(29 days)
TS-AAW-10 and TS-AAW-25
The Disposable Sensor is a single-patient use sensor intended for continuous non-invasive arterial oxygen saturation (SpO2) and pulse rate monitoring. Patient weight range: > 20 kg (>44 pounds)
TS-PAW-10 and TS-PAW-25
The Disposable Sensor is a single-patient use sensor intended for continuous non-invasive arterial oxygen saturation (SpO2) and pulse rate monitoring. Patient weight ronge: 3-20 kg (6.6-44 pounds)
The TruSignal SpO2 Adult and Pediatric Disposable Sensors are used together with standalone oximeters or modular patient monitors to measure continuous non-invasive arterial oxygen saturation (SpO2) and pulse rate monitoring.
The sensors are to be connected to a device using an interconnect cable TS-G3, TS-M3, TS-H3 or TS-N3 (cleared in K093881). The interconnect cable type depends on the monitor end connector of the device.
The sensors contain light emitting diodes (LEDs) that emit light of different wavelengths. The sensors also contain a photodetector for detecting the emitted light after it has been attenuated by tissue. The sensors further contain a resistor, which is used to encode the wavelength of the LEDs used in the sensor. The resistor value is read by the monitor to determine the calibration curve used for that specific sensor.
This document describes the acceptance criteria and the study performance for the TruSignal® SpO2 Adult and Pediatric Disposable Sensors.
1. Table of Acceptance Criteria and Reported Device Performance
| Feature | Acceptance Criteria (Predicate Device K093881) | Reported Device Performance (TruSignal® SpO2 Adult and Pediatric Disposable Sensors) |
|---|---|---|
| SpO2 Accuracy | TruTrak®/TruTrak+®: A_rms ± 2 digits in the range of 70% to 100% SpO2 | TruTrak®/TruTrak+®: A_rms ± 2.5 digits in the range of 70% to 100% SpO2 |
| Datex Ohmeda: A_rms ± 3 digits in the range of 70% to 100% SpO2 | Datex Ohmeda: A_rms ± 2.5 digits in the range of 70% to 100% SpO2 | |
| SpO2 Accuracy | (Specific for S5 Compact Monitors with E-PRESTN module) A_rms 20 kg (>44 pounds) | |
| Anatomical Sites | Not explicitly stated, but palm of hand and side of foot included. | Palm of the hand and side of the foot excluded. |
| Environment of Use | Not explicitly stated, but ESU included. | Step down units added. ESU removed. |
| Sensor Head Geometry | Identical (for predicate) | TS-AAW: Identical to predicate device. |
| TS-PAW: Geometry identical, but distance of optical components slightly less to fit smaller pediatric patients. | ||
| Materials (Body Contact) | Identical | No change in Body Contact materials. |
| Electro-optical components | Identical LEDs, detector, leadframes (light pink sensor head color) | Identical LEDs, detector, leadframes (white sensor head color). |
| Connector Geometry & Dimensions | Mating part identical | Mating part identical. Connector body size smaller to reduce material. |
| Materials (Non-body contact) | Specific materials for connector body, conductor insulation, outer jacket, raw cable tissue paper. | Connector body materials changed. Conductor insulation and outer jacket materials changed. Raw cable tissue paper removed. |
| Cable lengths | Not explicitly stated. | Not explicitly stated, but considered "Equivalent to the predicate device". |
| Compatibility with other devices | Specific compatibility list, including discontinued platforms. | Removed discontinued platforms, added platforms released after predicate clearance. |
| Electrical Safety | Identical to predicate K093881. | Identical to predicate K093881. |
| Thermal Safety | Identical to predicate K093881. | Identical to predicate K093881. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size (Adult Disposable Sensor): Not explicitly stated, but the study refers to "healthy adult volunteers (ages 19-31 yr.)".
- Data Provenance: The adult study was "conducted in an independent research laboratory." No country of origin is specified. The study appears to be prospective as it involved induced hypoxia in volunteers.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not specify the number or qualifications of experts used to establish the ground truth. It states that "the measured arterial hemoglobin saturation values of the proposed devices were compared to CO-oximeter based arterial hemoglobin saturation values." The CO-oximeter measurement is considered the gold standard (ground truth) for arterial hemoglobin saturation.
4. Adjudication Method for the Test Set
Not applicable. The ground truth was established by direct physical measurement (CO-oximeter) rather than expert consensus requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The study focused on the standalone performance of the device against a gold standard.
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)
Yes, a standalone performance study was done for the TruSignal® SpO2 Adult Disposable Sensor. The device's accuracy (A_rms) was measured against CO-oximeter readings during induced hypoxia in healthy volunteers.
- The proposed sensor demonstrated an A_rms of less than 2 during steady-state conditions over the range of 70-100%.
- When used with S5 Compact Monitors with an E-PRESTN module, the device achieved an A_rms of less than 2.5% for the same range (70-100%).
The TruSignal® SpO2 Pediatric Disposable Sensor did not undergo separate clinical studies but was deemed substantially equivalent because it has "identical materials and electro-optical components and equivalent sensor characteristics to TruSignal SpO2 Adult Disposable Sensor." Hence, the clinical data from the adult sensor applies.
7. Type of Ground Truth Used
The ground truth used was CO-oximeter based arterial hemoglobin saturation values. This is a direct, objective physiological measurement often considered the gold standard for SpO2 accuracy studies.
8. Sample Size for the Training Set
This document describes a medical device (pulse oximeter sensor) which does not use an algorithm that requires a "training set" in the context of machine learning. The device's performance is based on its physical design, electro-optical components, and signal processing, which are validated through engineering verification and clinical testing against established standards and gold-standard measurement devices (CO-oximeter).
9. How the Ground Truth for the Training Set Was Established
As noted in section 8, this device does not utilize a machine learning algorithm with a training set. The clinical performance is verified directly against CO-oximeter measurements, which serve as the 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).