(14 days)
The City Technology Medical replacement oxygen sensor is intended to replace the original oxygen-sensing component of an oxygen analyzer that measures oxygen concentration in breathing gas mixtures.
These medical Oxygen sensors are based on the amperometric electrochemical measurement principle. The sensors comprise a plastic body in which are two electrodes, a precious metal cathode and a lead anode immersed in a liquid electrolyte solution. Oxygen flows into the sensor through a solid membrane, which limits the flow and controls the output signal. Inside the sensor Oxygen reacts on the cathode to form hydroxyl ions. These hydroxyl ions then oxidise the metal anode. The electrons consumed at the cathode are supplied from the anode via the external circuit where a resistor is placed so that the voltage produced may be monitored. This voltage signal then constitutes a measure of the flux of Oxygen into the sensor and hence the partial pressure of Oxygen in front of the membrane.
This document describes the City Technology Medical Oxygen Sensors (MOX-1 through MOX-16), which are oxygen-sensing components designed to monitor oxygen concentration in breathing gas mixtures within medical devices like anesthesia machines, intensive care units, and incubators. The submission is for a 510(k) premarket notification, aiming to demonstrate substantial equivalence to a legally marketed predicate device.
Here's an analysis of the acceptance criteria and the study details:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" as a separate section with pass/fail thresholds. Instead, it presents a comparison table between the predicate device (Ceramatec CAG-10 Sensor) and the City Technology Medical Oxygen Sensors. The implication is that the City Technology sensors demonstrate performance at least equivalent to, or better than, the predicate device.
| Performance Characteristic | Predicate Device (CAG-10) | CTL MOX-1, 2, 3, 4, 7, 8 & 10 | CTL MOX-5, 6 and 9 | CTL MOX-16 |
|---|---|---|---|---|
| Measurement Range | 0-100% | 0-1500 mBar | 0-1500 mBar | 0-1500 mBar |
| T90 (Response Time to 90% of Signal) | 0.9999 | R2>0.9999 | R2>0.9999 | |
| Operating Life | >900,000 %O2 Hours | 1,600,000 %O2 Hours | >900,000 %O2 Hours | >650,000 %O2 Hours |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify the sample size used for performance testing. It presents performance characteristics as general specifications for the device families. There is also no information about the data provenance (e.g., country of origin, retrospective or prospective nature of studies).
3. Number of Experts Used to Establish Ground Truth and Qualifications:
This information is not applicable to this document. The device is a sensor (hardware component) measuring a physical quantity (oxygen concentration). The "ground truth" would be established by validated reference instruments or gas mixtures of known concentration, not by human experts.
4. Adjudication Method for the Test Set:
This information is not applicable for the same reasons as point 3.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
This information is not applicable. The device is a standalone sensor, not an AI-assisted diagnostic tool that would involve human readers interpreting images or data.
6. Standalone Performance Study:
Yes, a standalone performance assessment was conducted for the device. The table in point 1 presents the standalone performance characteristics of the City Technology Medical Oxygen Sensors. The device's operation is based on an amperometric electrochemical measurement principle, and its performance (e.g., T90, linearity, operating life, cross-interference) was evaluated and reported in comparison to the predicate device.
7. Type of Ground Truth Used:
The ground truth for evaluating the sensor's performance would have been established using known gas concentrations or calibrated reference instruments. For example, to assess linearity, the sensor would be exposed to various oxygen concentrations (e.g., 0%, 21%, 100% oxygen) and its output compared to the known values. Similarly, for cross-interference, the sensor would be exposed to specific interfering gases at known concentrations, and the impact on the oxygen reading would be measured. This implicitly relies on physical standards and calibrated equipment rather than expert consensus, pathology, or outcomes data.
8. Sample Size for the Training Set:
This information is not applicable. The MOX sensors are electrochemical sensors based on a well-understood physical principle. They are not AI/ML-based devices that require a "training set" in the computational sense. Their function is directly derived from their physical design and material properties.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable for the same reasons as point 8.
§ 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).