(87 days)
The MiniOX® 3000 Oxygen Monitor provides continuous, direct monitoring of oxygen mixtures in a wide variety of medical applications such as anesthesiology (e.g., anesthesia machines), respiratory therapy (e.g., respirators, ventilators, pediatric incubators), and oxygen therapy (e.g., oxygen tents). The MiniOX® 3000 Oxygen Monitor is to be used by trained health care professionals under the supervision, or on the order. of a physician in a hospital (or other clinical setting) and during emergency transport.
Battery operated and microprocessor controlled, the MiniOX® 3000 Oxygen Monitor measures oxygen concentrations in the 0 - 100% range. The performance features include a calibration function; high and low oxygen concentration alarms; low and depleted battery alarms: oxygen sensor indicator: automatic error detection: battery test and oxygen concentration alarm test.
The calibration function allows calibration of the device against room air (21% O.) or 100% O2. Audible and visual alarms alert the operator when monitor calibration is required. High and low oxygen concentration alarms may be set in the ranges of 19%-100% (high alarm) and 18%-99% (low alarm) or the default high/low settings may be used (50% and 18% respectively). Audible and visual alarms activate when oxygen concentrations fall below the preset (or default) low alarm setting or rise above the preset (or default) high alarm setting. The MiniOX® 3000 Oxygen Monitor detects low and depleted battery conditions and activates audible and visual alarms. The MiniOX® 3000 Oxygen Monitor also alarms for sensor disconnection or malfunction and for various internal operating errors.
The MiniOX® 3000 Oxygen Monitor conducts self checks at power-up (battery installation), turn-on, and during operation. Additionally, the monitor has two operator initiated test functions. The Alarm Test verifies the operation of the high and low oxygen level alams; the Battery Test assesses the relative remaining battery life.
The MiniOX® 3000 Oxygen Monitor consists of two components: the instrument and the oxygen sensor. The portable, hand-held instrument features a touch sensitive keypad; a liquid crystal display (LCD) that shows monitor status, continuous oxygen concentrations, and preset alarm levels; and two red light emitting diodes (LED) which serve as visual alarms. The back of the instrument case has a bail bar which allows the instrument to "stand" on a horizontal surface during monitoring operations. A plastic wedge on the back of the instrument slides into an optional bracket for mounting the instrument on a horizontal or vertical pole.
The oxygen sensor used in the MiniOX® 3000 Oxygen Monitor is the same oxygen sensor used in Mine Safety Appliances Company oxygen monitoring medical devices for the past 15 years. Connected to the instrument by a coiled cable, the galvanic oxygen sensor consists of a deflector assembly and a plastic housing containing two electrodes. A coiled cable connects the sensor to the instrument. Plugs at each end of the cable snap into jacks (one located in the sensor housing and one located in the instrument) and are held securely in place by twist collars.
In addition to the mounting bracket, the device has two accessories: a tee adapter and a retaining strap. The oxygen sensor is introduced into a breathing circuit through a Mine Safety Appliances Tee Adapter which connects two lengths of tubing. The sensor/tee assembly is positioned with the sensor deflector pointing downward to ensure that moisture does not collect on the sensor membrane. A Retaining Strap ensures that the sensor remains securely in place in the Tee Adapter.
The provided text describes the performance testing for the MiniOX® 3000 Oxygen Monitor. Here's a breakdown of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance:
The document doesn't explicitly state numerical acceptance criteria for each test in a detailed table. Instead, it refers to compliance with established standards and guidances. The reported device performance for all listed tests is "Pass," indicating that the device met the requirements outlined in those standards.
