(90 days)
The OxyMinder is intended for continuous monitoring of the concentration of oxygen being delivered to patients ranging from newborns to adults. This device can be used in the hospital and subacute settings. The monitor is not intended as a life supporting device or for diagnostics.
The OxyMinder is an air / oxygen blender mounted oxygen monitor capable of measuring the oxygen concentration from 18 to 100%. A Bio-Med specified oxygen sensor mounted to the blender outputs a voltage which is used by the OxyMinder to determine the concentration of oxygen. The OxyMinder calibrates at ambient air (21%) and 100% oxygen. The OxyMinder is software controlled. To measure the gas mixture of the blender the OxyMinder takes a sample of the gases to the sensor through a separate port and manifold which is separate from the gas pathway to the patient. This sample is then exhausted to the room. The OxyMinder sampling stream is not part of the gas pathway to the patient.
The OxyMinder is used for continuous monitoring of the concentration of oxygen delivered to patients via air oxygen blenders. The monitor provides the following features:
- Continuously displays the concentrated Oxygen level delivered to a patient.
- Accepts user inputs via touch screen or button (power button).
- Provides visual alarm messages, and audible alarms.
- Displays the current alarm setting levels (High and Low O2 alarms).
- Provides on-screen configuration tools such as O2 sensor calibration, touchscreen calibration, audio test, etc.
- Monitors and displays the battery level and power source.
- Ensures clean hospital airlines by automatically purging system periodically.
The OxyMinder is designed to be mounted to a Bio-Med Devices air / oxygen blender via a manifold that houses the oxygen sensor and a solenoid.
In addition to the primary function of monitoring oxygen concentration, the OxyMinder provides an automatic gas supply line purge function.
The provided text is related to a 510(k) premarket notification for the "OxyMinder" device, an oxygen gas analyzer. It describes the device, its intended use, and compares it to a predicate device (Maxtec MaxO2ME). The document states that "A series of non-clinical performance / bench testing was performed" and lists the types of tests, concluding that "The test results met the applicable standards and are similar to the reported performance of the predicate device." However, the document does not provide detailed acceptance criteria or the specific results of these tests. It only broadly states that the performance was similar to the predicate and met applicable standards.
Therefore, many of the requested details about the study cannot be extracted from this document.
Here's a summary of what can be inferred or explicitly stated:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance (OxyMinder) |
|---|---|
| Measurement Range: Intended for use with an air/oxygen blender which will not deliver oxygen below 18%. | 18% – 100% O2 |
| Resolution: (Implied to be sufficient for reading in 10% increments given blender knob resolution) | Displayed to nearest whole integer |
| Accuracy and Linearity: Similar to predicate which is ±1% of full scale at constant temperature, RH and pressure when calibrated at full scale. | ±1.0% of full scale at constant temperature and pressure |
| Total Accuracy: Similar to predicate which is ±3% Actual oxygen level over full operating temperature range. | ±2.5% Actual oxygen level over the full operating temperature range |
| Response Time: Similar to predicate which is 90% of final value in approx. 15 seconds at 23°C. | 90% of final value in approximately 6 seconds |
| Warm-up Time: None required. | None required |
| Operating Temperature: Similar to predicate which is 15°C – 40°C (59°F – 104°F). | 0° – 50°C [32° - 122° F] |
| Storage Temperature: Similar to predicate which is -15°C – 50°C (5°F – 122°F). | 0° - 40° C [32° - 104° F] |
| Atmospheric Pressure: Similar to predicate which is 800 - 1012 m Bars. | 345 - 2068 mBars |
| Humidity: Similar to predicate which is 0-95% (non-condensing). | 5 - 95% |
| Battery Life: (Implied to be sufficient for intended use with external power availability) | 16 hours at 100% brightness. |
| Low Battery Indications: Similar to predicate which is "LOWBAT" icon on LCD display. | On-screen icon & audible alarm |
| Expected Sensor Life: (Implied to be sufficient for intended use) | > 900,000 %O2 Hours |
| Low Oxygen Alarm Range: Similar to predicate which is 15%-99% (>1% lower than high alarm). | 18%-100% (>1% lower than high alarm) |
| High Oxygen Alarm Range: Similar to predicate which is 16%-99% (>1% higher than low alarm). | 19%-105% (>1% lower than low alarm) |
| Alarm Accuracy: Exact to display alarm value. | Exact to display alarm value |
| Compliance with Standards: Including IEC 60601-1, IEC 60601-1-2, IEC 60601-1-8, IEC 80601-2-55. | Met applicable standards |
| Software Verification and Validation: (Implicitly met standards) | Performed |
| Shelf-life / Aging: (Implicitly met standards) | Performed |
| Auto-purge functionality: (Implicitly met standards) | Performed |
| Battery Performance Testing: (Implicitly met standards) | Performed |
Study Details:
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- The document mentions "a series of non-clinical performance / bench testing" but does not specify the sample size for any of these tests nor the data provenance. It implies laboratory testing rather than patient data.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not provided. The testing appears to be bench/performance testing against specifications and standards, not expert-adjudicated clinical data.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not provided.
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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 or human-in-the-loop study was done or mentioned. This is a standalone oxygen analyzer, not an AI-assisted diagnostic tool.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, performance testing was done on the device (OxyMinder) as a standalone unit. The "Oxygen Accuracy with Blender" test refers to its performance when integrated with a Bio-Med Devices air/oxygen blender, but it's still about the device's accuracy rather than human interpretation.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the bench testing, the "ground truth" would be the known and controlled oxygen concentrations and environmental conditions used during calibration and testing against established performance standards and specifications.
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The sample size for the training set:
- Not applicable. This device is not described as using machine learning or AI that would require a 'training set' in the traditional sense. It's an oxygen gas analyzer, likely with embedded software and algorithms based on known physics and engineering principles for sensor readings.
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How the ground truth for the training set was established:
- Not applicable, as there's no mention of a training set for machine learning.
§ 868.1720 Oxygen gas analyzer.
(a)
Identification. An oxygen gas analyzer is a device intended to measure the concentration of oxygen in respiratory gases by techniques such as mass spectrometry, polarography, thermal conductivity, or gas chromatography. This generic type of device also includes paramagnetic analyzers.(b)
Classification. Class II (performance standards).