The ZMED VP4000 Video Processor is intended for use in any application where a viewing device (fluoroscope, endoscope, laparoscope, etc.) and monitor are incorporated to aid in diagnosis and treatment of a disease such as an arthroscopy or cholecystectomy.

Device Description

The ZMED VP4000 is a simple-to install, easy to use video processing system which provides powerful real-time enhancement of input video signals. The enhanced output video provides increased clarity, contrast, and detail, aiding in the ability to see through smoke, in poor lighting conditions, and other suboptimal conditions. The VP4000 is connected between a video source and a display. The system uses standard electronic components to implement patented algorithms which are designed to improve the ability of the human eye to perceive fine details in the image which might otherwise be obscured by smoke, haze, poor lighting, etc. This is accomplished via a combination of locally-adaptive contrast enhancement using a very large-kernel convolution operation (identical to that used in the CE3000), and histogram-based operations. Like the CE3000, a key feature of the VP4000 is its ability to perform these complex operations in real time, adding virtually imperceptible system latency from input of raw video to output of enhanced video. The effectiveness of the algorithms combined with this real-time capability makes the VP4000 ideally suited for use in applications which live video is required to perform a given function. The VP4000 chassis is constructed of lightweight aluminum, measures 15.7" wide by 12.0" deep by 1.7" high, and weighs 4.95 pounds. The device is compatible with DVI-D and HD-SDI video signals in a variety of standard resolutions, up to 1080p. Internally, the VP4000 is constructed using UL- and IEC-approved components, circuit boards, and harnessing.

AI/ML Overview

The provided text describes the ZMED VP4000 Video Processor, its intended use, and a comparison to a predicate device (DigiVision CE3000). It highlights the device's ability to enhance video signals for increased clarity, contrast, and detail, aiding in visualization in suboptimal conditions. However, the document does not contain any information regarding specific acceptance criteria, study methodologies, device performance metrics, sample sizes, expert qualifications, or ground truth establishment relevant to the device's enhanced video output capabilities.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them with the provided information. The document focuses on regulatory approval (510(k)) based on substantial equivalence to a predicate device, safety standards (IEC, FCC), and functional description, rather than clinical performance studies demonstrating the effectiveness of the video enhancement.

Here's a breakdown of why the request cannot be fully answered with the given text:

A table of acceptance criteria and the reported device performance: Not explicitly stated. The document focuses on meeting safety standards and being substantially equivalent to a predicate.
Sample sized used for the test set and the data provenance: Not mentioned. No performance study data is provided.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned. No performance study data is provided.
Adjudication method: Not mentioned. No performance study data is provided.
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 mentioned. The device is a video processor, not explicitly an AI system as described here, and no comparative effectiveness study data is provided.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not mentioned. No performance study data is provided.
The type of ground truth used: Not mentioned. No performance study data is provided.
The sample size for the training set: Not applicable, as this is not an AI/machine learning device in the context of the provided document. The device uses "patented algorithms" to enhance video, but no explicit "training set" for AI is discussed.
How the ground truth for the training set was established: Not applicable.

The document primarily serves as a 510(k) summary for FDA clearance, demonstrating substantial equivalence to a legally marketed predicate device (DigiVision CE3000) based on intended use, technological characteristics, and safety testing. It clarifies that the VP4000 is an evolutionary development of the CE3000, adapting to modern digital video formats and improved components, but does not detail a clinical study proving the performance benefits of its video enhancement features against specific, measurable criteria.

Summary

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K130929
Page 1 of 3

APR 1 2 2013

APPENDIX 1 510(k) SUMMARY

APPLICANT:	ZMED, Inc.9820 Summers Ridge RoadSan Diego, CA 92121858.831.7000
CONTACT:	Randall S. Millar858.831.7059
DATE OF SUMMARY:	20 MARCH 2013
DEVICE NAME:	ZMED VP4000 Video Processor
PREDICATE DEVICE:	DigiVision CE3000FDA 510(k) file #: K962260Year approved: 1996

DEVICE DESCRIPTION

The VP4000 is connected between a video source and a display. An example of a typical installation is shown below:

Image /page/0/Figure/7 description: The image shows a diagram of a ZMED VP4000 connected to a video source and a video display. The video source is labeled as "VIDEO SOURCE (camera, etc.)" and the video display is labeled as "VIDEO DISPLAY". Arrows indicate the direction of the video signal from the video source to the ZMED VP4000 and from the ZMED VP4000 to the video display.

