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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.

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.

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The Linde TOSCA 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 System is used for the simultaneous continuous monitoring of transcutaneous PCO2, functional oxygen saturation SpO2 and pulse rate, using a single sensor (Tosca Sensor) applied to the ear lobe.

The system consist of a TOSCA Monitor equipped with an integrated calibration unit which allows a fully automatic calibration and also provides a storage facility for the sensor; 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.

The acceptance criteria and device performance are described in the "Clinical Testing" section ({1}).

1. Table of acceptance criteria and reported device performance:

The document does not explicitly list numerical acceptance criteria or detailed results from the clinical testing. It states a general conclusion that the device meets performance requirements.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

The provided text does not specify the sample size used for the clinical test set or the data provenance (country of origin, retrospective/prospective nature of the data).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

This information is not provided in the document.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

This information is not provided in the document.

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:

This document describes a medical device for monitoring physiological parameters (PCO2, SpO2, Pulse Rate), not an AI-assisted diagnostic or interpretive tool that would typically involve human readers. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable and not mentioned.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

The document describes the performance of the "Tosca PCO2, SpO2 and Pulse Rate Monitoring System" as a whole, which includes the sensor and monitor. This would be considered the standalone performance of the device itself for its intended function (continuous monitoring of PCO2, SpO2, and pulse rate). It's not an "algorithm only" study as it involves hardware and sensor technology.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The document does not explicitly state the type of ground truth used for the clinical testing. For physiological monitoring devices like this, ground truth would typically come from:

• Reference standard devices: Comparing the Tosca system's readings for PCO2, SpO2, and pulse rate against established, highly accurate reference measurement methods (e.g., arterial blood gas analysis for PCO2, CO-oximetry for SpO2, or ECG for pulse rate).
• Clinical observation: Assessing the device's ability to accurately reflect a patient's physiological state as determined by other clinical assessments.

Given the nature of the device, it's highly probable that a comparison against established reference methods was used, however, this is an inference, not explicitly stated.

8. The sample size for the training set:

This information is not provided in the document. The document describes clinical testing, implying validation or verification, rather than the development and training of a learning algorithm.

9. How the ground truth for the training set was established:

This information is not provided, as the document does not mention a "training set" in the context of machine learning or AI development.

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The Linde Transcutaneous Monitor is intended to measure the partial pressure of oxygen and carbon dioxide that passes through the cutaneous layer of the skin of an infant who is not under gas anesthesia by a sensor attached to the surface of the infant's skin.

Detailed description of the device is contained in the MicroGas 7650 Operator's Manual located in Appendix 2 of this document.

The provided document for K991644, the MicroGas 7650 Transcutaneous Monitor, does not include acceptance criteria or a study proving the device meets acceptance criteria.

Instead, the submission states:

• Clinical and Non-Clinical Tests of Equivalency: "The MicroGas 7650 is exactly the same device as the MicroGas 7650 distributed by Kontron Instruments under PMA P810037. Both devices are manufactured by Linde Medical Sensors AG of Basel, Switzerland. Because there are no differences other than labeling between the Linde MicroGas 7650 and the Kontron MicroGas 7650, no additional clinical or non-clinical tests were performed or submitted in the premarket notification. Refer to PMA number P810037 for this data."

This means that the current K991644 submission obtained clearance based on substantial equivalence to a previously approved device (Kontron MicroGas 7650, PMA P810037) and did not present new performance data for acceptance criteria. To find the information requested, one would need to refer to PMA P810037.

Therefore, I cannot populate the table or answer the subsequent questions based on the provided text for K991644, as this information is explicitly stated to be in a separate, referenced document (PMA P810037).

Summary of missing information:

1. Table of acceptance criteria and reported device performance: Not provided in K991644.
2. Sample size for test set and data provenance: Not provided in K991644.
3. Number of experts and qualifications for ground truth: Not provided in K991644.
4. Adjudication method for test set: Not provided in K991644.
5. MRMC comparative effectiveness study: Not applicable/not provided as no new studies were conducted.
6. Standalone performance study: Not applicable/not provided as no new studies were conducted.
7. Type of ground truth used: Not provided in K991644.
8. Sample size for training set: Not applicable/not provided as no new studies were conducted.
9. How ground truth for training set was established: Not applicable/not provided as no new studies were conducted.

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