alarm)	16%-100% (>1% higher than low alarm) (Note: Proposed device allows 100%, predicate 99% - considered acceptable)	N/A	N/A
Pressure Monitoring	N/A (for oxygen comparison)	N/A (for oxygen comparison)
Pressure Measurement Range	N/A	N/A	Up to +99 cmH2O	-15 to +60 cmH2O (Note: Lower maximum range than predicate, but this difference is discussed and deemed acceptable)
Pressure Resolution	N/A	N/A	1 cmH2O	1 cmH2O
Display Resolution (Pressure)	N/A	N/A	0.5 cmH2O	0.5 cmH2O
Total Accuracy (Pressure)	N/A	N/A	± 1 cmH2O	± 1 cmH2O
Low Alarm Range (Pressure)	N/A	N/A	1-20 cmH2O	1 - 30 cmH2O (Note: Adjusted for lower max pressure, deemed acceptable)
High Alarm Range (Pressure)	N/A	N/A	5 - 99 cmH2O	1 – 60 cmH2O (Note: Adjusted for lower max pressure, deemed acceptable)
Alarm Delay (Pressure)	N/A	N/A	1-20 sec	3 seconds (Note: Shorter delay than predicate, deemed acceptable)
Zero Calibration (Pressure)	N/A	N/A	Yes	Yes
General
Indications for Use	Continuous monitoring of O2, newborns to adults, pre-hospital, hospital, sub-acute	Continuous monitoring of O2 and pressure, newborns to adults, hospital, sub-acute	Measurement of airway pressure with positive pressure devices, hospital, sub-acute, home care	Continuous monitoring of O2 and pressure, newborns to adults, hospital, sub-acute
Environments of Use	Pre-hospital, hospital and sub-acute settings	Hospital and sub-acute settings	Hospital, sub-acute institutions, home care	Hospital and sub-acute settings (Note: Not for home care like some predicates, deemed acceptable)
Patient Population	Newborns to adults	Newborns to adults	Not specified (implied similar)	Newborns to adults
Operating Temperature	15°C-40°C	15°C-40°C	15°C-45°C	15°C-40°C (Note: Slightly narrower range than one predicate, deemed acceptable)
Storage Temperature	-15°C-50°C	-15°C-50°C	-40°C-60°C	-15°C-50°C @ 95% RH (Note: Slightly narrower range than one predicate, deemed acceptable)
Atmospheric Pressure	800-1012 mBars	800-1013 mBars	Not specified	800-1013 m Bars
Humidity	0-95% (non-condensing)	0-95% (non-condensing)	15-95%RH	0-95% RH (Note: Slightly wider range for proposed device, deemed acceptable)
Power requirements	4 – AA Alkaline batteries	4 – AA Alkaline batteries	AC / DC	4x - AA alkaline batteries
Battery Life	Approx. 5000 hours	Approx. 5000 hours	Up to 24 hours	5000 hours (Note: Significantly longer battery life for proposed device, deemed acceptable advantage)
Standards	ES 60601-1, IEC 60601-1-2, IEC 60601-1-8, ISO 80601-2-55	ES 60601-1, IEC 60601-1-2, AIM 7351731:2017, IEC 60601-1-8, ISO 80601-2-55	IEC 601-1, IEC 601-1-2	ES 60601-1, IEC 60601-1-2, AIM 7351731:2017, IEC 60601-1-8, ISO 80601-2-55

2. Sample size used for the test set and the data provenance:

The document does not specify a sample size for a test set in terms of clinical data or patient samples.
The study primarily relies on non-clinical testing (bench testing and adherence to standards) to demonstrate performance.
No human clinical testing or animal testing was performed.
The data provenance is not applicable as it's not a study involving patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided in the document. Given that the testing was non-clinical (adherence to standards and bench testing), the "ground truth" would be established by the requirements of those standards and the accuracy of reference measurement equipment. Experts involved would be in engineering, quality assurance, and regulatory affairs, but specific numbers and qualifications are not detailed.

4. Adjudication method for the test set:

An adjudication method is not applicable as there was no study involving human readers or interpretation of results that would require consensus among experts. The testing involved verifying the device's performance against defined technical specifications and industry standards.

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 MRMC comparative effectiveness study was done. This device is an oxygen and pressure monitor, not an AI-powered diagnostic imaging device or a system designed to assist human readers in interpretation. Therefore, this type of study is not relevant to the MaxO2 ME+p.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

This question is not directly applicable in the context of this device. The MaxO2 ME+p is a standalone physical device (monitor) that measures oxygen concentration and pressure. Its performance is evaluated through non-clinical bench testing against established standards and specifications, not through an "algorithm only" performance study in the way it might be for a diagnostic AI. The device's functioning is its standalone performance without human input beyond its operation.

7. The type of ground truth used:

The "ground truth" for the performance evaluation was established by technical specifications, measurements from calibrated reference equipment, and compliance with recognized industry standards. These include:
- AAMI ANSI ES 60601-1: Medical electrical equipment safety and essential performance.
- IEC 60601-1-2: Electromagnetic Disturbances.
- AIM Standard 7351731: Electromagnetic Immunity Test for Exposure to Radio Frequency Identification Readers.
- IEC 60601-1-8: Alarm systems.
- ISO 80601-2-55: Respiratory gas monitors.
- ISO 10993-5, -10, -11, -18: Biocompatibility.
- ISO 18562-2, -3: Particulate material and VOCs.

8. The sample size for the training set:

This information is not applicable. This device is a hardware monitor, not a machine learning or AI algorithm that requires a training set of data.

9. How the ground truth for the training set was established:

This information is not applicable, as there is no training set for this type of device.

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