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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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