The Thoth ToPACS is an image management system whose intended use is to provide (scaleable ) DICOM compatible PACS solutions for hospital and related institutions/sites, which will archive/ distribute/ retrieve and display images and data from all hospital modalities (such as CR, CT, DR, MR and other devices) and information systems.

Lossy Compressed Mammographic Images and Digitized Film Screen Images must not be reviewed for primary Image interpretations. Mammographic Images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other specifications reviewed and accepted by FDA

Device Description

ToPACS is a stand-alone software package that is used on general purpose computing I of ACO is a bains aronivimum hardware requirements are met, the user or system integrator is free to choose his/her own hardware platform micegrator is free to enouse minage processing, measurement, communication and The soltware and is alguing to the specifications that are documented in a Storage. 1011 System Test Plan. Testing is an integral part of Thoth software Thours Process. The software does not contact the patient, nor does it control any life-sustaining devices. A physician has ample opportunity for competent human intervention while interpreting images and clinical information.

AI/ML Overview

The provided text does not contain a study to prove acceptance criteria for the ToPACS device. Instead, it describes a 510(k) summary for the device, which focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a study.

The document explicitly states: "The determination of substantial equivalence is not based on an assessment of performance tests." This means a performance study as typically understood with acceptance criteria, sample sizes, ground truth, and expert adjudication was not conducted or, at least, not the basis for the substantial equivalence determination reported here.

Therefore, I cannot fill in the requested table and information as a performance study proving device meets acceptance criteria is not present in the provided document.

However, I can extract information relevant to the device's intended use and limitations, which might be construed as "acceptance criteria" for its operation, rather than its performance.

Implicit "Acceptance Criteria" (Operational, not Performance) and Device Description:

Acceptance Criteria (Operational)	Reported Device Performance (Operational Description)
For Mammographic Image Interpretation:
1. Must not review Lossy Compressed Mammographic Images.	The software and its algorithms are built to the specifications that are documented in a System Test Plan. Testing is an integral part of Thoth software production Process.
2. Must not review Digitized Film Screen Images.
3. Must use an FDA approved Monitor for interpretation.
4. Monitor must offer at least 5 Mpixel resolution.
5. Monitor must meet other specifications reviewed and accepted by FDA.
General Device Operation:
1. DICOM compatibility.	ToPACS is a stand-alone software package used on general-purpose computing hardware, provided minimum hardware requirements are met. It supports image processing, measurement, communication, and storage. The Thoth ToPACS is an image management system whose intended use is to provide (scalable) DICOM compatible PACS solutions for hospital and related (sections/sites), which will archive/distribute/retrieve and display images and data from all hospital modalities (such as CR, CT, DR, MR and other devices) and information systems.
2. Archive/Distribute/Retrieve/Display images and data.
3. Support for various hospital modalities (CR, CT, DR, MR, etc.).
4. Physician intervention required.	ToPACS does not contact the patient, nor does it control any life-sustaining devices. A physician has ample opportunity for competent human intervention while interpreting images and clinical information. Also, "A physician, providing ample opportunity for competent human intervention interprets images and information being displayed and printed."
5. "Level of Concern" is minor (based on failure/flaw impact).	It is the manufacturer's conclusion that there is no software or hardware component whose failure or latent design flaw would be expected to result in death or injury to a patient.

Since no performance study is detailed, the following sections cannot be answered:

Sample sized used for the test set and the data provenance: Not applicable, no performance tests mentioned.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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, the device is a PACS system, not an AI-assisted diagnostic tool, and no such study is mentioned.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, the device is explicitly designed for human-in-the-loop interpretation.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
The sample size for the training set: Not applicable, as this is a PACS system not typically "trained" in the machine learning sense, and no training data is mentioned.
How the ground truth for the training set was established: Not applicable.

In summary, the provided document is a 510(k) summary demonstrating substantial equivalence based on technological characteristics and intended use compared to predicate devices, not on performance testing against specific acceptance criteria.

Summary

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SECTION 9 SUMMARY OF SAFETY AND EFFECTIVENESS

510(k) Summary

JAN 2 4 2007

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 ad 21CFR 807.92.

