(54 days)
The intended use for UpScan 120 is conversion of X-ray (stationary, C-arm, angiography, etc.), nuclear medicine, magnetic resonance, and ultrasound images either directly from their source, or from an intermediate storage device (like a video tape or video disk), for use on high resolution display monitors or other apparatus requiring a very-high-line rate video signal (e.g., 1023-1049 lines @ 60 frames/second, or 1249 lines @ 50 frames/second). The use of UpScan 120 is indicated whenever the source and destination of a video signal are incompatible due to different line and/or frame rates, and a very-high-line rate video signal is required.
UpScan 120 is intended for use in patient care areas, but is not intended to have any patient contact.
UpScan 120 is a digital image processing system that can convert from low-line rate video standard of 525/30 (or 625/25) or high-line rate video standard of 1023-1049/30 (or 1249/25), to very-high-line rate video standard of 1023-1049/60 (or 1249/50), often referred to as "flicker free" or "fast" video. Additionally, UpScan 120 can provide a (pre-)fixed amount of vertical edge enhancement to the output video signal, and can also invert the video image (black ⇌ white). Housed in a 1 ¾" EIA rack mount chassis, UpScan 120 operates from 100V to 240V AC power.
UpScan 120 consists of an enclosed sheet metal chassis housing one main printed wiring assembly, one secondary printed wiring assembly, and the power supply (100-240 VAC input and ±15 VDC, ±5 VDC outputs). UpScan 120 uses standard SSI/MSI/LSI semiconductor technology.
UpScan 120 utilizes nine basic electronic circuits on the primary printed wiring assembly. They are: input analog video conditioning circuit, analogto-digital conversion circuit, memory circuits, digital video line interpolator circuits, digital processing circuits, various control circuits, digital-toanalog conversion circuit, two clock circuits, and output analog video conditioning circuit.
All of the processing is done in the digital domain. The analog-to-digital converter changes the analog video to an 8-bit digital bus. That digital bus is sent to the memories for processing. Memory control circuits manage the locations and the timing of how the video is being stored in the memories. The line interpolator circuits interpolate the output digital bus from the memories, and the digital processing circuits add desired vertical edge enhancement and/or video inversion before sending the resultant signal to the 8-bit digital-to-analog circuit.
The write clock generator provides clock timing for analog-to-digital conversion, the memories and the memory control circuits. The read clock generator provides read clock timing for the memories, the line interpolator and the digital-to-analog circuits.
UpScan 120 and one of the predicate devices (Merlin UniScan) are realtime video processing systems which are designed to convert monochrome video images from one video format to another. The only differences are a higher clock frequency and the ability to output video at twice the standard frame rate. UpScan 120 and the other predicate device (Merlin CrisPics) are real-time video processing systems designed to provide edge enhancement and/or video inversion for monochrome video signals.
UpScan 120 and all of the predicate devices utilize similar technology to perform their functions. These systems all convert the incoming analog video signal to digital form using 8-bit analog-to-digital converters, process the signals in the digital domain, and convert back to analog video using 8bit digital-to-analog converters for the output.
The provided text describes the Merlin Engineering Works UpScan 120, a digital image processing system designed to convert video signals. The "Summary of Safety and Effectiveness" section outlines nonclinical performance tests conducted to establish substantial equivalence to predicate devices.
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Meets appropriate requirements of RS-170 and RS-343A | The data demonstrates that UpScan 120 meets these requirements. |
| Correctly compensates for aspect ratio changes | The system correctly compensates for aspect ratio changes (tested in accordance with SMPTE RP-133). |
| Permits low-contrast imaging resolution at the 1% level | It permits low-contrast imaging resolution at the 1% level (tested in accordance with SMPTE RP-133). |
| Electrically compatible with industry standard monochrome video signals | UpScan 120 is electrically compatible with industry standard monochrome video signals. |
| Image quality preservation | Image quality is preserved (within the limits of standard video technology). |
2. Sample size used for the test set and the data provenance:
The document describes nonclinical performance tests. It does not mention a "test set" in the context of patient data or clinical images. The testing appears to be based on validating the device's technical specifications against industry standards. Therefore, information about sample size for a test set and data provenance (e.g., country of origin, retrospective/prospective) is not applicable or provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided as the tests described are nonclinical performance tests of the device's adherence to technical standards, not evaluation against a ground truth established by experts interpreting medical images.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not provided. The performance tests are described as verifying compliance with technical standards, which typically do not involve adjudicated readings.
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:
No MRMC comparative effectiveness study is mentioned. The UpScan 120 is a video scan converter, not an AI-powered diagnostic tool, and the tests described are technical performance evaluations.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
The tests described are for the standalone performance of the UpScan 120 device in converting video signals. The device itself is not an algorithm in the sense of AI or image analysis that would typically be evaluated for human-in-the-loop performance. It performs its function independently.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for the nonclinical performance tests appears to be defined by established industry standards, specifically RS-170, RS-343A, and SMPTE RP-133. The device's output and functionalities were compared against the requirements stipulated by these standards.
8. The sample size for the training set:
The UpScan 120 is a hardware device with embedded electronic circuits and logic. It is not an AI system that undergoes "training" with a dataset in the typical sense. Therefore, information about a training set sample size is not applicable.
9. How the ground truth for the training set was established:
As the UpScan 120 is not an AI system that is "trained," the concept of establishing ground truth for a training set does not apply. Its functionality is based on its electronic design and implementation of video conversion and processing techniques.
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).