(70 days)
The TOSCA 500 Monitoring System is designed for the simultaneous continuous monitoring of transcutaneous PCO₂, functional oxygen saturation SpO₂ and Pulse Rate in adults and pediatrics.
The TOSCA 500 Monitoring System is designed for the simultaneous continous monitoring of transcutaneous PCQ2, functional oxygen saturation SpO2 and pulse rate, using a single sensor (TOSCA Sensor).
The system consists of a TOSCA Monitor equipped with an integrated calibration unit which allows a fully automatic calibration of the PCQz part of the sensor and also provides a storage facility for the sensor, and with the Masimo SET signal extraction technology for the calculation of the functional oxygen saturation and the pulse rate ; a TOSCA Sensor comprising the elements of an electrochemical Stow-Severinghaus-type carbon dioxide sensor and of an optical pulse oximelty sensor; supplies for the sensor preparation; supplies for the sensor attachment to the patient, and a gas mixture for the sensor calibration.
With the new TOSCA Fixation Rings 32mm (subject of this new 510(k)), the TOSCA sensor may be battled to the forehead or the cheek, and to other conventional mesuring sites for the for the for the for the for treacurement only measurement only.
Acceptance Criteria and Study for TOSCA 500 tcPCO2, SpO2 and Pulse Rate Monitoring System
Based on the provided text, the TOSCA 500 Monitoring System's acceptance criteria and the study proving its performance are focused on demonstrating substantial equivalence to a predicate device, particularly for the new fixation rings for forehead and cheek application. The document describes non-clinical and clinical tests performed.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by performing "as intended" and meeting "specified accuracy," as well as "good correlation" with the predicate device.
| Performance Metric | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| tcPCO2 Measurement (Forehead/Cheek) | Good correlation with predicate device (earlobe measurement). | "The results show that a good correlation exists between the values measured at the forehead and at the cheek and the values measured at the ear lobe." (Predicate device's earlobe tcPCO2 was validated against arterial blood gas values). |
| SpO2 Measurement (Forehead/Cheek) | Performs as intended and meets specified saturation accuracy. | "The results show that the TOSCA System performs as intended and that the specified saturation accuracy is met." (Compared to arterial blood samplings with a co-oximeter during induced hypoxia). |
| Pulse Rate Measurement (Forehead/Cheek) | Performs as intended and meets specified Pulse Rate accuracy. | "The results show that the TOSCA System performs as intended and that the specified Pulse Rate accuracy is met." (Compared to earlobe measurement of predicate device, which was validated against ECG heart rate). |
| Environmental, Electrical, EMC, Mechanical | Passed all applicable tests. | "Applicable environmental, electrical, EMC and mechanical Testing per Reviewers Guidance for Premarket Submissions - November 1993 were performed and the TOSCA 500 Monitoring System passed all tests." |
| Biocompatibility | All patient contact materials pass for prolonged contact. | "All patient contact materials were tested as Surface Devices with skin contact for prolonged contact duration (24 hours to 30 days) as defined in ISO-10993-1:1992...All patient contacting material passed." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The exact number of "adult volunteers" for the non-clinical and clinical tests is not specified in the provided text. It simply states "on adults volunteers" and "healthy adults volunteers."
- Data Provenance: The data for both non-clinical and clinical tests was generated prospectively in-house. The location is implied to be at Radiometer Basel AG, Switzerland, as the submission is from Basel and refers to "testing in house."
3. Number of Experts Used to Establish Ground Truth and Qualifications
The document does not explicitly state the number of experts used or their qualifications for establishing ground truth.
- For tcPCO2, the "predicate device by comparison with arterial blood gas values" implies a standard clinical method for ground truth, likely interpreted by medical professionals.
- For SpO2, "arterial blood samplings with a co-oximeter" provides the ground truth, and co-oximetry is a standard laboratory method.
- For Pulse Rate, "heart rate obtained by ECG" is the ground truth, a standard medical measurement.
While these methods represent established ground truths, the involvement of specific "experts" for adjudication or establishing ground truth related to the device's performance evaluation is not detailed.
4. Adjudication Method for the Test Set
No explicit adjudication method (e.g., 2+1, 3+1) is mentioned in the provided text for the test set results. The comparisons are made against established objective methods (arterial blood gas, co-oximeter, ECG), rather than subjective expert interpretation requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The study focuses on the device's performance against objective ground truths and a predicate device, not on human readers' improvement with or without AI assistance. The device is a monitoring system, not an AI-assisted diagnostic tool for human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the studies described are essentially standalone performance evaluations. The TOSCA 500 Monitoring System's measurements (tcPCO2, SpO2, Pulse Rate) are directly compared to reference ground truth methods. There is no mention of a "human-in-the-loop" component to the device's measurement process itself; it's a device generating readings that are then used by practitioners.
7. The Type of Ground Truth Used
- tcPCO2: Arterial blood gas values (indirectly, via validation of the predicate device's earlobe measurement).
- SpO2: Laboratory co-oximeter measurements from arterial blood samplings.
- Pulse Rate: Electrocardiogram (ECG) heart rate (indirectly, via validation of the predicate device's earlobe measurement).
8. The Sample Size for the Training Set
The document does not explicitly mention a "training set" or its sample size. The TOSCA 500 system utilizes the "Masimo SET signal extraction technology" for SpO2 and pulse rate. The Masimo SET technology itself states that "The values in the look-up table are based upon human blood studies against a laboratory co-oximeter on healthy adult volunteers in induced hypoxia states." This suggests that the Masimo SET algorithm was developed and validated on a dataset of healthy adult volunteers, but the size of that original dataset is not specified in this 510(k) summary. The current submission's studies serve as validation for the TOSCA 500 system incorporating this technology.
9. How the Ground Truth for the Training Set Was Established
For the Masimo SET technology incorporated into the device (which is where a "training set" might implicitly exist for its internal algorithms):
- The ground truth for SpO2 was established by "human blood studies against a laboratory co-oximeter on healthy adult volunteers in induced hypoxia states."
For the specific TOSCA 500 studies (which are more akin to test sets given the focus on comparing to predicate/established methods):
- Ground truth for these studies was established as described in point 7: arterial blood gas, co-oximeter, and ECG.
§ 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).