Lossy Compressed Mammographic Images and Digitized Film Screen Images must not be reviewed for primary Image Interpretations. Mammographic Images may only be interpreted using an FDA approved Monitor that offers at least 5 Mpixel resolution and meets other specifications reviewed and accepted by FDA

I. General Information

Establishment:

	Radiological Specialists, Inc.
Address:	5920 Noble Avenue, Van Nuys,CA 91411, U.S.A.
Phone:	(818) 908-9000
Fax:	(818) 908-9947

Registration Number:

Contact Person: Mr. Frank McMurray President, Phone: +1 (818) 908-9000 Fax: +1 (818) 908-9947 E Mail: radspecinc@aol.com

Date of Summary Preparation: July 27, 2006 Device Name:

●Trade Name: ToPACS

●Common Name: Picture Archiving Communications System

●Classification Number:

CFR 892.2050, System, Image Processing ●Classification: Class II

●Performance Standards:

None established under Section 514 the Food, Drug, and Cosmetic Act.

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II. Safety and Effectiveness Information.

Device Description: ●

· Device Description:
ToPACS is a stand-alone software package that is used on general purpose computing I of ACO is a bains aronivimum hardware requirements are met, the user or system integrator is free to choose his/her own hardware platform micegrator is free to enouse minage processing, measurement, communication and The soltware and is alguing to the specifications that are documented in a Storage. 1011 System Test Plan. Testing is an integral part of Thoth software Thours Process. The software does not contact the patient, nor does it control any life-sustaining devices. A physician has ample opportunity for competent human intervention while interpreting images and clinical information.

Intended Use: ●

The Thoth ToPACS is an image management system whose intended use is to provide (scaleable ) DICOM compatible PACS solutions for hospital and related (Sections/sites, which will archive/ distribute/ retrieve and display images and data from all hospital modalities (such as CR, CT, DR, MR and other devices) and information systems.

Technological Characteristics (comparison with predicate device): .
Predicated Device: . K030781: KODAK DirectView 5 K023460: PACSPLUS K031562: Ramsoft PACS

Statement of Substantial Equivalence: .

Thoth ToPACS is substantially equivalent to RamSoft PACS, PACSPLUS, and Kodak DirectView PACS. The determination of substantial equivalence is not based on an assessment of performance tests. It is our conclusion that there is no software component in ToPACS product or hardware component which would be used in conjunction with ToPACS product that we know of whose failure or latent design flaw would be expected to result in death or injury to a patient. Thus, the "Level of Concern" of ToPACS product is "minor."

General Safety and Effectiveness Concerns: ●

ToPACS does not contact the patient, nor does it control any life sustaining devices. A physician, providing ample opportunity for competent human intervention interprets images and information being displayed and printed.

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Image /page/2/Picture/1 description: The image shows a logo or emblem that appears to be associated with a health organization or government entity. The logo features a stylized graphic of three curved lines, possibly representing waves or abstract shapes, arranged vertically. To the left of the graphic, there is text that reads "MINISTRY OF HEALTH", arranged vertically along the curve of the graphic. The text is in a simple, sans-serif font and is oriented to be read from bottom to top.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

Mr. Frank McMurray President Radiological Specialists, Inc. 5920 Noble Avenue VAN NUYS CA 91411

JAN 2 4 2007

Re: K063294

Trade/Device Name: ToPACS Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: November 1, 2006 Received: November 8, 2006

Dear Mr. McMurray: .

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 Amendount microads commitered 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 mail. therefore, market the device, subject to the general controls provisions of the Act. The energly 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 (Premarket 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Image /page/2/Picture/10 description: The image shows a circular logo with the text "1906-2006" at the top and "Centennial" at the bottom. The letters "FDA" are prominently displayed in the center of the logo. There are three stars at the very bottom of the logo.

Protecting and Promoting Public Health

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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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification 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 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

21 CFR 876.xxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 894.xxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150

or at its Internet address http://www.fda.gov/cdrlv/industry/support/index.html.

Sincerely yours,

Nancy C. Hogdon

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

Enclosure

Page 2 -

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SECTION 6

INDICATIONS FOR USE STATEMENT

510(k) Number (if known): Korzzay

Device Name: ToPACS

Indications for Use Statement:

CAUTION: Federal (US) law restricts the use of this device to licensed professionals.

Description Use

David G. Syzon

ision of Reprodu

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).