Rapidia® is a software package intended for viewing and manipulating DICOM-compliant medical images from CT (computerized tomography) and MR (magnetic resonance) scanners. Rapidia can be used for real-time viewing, image manipulation, segmentation, 3D volume and surface rendering, virtual endoscopy, and reporting.

Device Description

Rapidia® is a fast, practical and accurate tool for 3D (three dimensional) and 2D (two dimensional) viewing and manipulation of CT and MRI images using the most advanced graphics rendering technology. The proposed software provides volume rendering (VR), maximum/minimum intensity projection 3D (MIP/MinIP), surface shaded display (SSD), multi-planar reconstruction (MPR), virtual endoscopy, 2D image editing and segmentation (2D), and issues reports.

AI/ML Overview

Here's an analysis of the provided text regarding the Rapidia® device, focusing on acceptance criteria and study details.

Executive Summary:

The provided 510(k) summary for the Rapidia® device offers very limited information regarding explicit acceptance criteria and a detailed study proving its performance. The primary focus of the document is on establishing substantial equivalence to a predicate device (Plug'n View 3D K993654) and demonstrating conformance to DICOM standards and internal functional requirements.

Acceptance Criteria and Device Performance:

Acceptance Criteria	Reported Device Performance
Conformance to DICOM Version 3	"The proposed Rapidia® software conforms to DICOM (Digital Imaging and Communications in Medicine) Version 3."
Performance of all input functions as specified in Software Requirements Specification (SRS)	"Validation testing was provided that confirms that Rapidia® performs all input functions...according to the functional requirements specified in the Software Requirements Specification (SRS)."
Performance of all output functions as specified in Software Requirements Specification (SRS)	"Validation testing was provided that confirms that Rapidia® performs all...output functions...according to the functional requirements specified in the Software Requirements Specification (SRS)."
Performance of all required actions as specified in Software Requirements Specification (SRS)	"Validation testing was provided that confirms that Rapidia® performs all...required actions according to the functional requirements specified in the Software Requirements Specification (SRS)."

Study Details:

The document describes a "Validation testing" but provides very few specifics about its methodology or results in terms of concrete performance metrics.

Sample size used for the test set and the data provenance: Not specified. The document only mentions "Validation testing was provided." We don't know the number of images, patient cases, or the origin (country, retrospective/prospective) of the data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified. The document does not mention any expert involvement in establishing ground truth for testing.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not specified.
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 is not mentioned. The device is purely an image processing and visualization tool, not an AI-assisted diagnostic aid in the context of this 2001 submission.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Yes, the "Validation testing" appears to be a standalone performance evaluation against the Software Requirements Specification (SRS), focusing on the software's functionality. It's an algorithm-only performance in the sense that it tests the software's ability to execute its programmed functions.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this device's validation appears to be its internal "Software Requirements Specification (SRS)." The testing confirmed the software performed "according to the functional requirements specified in the Software Requirements Specification (SRS)." This is essentially a black-box functional testing approach, not clinical ground truth.
The sample size for the training set: Not applicable/specified. This device, submitted in 2001, is described as an "Image processing and 3D visualization system." It does not appear to employ machine learning or AI that would require a "training set" in the modern sense. Its functionality is based on explicit programming for rendering and manipulation.
How the ground truth for the training set was established: Not applicable, as there's no mention of a training set or machine learning.

Summary

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K012290
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SEP 2 8 2001

510(k) SUMMARY 3D Med Co., Ltd. Rapidia®

Submitter Name and Address 1.

Mr. Jae Jeong Choi 3D Med Co., Ltd. 940-319 Research Park SNU, San 4-8 Bongcheon-dong, Gwanak-gu Seoul 151-818 REPUBLIC OF KOREA

82-2-889-1765 Telephone: Date Prepared: July 19, 2001

Device Name 2.

Rapidia® Proprietary Name: Common/Usual Name: Image processing and 3D visualization system Picture archiving and communications system Classification Name:

Predicate Device 3.

Plug'n View 3D (K993654)

4. Intended Use

The Rapidia® is a software package intended for viewing and manipulating DICOM-compliant medical images from CT (computerized tomography) and MR (magnetic resonance) scanners. Rapidia can be used for real-time viewing, image manipulation, segmentation, 3D volume and surface rendering, virtual endoscopy, and reporting.

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Device Description ನ.

K012290
Page 2 of 2

Technological Characteristics 6.

The proposed and predicate devices are both software programs that can be used for manipulation of DICOM-compliant CT and MRI images. The proposed and predicate software can be operated from a personal computer. Differences between the proposed and predicate devices are limited to the availability of certain image viewing and editing features.

7. Performance Testing

The proposed Rapidia® software conforms to DICOM (Digital Imaging and Communications in Medicine) Version 3. Validation testing was provided that confirms that Rapidia® performs all input functions, output functions, and all required actions according to the functional requirements specified in the Software Requirements Specification (SRS).

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 8 2001

3D Med Co., Ltd. % Cynthia J. M. Nolte, Ph.D., RAC Staff Consultant Medical Device Consultants, Inc. 49 Plain Street NORTH ATTLEBORO MA 02760 Re: K012290

Trade/Device Name: Rapidia® Image Processing System Regulation Number: 21 CFR 892.2050 Regulation Name: Picture Archiving and Communications System Regulatory Class: II

Product Code: 90 LLZ Dated: July 19, 2001 Received: July 20, 2001

Dear Dr. Nolte:

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); 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 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 11 you attime 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 Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on of 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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Kol2290 510(k) Number (if known):

Rapidia® Device Name:

Indications For Use:

Rapidia® is a software package intended for viewing and manipulating DICOM-compliant Rapidia - is a software paring - Rapidia® can be used for real-time viewing, moded manipulation, segmentation, 3D volume and surface rendering, virtual endoscopy, and issuing reports.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy C Brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K012290

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

3D Med Co., Ltd. 510(k) Rapidia®

July 19, 2001

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).