(140 days)
The Precision Medical Oxygen Monitor is intended to measure the concentration of oxygen being delivered to the patient. The oxygen monitor is not intended as a life supporting device.
The Precision Medical, Inc. Oxygen monitor is made of two components, the monitor, and the sensor, attached by a coiled cable. The monitor houses the LCD screen, circuit board, key pad, and batteries. The sensor is a galvanic oxygen sensor that produces a millivolt signal that is proportional to partial pressure of oxygen being measured. The monitor converts the millivolt signal sent from the sensor to a percent oxygen concentration displayed on the LCD screen.
Here's a breakdown of the acceptance criteria and the study information for the Precision Medical, Inc. Oxygen Monitor, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (Predicate Maxtec) | Reported Device Performance (Precision Medical) | Test Method/Report |
|---|---|---|---|
| Measurement Range | 0.0 - 100% | 0.0 - 100% | Not specified |
| Resolution | 0.10% | 0.10% | Not specified |
| Accuracy & Linearity | ±1% of full scale at constant temperature, R.H. and pressure when calibrated at full scale. | ±1% of full scale at constant temperature, R.H. and pressure when calibrated at full scale. | Precision Medical Test # 699-1 |
| Total Accuracy | ±3% Actual Oxygen Level over full operating temperature range | ±3% Actual Oxygen Level over full operating temperature range | Not explicitly listed as a separate test, but implied by specs |
| Response Time | 90% of final value in approximately 15 seconds at 23°C | 90% of final value in approximately 12 seconds at 25°C | Not specified |
| Operating Temperature | 15°C - 40°C [59°F - 104°F] | 10°C - 45°C [50°F - 113°F] | Precision Medical Test # 699-4 |
| Storage Temperature | -15°C - 50°C [5°F - 122°F] | -15°C - 50°C [5°F - 122°F] | Not specified |
| Humidity | 0 - 95% [non-condensing] | 0 - 95% [non-condensing] | Precision Medical Test # 699-4 |
| Power Requirements | 2, AA Alkaline Batteries [2 x 1.5 Volts] | 4, AA Alkaline Batteries [4 x 1.5 Volts] | Not specified |
| Battery Life | Approximately 3000 hours in typical use | Approximately 1500 hours in continuous use. Non alarm condition | Not specified |
| Low Battery Indication | "LOW BAT" icon displayed on screen | "LOW BAT" icon displayed on screen | Not specified |
| Sensor Type | Maxtec MAX-250E galvanic fuel cell | Precision Medical 504877 Galvanic fuel cell | Not specified |
| Expected Sensor Life | >900,000% O2 Hours | >1,000,000% O2 Hours | Not specified |
| Alarm System | high/low alarms, flashing red LEDs, audible alarm beeper | high/low alarms, flashing red LEDs, audible alarm beeper | Not specified |
| Low Alarm Range | 18% - 99% | 18% - 99% | Not specified |
| High Alarm Range | 19% - 99% | 19% - 99% | Not specified |
| Alarm Accuracy | Exact to displayed alarm value | Exact to displayed alarm value | Not specified |
| Dimensions | 3.5"[W] x 5.5"[H] x 1.5"[D] [89mm x 140mm x 38mm] | 3.6"[W] x 5.4"[H] x 1.5"[D] [89mm x 140mm x 38mm] | Not specified |
| Weight | Approximately 0.92 lbs. [417g] | Approximately 1.11 lbs. [430g] | Not specified |
| Cable Length | 10 ft. [3m] | 10 ft. [3m] | Not specified |
| Diverter Fitting | fits industry standard, 15 mm "T" adapter | fits industry standard, 15 mm "T" adapter | Not specified |
| Electromagnetic Compatibility | Not explicitly stated as acceptance criteria, but tested for predicate | Complied with IEC 60601-1-2:2004 | Retlif Testing Laboratories Test Report No. R-2915P |
| Software Validation | Compliance with Guidance document: General Principles of Software Validation | Complied with Guidance document: General Principles of Software Validation, Final Guidance for Industry and FDA Staff | Not specified |
| Mechanical / Climatic | Not explicitly stated as acceptance criteria, but tested for predicate | Passed | Precision Medical Test # 699-4 |
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective). It only lists the tests performed.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the document. The tests performed are engineering and performance validation tests on the physical device itself (e.g., accuracy, temperature range), not on interpretations by experts.
4. Adjudication Method for the Test Set
This is not applicable as the tests described are technical performance measurements of the device, not analyses requiring expert adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study and Effect Size
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed, nor is it applicable to this type of device. The device is an oxygen monitor, which provides a direct measurement, not an AI-assisted diagnostic tool for human readers.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This is not applicable as the device is a physical oxygen monitor, not an algorithm. Its performance is inherent to its physical and electronic design. The data provided describes standalone device performance.
7. Type of Ground Truth Used
The ground truth used for these performance tests would be calibrated reference standards or known environmental conditions. For example, for "Accuracy & Linearity," the ground truth would be precisely measured oxygen concentrations and controlled temperature/humidity. For "Electromagnetic Emissions & Immunity," the ground truth would be established by the testing standards themselves.
8. Sample Size for the Training Set
This is not applicable as the Precision Medical, Inc. Oxygen Monitor is a hardware device that measures oxygen concentration using a galvanic fuel cell. It does not employ machine learning or AI models that require a training set.
9. How the Ground Truth for the Training Set Was Established
This is not applicable as there is no training set for this device.
§ 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).