(483 days)
The Model O2 is intended to provide continuous, direct patient monitoring of oxygen mixtures in a wide variety of medical applications such as anesthesiology (e.g., anesthesia and breathing machines), respiratory therapy (e.g., breathing circuits, respirators, ventilators and pediatric incubators), and oxygen therapy (e.g., oxygen concentrators, tents, masks and nasal cannulas). The Model O2 is designed to be used by trained health care professionals under the supervision of a physician in a hospital, clinic, or emergency medicine setting.
The Model 02 Fast Oxygen Analyzer consists of laser diode oxygen sensor, sampling pump, pressure sensor, flow and gas temperature controllers, displays, keypad, and alarm packaged in an instrument case. The oxygen concentration displayed is corrected with respect to any changes in barometric or ambient temperature. Calibration may be performed using the keypad and display prompts. Audible and visual alarms are available for low and high oxygen concentration and for low flow and high pressure. The unit is powered by an external 12 volt, 2 amp universal input power supply. Non-sterile inlet filters and airway adapter sets labeled "single patient use" remove water from the sampled gas.
The provided text describes the acceptance criteria and performance of the Oxigraf Model O2 Oxygen Analyzer through comparison with a predicate device, the MSA MiniOx III/3000. It's important to note that this document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than a full, independent clinical study report. Therefore, some of the requested information (like detailed sample sizes for training/test sets, number and qualifications of experts for ground truth, and MRMC studies) are not present in this type of submission.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly set by matching or improving upon the performance of the predicate device (MSA MiniOx III/3000). The table below summarizes the reported performance of both devices based on bench testing.
| Feature | Oxigraf Model O2 Oxygen Analyzer (Reported Performance) | MSA MiniOx III/3000 Oxygen Monitor (Predicate Performance) | Acceptance Criteria (Implicit) |
|---|---|---|---|
| Range | 5 - 100% | 0 - 100% oxygen | Comparable to predicate |
| Resolution | 0.1% | 0.1% | Comparable to predicate |
| Humidity Range | 0 - 95% RH | 5 - 95% RH | Comparable to predicate |
| Alarm | Yes, hi/low audible/visible | Yes, hi/low audible/visible | Comparable to predicate |
| Response Time (10-90%) | 133 ms @ 150 ml/min. (10 to 90%) | 8 sec @ 2000 ml/min. (10 to 90%) | Faster than predicate (achieved) |
| Response Time (0.25-99.75%) | 1.1 s @ 150 ml/min. | 147 s @ 2000 ml/min. | Faster than predicate (achieved) |
| Accuracy (Specified) | +/- 0.2% | +/- 1% @ constant pressure/temp | Better than predicate (achieved) |
| Linearity (Specified) | +/- 0.2% | +/- 1% @ constant pressure/temp | Better than predicate (achieved) |
| Accuracy + Linearity (Specified) | +/- 0.5% | +/- 2% @ constant pressure/temp | Better than predicate (achieved) |
| Cross-Sensitivity (Specified) | 0.2% all anesthetic gases | 0.5% Desflurane, 0.9% Halothane, 2.3% Methoxyflurane, 0.8% Nitrous Oxide | Better than predicate (achieved) |
| Pressure Correction | +/- 0.2%, 75 to 120 kPascal (Corrected) | Not corrected; % varies w. pressure | Better than predicate (achieved) |
| Temperature Correction | +/- 0.2%, 0 to 35 C (Corrected) | 3%, 0 to 40 C | Better than predicate (achieved) |
| Time to service | 10,000 hours | 1200 hours battery, 7500 hours sensor | Comparable/Better |
| Accuracy (Bench Test) | +/- 0.0% (reported, likely rounded or ideal) | +/- 0% @ constant pressure/temp (reported, likely rounded or ideal) | Comparable to predicate |
| Linearity (Bench Test) | +/- 0.2% | +/- 0.3% @ const. pressure/temp | Better than predicate (achieved) |
| Accu. + Lin. (Bench Test) | +/- 0.2% | +/- 0.3% @ const. pressure/temp | Better than predicate (achieved) |
| Cross-Sensitivity (Bench Test) | +0.1%, -0.3%, all anesthetic gases | 0.4% Desflurane, 1.0% Halothane, 0.9% Isoflurane, 0.8% Nitrous Oxide | Better than predicate (achieved) |
| Pressure (Bench Test) | +/- 0.2%, 80 to 110 kPascal (Corrected) | Not corrected; % varies w. pressure | Better than predicate (achieved) |
| Temperature (Bench Test) | +/- 0.2%, 0 to 35 C (Corrected) | 3%, 0 to 40 C | Better than predicate (achieved) |
| Humidity | Not corrected | Not corrected | Comparable to predicate |
Study Proving Device Meets Acceptance Criteria:
The study proving the device meets the acceptance criteria is referred to as "Extensive bench testing" and "actual laboratory bench testing."
2. Sample Size for the Test Set and Data Provenance
- Sample Size: The document does not explicitly state a specific numerical sample size for the test set (number of measurements, gas mixtures, or environmental conditions tested). It refers to "certified calibration gas mixtures" and "common anesthetic and atmospheric gases."
- Data Provenance: The data provenance is from laboratory bench testing. The country of origin is not explicitly stated, but the manufacturer (Oxigraf, Inc.) is based in Mountain View, CA, USA, suggesting the testing likely occurred in the USA. The testing is prospective in the sense that the device was actively tested under controlled conditions.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
- This information is not provided. For a device like an oxygen analyzer, the "ground truth" for gas concentrations would typically be established by using certified calibration gas mixtures with known, precise oxygen concentrations. These standards are traceable to national or international measurement standards, rather than relying on human expert consensus.
4. Adjudication Method for the Test Set
- Not applicable in the context of bench testing for an oxygen analyzer. The "ground truth" is derived from the certified calibration gases, not from disputed human readings requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for imaging devices or diagnostic algorithms where human interpretation is involved. The Oxigraf Model O2 is a direct measurement device, not an AI-assisted diagnostic tool.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
- Yes, a standalone performance evaluation was done. The "Extensive bench testing" describes the performance of the device (the "algorithm only," in a sense, as it performs its measurement functions) in isolation, measuring known gas concentrations and responding to various environmental conditions. There is no human interaction explicitly described as part of the performance measurement beyond setting up the test conditions and observing the output.
7. The Type of Ground Truth Used
- The type of ground truth used was certified calibration gas mixtures. These mixtures have precisely known oxygen concentrations, serving as the "gold standard" against which the device's measurements (accuracy, linearity) were compared.
8. The Sample Size for the Training Set
- The document does not explicitly state a "training set sample size." For a device that measures physical properties based on principles of spectroscopy, the "training" (calibration) process typically involves using a small number of known calibration gases (e.g., 20.9% and 100% oxygen as mentioned for calibration in the device description). There isn't an "AI training set" in the conventional sense for this type of hardware-based measurement device.
9. How the Ground Truth for the Training Set Was Established
- The ground truth for what could be considered the "training set" (calibration gases) is established by using certified calibration gas mixtures. The document states: "Calibration is recommended whenever a humidity change occurs or at least once every 400 hours" and describes the process of using "two cal gas values... 20.9 and 100%," where the operator introduces the "appropriate cal gas" and the device is then adjusted ("Set key records new cal scale factors reducing the deviation to zero"). This implies the known values of these certified gases serve as the ground truth for calibration.
§ 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).