(126 days)
The Disposable SPO2 Sensor is indicated for continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) for adult patients weighing greater than 40 kg at hospital facilities.
The proposed device, Disposable SpO2 Sensor is accessory to the oximeter, which is intended for continuous monitoring of functional arterial oxygen saturation and pulse rate in non-invasive with U.S. legally marketed oximeter. It is only intended for adult. The sensor shall be connected with the corresponding monitor (Nellcor N-600). Oxygenation of blood is measured by detecting the infrared and red-light absorption characteristics of deoxygenated hemoglobin and oxygenated hemoglobin, which consists of a probe attached to the patient's finger. The sensor is connected to a data acquisition system which is used to calculate and display oxygen saturation levels and heart rate conditions. Each sensor has two LEDs, emitting both red and infrared light, and a photodiode. Red and infrared light lit alternately according to certain sequence, when the fingertips of capillary repeatedly with the heart pumps blood congestion, light emitting diode after blood vessels and projected onto a photodiode, photodiode can be induced to change with pulse light intensity, the electrical signals in the form of change. Then the received signal is forwarded to the corresponding oximeter that amplifies the signal and an algorithm that calculates the ratio. By measuring the wave crest of the pulse wave and the absorbance of the trough, SpO2 is calculated to obtain the correct oxygen saturation value. The saturation value is determined by the percentage ratio of the oxygenated hemoglobin (HbO2) to the total amount of hemoglobin (Hb).
The provided text describes a 510(k) premarket notification for a Disposable SpO2 Sensor and includes information about its performance data. However, it does not contain a detailed study proving the device meets specific acceptance criteria in the format requested. While it states that clinical studies were conducted to verify accuracy and that the device complies with ISO 80601-2-61:2017, the specifics of those studies (sample size, ground truth methodology, expert qualifications, etc.) are lacking.
Therefore, I will extract what is available and indicate where information is not provided in the document.
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (Predicate Device) | Reported Device Performance (Subject Device) |
|---|---|---|
| SpO2 Range | 70% - 100% | 70% - 100% |
| SpO2 Accuracy | ±3% | ±3% |
| PR Range | 35 bpm - 240 bpm | 30 bpm - 250 bpm |
| PR Accuracy | ±2 bpm | ±3 bpm |
| Sterility | No | No |
| Usage | Disposable | Disposable |
| Electrical Safety | Complied with IEC 60601-1 | Complied with IEC 60601-1 |
| EMC | Complied with IEC 60601-1-2 | Complied with IEC 60601-1-2 |
| Performance | Complied with ISO 80601-2-61 | Complied with ISO 80601-2-61 |
| Biocompatibility | Complied with ISO 10993-5 | Complied with ISO 10993-5 |
| Skin Irritation | Complied with ISO 10993-10 | Complied with ISO 10993-10 |
| Sensitization | Complied with ISO 10993-10 | Complied with ISO 10993-10 |
2. Sample size used for the test set and the data provenance
The document states: "Clinical hypoxia test results were obtained in human adult volunteers to validate the accuracy of disposable SpO2 Sensor versus arterial oxygen saturation (SaO2) as determined by co-oximetry."
- Sample Size (Test Set): Not specified.
- Data Provenance: Human adult volunteers, prospective study (clinical hypoxia test). Country of origin is not specified, but the submission sponsor and correspondent are based in Shenzhen, China.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
4. Adjudication method for the test set
- Adjudication Method: Not specified. The ground truth was established by "co-oximetry," which is an objective measurement rather than expert consensus on images.
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
This is an accessory device (SpO2 sensor) for an oximeter, not an AI-powered diagnostic system involving human readers. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable and was not performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the performance evaluation of the Disposable SpO2 Sensor for SpO2 accuracy and PR accuracy is a standalone assessment of the device's measurement capabilities. The clinical hypoxia test specifically aims to validate the accuracy of the device against a reference standard (co-oximetry). There is no "human-in-the-loop" component in the performance of the sensor itself, as it is a measurement device.
7. The type of ground truth used
- Type of Ground Truth: Arterial oxygen saturation (SaO2) as determined by co-oximetry, which is considered an objective, established medical measurement for blood oxygen levels.
8. The sample size for the training set
The document does not mention a "training set" in the context of machine learning. The device's performance is verified through clinical testing against a reference standard rather than through algorithm training on a dataset.
9. How the ground truth for the training set was established
Not applicable as no training set for a machine learning algorithm is discussed. The device is a direct measurement sensor.
§ 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).