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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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The Expression Information Portal (Model IP5) is intended to monitor vital signs for patients undergoing MRI procedures. The Expression Information Portal (Model IP5) is intended for use by healthcare professionals.

The Expression Information Portal (Model IP5) is a secondary patient monitoring display intended for use outside the MR system room as a supplement or alternate for the cleared device's display. It is a "repeater" display and does not perform any data collection or processing as a stand-alone patient monitoring system. It relies upon the cleared device's processing unit, wireless modules, and patient applied parts to complete data collection and processing. The modified device consists of a color 19-inch LCD display with a touch screen, AC-DC power supply, and a radio module. Optional peripheral equipment includes a printer, wireless keyboard and mouse, wireless barcode scanner, uninterruptible power supply, desk stand, and wall mounting arm.

Here's a summary of the acceptance criteria and the study that proves the device meets the acceptance criteria for the Expression Information Portal (Model IP5), based on the provided text:

Important Note: The Expression Information Portal (Model IP5) is a repeater display for an existing patient monitoring system. Therefore, the core vital sign algorithms, measurement range, and accuracy are not evaluated in this 510(k) submission, as these are handled by the cleared predicate device's processing unit. This submission focuses on the safety and performance of the display unit itself and its modifications.

Acceptance Criteria and Reported Device Performance

The provided document primarily details modifications to a previously cleared device (MRI Patient Monitoring System, Model 865214) and demonstrates substantial equivalence. The acceptance criteria are therefore largely based on compliance with relevant national and international safety and performance standards for medical electrical equipment and specific patient monitoring functions, as well as verification of the modified features.

Table of Acceptance Criteria and Reported Device Performance:

Study Information:

The provided document describes a non-clinical performance study to demonstrate substantial equivalence, rather than a clinical study involving human patients. The study focuses on verification and validation (V&V) testing of the modified device against applicable standards and internal specifications.

1. Sample size used for the test set and the data provenance:

   • Sample size: Not explicitly stated as a numerical patient or case count, as this was a non-clinical, bench-top V&V study. The "test set" consisted of the modified device (Expression Information Portal, Model IP5) and its peripheral equipment.
   • Data provenance: Not directly applicable in the terms of patient data origin (country, etc.), as it's a non-clinical study. The data was generated through in-house verification testing by Invivo Corporation and third-party laboratory testing (e.g., for IEC 60601-1 series). The study is prospective in the sense that the testing was performed specifically for this 510(k) submission to demonstrate compliance of the modified device.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable. The "ground truth" for this non-clinical study is established by adherence to engineering specifications, safety and performance standards, and the functional behavior of the cleared predicate device. There is no expert human assessment to establish a diagnostic ground truth for patient data or images. The "experts" involved would be the engineers, quality assurance personnel, and regulatory affairs specialists who designed, tested, and evaluated the device against the objective standards.

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

   • Not applicable. Adjudication methods are typically used in clinical studies for resolving discrepancies in expert interpretations of data (e.g., medical images). This was a non-clinical V&V study where direct objective measurements, compliance with specified thresholds, and functional confirmations were the primary verification methods.

4. 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:

   • No. An MRMC study was not conducted. This device is a display monitor, not an AI-powered diagnostic system. Its purpose is to display vital sign data provided by an existing patient monitoring system.

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

   • No. While the device itself is a "standalone" display unit, it functions solely as a display for data generated by a separate, already cleared patient monitoring system. The document explicitly states: "The modified device does not perform any data collection or processing as a stand-alone patient monitoring system." (Page 4). Therefore, no standalone algorithm performance (as in diagnostic AI) was performed or is relevant.

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

   • The "ground truth" for this device's performance is objective compliance with:
     • International and national medical device standards (e.g., IEC 60601 series, ISO 14971, ASTM F2503, FCC Part 15).
     • Functional specifications (e.g., display dimensions, resolution, interface type, alarm characteristics, wireless communication integrity).
     • Equivalence to the predicate device's display capabilities (e.g., displaying the same vital signs, same time for data availability).

7. The sample size for the training set:

   • Not applicable. This device does not employ machine learning or AI algorithms that require a "training set" of data.

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

   • Not applicable. As there is no training set for machine learning.

