(217 days)
MySign® S is a handheld pulse oximeter with accessory sensors indicated for continuous non-invasive monitoring of the functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate for adult and pediatric (excluding neonatal and infant) patients in hospitals, hospital-type facilities, and mobile transport units. For professional use only.
The EnviteC MySign® S Pulse Oximeter is a handheld pulse oximeter monitor validated for use in portable applications, including out of hospital transport. The MySign® S Pulse Oximeter features large readable numeric displays for SpO2 and pulse rate and a pulse bar indicator or waveform for visual assessment of pulsation. The device has settable alarms and an audible pulse tone which varies with saturation level. The MySign® S is offered with a family of Reusable and Disposable SpO2 Sensors for adult and pediatric applications. MySign® PC Software may be used to obtain retrospective monitoring data from MySign® series monitors and to perform utility functions such as setting the institution identification.
The EnviteC MySign® S Pulse Oximeter, Accessory SpO2 Sensors, and MySign® PC Software are evaluated based on their performance in measuring functional oxygen saturation (SpO2) and pulse rate.
Here's an analysis of the acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Parameter | Acceptance Criteria (Stated or Implied) | Reported Device Performance |
|---|---|---|
| SpO2 Accuracy | ARMS = ± 2 % (70-100% saturation) | ARMS = ± 2 % (70-100% SpO2) (with SoftTip R3211-12 MySign); varies slightly by sensor type |
| SpO2 Range | 1-100% | 1-100% |
| Pulse Rate Accuracy | ± 3 BPM (30-250 BPM) | ± 3 BPM (30-250 BPM) |
| Pulse Rate Range | 0-300 BPM | 0-300 BPM |
2. Sample Size and Data Provenance for the Test Set
- Sample Size: The document does not explicitly state the number of subjects (the sample size) used in the clinical test. It mentions that "All testing was performed under an institutionally approved protocol with subject informed consent."
- Data Provenance: The clinical testing was performed to validate performance "under controlled hypoxia versus arterial oxygen saturation as determined by co-oximetry." This implies a prospective study design where subjects were intentionally desaturated. The country of origin of the data is not specified, but the submission is from a German company (EnviteC-Wismar GmbH by Honeywell).
3. Number of Experts and their Qualifications for Ground Truth
- The document implies that the ground truth for SpO2 was established by co-oximetry readings from arterial blood samples. This is a standard and highly accurate method for determining arterial oxygen saturation.
- The document does not mention the use of human experts to establish ground truth for the device's primary measurements (SpO2 and pulse rate). The gold standard for SpO2 measurement in these types of studies is the direct measurement of arterial blood gases using a co-oximeter, not expert consensus on visual assessment. Therefore, the concept of "number of experts" is not directly applicable in the context of establishing ground truth for SpO2 accuracy.
4. Adjudication Method for the Test Set
- There is no mention of an adjudication method in the context of the clinical accuracy testing. The ground truth was established by co-oximetry, which is a direct measurement, and thus expert adjudication would not be typical for this type of quantitative assessment.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or reported. This device is a pulse oximeter, and its performance is assessed against a gold standard (co-oximetry), not by comparing human reader performance with and without AI assistance.
6. Standalone Performance Study
- Yes, a standalone performance study was done for the algorithm (the pulse oximeter device itself). The clinical testing described directly assesses the accuracy of the EnviteC MySign® S Pulse Oximeter with its sensors in measuring SpO2 against co-oximetry, and pulse rate against what is presumed to be the co-oximeter's pulse rate measurement or an ECG/reference monitor. This is a standalone performance assessment of the device.
7. Type of Ground Truth Used
- The ground truth for SpO2 accuracy was established by arterial oxygen saturation as determined by co-oximetry. This is considered a highly accurate and direct measure for oxygen saturation.
8. Sample Size for the Training Set
- The document does not provide information regarding a "training set" or its sample size. Pulse oximeters typically rely on established physiological principles and spectrophotometric measurements. While their algorithms are developed and refined, the concept of a distinct "training set" for a machine learning model, as seen in AI/ML medical devices, is not explicitly detailed or a standard regulatory requirement for conventional pulse oximeters. The development process would involve calibration and internal testing, but not typically a labeled "training set" as understood in current AI contexts.
9. How the Ground Truth for the Training Set Was Established
- Since a "training set" is not explicitly mentioned or described, there is no information on how its ground truth was established.
§ 870.2700 Oximeter.
(a)
Identification. An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.(b)
Classification. Class II (performance standards).