(89 days)
The use of SplitScreen is indicated whenever two images are required to be shown together side-by-side 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.
SplitScreen is a digital image processing systems that can display 2 pictures side-by-side on a single video monitor. Additionally, SplitScreen has provisions for video scan rate conversion. SplitScreen accepts two input signals at various scan rates, and it outputs video at high-line rate. Both images share the full video frame by splitting them with a vertical boundary. The position of the boundary can be adjusted right or left (thus adjusting the relative amounts of each image viewed), and each image can be panned horizontally within each split area. The result is two images, each of which is full height but cropped horizontally. The output composite image is compatible with high-resolution monitors capable of displaying high-line rate video which is compatible with EIA standard RS-343A.
The Merlin Engineering Works, Inc. SplitScreen (Model ME-975) is a digital image processing system that can display two pictures side-by-side on a single video monitor and provides video scan rate conversion.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Meets appropriate requirements of RS-170 and RS-343A standards for specific signals. | The data demonstrates that SplitScreen meets these standards, as appropriate to the specific signal, as is the case for the predicate devices. |
| Correctly compensates for aspect ratio changes in accordance with SMPTE RP-133 requirements for the selected scan conversion. | The system correctly compensates for aspect ratio changes in accordance with the requirements of the particular scan conversion selected. |
| Permits low-contrast imaging resolution at the 1% level. | The system permits low-contrast imaging resolution at the 1% level. |
| Electrically compatible with industry standard monochrome video signals. | SplitScreen is electrically compatible with industry standard monochrome video signals. |
| Preserves image quality (within the limits of standard video technology and selected line rates). | The image quality is preserved (within the limits of standard video technology and the line rates selected). |
| Functionality to convert and combine X-ray (stationary, C-arm, angiography, etc.), nuclear medicine, magnetic resonance, and ultrasound images, directly from source or intermediate storage, for display on monitors or other apparatus requiring a high-line rate video signal. | The intended use for SplitScreen is conversion and combining 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 display monitors, optical, tape, disk, or other apparatus requiring a video signal. The device is indicated whenever two images are required to be shown together side-by-side in a single image/display, and a high-line rate video signal is required. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size of images or video signals used for testing. The testing described focuses on evaluating the device's technical specifications and adherence to industry standards rather than a clinical performance study with a 'test set' in the typical sense of medical image analysis. No information on data provenance (country of origin, retrospective/prospective) is provided.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The performance tests described are technical validations against established video standards (RS-170, RS-343A, SMPTE RP-133) rather than a clinical study requiring expert ground truth annotations for medical images.
4. Adjudication Method for the Test Set
Not applicable. As noted above, the validation involved technical adherence to standards, not human adjudication of medical image interpretations.
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 was done. The SplitScreen device is a video processing system, not an AI-powered diagnostic tool, and therefore, its performance is not evaluated in terms of improving human reader effectiveness with AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
A standalone performance evaluation was conducted. The device was tested to ensure it met specific technical standards (RS-170, RS-343A, SMPTE RP-133) and maintained image quality and electrical compatibility without human interaction or interpretation as part of the core performance validation.
7. The Type of Ground Truth Used
The "ground truth" for the performance tests was based on established industry standards and specifications for video signals and image display, specifically:
- RS-170 and RS-343A: Standards for analog video signals.
- SMPTE RP-133: Recommended practice for aspect ratio compensation.
- 1% low-contrast imaging resolution: A quantitative performance metric.
- Electrical compatibility: Adherence to defined electrical characteristics for monochrome video signals.
8. The Sample Size for the Training Set
Not applicable. The SplitScreen device is a video hardware/firmware processing system, not a machine learning or AI model, thus no "training set" in the context of AI development was used.
9. How the Ground Truth for the Training Set was Established
Not applicable. As there is no training set, there is no ground truth established for it.
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Image /page/0/Picture/0 description: The image shows a black and white drawing of an eagle's head. The eagle has a sharp, curved beak and piercing eyes. Above the eagle's head is a dark, semi-circular shape, possibly representing a cap or a shadow. Below the eagle, there is some text that is difficult to read due to the image quality.
Image /page/0/Picture/1 description: The image shows a partial view of a drawing or illustration. On the left side, there is a detailed depiction of a wing, possibly belonging to a bird or insect, rendered with fine lines and shading. To the right of the wing, there is a fragment of text, with only the letters 'Wing' visible, suggesting that it might be a label or part of a longer word associated with the wing illustration.
