(208 days)
Solaris Medical Technology, Inc. SpO2 sensors are indicated for use in continuous, non-invasive monitoring of arterial oxygen saturation and pulse rate for patients weighing more than 40 kg.
Solaris Compatible Reusable Adult SpO2 Finger Sensors (Solaris Sensors) are compatible reusable sensors for use with major brands of patient monitors and oximeter devices. Solaris Sensors are electro-optical sensors which function without skin penetration, electrical contact, or heat transfer. The sensors use optical means to determine the light absorption of functional arterial hemoglobin by being connected between the patient and the patient monitor or oximeter device. 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 silicon rubber pads.
The provided 510(k) summary for K061931 concerns Solaris Compatible Reusable Adult SpO2 Finger Sensors. According to the document, the device itself is an electro-optical sensor for non-invasive monitoring of arterial oxygen saturation and pulse rate. The study design focuses on establishing substantial equivalence by demonstrating the device meets performance, safety, and accuracy specifications.
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Table of Acceptance Criteria and Reported Device Performance:
Acceptance Criteria Reported Device Performance Cleaning Instructions Testing: Do not damage sensor labeling or degrade the material after cleaning. Test results indicated that the cleaning instructions do not damage sensor labeling or degrade the material. Biocompatibility Testing (ISO 10993-1:2003): Patient contact materials are non-toxic, non-sensitizing, and non-irritating for skin surface-contact, limited-duration devices. Test results indicated that the patient contact materials were non-toxic, non-sensitizing, and non-irritating. Electrical Safety Testing (IEC 60601-1:1988; Am1:1991; A2:1995, Clauses 3, 5, 6, 48 and 56): Compliance with stated clauses for medical electrical equipment. Test results indicated that the sensors comply with the stated clauses. Electromagnetic Compatibility Testing (IEC 60601-1-2:2001, Clauses 5.1.1, 6.2.1 and 6.3.1): Compliance with stated clauses for electromagnetic compatibility. Test results indicated that the sensors comply with the stated clauses of the Standard. Clinical Testing (Accuracy): Meet published specifications for accuracy over the 70% - 100% SpO2 range, using controlled hypoxia and co-oximetry comparison. Test results indicated that the sensors meet the published specifications for accuracy over the 70% - 100% SpO2 range. (Specific accuracy metric or threshold is not detailed in the summary.) -
Sample size used for the test set and the data provenance:
The document does not explicitly state the sample size (number of subjects) for the clinical testing. It mentions that testing was performed under an "institutionally approved protocol with subject informed consent." The provenance of the data is not specified beyond being generated through "clinical testing." It is implied to be prospective data collected specifically for this submission. -
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable to this type of device and study. Ground truth for SpO2 accuracy is typically established by a recognized reference method like co-oximetry during controlled hypoxia, not by human experts. -
Adjudication method for the test set:
Not applicable. The ground truth (arterial oxygen saturation by co-oximetry) is an objective measurement, not subject to expert adjudication. -
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:
Not applicable. This device is an SpO2 sensor, not an AI-assisted diagnostic imaging device that involves human readers. -
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Yes, the clinical testing described is a standalone performance assessment of the sensor against a reference standard (co-oximetry) without human interpretation in the loop. The sensor directly outputs SpO2 values. -
The type of ground truth used:
The ground truth for the clinical accuracy testing was "arterial oxygen saturation as determined by co-oximetry" during "controlled hypoxia." This is an objective, gold-standard physiological measurement. -
The sample size for the training set:
Not applicable. This device is a hardware sensor, not a machine learning algorithm that requires a training set in the conventional sense. Its performance is based on its electro-optical design and calibration, which would be validated in testing, not "trained." -
How the ground truth for the training set was established:
Not applicable, as there is no "training set" 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).