(88 days)
The Linde 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 Linde TOSCA 500 Monitoring System is designed for the simultaneous continous monitoring of transcutaneous PCO2 functional oxygen saturation SpO2 and pulse rate, using a single sensor (Tosca Sensor) applied to the ear lobe.
The system consists of a Tosca Monitor equipped with an integrated calibration unit which allows a fully automatic calibration of the PCO2 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 oximetry sensor; supplies for the sensor preparation; supplies for the sensor attachment at the ear lobe; and a gas mixture for the sensor calibration.
Here's an analysis of the provided text regarding the Linde TOSCA 500 Monitoring System, focusing on acceptance criteria and the supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state numerical acceptance criteria for the PCO2, SpO2, or Pulse Rate measurements. Instead, it makes general statements about the device's performance. The "Substantially Equivalent Device" (K032291) is referenced, implying that the acceptance criteria are likely aligned with the performance demonstrated by that predicate device. However, without access to the predicate device's documentation, specific numerical criteria cannot be extracted from this submission.
| Measurement Type | Acceptance Criteria (Not explicitly stated in this document) | Reported Device Performance (as stated) |
|---|---|---|
| Transcutaneous PCO2 | Implied to be comparable to predicate device performance. | "The results show that the TOSCA System performs as intended and that a good correlation exists between transcutaneous PCO2 and arterial blood gas values." |
| Functional SpO2 | Implied to be comparable to predicate device performance. | "The results show that the TOSCA System performs as intended and that the specified saturation accuracy is met." |
| Pulse Rate | Implied to be comparable to predicate device performance. | (Not explicitly stated for pulse rate in the same detail as PCO2 and SpO2, but implied by the overall "performs as intended" statement.) |
2. Sample Size Used for the Test Set and Data Provenance
- PCO2 Clinical Studies:
- Sample Size: Not explicitly stated. The text mentions "adults and infants."
- Data Provenance: Clinical comparative studies. The country of origin is not specified but is implicitly European given the submitter's address (Basel, Switzerland). It is a prospective study as it refers to "clinical comparative studies...were performed."
- SpO2 Clinical Studies:
- Sample Size: Not explicitly stated. The text mentions "healthy adults volunteers."
- Data Provenance: Clinical studies. The country of origin is not specified but implicitly European. It is a prospective study as it refers to "clinical studies...were performed."
- SpO2 Algorithm (
Masimo SET):- Sample Size: Not explicitly stated for specific a number, but generally mentioned as "healthy adult volunteers."
- Data Provenance: "human blood studies against a laboratory co-oximeter on healthy adult volunteers in induced hypoxia states." The origin of this foundational data for Masimo SET is not specified by geographical location, but it underlies the SpO2 performance. This would be prospective data collection.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not provide details on the number or qualifications of experts used to establish ground truth for the clinical studies. For the PCO2 and SpO2 clinical studies, the ground truth was established by:
- PCO2: Arterial blood gas values. These would typically be analyzed by trained laboratory personnel.
- SpO2: Arterial blood samplings with a co-oximeter. These would also be analyzed by trained laboratory personnel.
The "experts" in this context would be the medical professionals (e.g., physicians, nurses, lab technicians) responsible for collecting and analyzing the arterial blood gas and co-oximetry data, but their specific number or qualifications are not detailed in this summary.
4. Adjudication Method for the Test Set
No explicit adjudication method (e.g., 2+1, 3+1) is mentioned or implied for either the PCO2 or SpO2 clinical studies. The ground truth (arterial blood gas and co-oximeter readings) are typically objective measurements from laboratory equipment, not subjective assessments requiring adjudication like image interpretation.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
No MRMC study was performed as this device is a monitoring system directly measuring physiological parameters, not an AI or CAD (Computer-Aided Detection/Diagnosis) system that assists human readers in interpreting complex data like medical images. Therefore, the concept of "human readers improve with AI vs. without AI assistance" does not apply here.
6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, the device's performance is effectively standalone. The clinical studies (comparing transcutaneous PCO2 to arterial blood gas, and TOSCA SpO2 to co-oximeter SpO2) are designed to assess the accuracy of the device's measurements directly against a gold standard, without human intervention in the device's measurement process itself. The "algorithm" for SpO2 (Masimo SET Signal Extraction Technology) is an integral part of the device's standalone operation.
7. The Type of Ground Truth Used
- Transcutaneous PCO2: Arterial blood gas values. This is a recognized gold standard for measuring blood PCO2.
- Functional Oxygen Saturation (SpO2): Arterial blood samplings with a co-oximeter. Co-oximetry is considered a gold standard for measuring arterial oxygen saturation.
- Pulse Rate: Not explicitly detailed, but generally derived from the same optical sensor as SpO2, and the ground truth would typically be from an ECG or another validated pulse measurement method. The submission does not detail the pulse rate ground truth specifically but implies it performed as intended.
8. The Sample Size for the Training Set
The document does not explicitly mention a "training set" for the TOSCA 500 itself in the machine learning sense. The Masimo SET technology, which is incorporated into the TOSCA 500, did use human blood studies to develop its look-up table and algorithms. For Masimo SET:
- Sample Size: Not explicitly stated as a number, but generally mentioned as "healthy adult volunteers."
- Data Provenance: "human blood studies against a laboratory co-oximeter on healthy adult volunteers in induced hypoxia states."
9. How the Ground Truth for the Training Set Was Established
For the foundational Masimo SET technology (which informs the SpO2 measurements of the TOSCA 500):
- Ground Truth Establishment: "laboratory co-oximeter on healthy adult volunteers in induced hypoxia states." The co-oximeter measurements served as the ground truth against which the optical signals were correlated to develop the SpO2 look-up tables and algorithms.
§ 868.2480 Cutaneous carbon dioxide (PcCO2) monitor.
(a)
Identification. A cutaneous carbon dioxide (PcCO2) monitor is a noninvasive heated sensor and a pH-sensitive glass electrode placed on a patient's skin, which is intended to monitor relative changes in a hemodynamically stable patient's cutaneous carbon dioxide tension as an adjunct to arterial carbon dioxide tension measurement.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Cutaneous Carbon Dioxide (PcCO2) and Oxygen (PcO2) Monitors; Guidance for Industry and FDA.” See § 868.1(e) for the availability of this guidance document.