(143 days)
Models: U403-91, U410-91 Unimed Reusable Finger Clip 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 30 kg. These devices are for prescription use only.
The subject devices, Unimed Reusable Finger Clip SpO2 Sensors (UXXX-91 Series), are fully compatible reusable sensors for use with Philips Itellivue MP30. These sensors are supplied non-sterile. The subject sensors (Models: U403-91 and U410-91) consist of a plug/connector (Philips D8 sensor connector), a cable, and a patient-contacting (finger clip) where light-emitting diode (LED) and photodetector (PD) are located. The subject sensors share the same principle of operation as the predicate device for functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) measurements. Patient-contacting materials of the subject sensors include ABS, silicone, and TPU, all of which have been qualified against biocompatibility requirements in ISO 10993-5, ISO 10993-10, and ISO 10993-23.
The Unimed Reusable Finger Clip SpO2 Sensors (UXXX-91 Series) are subject to the following acceptance criteria and the performance study described was conducted to prove the device meets these criteria. It's important to note that the provided document is a 510(k) summary, which is a premarket notification to demonstrate substantial equivalence to a legally marketed predicate device, not necessarily a full clinical trial report for novel device approval.
1. Table of Acceptance Criteria and Reported Device Performance
| Feature / Acceptance Criteria | Subject Device (Model: U410-91, U403-91) Reported Performance | Predicate Device (K062605) Performance |
|---|---|---|
| Performance (Arms) | ||
| Saturation Accuracy (SpO2), No Motion (70-100%) | ±3% (70-100%) | ±3% (70-100%) |
| Pulse Rate Accuracy (PR), No Motion (30-250 bpm) | ±3 bpm (30-250 bpm) | ±2% or 1 bpm, whichever is greater (30 to 300 bpm) |
| Low Perfusion Accuracy (SpO2, 70-100%) | SpO2 ±3% (70-100%) | SpO2 ±3% (70-100%) |
| Low Perfusion Accuracy (Pulse, 30-250 bpm) | Pulse ±3 bpm (30-250 bpm) | Pulse ±2% or 1 bpm, whichever is greater (30 to 300 bpm) |
Note¹: The document states that according to ISO 80601-2-61:2017, both Subject Device and Predicate Device have validated accuracy over the claimed pulse range and are therefore considered substantially equivalent, despite the difference in stated accuracy metrics for pulse rate.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size:
- Clinical Study Test Set: 12 human adult volunteers.
- Data Points: The clinical study contains "more than the minimum 200 data points."
- Data Provenance:
- The document implies the clinical study was conducted by or on behalf of Unimed Medical Supplies Inc., which is based in China. The data provenance regarding the country of origin of the study conduct is therefore likely China or an authorized testing facility.
- The study involved clinical hypoxia tests, which are prospective in nature, as they involve actively inducing hypoxia in volunteers to collect data on sensor performance.
3. Number of Experts Used to Establish Ground Truth and Qualifications
The document does not explicitly state the number of experts or their specific qualifications for establishing the ground truth. However, for pulse oximetry accuracy studies involving induced hypoxia, the ground truth (arterial oxygen saturation, SaO2) is typically established by co-oximetry readings from arterial blood samples, which are analyzed by laboratory equipment. This process relies on the accuracy of the co-oximeter and the proper drawing and handling of blood samples by trained medical personnel. It doesn't involve subjective expert consensus in the same way an imaging study would.
4. Adjudication Method for the Test Set
Not applicable. For pulse oximetry accuracy studies using induced hypoxia and co-oximetry, the ground truth is an objective physiological measurement from a laboratory instrument (co-oximeter) from arterial blood samples. There is no human adjudication process involved in establishing this ground truth, unlike with subjective visual assessments in imaging.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No. The provided document details a clinical study to validate the device's standalone accuracy against established physiological measurements (co-oximetry) in human volunteers. It is not an MRMC study comparing human reader performance with and without AI assistance, as the device is a sensor for measuring physiological parameters, not an AI-powered diagnostic imaging tool.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
Yes. The clinical hypoxia test described is a standalone performance test for the Unimed Reusable Finger Clip SpO2 Sensors. The study directly assesses the device's ability to accurately measure SpO2 against the ground truth (SaO2 from co-oximetry) without human interpretation or intervention in the measurement process itself.
7. The Type of Ground Truth Used
The ground truth used was outcomes data / physiological measurement, specifically:
- Arterial oxygen saturation (SaO2) as determined by co-oximetry. This is considered the gold standard for measuring oxygen saturation in blood for pulse oximeter accuracy studies.
8. The Sample Size for the Training Set
The document does not specify a separate "training set" sample size. For medical device premarket notifications like this, the focus is on a verification/validation study (the "clinical study" mentioned here) rather than an AI/machine learning model where distinct training and test sets are common. The device is a sensor, not a machine learning algorithm that undergoes a training phase.
9. How the Ground Truth for the Training Set was Established
As this is a sensor device and not an AI/ML model, there isn't a "training set" in the typical sense for which ground truth would be established for model training. The "ground truth" (SaO2 via co-oximetry) was established for the 12-subject clinical validation study as described above.
§ 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).