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The MRI Patient Monitoring System Tesla M3 is intended for monitoring of vital signs during MRI examinations (MRI procedures) of patients.

The Tesla M3 is intended for use in the Adult, Pediatric and Neonatal populations for the continuous monitoring of Electrocardiogram (ECG), Non-Invasive Blood Pressure (NIBP), Invasive Blood Pressure (IBP), Temperature, Respiration, Capnography (etCO₂), Oxygen and Anesthetic Agents.

The Tesla M3 is intended for use in the Adult and Pediatric populations for the continuous monitoring of Pulse Oximetry (SpO2).

The Tesla M3 is intended for use by health care professionals.

The Tesla M3 is a MRI Patient Monitoring System that is intended to monitor and display vital signs during MRI examinations (MRI procedures) of patients. It is capable for continuous monitoring and displaying data from the following sensors/measurement modules in graphic and numeric form:

• Electrocardiogram (ECG),
• Pulse Oximetry (SpO2),
• . Non-Invasive Blood Pressure (NIBP),
• . Invasive Blood Pressure (IBP),
• Temperature, Respiration,
• Capnography (etCO2), and
• . Oxygen and Anesthetic Agents

Here's a breakdown of the acceptance criteria and study information for the MRI Patient Monitoring System Tesla M3, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Sizes Used for the Test Set and Data Provenance

The provided summary does not mention specific sample sizes for any clinical test sets. The testing conducted was primarily non-clinical compliance testing to established international standards. The provenance of data is not specified beyond being "non-clinical testing" conducted by the manufacturer, MIPM.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the 510(k) summary. Since the testing was non-clinical and focused on compliance to international standards, it's unlikely that "experts" in the sense of medical professionals establishing a ground truth for a test set were used in the same way they would be for an AI-driven diagnostic device. The ground truth would be defined by the specifications of the standards themselves (e.g., a known electrical signal for ECG accuracy, a calibrated pressure source for NIBP accuracy).

4. Adjudication Method for the Test Set

This information is not provided. Given the nature of compliance testing against objective standards, a formal adjudication method like "2+1" or "3+1" used in clinical studies with subjective assessments would not be applicable. The results are typically "Pass" or "Fail" based on whether the device meets the quantitative requirements of the standard.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Readers Improve with AI vs. Without AI Assistance

No, an MRMC comparative effectiveness study was not done. The device is a physiological patient monitor, not an AI-assisted diagnostic tool, and the submission explicitly states that "no clinical testing was required to support the medical device."

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The device is a physiological patient monitor; therefore, it's an "algorithm only" device in the sense that its measurements are generated by internal algorithms without human interpretation being part of its performance determination. However, it's important to differentiate this from AI-driven diagnostic algorithms. The "standalone" performance here refers to the device's ability to accurately measure vital signs against established standards, independent of human interpretation or intervention in the measurement process itself. The non-clinical performance testing summarized in the table above represents its standalone performance against these technical standards.

7. The Type of Ground Truth Used

The ground truth used for these tests is based on the objective specifications and requirements outlined in the referenced international standards (e.g., IEC, ISO). For example:

• For ECG: known electrical signals or waveforms.
• For NIBP: calibrated pressure sources.
• For Pulse Oximetry: simulated oxygen saturation levels.

It is not expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set

This information is not applicable and not provided. The Tesla M3 is a hardware-based physiological monitor with embedded software/firmware for data acquisition and processing, not a machine learning or AI device that requires a "training set" in the context of deep learning or similar algorithms. Its development and validation are based on engineering principles and compliance with medical device standards.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable as there is no "training set" in the context of an AI/ML algorithm being trained. The "ground truth" for the device's functioning, as mentioned above, is established by adherence to the specifications of recognized international medical device standards.

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The MRI Patient Monitoring System (Model 865214) is intended to monitor vital signs for patients undergoing MRI procedures and to provide signals for synchronization for the MRI scanner. The MRI Patient Monitoring System (Model 865214) is intended for use by healthcare professionals.

