(10 days)
The RadiForce Large Monitor System 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 system consists of the following components:
- LS560W Large Monitor Model No. 6GF6200-8A$## mandatory component
- LMM56800 Large Monitor Manager Model No. 6GF6020-1A$## mandatory component
- PDC0100 Analog DVI Converter -- Model No. 6GF6010-0B$## -- optional accessory
- PDS0800 DV! Splitter/Scaler Model No. 6GF6020-0AA00-#$$# optional accessory
- TDL3600 Transmission Link Model No. 6GF6010-#$$## optional accessory
- CID1000P Control Interface Device 6GF6550-2H$## optional accessory
- Cabinet optional accessory
where "$" signifies a letter from A to Z, and "#" a number from 0 to 9.
The RadiForce Large Monitor System is a large color flat panel 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. To appreciate all of the advantages of the large widescreen monitor, the data has to be collected from the various sources and prepared for variable viewing. This is handled by the mandatory "Large Monitor Manager" ("LMM"). In some reports or references you will find the "LMM" being called "MDM" for "Multi Display Manager" (customer specific product name). The various video sources are being bundled using the Large Monitor Manager and from there being fed into the Large Display via two DVI lines.
Control of the video sources can also be accomplished using Eizo's Control Interface Device CID as optional part of the system or any other standard browser compatible operator console.
The RadiForce Large Monitor System uses a color LCD panel employing Multi-domain Vertical Alignment (MVA) technology to allow wide viewing angles. It has a resolution of 3840 x 2160 pixels and is used in landscape mode.
The various video sources from medical and other devices are being collected using the Large Monitor Manager and from there being fed into the Large Display via two DVI lines. An optional external operator console (Control Interface Device CID) can be used as optional part of the system to rearrange pictures from the regarding sources or switch between numerous presets according to specific user's needs.
The RadiForce Large Monitor System may be offered in different housing colors and with different logos. These are cosmetic differences and of no effect on the function and performance of the system.
The provided text describes the EIZO RadiForce Large Monitor System, but it does not contain details about specific acceptance criteria or a study designed to prove the device meets such criteria in terms of clinical performance or diagnostic accuracy.
The document focuses on:
- Device Description and Intended Use: A large color flat panel monitor system for integrating and displaying video from various medical instruments.
- Technological Characteristics: Resolution, panel technology, and how it handles multiple video sources.
- Performance Testing (Compliance): Verification that the system complies with certain standards (NEMA DICOM, IEC, UL, FCC) for electrical safety and electromagnetic compatibility.
- Substantial Equivalence: A claim that the device is substantially equivalent to a predicate device (Cardio-View, K083321) regarding technical characteristics, application, and intended use, and that differences do not affect safety or effectiveness.
Therefore, many of the requested sections about acceptance criteria, clinical study details, sample sizes, ground truth, and expert involvement cannot be extracted.
Here's a breakdown of what can be inferred from the text based on the provided categories:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Inferred from text) | Reported Device Performance |
|---|---|---|
| Grayscale Standard Display Function | Compliance with NEMA's PS 3.14 DICOM standard. (Though no precise pass/fail criterion is stated in the document, compliance to the standard is implied as the criterion). | "The RadiForce Large Monitor was successfully tested to comply with NEMA's PS 3.14 DICOM standard (Grayscale Standard Display Function)." "We consider the compliance to be excellent because of the very close proximity of the measured values towards the ideal curve represented by the Barten model." |
| System Functionality | The system performs in accordance with its specifications. | "EIZO GmbH performed a range of system and performance tests to ensure that the RadiForce Large Monitor System performed in accordance with its specifications. None of the tests revealed behaviors inconsistent with the expected performance of a large color flat panel display system." "A system test was conducted successfully on the RadiForce Large Monitor System, including MDM/LMM, Large Monitor, FPGA + Bootsoftware + Firmware, photometers SSM and ASLM." |
| Electrical Safety | Compliance with relevant electrical safety standards. | Certified to IEC 60601-1 for Large Monitor, Transmission Link and CID; IEC 60950-1 for CID and Converterbox; UL 60950-1 for MDM/LMM and Splitter; IEC 60601-1-1 for Large Monitor System. "Thus the electrical safety...of the system and its components could be verified by third party laboratories." |
| Electromagnetic Compatibility (EMC) | Compliance with relevant electromagnetic compatibility standards. | Certified to IEC 60601-1-2 for CID, Converterbox and Large Monitor; FCC Part 15, subpart B for Large Monitor System; IEC 60601-1-2 (radiated emissions only) for Large Monitor System. "Thus the...electromagnetic compatibility of the system and its components could be verified by third party laboratories." |
| Substantial Equivalence | Functionality and safety/effectiveness are comparable to the predicate device. | "The RadiForce Large Monitor System is substantially equivalent to the predicate device with respect to technical characteristics, application and intended use. All functions of the Radiforce Large Monitor System are identical to the predicate device. Any differences between the devices do not affect safety or effectiveness." |
2. Sample size used for the test set and the data provenance
- Not Applicable. The document describes engineering/compliance testing of a display device, not a clinical study involving a "test set" of patient data. The "test set" in this context would refer to internal company "system and performance tests" without specifying sample sizes or data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. This information is not provided because the testing described is not related to establishing clinical ground truth for diagnostic accuracy.
4. Adjudication method for the test set
- Not Applicable. This information is not provided.
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. No MRMC or human-in-the-loop study is mentioned. This device is a display monitor, not an AI diagnostic algorithm.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This device is a display monitor, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For the DICOM compliance test, the "ground truth" is the ideal curve represented by the Barten model.
- For safety and EMC tests, the "ground truth" is compliance with the specified international standards (IEC, UL, FCC).
- For system functionality, the "ground truth" is the device's own specifications.
8. The sample size for the training set
- Not Applicable. This device does not use a "training set" in the context of machine learning.
9. How the ground truth for the training set was established
- Not Applicable. This device does not have a "training set."
§ 870.2450 Medical cathode-ray tube display.
(a)
Identification. A medical cathode-ray tube display is a device designed primarily to display selected biological signals. This device often incorporates special display features unique to a specific biological signal.(b)
Classification. Class II (performance standards).