The KIMAX ™ Remote Viewing Station software and hardware (RVS) are intended to allow physicians to view static or dynamic digital images from radiographic and other medical imaging equipment. The RVS includes a high-performance computer, data storage devices, a high-resolution monitor and software to: 1) accept AVI images or import other image formats; 2) allow physician to quickly locate and display images; 3) adjust contrast and brightness, apply filters to enhance the images, zoom in on selected features of interest, pan to selected areas, and annotate images; 4) print out selected images; and 5) create reports that include text and annotated images. The RVS is intended to be used in the clinical workspace of a practicing physician.

Device Description

The KIMAX ™ Remote Viewing Station software and hardware (RVS) includes a high-performance computer, data storage devices, a high-resolution monitor and software.

AI/ML Overview

Here's an analysis of the provided text to extract the acceptance criteria and study information:

Based on the provided text, it's not possible to fully detail the acceptance criteria and the study that proves the device meets those criteria because the document is a 510(k) clearance letter from the FDA, not the full 510(k) application or a study report itself. The 510(k) letter primarily confirms substantial equivalence to a predicate device and outlines regulatory responsibilities.

However, I can extract what is available and highlight what's missing, based on the typical requirements for and contents of a 510(k) submission.

Missing Information:
The provided document is the FDA's clearance letter for the KIMAX™ Remote Viewing Station, not the detailed submission itself. As such, it does not contain the specific acceptance criteria, comprehensive study details, or performance metrics beyond a general statement of intended use. The letter states, "We have reviewed your Section 510(k) premarket notification of intent to market the device...and have determined the devices is substantially equivalent (for the indications referenced above...)." This indicates that the manufacturer provided data, but the data itself is not within this letter.

Therefore, the tables and detailed points below will reflect this limitation, categorizing information as "Not Provided in Document" when it's absent from the supplied text.

Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria or detailed performance metrics. The clearance is based on "substantial equivalence" to a predicate device, meaning its performance for its intended use is considered comparable and within acceptable safety and effectiveness limits as proven by the submission. The "Intended Use" section outlines the functional capabilities the device is designed to perform.

Acceptance Criterion (Implicit from Intended Use)	Reported Device Performance (as implied by FDA Clearance)
View static or dynamic digital images from radiographic and other medical imaging equipment	Substantially equivalent to legally marketed PACS devices for this function.
Accept AVI images or import other image formats	Substantially equivalent to legally marketed PACS devices for this function.
Quickly locate and display images	Substantially equivalent to legally marketed PACS devices for this function.
Adjust contrast and brightness	Substantially equivalent to legally marketed PACS devices for this function.
Apply filters to enhance images	Substantially equivalent to legally marketed PACS devices for this function.
Zoom in on selected features	Substantially equivalent to legally marketed PACS devices for this function.
Pan to select regions of interest	Substantially equivalent to legally marketed PACS devices for this function.
Annotate images	Substantially equivalent to legally marketed PACS devices for this function.
Print out selected images	Substantially equivalent to legally marketed PACS devices for this function.
Create reports that include text and annotated images	Substantially equivalent to legally marketed PACS devices for this function.
Use in the clinical workspace of a practicing physician	Substantially equivalent to legally marketed PACS devices for this context.

Study Details and Ground Truth Establishment

The provided 510(k) clearance letter does not contain the detailed study information regarding device performance. This information would typically be part of the original 510(k) submission that the FDA reviewed.

Sample size used for the test set and the data provenance: Not provided in the document.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided in the document.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not provided in the document.
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 applicable / Not provided. The KIMAX™ Remote Viewing Station is described as "software and hardware" for viewing and manipulating images, not an AI-assisted diagnostic tool that would typically undergo an MRMC study for AI enhancement. Its purpose is a PACS-like viewing station.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. The device is a "Remote Viewing Station," implying human interaction is integral to its intended use. It's a display and manipulation tool, not an autonomous diagnostic algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not provided in the document. For a viewing station, ground truth might relate to image fidelity, display accuracy, or function verification, rather than clinical diagnostic accuracy per se.
The sample size for the training set: Not applicable. The KIMAX™ Remote Viewing Station, as described, is not an AI/ML algorithm that is "trained" on a dataset in the conventional sense. It's software and hardware for image display and manipulation.
How the ground truth for the training set was established: Not applicable, as it's not a trained AI/ML device.

Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 0 7 2001

Mr. George T. Knackstedt Director Medical Metrics, Inc. 10540 Rockley Road, Suite 200 HOUSTON TX 77099

Re: K013098 K013098
Trade/Device Name: KIMAX™ Remote Viewing Station
Trade/Device Name: KIMAX™ 200 2050 TraderDevice Namber: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II

Product Code: 90 LLZ Dated: August 27, 2001 Received: September 17, 2001

Dear Mr. Knackstedt:

We have reviewed your Section 510(k) premarket notification of intent to market the device
ty the indication of the said to since is substantially equivalent (for the indica We have reviewed your Section 5 IQ(k) prematice in univation in muirvalent (for the indications
referenced above and have detectived the devices is substantially equivale referenced above and have determined the devices marketed in interstate
for use stated in the enclosure) to legally marketed prodicale devices marketed in interstate for use stated in the enclosure) to legally market predical Device Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Federal Food, Drug, commerce prior to May 28, 1976, the enactment with the provisions of the Federal Food, Drug,
devices that have been reclassified in accordance with the provisions of the Rede devices that have been reclassified in accordance will the proval application (PMA).
and Cosmetic Act (Act) that do ice approval of a premalces approval application (PMA). and Cosmetic Act (Act) that do not require approval or a provisions of the Act. The
You may, therefore, market the device, subject to the general controls provisions of You may, therefore, market the device, subject to may begistration, listing of
general controls provisions of the Act include requirements for annual registrations and general controls provisions of the Act include requirements of the Groupen in Maranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), If your device is classified (see above) into extrem confections affecting your device can be
it may be subject to additional controls. Existing major regulations affective it may be subject to additional controls. Existing major regulations and and of your of the may
found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In add found in the Code of Federal Regulations, Trilo 21, I accords
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
ts of the Act Please be advised that FDA's issuance of a substanted doler requires with other requirements of the Act
that FDA has made a determination that your device complies with of th that FDA has made a determinations administered by other Federal agencies. You must
or any Federal statutes and regulations anningiting by other Federal on and listi or any Federal statutes and regulations and including, but not listing the mand listing
comply with all the Act's requirements, including, but not listing requirements as comply with all the Act's requirements, finciding, our not minted to reguirements as se
(21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirement (21 CFR Part 807); labeling (21 CFR Part 801); good manataotande for mobile, the electronic
forth in the quality systems (QS) regulation (21 CFR 1000-1050. forth in the quality systems (QS) regulation (21 CFR Part 25) -542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (sections 531-542 of the Act); 21 CFR 1

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Page 2

This letter will allow you to begin marketing your device as described in your 510(k) premarket This letter will allow you to begin marketing your device of your device to a legally marketed
notification. The FDA finding of substantial equivaler and thus nemits your d notification. The FDA finding of substantial equivalence or 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 801), please
r in the regulation If you desire specific advice for your device on our laboring agains.
contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

8xx.1xxx	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

Additionally, for questions on the promotion and advertising of your device, please contact the Additionally, for questions on the promotion and and one one of essent of the mating.
Office of Compliance at (301) 594-4639. Also, please noneral information on Office of Compliance at (301) 394-4057. Also, production) Other general information of Small Manufacture by reference to premarket notification (21 Cr F r a F orision of Small Manufacturers,
your responsibilities under the Act may be obtained from the Division of Small Manufactu your responsibilities under the Act may or obtails nonemal (800) 638-2041 or (301) 443-6597
International and Consumer Assistance at 11 1 14 modemons btml International and Consumer Tissistance at the form of the main.html.

Sincerely yours,

Vernie C. Snodgin

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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2013098 510(k) Application

Medical Metrics, Inc. Medical Metrics, te Viewing Station

Statement of Intended Use 1.0

The KIMAX ™ Remote Viewing Station software and hardware (RVS) are intended
ed to the Remote with and mamic digital images from radiographic and The KIMAX ™ Remote Viewstatic or dynamic digital images from radiographic and
to allow physicians to view static or dynamic digital images from radiographic and to allow physicians to view station of dynamic digh-performance computer,
other medical imaging equipment. The RVS includes a high-performance computer, other medical imaging equipment. The R V > includes a magn-pons intended to be used
data storage devices, a high-resolution monitor and software to: l) data storage devices, a high-resolution monitor and Socware to: 1)
in the clinical workspace of a practicing physician. The RVS includes software to: 1)
Pressure of a the tha in the clinical workspace of a practicing physician: 2) allow physician to quickly
accept AVI images or import other image formats; 2) allow physician to quickly accept AVI images or import other image formals, 27 and prightsess, apply filters to enhance
locate and display images; 3) adjust contrast and brightness, apply filters to en locate and display images; 3) adjust contrast and offectures of interest, and the images, zoom in on selected teatures, pan to select reading of more of the rest
annotate images; 4) print out selected images; and 5) create reports that include text and annotated images.

Tämit le. A. yper

Prescription Use K0/3098

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).