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The MRI Patient Monitor (Model 865353) is intended to monitor vital signs for patients undergoing MRI procedures. The MRI Patient Monitor (Model 865353) is intended for use by healthcare professionals.

The MRI Patient Monitor (Model 865353) is substantially equivalent to the cleared device. Invivo has marketed a stand-alone pulse oximeter for the last 20 years as cleared to market in K864730 (Invivo Pulse Oximeter, Model 4500). This technology is over 20 years old and has not changed in design or fundamental technology since cleared to market. Invivo has identified the need to market an improved standalone pulse oximeter as a replacement for this device. The modified device is predicated from the MRI Patient Monitoring System (Model 865214) which received clearance to market under 510(k) K090785 on December 15, 2009. The cleared device consists of a processing unit, display, and wireless SpO2 module which is directly connected to the patient by a fiber optic sensor, clip, and grip. All oximetry data collection and processing is completed by the wireless SpO2 module and fiber optic sensor. The module transmits the patient data to the processing unit using telemetry, and the processing unit transmits the data to the display using telemetry. The modified device incorporates the same wireless SpO2 module and fiber optic sensor that is currently used with the cleared device. In the modified device, the module transmits the data directly to the display using telemetry. The following modifications have been incorporated to create the modified device: The display was reduced in size and weight. The operator interface is a touch screen (instead of a rotary knob and keypad). SpO2, pulse rate (derived from SpO2), and perfusion index parameters only are measured and displayed. The following parameters are no longer measured and displayed: ECG, non-invasive blood pressure, invasive blood pressure, respiration, temperature, end-tidal CO2, and anesthetic agents concentrations. The device does not provide signals for synchronization for the MRI scanner ("gating"). "Gating", or lack thereof, has no effect on patient monitoring ability or quality. The display is battery-operated only. The display does not offer connections to AC mains. The radio printed circuit board layout was reduced in size to accommodate the smaller display size. The display radio antenna was reduced in size to accommodate the smaller display size and the antenna was concealed in the device handle. The module used with the device also communicates with the existing cleared MRI Patient Monitoring Systems, Models 865214 and 3160. The operating platform was modified to the MicroBlaze soft-core microprocessor running on the Spartan 6LX45 FPGA. The operational system was modified to the uC ("micro C") from company Micrium. The display was modified to provide unlatched alarms only. Latched alarms are no longer provided. The intelligent battery charger is located in the battery (instead of in the device). The modified device has the same performance specifications (SpO2 operating range and accuracy) and uses the same patient applied parts (wireless SpO2 module, fiber optic sensor, clips, and grips) as the cleared device. The MRI Patient Monitor consists of the following primary components: Display ("Vital Signs Viewer"), Wireless SpO2 Module, SpO2 Sensor, SpO2 Grips and Clips. The display and SpO2 module enclose the transceiver and antennas that support bi-directional 2.4 GHz wireless communication. The modified device's operator interface consists of a color 5.7-inch LCD display and touch screen. The modified device's display provides the same vital sign information regarding SpO2, generates the same types of alarms (audible, lights, and text), and controls the same functions (alarm limits, patient type, display setup, and network selection) as the cleared device.

This document is a 510(k) summary for the Invivo Essential MRI Patient Monitor (Model 865353). It describes the device, its intended use, and its substantial equivalence to a previously cleared device (Invivo MRI Patient Monitoring System, Model 865214, K090785). The submission primarily focuses on demonstrating that modifications made to the predicate device do not raise new questions of safety or effectiveness.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Important Note: This 510(k) submission primarily focuses on demonstrating substantial equivalence to a predicate device, not on proving general safety and effectiveness through de novo clinical trials. The document explicitly 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." Therefore, many of the typical clinical study components (like expert consensus for ground truth, MRMC studies, standalone performance studies with large patient datasets) are not applicable or not explicitly detailed in this type of submission. The focus is on demonstrating that the modified device's performance aligns with the predicate, especially in critical areas like SpO2 accuracy.

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't present a formal "acceptance criteria" table in the sense of a clinical trial endpoint. Instead, it refers to compliance with standards and equivalence to the predicate device's established performance. The key performance specifications for SpO2 are considered unchanged from the predicate device.

