(177 days)
The oxygen measuring device MySign® O is designed for continuous or spot monitoring of inspired oxygen concentrations in breathing gas.
MySign® O can be used for monitoring the breathing gases dispensed by the following devices:
Anaesthesia breathing systems
Respiratory equipment
Infant incubators
Oxygen therapy systems
The system is suitable for use inside hospitals as well as during transport (except by air), emergencies, and artificial respiration provided at home.
The EnviteC MySign® O Oxygen Measuring Device is a hand held oxygen monitor which uses the established technology of the EnviteC electrogalvanic oxygen sensor type OOM111. The EnviteC OOM111 medical oxygen sensor has been previously evaluated and cleared under 510(k) K082655.
The MySign® O Oxygen Measuring Device incorporates a medical oxygen sensor placed in the inspired air path or gas supply, a sensor cable, and a monitor to display the measurements. The device is intended for continuous or spot monitoring of inspired oxygen concentrations in breathing gas and provides settable low and high alarm limits.
The optional MySign® PC Software can be used to configure MySign® devices and to transmit data from the device to the PC for the readout of measurement data which is stored in the memory of MySign® monitor. The PC software is not intended for diagnostic functions nor will it influence essential performance functions of the monitor - the MySign® O monitor will not perform measurements when PC connected.
Here's a breakdown of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text only explicitly states the acceptance criteria for a general category and does not detail specific numerical targets or thresholds for each test within that category. It also doesn't provide specific numerical performance results beyond stating that the device "met test acceptance criteria."
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Linearity | Met test acceptance criteria established by the respiratory gas monitoring standard. |
| Measurement Accuracy | Met test acceptance criteria established by the respiratory gas monitoring standard. |
| Drift | Met test acceptance criteria established by the respiratory gas monitoring standard. |
| Medical device electrical safety | Tested in accordance with current applicable standards (e.g., IEC 60601-1, IEC 60601-1-2, ISO 21647, IEC 60601-1-8). |
| Electromagnetic compatibility | Tested in accordance with current applicable standards (e.g., IEC 60601-1-2). |
| Risk Management | Performed in accordance with ANSI/AAMI/ISO 14971. |
| Software Validation | Performed in accordance with IEC 62304 and FDA/ODE Guidance. |
| Biocompatibility | Accessories tested to meet EN ISO 10993. |
2. Sample size used for the test set and the data provenance
The document does not specify a "test set" in the context of clinical or performance data with a sample size. The testing described refers to bench testing of the device and its components. No patient data or clinical data is mentioned for testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No ground truth based on expert assessment of a test set is mentioned. The ground truth for the technical performance tests would be established by reference standards or direct measurement instruments.
4. Adjudication method for the test set
Not applicable. No adjudicated test set is mentioned.
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 device is an oxygen measuring device and doesn't involve human readers or AI assistance in the way a diagnostic imaging AI would.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This refers to a standalone performance study in the context of an algorithm. The device, an oxygen monitor, is itself a standalone measuring device. Its performance was assessed through bench testing as described. There is no mention of a human-in-the-loop aspect for its core function.
7. The type of ground truth used
For the linearity, measurement accuracy, and drift tests, the "ground truth" would have been established by precisely controlled oxygen concentrations generated by calibrated equipment or reference standards. For electrical safety, EMC, risk management, software, and biocompatibility, the ground truth refers to compliance with the respective recognized standards.
8. The sample size for the training set
Not applicable. This device is a measurement device with established physical principles, not a machine learning or AI algorithm that requires a training set of data.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of 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).