Rational Imaging PACS is intended for use by a physician or other medical professionals in the acquisition of medical images and demographic detail from all institutional imaging modalities, including CT, MRI, NM, DR, US, nuclear medicine, Angio and secondary capture devices such as film digitizers or other imaging sources. The acquired medical images and demographic information may be displayed, processed, reviewed optionally utilizing Multi-planar Reconstruction (MPR), Anatomic Triangulation (AT) and 3D display, sent to and retrieved by radiologists at remote sites, stored, archived or printed.

Device Description

Rational Imaging PACS is designed for use by a physician or other medical professionals in the acquisition of medical images and demographic detail from all institutional imaging modalities, including CT, CR, MRI, NM, DR, US, Angio, nuclear medicine, and secondary capture devices such as film digitizers or other imaging sources. The acquired medical images and demographic information may be displayed, processed, reviewed, sent to and retrieved by radiologists at remote sites, stored, archived or printed. Multi-planar Reconstruction (MPR). Anatomic Triangulation (AT) and 3D display are optionally available.

AI/ML Overview

The provided text describes a 510(k) summary for the Rational Imaging PACS. However, it does not contain specific acceptance criteria, performance data from a study, or details about such a study (sample size, expert qualifications, adjudication methods, MRMC study, standalone performance, ground truth types, or training set details).

The document primarily focuses on establishing substantial equivalence to a predicate device (Algotec Systems Ltd.'s MediSurf) based on functional and technical similarities. It discusses the device's intended use, safety, and general description.

Here's a breakdown of the requested information based on the provided text:

Acceptance Criteria and Device Performance Study

The provided document does not specify numerical acceptance criteria for performance (e.g., accuracy, sensitivity, specificity, processing speed targets, or image quality metrics) or detail a specific study proving the device meets such criteria.

The submission focuses on demonstrating substantial equivalence to a predicate device (Algotec Systems Ltd.'s MediSurf) by highlighting that both are software suites that process DICOM compliant images and provide comparable features for image processing, archiving, and networking.

Given the nature of a Picture Archiving and Communication System (PACS) as a foundational imaging infrastructure product, the "performance" demonstrated for regulatory purposes here is primarily its ability to perform its stated functions reliably and safely, similar to its predicate. This typically involves software validation and verification against functional specifications rather than a clinical performance study with specific metrics like those for a diagnostic AI algorithm.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Not explicitly stated as quantifiable metrics in the document. The overarching "acceptance criterion" from a regulatory perspective is substantial equivalence to the predicate device in terms of intended use, technological characteristics, and safety and effectiveness.	Fulfills the functions described for a PACS system: acquisition, display, processing, review, transmission, storage, archiving, and printing of medical images and demographic information. The device is described as "DICOM compliant" and having "comparable" image manipulation tools and storage techniques to the predicate.

2. Sample size used for the test set and the data provenance:

Not applicable / Not provided. The document does not describe a clinical performance study with a test set of medical images. The evaluation appears to be based on functional verification and validation of the software's capabilities and compliance with standards (e.g., DICOM).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable / Not provided. This information is relevant for clinical performance studies, which are not detailed in this submission.

4. Adjudication method for the test set:

Not applicable / Not provided. This information is relevant for clinical performance studies, which are not detailed in this submission.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No. The document does not mention an MRMC study. This type of study is more common for diagnostic AI algorithms rather than a PACS system, which provides infrastructure for image management.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Not applicable / Not provided. The Rational Imaging PACS is an infrastructure system for managing and displaying images, not a standalone diagnostic algorithm. Its "performance" is inherently tied to its functionality as a system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Not applicable / Not provided. Ground truth is used in performance studies to validate diagnostic or predictive algorithms. This document describes a PACS system, for which the "ground truth" would be its adherence to functional specifications and industry standards like DICOM.

8. The sample size for the training set:

Not applicable / Not provided. This document does not describe the development or training of an AI algorithm based on a training set of medical images.

9. How the ground truth for the training set was established:

Not applicable / Not provided. Similar to point 8, this document does not describe the training of an AI algorithm.

Summary of the Study (or Lack thereof, in the context of performance metrics):

The provided 510(k) summary for the Rational Imaging PACS describes a regulatory submission focused on demonstrating substantial equivalence to a predicate device (MediSurf, K971347). The "study" in this context is a comparison of the Rational Imaging PACS's intended use, technological characteristics (e.g., DICOM compliance, image manipulation tools, networking, archiving capabilities), and safety measures against those of the predicate device.

The document states: "The proposed Rational Imaging PACS... and the predicate device MediSurf are both software suites that process DICOM compliant images and provide a standard set of features pertaining to image processing, archiving and networking. The image manipulation tools and storage techniques are essentially comparable."

