(250 days)
SpO2 Sensors are indicated for continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate(PR) for adult patients weighing greater than 40kg at hospital facilities.
The SpO2 Sensors are a family of oximeter sensors designed for compatibility with listed predicate oximeter manufacturers/monitors. The sensors are made up of connector, cable, two specific wavelength LEDs & a photo detector assembled into the sensor housing. The sensors use optical means to determine the light absorption of functional arterial hemoglobin by being connected between the patient and the oximeter. The Sensors contain finger clip type, soft tip and textile adhesive type. All the sensors will be labeled for compatibility for a specific monitor.
Here's a breakdown of the acceptance criteria and study information for the SpO2 Sensor, based on the provided text:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| SpO2 Accuracy | ±3% (70-100%) |
| Pulse Rate Accuracy | ±3 (30-250bpm) |
Note: The document explicitly states these criteria and performance in the "Comparison to predicate device" section (page 5-6) and confirms that the subject device's accuracy for fingers "meets the requirements of ISO 80601-2-61" (page 6).
Study Information
2. Sample size used for the test set and the data provenance:
- Sample Size: 13 human adult volunteers.
- Data Provenance: Not explicitly stated, but the study was a "Clinical hypoxia test" performed on "human adult volunteers." This indicates prospective data collection for the purpose of the study. The country of origin is not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the document. The ground truth method is specified (co-oximetry), but details about experts establishing this ground truth are absent.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This information is not provided in the document.
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:
- An MRMC study was not performed. This device is an SpO2 sensor (a measurement device), not an AI-assisted diagnostic tool. Therefore, a study comparing human readers with and without AI assistance is not applicable.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- A standalone performance study was done in the sense that the device's accuracy was tested directly against an established reference method (co-oximetry) without human interpretation being the primary variable. The device's output (SpO2 and pulse rate) is a direct measurement.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth for the SpO2 accuracy was "arterial oxygen saturation (SaO2) as determined by co-oximetry." Co-oximetry is a recognized reference method for measuring oxygen saturation in arterial blood.
8. The sample size for the training set:
- This information is not provided. As this is a sensor (hardware device) and not an AI/software algorithm typically requiring a "training set" in the machine learning sense, such a concept might not apply directly. The document focuses on the sensor's optical principles and signal processing.
9. How the ground truth for the training set was established:
- This information is not provided as the concept of a "training set" in the context of machine learning and its associated ground truth establishment is not applicable to this device's description. The device's performance is validated through clinical testing against a reference standard.
§ 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).