(254 days)
The devices are intended for spot checking or continuous monitoring of functional arterial oxygen saturation and pulse rate in non-invasive oximeter equipment. The sensors are reusable depending on models, and are intended for adult, pediatric or infant, depending on models. They shall be used in healthcare settings.
The proposed device, SpO2 Sensors are accessories to the oximeters, which are intended for spot checking or continuous monitoring of functional arterial oxygen saturation and pulse rate in noninvasive U.S. legally marketed oximeters or patient monitors. The sensors are reusable or disposable depending on models, and are intended for adult, pediatric or infant, depending on models.
The proposed devices measure, along with the corresponding oximeters, non-invasively, the arterial oxygen saturation of blood. The measurement method is based on the red and infrared light absorption of hemoglobin and oxyhemoglobin. Each sensor has two LEDs, emitting both red and infrared light, and a photodiode. The light is emitted through human finger and received by a photodiode. Then the received signal is forwarded to the corresponding oximeter that amplifies the signal and an algorithm that calculates the ratio. The saturation value is determined by the percentage ratio of the oxygenated hemoglobin (HbO2) to the total amount of hemoglobin (Hb).
The patient contact components include cable and sensor. The contact level is surface device and contact duration is limited contact (less than 24h).
This document describes the validation of SpO2 Sensors. Here's a breakdown of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance (Proposed Device) | Predicate Device Performance for Comparison |
|---|---|---|
| SpO2 Range | 70-100% | 70-100% |
| SpO2 Accuracy | ± 3% @ 70-100% | ± 3% @ 70-100% |
| PR Range | 30-245 bpm | 30-250 bpm |
| PR Accuracy | ± 3 bpm | ± 3 bpm |
| Sterility | No | No |
| Usage | Reusable & Disposable | Reusable & Disposable |
| 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: Cytotoxicity | Complied with ISO 10993-5 | Complied with ISO 10993-5 |
| Biocompatibility: Skin Irritation | Complied with ISO 10993-10 | Complied with ISO 10993-10 |
| Biocompatibility: Sensitization | Complied with ISO 10993-10 | Complied with ISO 10993-10 |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document states that "Clinical hypoxia test results were obtained in human adult volunteers." While the specific number of volunteers is not explicitly stated in this summary, it is implied that a sufficient number participated to "validate the accuracy."
- Data Provenance: The data was obtained from clinical hypoxia tests conducted in human adult volunteers. The document does not specify the country of origin, but the submitting company is based in China. The study appears to be prospective as it involves active testing on human subjects.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
The document does not provide details on the number or qualifications of experts involved in establishing the ground truth. It states that "arterial oxygen saturation (SaO2) as determined by co-oximetry" was used as the ground truth. This suggests that the ground truth was established through a gold standard measurement technique rather than human expert interpretation of images or other data.
4. Adjudication Method for the Test Set
Not applicable. The ground truth was established by co-oximetry, which is a direct measurement, not an interpretation requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This study is for an SpO2 sensor, not an AI or imaging device where human readers would interpret results. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this device.
6. Standalone (Algorithm Only) Performance
Yes, in a sense. The primary performance evaluation (SpO2 and Pulse Accuracy) is an assessment of the device's ability to measure these parameters against a known ground truth (arterial oxygen saturation by co-oximetry). While the sensor is an accessory to an oximeter, its accuracy is evaluated inherently as a standalone measurement component interacting with the human body to produce data.
7. Type of Ground Truth Used
The ground truth used was outcomes data/physiological measurement. Specifically, "arterial oxygen saturation (SaO2) as determined by co-oximetry." Co-oximetry is a laboratory method considered a gold standard for measuring oxygen saturation in arterial blood.
8. Sample Size for the Training Set
Not applicable. This document describes the validation of a medical device (SpO2 sensor), not an AI algorithm that requires a separate training set. The device's underlying principles are based on established physics (red and infrared light absorption of hemoglobin), not machine learning from a large dataset.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set mentioned or implied for this type of medical device.
§ 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).