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The Essence 55SP Large Monitor System (Essence 55SP) is intended to be used by health care professionals to integrate the video output from various commercially-available instruments commonly used in a medical procedure laboratory into a single video display.

The Essence 55SP Large Monitor System is a large color LCD monitor for viewing images derived from several video sources on a single display and to rearrange these images to the situational requirements of the user. The system consists of a 55" TFT color LCD Monitor, and optionally a video wall controller, optical graphic extension module, a common PC, and cables.

The provided document is a 510(k) Summary for the Essence 55SP Large Monitor System. It describes the device and claims substantial equivalence to a predicate device. However, it does not contain the kind of detailed study information (sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth details for training/test sets) that would typically be found for an AI/ML medical device submission.

This document describes a medical monitor, not an AI/ML device. Therefore, the specific criteria requested, which are typically for assessing the performance of AI/ML algorithms against a clinical ground truth, are not applicable or present in this submission. The tests mentioned are performance tests for the display itself, ensuring it meets technical specifications and is equivalent to the predicate device.

Here's an attempt to answer the questions based on the available information, noting where the requested information is not present due to the nature of the device:

1. A table of acceptance criteria and the reported device performance

The document compares the proposed device (Essence 55SP) with a predicate device (Essence 55S) based on technical specifications. The acceptance criteria essentially appear to be demonstrating "substantial equivalence" to the predicate device, meaning its technical performance is either the same or, if different, the difference does not raise new questions of safety or effectiveness.

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

Not applicable. This is a medical monitor, and the "tests" performed are bench tests and display validation tests to confirm its technical specifications and equivalence to a predicate device. It does not process or analyze medical data in a way that would involve a "test set" of patient 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)

Not applicable. Ground truth, in the context of AI/ML, refers to clinically verified labels or diagnoses. This device is a display system, not a diagnostic AI. Its performance is assessed against technical specifications, not clinical judgment.

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

Not applicable. There is no test set in the sense of clinical cases 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

Not applicable. This device is a display monitor, not an AI system. It does not provide AI assistance for human readers, therefore, an MRMC study comparing human readers with and without AI would not be relevant.

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

Not applicable. This is a monitor, not an algorithm.

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

Not applicable. The performance is based on meeting technical specifications as specified by standards and comparison to a predicate device's measured performance. There is no "ground truth" related to medical disease states as one would find in an AI/ML submission.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable. There is no training set or medical ground truth for this device.

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The Essence 55S Large Monitor System (Essence 55S) is intended to be used by health care professionals to integrate the video output from various commercially-available instruments commonly used in a medical procedure laboratory into a single video display.

The Essence 55S Large Monitor System is a large color LCD monitor for viewing images derived from several video sources on a single display and to rearrange these images to the situational requirements of the user. Thanks to the advantages of the large widescreen monitor, the data can be collected from the video sources using the optional video wall controller AVS-540 and fed into the large display via the DVI lines and / or DP. The optical graphic extension module M1-201SA-TR can be used to convert / transmit the video signal, and the common PC can be taken as a video device.

The provided 510(k) summary (K172969) describes a medical monitor, the Essence 55S Large Monitor System. The acceptance criteria and the study that proves the device meets them are based on comparisons to a predicate device and bench testing.

1. Table of Acceptance Criteria and Reported Device Performance

The device is a medical monitor, and its "performance" is primarily defined by its technical specifications and its ability to integrate video output for medical professionals. The acceptance criteria are implicitly met by demonstrating substantial equivalence to a predicate device and successful bench and system tests.

Comparison Table for Key Technical Specifications (Excerpt from Table 2 in document):

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

This is a medical display device, not an AI or diagnostic imaging device. Therefore, the concept of a "test set" in the context of patient data or clinical images is not applicable. The "tests" performed are engineering and performance validation tests.

• Sample Size: Not applicable in the context of patient data. The "sample" would be the device itself (Essence 55S Large Monitor System).
• Data Provenance: Not applicable. The "data" are technical specifications and test results generated from the device in a laboratory setting.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. Ground truth, in the context of expert consensus on medical images, is not relevant for a medical display device. The "ground truth" for this device's performance is its adherence to technical specifications and safety standards, as verified through engineering tests.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (like 2+1 or 3+1) are used for resolving disagreements among human readers in interpreting medical images. This device is a display, not an interpretation tool.

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

No, an MRMC comparative effectiveness study was not done. Such studies are typically performed for diagnostic devices or AI algorithms that assist in interpretation, to measure the impact of the device on human reader performance. This device is a monitor, not an interpretative aid.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, but not in the typical sense of an "algorithm-only" performance for a diagnostic task. The "standalone" performance here refers to the device's technical specifications and functionality as a display system, independent of a human's diagnostic interpretation using the displayed images. The "Display bench tests," "Display validation tests," and "System tests" are essentially standalone performance evaluations of the monitor.

7. The Type of Ground Truth Used

The "ground truth" for this device is based on:

• Technical Specifications: Adherence to defined physical and electrical parameters (e.g., resolution, brightness, contrast, response time).
• Regulatory Standards: Compliance with relevant medical device safety and performance standards (e.g., EN60601-1, ANSI/AAMI ES60601-1, FCC-B, RoHS).
• Predicate Device Equivalence: The performance and characteristics of the legally marketed predicate device (RadiForce Large Monitor System) serve as a benchmark for substantial equivalence.

8. The Sample Size for the Training Set

Not applicable. This device is a hardware display system, not a machine learning model that requires a "training set" of data.

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

Not applicable, as there is no training set for this type of device.

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