Search Results

The use of DownScan LT is indicated whenever the source and destination of a video signal are incompatible due to different line rates or other signal attributes, and a standard frame rate video signal (30 or 25 frames/second) is required. Examples include 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 display monitors, optical, tape, or disk recorders, or other apparatus requiring a standard frame rate signal.

DownScan LT is a digital image processing system that can convert from high line rate video standard of 1023-1125/60 or 1249/50 to low line rate video standards of 525/30 or 625/25. Housed in a 1 3/4" EIA half-rack mount chassis, DownScan LT operates from 100V to 240V AC power.

This document describes the Merlin DownScan LT, a digital image processing system designed to convert high line rate video to low line rate video. It serves as a regulatory submission (510(k)) to the FDA, demonstrating substantial equivalence to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a distinct "test set" with a dedicated sample size in the conventional sense of a clinical or image-based study. The performance tests described are related to engineering and signal processing standards. The data provenance is not explicitly stated as retrospective or prospective, but the tests were conducted by the manufacturer, Merlin Engineering Works, to demonstrate compliance with industry standards. The country of origin for the device's testing and manufacturer is the USA.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided. The "ground truth" for the tests appears to be defined by established industry technical standards (RS-170, RS-343A, SMPTE RP-133) rather than expert consensus on medical images.

4. Adjudication Method for the Test Set

This information is not provided. Given the nature of the tests (compliance with technical specifications), it is likely that measurements and comparisons to defined standards were performed, rather than an adjudication process involving human interpretation of medical images.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done for this device. The document describes a video signal processing system, not a diagnostic imaging aid that would typically involve human readers.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

Yes, the performance tests described are inherently standalone in the sense that they evaluate the device's adherence to technical standards and objective performance metrics (e.g., aspect ratio compensation, low-contrast resolution) without human intervention in the primary function or assessment. The device's role is to convert video signals, not to interpret medical images.

7. The Type of Ground Truth Used

The ground truth used for these tests is based on established technical standards and specifications:

• RS-170 (a standard for monochrome video signals)
• RS-343A (another standard for monochrome video signals, often related to higher resolution)
• SMPTE RP-133 (a recommended practice by the Society of Motion Picture and Television Engineers, likely related to image quality and display characteristics for medical imaging).
  The performance criteria are objective measurements against these predefined benchmarks.

8. The Sample Size for the Training Set

This information is not applicable and not provided. The DownScan LT is a digital image processing system that converts video signals. It is not an AI/ML algorithm that requires a "training set" in the typical sense for learning patterns from data. Its function is based on engineered signal processing algorithms, not learned models.

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

This information is not applicable, as there is no "training set" for this type of device. The device's operation is based on predefined signal processing logic and hardware, not on machine learning from a dataset with established ground truth.

Ask a specific question about this device

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

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.

Ask a specific question about this device

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:

1. 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)."

2. 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.

3. 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.

4. Adjudication method for the test set:
   Not applicable. The tests are against engineering standards, not subjective assessments 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:
   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.

6. 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.

7. 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.

8. 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.

9. How the ground truth for the training set was established:
   Not applicable, as there is no training set for this type of device.

Ask a specific question about this device

The intended use for DownScan 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 display monitors, optical, tape or disk recorders, or other apparatus requiring a standard frame rate video signal (30 or 25 frames/second). The use of DownScan 120 is indicated whenever the source and destination of a video signal are incompatible due to different line and/or frame rates, and a standard frame rate video signal is required. DownScan 120 is intended for use in patient care areas, but is not intended to have any patient contact.

DownScan 120 is a digital image processing system that can convert from very-high-line rate video standard of 1023-1049/60 or 1249/50 (~64 KHz horizontal frequency, often referred to as "flicker free" or "fast" video) to high-line rate video standards of 1023-1049/30 or 1249/25, or to low-line rate video standards of 525/30 or 625/25. Housed in a 1 3/4" EIA rack mount chassis, DownScan 120 operates from 100V to 240V AC power.

DownScan 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). DownScan 120 uses standard SSI/MSI/LSI semiconductor technology.

DownScan 120 utilizes eight basic electronic circuits on the primary printed wiring assembly. They are: input analog video conditioning circuit, analog-to-digital conversion circuit, memory circuits, various control circuits, digital-to-analog 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 and then read from memory 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 and the digital-to-analog circuits.

This document describes the DownScan 120, a digital image processing system that converts specialized video signals (e.g., from X-ray) to standard video formats. The submission focuses on demonstrating substantial equivalence to a predicate device, the UniScan.

Here's an analysis of the provided information, framed by your requested criteria:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by compliance with industry standards and maintenance of image quality. The performance data is largely a statement of compliance and capability rather than specific metrics in a typical sense for a diagnostic device.

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

• Sample Size: Not explicitly stated in terms of 'cases' or 'patient data'. The testing described is a functional and technical validation of the device's video processing capabilities against established standards. It's not a study involving a "test set" of medical images in the way one would evaluate an AI diagnostic tool.
• Data Provenance: Not applicable in the context of diagnostic data. The "data" here refers to the output of the device itself when processing various video signals, and its compliance with technical specifications.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts

• Number of Experts: Not applicable. The ground truth for this device's performance is compliance with engineering standards (RS-170, RS-343A, SMPTE RP-133) and the inherent functioning of its electronic circuits.
• Qualifications of Experts: Not applicable. Device testing against standards typically involves engineers and technical staff.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. Testing against technical standards does not involve human adjudication in the same way clinical diagnostic accuracy studies do. Performance is assessed by direct measurement against defined technical parameters.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

• MRMC Study: No. This device is a video signal converter, not a diagnostic algorithm that assists human readers. Its purpose is to present images, not interpret them.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done

• Standalone Study: Yes, in a sense. The described tests are "standalone" in that they evaluate the device's technical performance metrics (e.g., meeting RS-170, RS-343A, SMPTE RP-133) independent of a human operator's diagnostic interpretation. The device's primary function is a technical one (video conversion), not a diagnostic one.

7. The Type of Ground Truth Used

• Type of Ground Truth: Technical specifications and industry standards (RS-170, RS-343A, SMPTE RP-133). The "ground truth" is that the device should accurately convert video signals and maintain image quality as defined by these engineering benchmarks.

8. The Sample Size for the Training Set

• Sample Size: Not applicable. This is a hardware device with embedded firmware, not an AI/ML algorithm that undergoes a "training" phase with a dataset.

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

• Ground Truth Establishment: Not applicable, as there is no training set in the context of AI/ML. The device's design and functionality are based on established electrical engineering principles and standards.

Ask a specific question about this device

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:

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.

Ask a specific question about this device