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K130928
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The system uses standard electronic components to implement patented algorithms which are designed to improve the ability of the human eye to perceive fine details in the image which might otherwise be obscured by smoke, haze, poor lighting, etc. This is accomplished via a combination of locallyadaptive contrast enhancement using a very large-kernel convolution operation (identical to that used in the CE3000), and histogram-based operations. Like the CE3000, a key feature of the VP4000 is its ability to perform these complex operations in real time, adding virtually imperceptible system latency from input of raw video to output of enhanced video. The effectiveness of the algorithms combined with this real-time capability makes the VP4000 ideally suited for use in applications which live video is required to perform a given function.

The VP4000 chassis is constructed of lightweight aluminum, measures 15.7" wide by 12.0" deep by 1.7" high, and weighs 4.95 pounds. The device is compatible with DVI-D and HD-SDI video signals in a variety of standard resolutions, up to 1080p. Internally, the VP4000 is constructed using UL- and IEC-approved components, circuit boards, and harnessing. The VP4000 has been successfully tested to meet IEC60601-1 Second Edition safety standards, and FCC Part 15 Subpart B. These tests were performed by:

TÜV SÜD America Inc., 10040 Mesa Rim Road. San Diego, CA 92121 Tel: (858) 678-1400

No adaptations to or deviations from these Standards were employed during testing.

STATEMENT OF INTENDED USE

" The ZMED VP4000 Video Processor is intended for use in any application where a viewing device (fluoroscope, endoscope, laparoscope, etc.) and monitor are incorporated to aid in diagnosis and treatment of a disease such as an arthroscopy or cholecystectomy."

This statement is virtually identical to that of the predicate device (CE3000). Both the subject and predicate devices have the same function and purpose and the differences in intended use do not create new safety or effectiveness issues.

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS

The VP4000 is an evolutionary development of the CE3000. Whereas the CE3000 is compatible with outdated analog video signals, the VP4000 has been designed to work with modern high-definition digital video formats. Additionally, advancements in electronic component capability since the CE3000 was designed have allowed for a higher degree of integration (fewer components required) when implementing the enhancement algorithms.

Both systems operate on standard AC power (100-240VAC). Both systems utilize an internal medical-grade power supply to convert the input AC power to low-voltage DC supplies for use by the electronics. Refer to the table below for a

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KB0929
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summary comparison of changes between the unmodified (CE3000) and proposed (VP4000) devices.

Features	VP4000	CE3000 (unmodified)
Similarities
Intended Use	The ZMED VP4000 VideoProcessor is intended for usein any application where aviewing device(fluoroscope, endoscope,laparoscope, etc.) andmonitor are incorporated toaid in diagnosis andtreatment of a disease suchas an arthroscopy orcholecystectomy.	The CE3000 ContrastEnhancer like theFluoroVision, may be used inany application where aviewing device (fluoroscope,endoscope, laparoscope, etc.)and monitor is incorporated toaid in diagnosis and treatmentof a disease such as anarthroscopy orcholecystectomy.
Device	Non-patient contact	Non-patient contact
Category	Pre-market notification510(k)	Approved via 510(k)submission
Technology	Real-time videoenhancement	Real-time video enhancement
Differences
User Interface	Simplified, selectablepresets	Individual controls forparametric settings
Supportedvideo formats	Digital, high-definition	Analog, standard-definition

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Image /page/3/Picture/1 description: The image shows the logo for the United States Department of Health and Human Services. The logo features a stylized abstract symbol resembling an eagle or bird in flight, composed of three curved lines. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 12, 2013

ZMed, Inc. % Mr. Randall Millar VP of Engineering 9820 Summers Ridge Road SAN DIEGO CA 92121

Re: K130929

Trade/Device Name: ZMED VP4000 Video Processor Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: March 27, 2013 Received: April 3, 2013

Dear Mr. Millar:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Millar

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/delault.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industrv/default.htm.

Sincerely yours,

Smh.7)

for

Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

K130929 510(k) Number (if known):

ZMED VP4000 Video Processor Device Name:

Indications for Use:

Prescription Use X ____________________________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

Smh.7)

(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health

510(k) # K130929

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Regulation Number and Section

§ 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).