(90 days)
The SpO2 finger sensors are indicated for use to measure the approximate, non-invasive and continuous arterial oxygen saturation and pulse rate of patients weighting more than 40kg.
Unimed's Spo2 reusable sensors are designed to function the same as the compatible Original Equipment Manufacturer (OEM) Puise Oximeter Sensor. The sensors contain two specific wavelength LEDs and a photo detector assembled into the silicon pads. The sensor cable terminates into an OEM compatible connector. The sensors use optical means to determine the light absorption of functional arterial hemoglobin by being connected between the patient and the oximeter.
The provided 510(k) summary for the Unimed compatible oximeter sensors (K082546) includes information on performance testing, but it does not provide a detailed table of acceptance criteria or how the device performance specifically met those criteria in the typical format of a device's accuracy specifications. It mentions that performance testing was conducted and validated claims.
Here's a breakdown of the available information based on your requested points:
1. A table of acceptance criteria and the reported device performance
The submission mentions "Performance testing was conducted during clinical hypoxia studies... and was shown to validate performance claims and accuracy. Bench testing was performed to verify pulse rate accuracy." However, specific numerical acceptance criteria (e.g., A_rms values, limits for bias) and the corresponding reported device performance values are not explicitly stated in the provided document.
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified in the provided text.
- Data Provenance: The studies were conducted in an "independent lab." The text does not specify the country of origin of the data or whether the study was retrospective or prospective, though hypoxia studies are typically prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not provide information on the number of experts used or their qualifications for establishing ground truth. For SpO2 sensors, ground truth in clinical hypoxia studies is typically established by CO-oximetry of arterial blood samples.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
The document does not describe any adjudication method. This is generally not applicable to the type of performance testing (clinical hypoxia study) described for oximeter sensors, where the accuracy of the device is compared against a physiological reference standard.
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
- MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is not relevant for an SpO2 sensor, which is a standalone measurement device, not an AI-assisted diagnostic tool that aids human readers.
- Effect Size of Human Readers with/without AI: Not applicable, as this device does not involve AI assistance for human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Yes, the performance testing described is for the device in a standalone capacity. The "clinical hypoxia studies" and "bench testing" evaluate the sensor's ability to measure SpO2 and pulse rate independently.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the clinical hypoxia studies, the ground truth for arterial oxygen saturation would typically be established using arterial blood gas analysis with a CO-oximeter – considered the reference standard for blood oxygen saturation measurement. The document doesn't explicitly state this, but it's the standard methodology for such studies.
8. The sample size for the training set
The document does not mention a "training set" or any machine learning related development. This device is a traditional medical device (an SpO2 sensor), not an AI/ML-driven device.
9. How the ground truth for the training set was established
Not applicable, as there is no mention of a training set or AI/ML components.
§ 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).