Explanation: The fundamental premise of this 510(k) is that the core SpO2 measurement technology (module, technology, patient-applied parts, algorithm, and software) is identical to the cleared predicate device. Therefore, its performance in these aspects is assumed to be the same and does not require re-validation. The validation efforts for the modified device focused on ensuring that the changes (smaller display, touch screen, reduced parameters, battery-operated display, modified radio layout, etc.) did not negatively impact safety or the existing performance specifications.

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

Given this is a 510(k) for a modified device and "clinical data was not required," specific sample sizes for a traditional test set (e.g., patient data for algorithm evaluation) are not provided.

The "test set" in this context refers to various engineering and functional tests:

• Verification and validation of performance specifications: Protocols were established for modified specifications.
• Verification and validation of MR conditions of use: This involved testing using "3.0T and 1.5T magnetic fields, simulators, and test equipment under the most extreme use conditions." No human subject sample size is mentioned for these MR compatibility tests.
• Environmental testing: Conducted to confirm conformity over device use life.
• Evaluation of wireless technology: FCC Part 15 testing and integrity validation of wireless communication.

Data Provenance: The data provenance is from in-house engineering testing (Invivo Corporation) and third-party laboratory testing for standards compliance (e.g., IEC 60601 series). It is entirely prospective in the sense that the new device was built and then specifically tested against established standards and internal specifications. There is no mention of external data or patient data from a specific country of origin in the context of device performance evaluation.

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

This information is not applicable and not provided in the document. For 510(k) submissions focusing on substantial equivalence of a modified device, especially one where "clinical data was not required," the ground truth is established by:

• Engineering specifications and national/international standards (e.g., ISO 9919 for pulse oximeters, IEC standards for electrical safety).
• The performance of the legally marketed predicate device.

No medical experts are mentioned as establishing ground truth for performance testing of this device.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

This information is not applicable and not provided. Adjudication methods like "2+1" or "3+1" are typically used in clinical studies involving interpretation of medical images or patient outcomes, often with multiple human readers. The tests described are engineering and compliance tests (e.g., electrical safety, MR compatibility, wireless function), where results are objective and measured against predefined limits or standards, not subject to subjective expert interpretation requiring adjudication.

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

An MRMC comparative effectiveness study was not done. This type of study is relevant for AI/CADe devices that assist human interpretation of medical images. The Invivo MRI Patient Monitor is a vital signs monitor, not an imaging analysis device with an AI component designed to assist human readers, and it explicitly states that "clinical data was not required."

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

A standalone performance evaluation of the SpO2 algorithm was not done for the modified device, per se. The document states: "Verification and validation of SpO2 accuracy in the modified device is not required because the SpO2 module, technology, patient-applied parts, algorithm, and software is the same as the cleared device." This implies that the standalone performance of the SpO2 algorithm was established during the clearance of the predicate device (K090785) and is considered identical in the modified device.

The "standalone" performance that was evaluated for the modified device focused on its new components and functionalities separate from core SpO2 algorithm, such as:

• The display (size, resolution).
• The operator interface (touch screen).
• The new radio layout and antenna.
• The operating platform and system.
• MR compatibility.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the core physiological measurements (SpO2, pulse rate) relies on the established accuracy and performance of the predicate device's SpO2 module, technology, algorithm, and software, which are stated to be identical. This performance would have originally been validated against a reference standard for pulse oximetry, likely involving subjects in a controlled hypoxia study, as per ISO 9919. However, this specific validation against a "ground truth" was not repeated for the modified device.

For the other aspects, the ground truth was based on:

• National and international standards: e.g., IEC 60601 series for safety, ISO 9919 for pulse oximeters, ASTM F2503 for MR compatibility.
• Internal performance specifications: Defined by Invivo Corporation based on market needs and risk management.
• FCC regulations: For wireless technology evaluation.

8. The Sample Size for the Training Set

This information is not applicable and not provided. The device is not an AI/ML device that requires a "training set" in the conventional sense. The "algorithm" for SpO2 measurement is a mature, established technology from the predicate device.

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

This information is not applicable and not provided as there is no "training set" for an AI/ML algorithm. The core SpO2 algorithm's performance would have been validated against a "ground truth" during its initial development and clearance, likely through controlled studies comparing measured SpO2 values to arterial blood gas measurements, as per relevant standards for pulse oximeters. This process is not described for the modified device as its algorithm is considered identical to the predicate.

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