(74 days)
The EnviteC Medical Oxygen Sensors are intended to replace the original oxygen-sensing component of an oxygen analyzer that measures oxygen concentration in breathing gas mixtures.
Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.
The subject of this 510(k) is a family of EnviteC Medical Oxygen Sensors which may be used as industry replacement types with various medical inspired-oxygen measuring devices.
The EnviteC Medical Oxygen Sensors all utilize the commonly accepted electro-galvanic operating principle with defined variations in the mounting configuration and electrical connections to correspond to common industry family replacement types.
The provided text describes the EnviteC Medical Oxygen Sensors and its 510(k) summary. However, it does not include detailed information regarding specific acceptance criteria, a separate study proving its capabilities, or the methodology for establishing ground truth for a training set. The device is a physical sensor, not an AI/ML algorithm, which explains the absence of some of the requested information.
Here's a breakdown of the available information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The text states that the sensors were evaluated against applicable standards for respiratory gas monitors and "met all of the performance criteria." However, the specific quantitative acceptance criteria or the reported performance values are not provided.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | "met all of the performance criteria" including signal characteristics in the presence of temperature, pressure, humidity, and interfering gases. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly mentioned. The text indicates "compliance tests included evaluation of basic safety, mechanical characteristics, and environmental operation and storage conditions" and "evaluation of device performance characteristics." However, the number of sensors tested or the amount of data collected for these evaluations is not specified.
- Data Provenance: The testing was conducted by EnviteC-Wismar GmbH (Germany), implying the data originated from their internal testing processes. The text does not specify if the tests were retrospective or prospective, but the context generally suggests prospective testing during device development and validation.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This question is largely not applicable in the context of a physical oxygen sensor's performance evaluation. The "ground truth" for sensor performance is typically established through calibrated reference instruments and defined environmental conditions, not through expert human interpretation. Therefore, there's no mention of experts establishing a ground truth for a test set in the way it would be done for, for example, image analysis.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods like 2+1 or 3+1 are used for human expert review of complex data (e.g., medical images) to establish a consensus ground truth. For a physical sensor, performance is measured against established physical standards and calibrated instruments, not subjective expert judgment that requires adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. The document is for a physical oxygen sensor. MRMC studies are typically performed for diagnostic tools that involve human interpretation, often in the field of AI/ML, to assess the impact of the tool on human reader performance. This type of study is not relevant to the described device.
6. Standalone Performance Study
Yes, implicitly. The "Non-Clinical Tests Submitted" section describes the evaluation of the sensors' performance characteristics independently. The sensors were "evaluated for device performance characteristics including signal characteristics in the presence of temperature, pressure, humidity, and interfering gases." This constitutes a standalone performance evaluation of the device itself, without human-in-the-loop.
7. Type of Ground Truth Used
The ground truth for evaluating the EnviteC Medical Oxygen Sensors would be based on:
- Calibrated Reference Measurements: Oxygen concentration, temperature, pressure, humidity, and the presence of interfering gases would be precisely controlled and measured using highly accurate and calibrated reference instruments.
- Established Physical Standards: Compliance to applicable elements of standards for respiratory gas monitors indicates comparison against predefined benchmarks and acceptable ranges of performance.
Therefore, the ground truth is derived from instrumentation and physical standards, not expert consensus, pathology, or outcomes data in the usual sense.
8. Sample Size for the Training Set
Not applicable/Not specified. This device is a physical sensor operating on "electro-galvanic operating principle." It is not an AI/ML algorithm that requires a "training set" in the computational sense. The device's operational parameters are inherent to its design and manufacturing, not learned from data.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As the device is not an AI/ML algorithm, there is no training set or ground truth established in this manner. The device's functionality is determined by its physical and chemical properties and engineering design.
§ 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).