The modified device, MRI Patient Monitoring System (Model 865214), is substantially equivalent to the cleared device. Both devices are multi-parameter patient monitors intended for use by healthcare professionals to monitor vital signs for patients undergoing MRI procedures and to provide signals for synchronization for the MRI scanner. Both devices provide patient monitoring data for ECG. SpO2, respiration, non-invasive blood pressure (NIBP), invasive blood pressure (IBP), temperature, oxygen (O2), end-tidal carbon dioxide (EtCO2), and anesthetic agents. The modifications to the cleared device are only in regards to the temperature parameter, specifically the reusable temperature sensor.

Here's a breakdown of the acceptance criteria and study information for the Invivo MRI Patient Monitoring System (Model 865214), based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document explicitly states that the modifications only pertain to the temperature parameter, specifically the reusable temperature sensor. Therefore, the acceptance criteria and performance for other vital signs (ECG, SpO2, NIBP, IBP, end-tidal CO2 (ETCO2), oxygen (O2), and anesthetic agents) are presumed to remain unchanged from the cleared device and are not detailed in this submission as they were not re-evaluated.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the "sample size" in terms of number of patients or individual measurements for the performance verification tests. It refers generally to "results of the complete verification and validation" for performance specifications and "the modified device's reusable temperature sensor was evaluated" for MRI conditions of use.

• Data Provenance: The studies were conducted by Invivo Corporation as part of their verification and validation process for the modified device. The studies were likely internal, prospective tests, rather than retrospective analysis of patient data. The country of origin for the data is not specified, but the manufacturer is based in the USA.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

• Not Applicable. The ground truth for this device modification (temperature sensor accuracy) was established against calibrated reference standards and physical measurements, not through expert consensus on medical images or clinical observations.

4. Adjudication Method for the Test Set

• Not Applicable. As the ground truth was established through physical measurements and calibrated equipment, an adjudication method for human reviewers is not relevant.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No. This was not an MRMC study. The device is a physiological monitor, not a diagnostic imaging device requiring human interpretation for its primary function. Its performance was assessed against technical specifications and standards.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Yes. The performance evaluation was a standalone assessment of the device's measurement capabilities. There is no "human-in-the-loop" performance being evaluated in this context. The device directly measures physiological parameters.

7. The Type of Ground Truth Used

• Calibration Standards and Physical Measurements: For temperature accuracy, the ground truth would have been established using highly accurate, calibrated temperature reference devices and control environments (e.g., water baths, environmental chambers). For MRI conditions of use, physical measurements and established protocols (e.g., using a thermocouple for RF heating, measuring displacement force in a magnetic field) would have constituted the ground truth.

8. The Sample Size for the Training Set

• Not Applicable. This is a hardware device modification and its performance was evaluated through engineering verification and validation, not through machine learning or AI models that require training data.

9. How the Ground Truth for the Training Set Was Established

• Not Applicable. (See point 8).

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The MRI Patient Monitoring System (Model 865214) is intended to monitor vital signs for patients undergoing MRI procedures and to provide signals for synchronization for the MRI scanner. The MRI Patient Monitoring System (Model 865214) is intended for use by healthcare professionals.