Merim Engineering Works 1888 Embarcadero Road, Pato Alto, CA 94303 Tot (415) 856-0900 Fax (415) 858-2302
Summary of Safety and Effectiveness 2.
| Submitter: | Merlin Engineering Works, Inc.1888 Embarcadero RoadPalo Alto, California 94303 | JUN 2 5 1997 | ||
|---|---|---|---|---|
| Telephone:Facsimile: | (415) 856-0900(415) 858-2302 | |||
| Contact: | Gerald Engbretson,Operations Manager / Director, Regulatory Affairs | |||
| Device identification: | Trade Name: | SplitScreen | ||
| Model Number(s): | ME-975 | |||
| Common Name: | Multiple Picture Digital Scan Converter. | |||
| ClassificationName: | (A component of) stationary x-ray system, per 21CFR 892.1680 (or equivalent) | |||
| Device(s) to whichsubstantial equivalenceis claimed: | K953398 | UniScan(a.k.a. Model ME-959) | Merlin EngineeringWorks, Inc. | |
| K920550 | IDP-5100 InterventionalDisplay Processor | Perkins ManufacturingCo. | ||
| Description of thedevice: | SplitScreen is a digital image processing systems that can display 2pictures side-by-side on a single video monitor. Additionally,SplitScreen has provisions for video scan rate conversion.SplitScreen accepts two input signals at various scan rates, and it outputsvideo at high-line rate. Both images share the full video frame bysplitting them with a vertical boundary. The position of the boundary canbe adjusted right or left (thus adjusting the relative amounts of eachimage viewed), and each image can be panned horizontally within eachsplit area. The result is two images, each of which is full height butcropped horizontally. The output composite image is compatible withhigh-resolution monitors capable of displaying high-line rate video whichis compatible with EIA standard RS-343A.When used in conjunction with a Video Scan Converter capable ofconverting from high-line to low-line rate, such as Merlin's UniScan(submission K953398), the resulting SplitScreen image can be recordedon standard VHS, S-VHS, and other readily available recorder formats,and can be viewed with standard video monitors. |
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Intended use of the device:
Summary of how the technological characteristics compare to predicate device(s):
Summary of (nonclinical) performance tests and how their results support a determination of substantial equivalence:
Conclusions drawn from the performance tests:
The intended use for SplitScreen is conversion and combining of X-rav (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 display monitors, optical, tape, disk, or other apparatus requiring a video signal.
The use of SplitScreen is indicated whenever two images are required to be shown together side-by-side 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. SplitScreen is not intended to have any patient contact.
SplitScreen and the predicate devices are real-time video processing systems designed to convert monochrome video images from one format to another (e.g., low line-rate to high line-rate, or visa versa) and/or to convert from full size/full view images to other size/other view images. SplitScreen and all of the predicate devices utilize similar technology to perform the scan conversion. 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 8-bit digital-to-analog converters for the output.
SplitScreen and one of the other predicates (Perkins IDP-5100) produce outputs where parts of one input image cover parts of the other input. since full sized/full view images must either be sized or cropped to allow multiple images on a single display. The Perkins unit does this by shrinking one of the images to quarter size (covering up an equivalent amount of the second image), while SplitScreen does this by horizontally cropping both images, keeping both of them full height.
SplitScreen was tested to ensure that it meets the appropriate requirements of RS-170 and RS-343A. The data demonstrates that SplitScreen meets these standards, as appropriate to the specific signal, as is the case for the predicate devices.
In addition, SplitScreen 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. In addition, the system permits low-contrast imaging resolution at the 1% level.
SplitScreen is electrically compatible with industry standard monochrome video signals. The image quality is preserved (within the limits of standard video technology and the line rates selected).
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Image /page/2/Picture/0 description: The image shows a black and white logo for the Department of Health & Human Services. The logo features a stylized representation of a human figure with three overlapping profiles, suggesting a sense of community and care. The text "DEPARTMENT OF HEALTH & HUMAN" is arranged in a circular fashion around the figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Gerald Engbretson Operations Manager and Director of Regulatory Affairs Merlin Engineering Works, Inc. 1888 Embarcadero Rd. JUN 2 5 1997 Palo Alto, CA 94303
Re: K971153 Splitscreen ME-975 Multiple Picture Digital Scan Converter Dated: March 27, 1997 Received: March 28, 1997 Regulatory Class: II 21 CFR 892.1680/Procode: 90 LMD
Dear Mr. Engbretson:
We have reviewed your Secuon 510(k) notification of intent to market the device referenced above and we have decemined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Prematket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. This response to your prematics notification does not affect any obligation you might have under sections 51 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations,
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predication for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 80) and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-591 for Radiology devices or 594-4613 for Ear, Nose and Throat devices. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours.
Lillian Yin, Ph.D.
Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known):
Device Name: SplitScreen
Indications For Use:
The use of SplitScreen is indicated whenever two images are required to be shown together side-by-side 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.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel A. Segner
ivision Sign-Off) Division of Reproductive, Abdominal, ENIT and Radiological Devices 510(k) Number
OR
Prescription Use
(per 21 CFR 801.109)
Over-The-Counter Use
(Optional Format 1-2-96)
§ 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.