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510(k) Data Aggregation
(172 days)
MaxO2ME
The MaxO2ME oxygen monitor is intended for continuous monitoring of the concentration of oxygen being delivered to patients ranging from newborns to adults. It can be used in the pre-hospital, hospital and sub-acute settings. The MaxO2ME is not intended as a life supporting device.
The MaxO-ME is a handheld oxygen analyzer/monitor capable of measuring the oxygen concentration from 0% to 100% in a sample gas. A MAX-550E oxygen sensor outputs a voltage which is used by the Max O2ME to determine the concentration of oxygen based on a calibration at room air or 100% oxygen. The MaxO2ME contains alarms that can be controlled by the user to set a maximum or minimum allowable oxygen concentration.
Below is an analysis of the provided text regarding the MaxO2ME oxygen monitor's acceptance criteria and studies.
1. Table of Acceptance Criteria and Reported Device Performance
The document outlines acceptance criteria implied by the "Performance Specifications" and the reported performance of the MaxO2ME device compared to a predicate device (Precision Medical PM5900 - K063096) and a reference device (MiniOX - K961644). The "Discussion" section for "Non-clinical Testing" states, "In all cases the proposed device passed or meets the acceptance criteria," but does not explicitly list the criteria themselves or the specific values for each test type in the Performance Testing section beyond the initial performance specifications table.
Based on the "Performance Specifications - The following is a list of the differences between the proposed device and the predicate" and the subsequent "Discussion" for performance, some criteria and performance points can be inferred:
| Performance Attribute | Predicate Device (PM5900) Acceptance Criteria (or comparable performance) | MaxO2ME Reported Device Performance | Reference Device (MiniOX) Performance (for context) |
|---|---|---|---|
| Measurement Range | 0.0 to 100% | 0.0 to 100% | (Not explicitly stated for MiniOX) |
| Resolution | 0.1% | 0.1% | (Not explicitly stated for MiniOX) |
| Accuracy and Linearity | ±1% of full scale (constant T, RH, P; calibrated at full scale) | ±1% of full scale (constant T, RH, P; calibrated at full scale) | (Not explicitly stated for MiniOX) |
| Total Accuracy | ±3% Actual oxygen level over full operating temperature range | ±3% Actual oxygen level over full operating temperature range | (Not explicitly stated for MiniOX) |
| Response Time | 90% of final value in 12 seconds at 25°C | 90% of final value in approx. 15 seconds at 23°C | 90% in 20 to 30 seconds |
| Warm-up Time | None required (predicate is 3 seconds less than 15s warm-up time of proposed device) | None required | (Not explicitly stated for MiniOX) |
| Operating Temperature | 10°C – 45°C (50°F – 113°F) | 15°C – 40°C (59°F – 104°F) | (Not explicitly stated for MiniOX) |
| Storage Temperature | -15°C – 50°C (5°F – 122°F) | -15°C – 50°C (5°F – 122°F) | (Not explicitly stated for MiniOX) |
| Atmospheric Pressure | Up to 8,000 ft. | 800 – 1012 mBars | (Not explicitly stated for MiniOX) |
| Humidity | 0-95% (non-condensing) | 0-95% (non-condensing) | (Not explicitly stated for MiniOX) |
| Battery Life | Approx. 1,500 – 2,000 hours, typical use | Approx. 5000 hours, typical use | (Not explicitly stated for MiniOX) |
| Expected Sensor Life | > 1,000,000% O2 Hours | > 1,500,000 % O2 Hours, over 2 years typical application | (Not explicitly stated for MiniOX) |
| Low Oxygen Alarm Range | 15% - 99% (>1% lower than high alarm) | 15% - 99% (>1% lower than high alarm) | 15 – 99% |
| High Oxygen Alarm Range | 18% - 99% (>1% higher than low alarm) | 16% - 100% (>1% higher than low alarm) | 16 - 100% |
| Alarm Systems (Audible) | Not explicitly detailed for audible | Nominal 975 Hz audio buzzer (IEC 60601-1-8) | Not explicitly detailed for audible |
Study Proving Acceptance Criteria:
The document states: "We performed a number of tests to demonstrate that the proposed device performed as intended."
The following non-clinical performance tests were conducted:
- ISO 80601-2-55 Performance of respiratory gas monitors
- ISTA2A Shipping Validation Test Report
- Sensor performance Test Report
- Gas leakage Test Report
- Interfering gas effects Test Report
- Temperature compensation Test Report
- Drift of measurement accuracy Test Report
- MaxO2ME Operating and Storage Environment Report
- Device Cleaning Report and Disinfection Test
- Measurement accuracy Test Report
- IEC 60601-1 Electrical safety
- IEC 60601-1-2 - EMC
- IEC 60601-1-8 - Alarms
- Shelf-life / Real-time
The document concludes: "In all cases the proposed device passed or meets the acceptance criteria."
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 specify the sample size for any test set or the data provenance. The tests listed are general performance and safety tests for a medical device, which typically involve device units rather than patient data.
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)
Not applicable. The tests performed are objective, non-clinical engineering and performance tests on the device itself, not requiring expert ground truth for interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. As noted above, the tests are objective, non-clinical performance and safety tests, not requiring adjudication of results from multiple reviewers.
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
Not applicable. This is not an AI/imaging device. No MRMC study was conducted. The device is an oxygen monitor, and its performance tests are related to its physical and functional specifications.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the studies conducted were standalone tests of the device itself ("algorithm only" in the sense of the device's functionality) without human-in-the-loop performance being evaluated. The device is an oxygen monitor and its performance is measured against technical specifications.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth for the performance and safety tests would have been established by calibrated reference equipment and standardized testing protocols (e.g., ISO and IEC standards). For example, a gas analyzer would be calibrated against known gas concentrations to determine its accuracy.
8. The sample size for the training set
Not applicable. This is not a machine learning or AI-based device, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable. As there is no training set for an AI/machine learning model, this question is not relevant.
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