Here's a generalized table inferred from the text:
| Acceptance Criterion (Based on Standard/Guidance) | Reported Device Performance |
|---|---|
| Response Time (ANSI Z79.10 4.3.2.1) | Pass |
| Reading Accuracy (ANSI Z79.10 3.2.1.1) | Pass |
| Ambient Operating Temperature (ANSI Z79.10 3.2.3.1, FDA MDS 201-0004) | Pass |
| Storage Temperature (ANSI Z79.10 3.2.3.2, FDA MDS 201-0004) | Pass |
| Humidity/Condensation Effects (ANSI Z79.10 3.2.1.4) | Pass |
| Stability (ANSI Z79.10 3.2.1.2) | Pass |
| Electromagnetic Compatibility (ANSI Z79.10 3.2.3.4, FDA MDS 201-0004) | Pass |
| Shock and Vibration (ANSI Z79.10 3.2.3.3, FDA MDS 201-0004) | Pass |
| Battery Operation Time (FDA MDS 201-0004) | Pass |
| Audible Alarm Output (ANSI Z79.10 3.2.2.3.1, FDA MDS 201-0004) | Pass |
| Battery Reversal (reverse polarity) (FDA MDS 201-0004) | Pass |
| Shipping/Handling Shock Resistance (MIL-STD 516-4) | Pass |
| Fluid Spill (IEC 601-1, 529, FDA MDS 201-0004) | Pass |
| Function (Performance Features) (FDA Guidance) | Pass |
| Oxygen Alarm Accuracy (ANSI Z79.10 3.2.1.3, FDA MDS 201-0004) | Pass |
2. Sample size used for the test set and the data provenance:
- Sample Size: The document does not specify the exact number of MiniOX® 3000 Oxygen Monitor units tested for each criterion. It simply states that "the MiniOX® 3000 Oxygen Monitor was tested."
- Data Provenance: The study is described as "non-clinical performance testing," implying it was conducted as part of the device development and regulatory submission process by the manufacturer, Mine Safety Appliances Company. The country of origin for the data is not explicitly stated but is implicitly the United States, given the FDA guidances and ANSI standards referenced. The testing appears to be prospective as it was conducted to verify the device's performance against specifications before market release.
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. The testing described is for an oxygen monitor, which measures a physical parameter (oxygen concentration). The "ground truth" for such a device typically refers to known, calibrated reference values for oxygen concentration, temperature, humidity, etc., rather than expert interpretation of a complex medical image or signal. Therefore, human experts establishing "ground truth" in the sense of adjudication for medical diagnoses would not be applicable here. The "experts" involved would likely be engineers or technicians ensuring correct test setup and calibration according to the specified standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
An adjudication method like "2+1" or "3+1" is relevant for studies where subjective interpretation or diagnosis is involved, such as reading medical images. For the performance testing of an oxygen monitor, the results are objective measurements compared against predefined technical specifications from standards. Therefore, an adjudication method is not applicable and not mentioned. The "pass" results are determined directly by comparing measured values to the limits set by the referenced 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:
This is not applicable to the MiniOX® 3000 Oxygen Monitor. This device is an oxygen monitor, not an AI-assisted diagnostic tool that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
The performance described is essentially "standalone" in the sense that it evaluates the device's inherent ability to measure oxygen and perform its functions according to specifications, independent of human operators beyond basic setup and operation. However, the term "standalone" in AI context usually refers to an algorithm making decisions without human intervention. While the device operates automatically, it's not an "algorithm" in that sense. The tests assess the device's functionality as a standalone piece of equipment.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The ground truth used for this testing is based on established technical standards and guidances. For parameters like "Reading Accuracy," the ground truth would be precise, known oxygen concentrations (e.g., from calibrated gas mixtures). For "Temperature," it would be known ambient and storage temperatures. The device's performance is then compared to the acceptable ranges or thresholds defined in standards like ANSI Z79.10, FDA MDS 201-0004, and MIL-STD 516-4.
8. The sample size for the training set:
This is not applicable as the MiniOX® 3000 Oxygen Monitor is a hardware device with embedded firmware, not a machine learning or AI algorithm that requires a "training set" in the conventional sense. Its design and functionality are based on engineering principles and established oxygen sensing technology.
9. How the ground truth for the training set was established:
As there is no "training set" for this device, this question is not applicable.
§ 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).