Safety is addressed by a risk management plan, software development and validation process, and verification plan.

Therefore, the "proof" the device meets its "acceptance criteria" (which are implicit in the concept of substantial equivalence for a PACS) is through this detailed comparison of features and capabilities to a legally marketed predicate device, rather than a clinical performance study with quantitative metrics.

Summary

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OCT 3 0 2003

510(k) Summary of Safety and Effectiveness

K 031473

Submitted by

Intuitive Imaging Informatics, LLC 30 Hackamore Lane Suite 4 Bell Canyon, CA 91307-1061

818-347-8919 (phn) 818-347-8909 (fax)

29 April 2003

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K031473

Per Title 21 CFR 807 . 92, the following is the 510(k) Summary for the Rational Imaging PACS manufactured and marketed by Intuitive Imaging Informatics, LLC under the trade-name

SUBMITTER: (1)

Intuitive Imaging Informatics, LLC 30 Hackamore Lane Suite 4 Bell Canyon, CA 91307-1061

818-347-8919 (phone) 818-347-8909 (fax)

CONTACT:

Donald Mundt Manager, Regulatory Affairs Intuitive Imaging Informatics, LLC 30 Hackamore Lane Suite 4 Bell Canyon, CA 91307-1061

818-347-8919 (phone) 818-347-8909 (fax)

29 April 2003 SUBMISSION DATE:

(2) DEVICE NAME:

Rational Imaging PACS TRADE NAME:

CLASSIFICATION NAME: (per regulation 21 CFR 892.2030) (Class II device) Picture Archiving and Communication System
PRODUCT CODE: LLZ

PREDICATE DEVICE: (3)

Intuitive Imaging Informatics claims Substantial Equivalence to the following device:

Manufacturer	Trade Name	510(k) Number	Decision Date
Algotec Systems Ltd.	MediSurf	K971347	07-03-1997

DEVICE DESCRIPTION: (4)

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1214 +

such as film digitizers or other imaging sources. The acquired medical images and demographic information may be displayed, processed, reviewed, sent to and retrieved by radiologists at remote sites, stored, archived or printed. Multi-planar Reconstruction (MPR). Anatomic Triangulation (AT) and 3D display are optionally available.

(5) INTENDED USE OF DEVICE

The Rational Imaging PACS is intended to be used in a Radiological Laboratory or Doctors office to allow the medical professionals to retrieve and review exam images at various rotations and options, add patient identification and compress the image using industry accepted techniques. Lossy and lossless compressed images are encapsulated in DICOM v3.0 format, which then may be transmitted via various communication protocols to other sites or archived by a PACS host.

SUBSTANTIAL EQUIVALENCE TO PREDICATE DEVICE (6)

The proposed Rational Imaging PACS, with MPR, AT options, and the predicate device MediSurf are both software suites that process DICOM compliant images and provide a standard set of features pertaining to image processing, archiving and networking. The image manipulation tools and storage techniques are essentially comparable. Workstations are technologically the same with some differences in media type for archival storage. Compression algorithms are different but accomplish the same results. Both products operate on commercially available equipment and are available as either a hardware/software package or software only.

(7) SAFETY

The potential hazards are identified and controlled by a risk management plan. The plan consists of a risk management summary, a software development and validation process, a software verification plan and conformance to Federal Regulations and Industry Standards.

(8) CONCLUSION

The Rational Imaging PACS DICOM compliant imaging system acquires, processes, archives and distributes images over the Internet utilizing similar techniques and functions as the predicate device MediSurf.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird with three curved lines extending from its head, resembling feathers or wings. The bird is positioned within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the upper portion of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 3 0 2003

Mr. Donald Mundt Manager, Regulatory Affairs Intuitive Imaging Informatics, LLC 30 Hackamore Lane, Suite 4 BELL CANYON CA 91307-1061

Re: K031473

Trade/Device Name: Rational Imaging PACS Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communication system

Regulatory Class: II Product Code: 90 LLZ Dated: September 2, 2003 Received: September 4, 2003

Dear Mr. Mundt:

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 adultcration.

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); 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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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 the 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 Office of Compliance at (301) 594-4639. 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 may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Brogdon

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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510(k) Number (if known): _ KO31473

Device Name: Rational Imaging PACS

Indications for Use

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Symm

(Division Sign-Off) Division of Reproductive, Abdomina and Radiological Devices 510(k) Number_

Prescription Use (Per 21 CFR 801.109) (Optional Format 1-2-96) OR

Over-the-Counter Use

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).