The modified device, MRI Patient Monitoring System (Model 865214), is substantially equivalent to the cleared device. Invivo has marketed the cleared device. MRI Patient Monitoring System (Model 865214), since 2009. Invivo identified the opportunity to reduce healthcare costs by replacing the current temperature option which is an Ethylene Oxide (EO) sterilized single-use temperature sensor with a reusable temperature sensor that utilizes single-use gamma irradiated sterilized jackets (sheath). The modified device. MRI Patient Monitoring System (Model 865214) and the previously cleared device, also identified as MRI Patient Monitoring System (Model 865214) which received clearance to market under 510(k) K090785 on December, 15 2009, are identical with respect to indications for use, intended use, fundamental scientific technology, software architecture and design. Both devices are multi-parameter patient monitors intended for use by healthcare professionals to monitor vital signs for patients undergoing MRI procedures and to provide signals for synchronization for the MRI scanner. Both devices provide patient monitoring data for ECG, SpO2, respiration, non-invasive blood pressure (NIBP), invasive blood pressure (IBP), temperature, oxygen (02), end-tidal carbon dioxide (EtCO2), and anesthetic agents. The modifications to the previously cleared device are only in regards to the temperature parameter. The primary differences between the MRI Patient Monitoring System (Model 865214) and the previously cleared device are listed below: - Body temperature measurement is completed with a reusable sensor that is . covered with a sterilized jacket (sheath)(rather than a single-use sterilized sensor). - Sterilization method is Gamma Radiation (rather than Ethylene Oxide (EO)). ● - The reusable sensor is not sterilized. Labeling of the sensor including the . instructions for use (IFU) identify the need to use a sterile jacket (sheath). - Product labeling and the IFU have been updated to reflect the modifications . accordingly

Here's a summary of the acceptance criteria and study information for the MRI Patient Monitoring System (Model 865214) based on the provided text, structured according to your request:

Device: MRI Patient Monitoring System (Model 865214)
Modification: Replacement of single-use, EO-sterilized temperature sensor with a reusable sensor using single-use, gamma-irradiated sterilized jackets.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document details the verification and validation (V&V) activities performed for the modified device. Rather than a specific "acceptance criteria" table with performance metrics, the document focuses on compliance with recognized standards and successful V&V of performance specifications and MRI conditions of use.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: The document does not specify a distinct "test set" sample size in terms of patient data or case numbers. The testing appears to be primarily device-centric, focusing on engineering verification and validation of the modified temperature component and its interaction with the MRI environment.
• Data Provenance: The document does not mention the use of patient or clinical data for the V&V of the modified device. It states, "The results do not raise issues regarding the safety and effectiveness of the device and clinical data was not required to substantiate claims of safety and effectiveness."

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

• Number of Experts: Not applicable. The ground truth for the verification and validation appears to be based on compliance with established engineering and medical device standards, and the device's own defined performance specifications, rather than expert interpretation of clinical cases.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. There is no mention of a human-centric adjudication process for evaluating the device's performance, as the study is device-focused rather than clinical.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• MRMC Study: No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The submission specifically states that "clinical data was not required to substantiate claims of safety and effectiveness."
• Effect Size of Human Reader Improvement: Not applicable, as no MRMC study was conducted.

6. Standalone Performance Study

• Standalone Performance Study: Yes, a standalone performance assessment was conducted for the device's temperature measurement capabilities and its compliance with MR conditions. This included:
  • Verification and validation of temperature measurement parameters against Invivo's defined performance specifications.
  • Evaluation of the reusable temperature sensor for magnetically induced displacement force, proton emissions, image artifact, and RF heating in an MRI environment.
  • Compliance with numerous voluntary standards related to safety, EMC, usability, patient monitoring, electronic thermometers, risk management, MR safety markings, MR induced displacement, and biocompatibility.

7. Type of Ground Truth Used

• Type of Ground Truth: The ground truth used for this submission is based on:
  • Compliance with recognized voluntary standards: (e.g., IEC, ASTM, ISO standards).
  • Manufacturer-defined performance specifications: These specifications were established according to national standards, international standards, market needs, risk management, and intended use.
  • Worst-case environment testing: The device was verified using a worst-case environment.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This submission does not describe a machine learning algorithm or an AI-based device that would require a "training set." The device is a traditional patient monitoring system for which hardware and software modifications were made to a temperature sensor.

9. How the Ground Truth for the Training Set Was Established

• Ground Truth for Training Set: Not applicable, as there was no training set for an AI/ML algorithm.

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