(89 days)
The use of MultiPics is indicated whenever multiple images (2, 3, or 4) are required to be shown together in a single image/display, and a high-line rate (e.g., 1049 lines @ 30 frames/sec or 1249 lines @ 25 fps) video signal is required. Examples include conversion/combining of X-ray (stationary, C-arm, angiography, etc.), nuclear medicine, magnetic resonance, and/or ultrasound images either directly from their source, or from an intermediate storage device (like a video tape or video disk), for use on display monitors, optical, tape, disk, or other apparatus requiring a high-line rate video signal.
MultiPics (Multiple Picture Scan Converter) is a digital image processing system that can display 2, 3, or 4 pictures on a single video monitor. Additionally, MultiPics has provisions for video scan conversion. MultiPics provides up to three modes of operation: DuoPics operation (Model ME-977-2), TriPics operation (Model ME-977-3), and QuadPics operation (Model ME-977-4).
The provided text describes the Merlin MultiPics device, a digital image processing system that can display 2, 3, or 4 pictures on a single video monitor and provides video scan conversion.
Here's an analysis based on your requested points:
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Table of Acceptance Criteria and Reported Device Performance:
Acceptance Criteria Reported Device Performance Functionality: Display 2, 3, or 4 images on one monitor. The device provides "DuoPics operation (Model ME-977-2)", "TriPics operation (Model ME-977-3)", and "QuadPics operation (Model ME-977-4)", which accept 2, 3, or 4 input signals respectively and output images as one-quarter of their original size, arranged on a single video frame without cropping. Video Scan Conversion: Ability to convert video signals. MultiPics has "provisions for video scan conversion." It is a "real-time video processing system designed to convert monochrome video images from one format to another (e.g., low line-rate to high line-rate, or visa versa)." Standard Compliance (RS-170 and RS-343A): Meet appropriate requirements of these video standards. "MultiPics was tested to ensure that it meets the appropriate requirements of RS-170 and RS-343A. The data demonstrates that MultiPics meets these standards, as appropriate to the specific signal, as is the case for the predicate devices." Standard Compliance (SMPTE RP-133): Correct compensation for aspect ratio changes. "In addition, MultiPics was tested in accordance with SMPTE RP-133. The system correctly compensates for aspect ratio changes in accordance with the requirements of the particular scan conversion selected." Low-Contrast Imaging Resolution: Achieves 1% level. "In addition, the system permits low-contrast imaging resolution at the 1% level." Electrical Compatibility: Electrically compatible with industry-standard monochrome video signals. "MultiPics is electrically compatible with industry standard monochrome video signals." Image Quality Preservation: Preserved within limits of standard video technology and line rates. "The image quality is preserved (within the limits of standard video technology and the line rates selected)." -
Sample size used for the test set and the data provenance:
The document does not specify a distinct "test set" in terms of patient data or a specific dataset. The performance tests ("nonclinical performance tests") were conducted on the device itself against established video and image processing standards (RS-170, RS-343A, SMPTE RP-133). The data provenance is implied to be from internal testing by Merlin Engineering Works. -
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This device is a video signal processing and display system, not an AI or diagnostic tool that requires expert-established ground truth on medical images. The "ground truth" for its performance is defined by adherence to engineering standards (RS-170, RS-343A, SMPTE RP-133) for video signals, which are objectively measurable. No experts are mentioned as establishing ground truth in a clinical sense. -
Adjudication method for the test set:
Not applicable. The tests are against engineering standards, not subjective assessments requiring adjudication. -
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 comparative effectiveness study was not done. This device is a display and conversion system for medical images, not an AI diagnostic tool that assists human readers. -
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Yes, the performance tests described (adherence to RS-170, RS-343A, SMPTE RP-133) represent a standalone evaluation of the device's technical specifications and capabilities, independent of human interaction beyond operating the device for testing purposes. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for the device's performance is adherence to industry-standard specifications for video signals and image processing (RS-170, RS-343A, SMPTE RP-133). This is a technical, objective ground truth, not a clinical one based on expert consensus, pathology, or outcomes data. -
The sample size for the training set:
Not applicable. This device is a hardware/software system for video signal processing, not a machine learning model that requires a training set. -
How the ground truth for the training set was established:
Not applicable, as there is no training set for this type of device.
§ 892.2020 Medical image communications device.
(a)
Identification. A medical image communications device provides electronic transfer of medical image data between medical devices. It may include a physical communications medium, modems, and interfaces. It may provide simple image review software functionality for medical image processing and manipulation, such as grayscale window and level, zoom and pan, user delineated geometric measurements, compression, or user added image annotations. The device does not perform advanced image processing or complex quantitative functions. This does not include electronic transfer of medical image software functions.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 892.9.