(268 days)
When used with a compatible patient monitor or a pulse oximeter device, Solaris Medical Technology, Inc. reusable & disposable SpO2 sensors are intended to be used for continuous, non-invasive functional arterial oxygen saturation (SpO2) and pulse rate monitoring.
Solaris Medical Technology, Inc. reusable multi-patient use SpO2 Soft Sensors, reusable multi-patient use SpO2 Finger Sensors, and disposable single patient use SpO2 Soft-finger Sensors are for use with adult/pediatric patients weighing greater than 40kg.
Solaris Medical Technology, Inc. disposable single patient use SpO2 Adhesive Sensors are for use with adult patients weighing greater than 40kg, pediatric patients weighing 10 - 40 kg, and infant (non-neonatal) patients weighing 3 - 15 kg.
Prescription device.
Solaris Compatible Reusable and Disposable SpO2 Sensors (Solaris Sensors) are compatible sensors for use with major types of patient monitors and oximeter devices as listed above.
Solaris Sensors employ non-invasive electro-optical means to determine the light absorption of functional arterial hemoglobin. The sensor contains three optical components: two light emitting diodes (LED) that serve as light sources and one photodiode that acts as a light detector. The LED and photodiode are contained in the sensor housing.
Four types of sensor housings are described in this submission:
- Reusable soft finger sensor comprised of an integrated silicone rubber tube.
- Reusable finger clip sensor with rigid halves and silicone pads
- Disposable soft-digit sensor with flexible silicone housing
- Disposable adhesive sensors constructed of a medical tape laminate
Each sensor has unique labeling and specifications designed for compatibility with the specific monitor manufacturer (Nellcor, Nonin, HP/Philips, BCI).
Here's an analysis of the provided text to extract the requested information about acceptance criteria and the study proving device performance:
1. Table of Acceptance Criteria and Reported Device Performance:
The document explicitly states that the acceptance criterion for the Solaris SpO2 sensors is "stated accuracy claims over the 70% - 100% range." The reported device performance is that the "Clinical test results indicated that the sensors meet the stated accuracy claims over the 70% - 100% range."
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Sensors meet stated accuracy claims over the 70% - 100% range | Clinical test results indicated that the sensors meet the stated accuracy claims over the 70% - 100% range. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document does not specify an exact numerical sample size for the clinical test set. It only mentions "clinical testing... with subject informed consent."
- Data Provenance: The document does not explicitly state the country of origin for the clinical data or whether it was retrospective or prospective. It was performed "under an institutionally approved protocol."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- The document describes the ground truth as "arterial oxygen saturation as determined by co-oximetry." It does not mention the involvement of human experts for establishing this ground truth, as co-oximetry is a laboratory measurement.
4. Adjudication Method for the Test Set:
- Not applicable as the ground truth was established by co-oximetry, not expert consensus.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:
- This is not applicable. The device is a physical SpO2 sensor, not an AI or imaging diagnostic tool that would involve human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- The clinical testing assessed the "performance and accuracy of the Solaris Reusable and Disposable sensors" (algorithm/device only) against co-oximetry. There's no mention of a human-in-the-loop component in this specific accuracy study.
7. The Type of Ground Truth Used:
- Co-oximetry: The ground truth for the clinical study was "arterial oxygen saturation as determined by co-oximetry."
8. The Sample Size for the Training Set:
- The document does not describe a "training set" as this is not an AI/machine learning device that typically requires a separate training phase. The clinical testing was for validation.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable, as there is no mention of a training set for an AI/machine learning model. The clinical validation directly compared the sensor's readings to co-oximetry.
§ 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).