RapidiaColon ™ is a software application for the display and 3D visualization of medical data derived from digital modalities (CT and MRI scanners). It is intended for use by radiologists, clinicians and referring physicians to acquire, process, render, review, store, print, and distribute DICOM compliant image studies using standard PC hardware.

Device Description

RapidiaColon™ is a software device for 3D (three dimensional) and 2D (two dimensional) viewing and manipulation of digital DICOM compliant images using graphics rendering technology. The software device provides 3D volume rendering (VR), multi-planar reconstruction (MPR), virtual endoscopy, and issues reports.

AI/ML Overview

Here's an analysis of the provided text regarding the RapidiaColon™ device, focusing on the acceptance criteria and study information:

Unfortunately, the provided 510(k) summary for the INFINITT RapidiaColon™ System does not contain the detailed information necessary to fully answer all aspects of your request. This document focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed performance study with acceptance criteria and results.

Specifically, it lacks information on:

Specific acceptance criteria.
A dedicated study proving the device meets these criteria.
Sample sizes for test or training sets.
Data provenance.
Details on expert consensus for ground truth.
Adjudication methods.
MRMC study results.
Standalone performance.
The type of ground truth used for performance evaluation.
How ground truth was established for "training" data (though the device appears to be a viewing/processing tool, not one that uses machine learning in the modern sense of training data).

Based on the provided text, here's what can be extracted and what remains unknown:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Not specified	Not specified

Explanation: The 510(k) summary for RapidiaColon™ System does not provide explicit acceptance criteria or measured performance metrics for the device. The document's primary purpose is to establish substantial equivalence to a predicate device (Voxar Limited's plug 'n view 3d, version 1.0) based on technological characteristics and intended use, rather than presenting a detailed performance study with defined criteria and results. It primarily states that "Validation testing was provided that confirms that RapidiaColon performs all input functions, output functions, and all required actions according to the functional requirements specified in the Software Requirements Specification (SRS)." However, the specifics of these functional requirements, the tests performed, and the quantitative results are not included in this summary.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not specified.
Data Provenance: Not specified (country of origin, retrospective/prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Number of Experts: Not specified.
Qualifications of Experts: Not specified.
Role of Experts: Given the nature of the device (viewing and processing), "ground truth" as typically understood in AI/CAD performance studies (e.g., presence/absence of a lesion) is not directly applicable in the same way. The validation would likely involve functional testing to ensure accurate display and manipulation of images, not diagnostic accuracy against a ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Adjudication Method: Not specified.

5. 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

MRMC Study: Not mentioned or implied. The device is described as a "Picture Archiving Communications System" and a "software application for the display and 3D visualization of medical data." It does not appear to incorporate AI for diagnostic assistance, so an MRMC study comparing human readers with and without "AI assistance" would not be relevant in this context. It's a tool for visualization and manipulation, not an interpretation aid.

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

Standalone Performance: The concept of "standalone performance" as it relates to AI algorithms is not applicable here. RapidiaColon™ is a software tool for image viewing and manipulation, not an independent algorithm making diagnostic determinations. Its "performance" would be related to its functionality (e.g., speed of rendering, accuracy of MPR reconstruction, stability) rather than a diagnostic output. The validation would have focused on its ability to perform its specified functions: acquiring, processing, rendering, reviewing, storing, printing, and distributing DICOM-compliant image studies.

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

Type of Ground Truth: Not specified in the context of diagnostic accuracy. For a viewing and processing system, "ground truth" would more likely refer to the correctness of the displayed medical data against the original DICOM data or the accuracy of its reconstruction algorithms, verifiable through technical specifications and controlled test cases rather than clinical outcomes or pathology.

8. The sample size for the training set

Sample Size for Training Set: Not applicable/Not specified. This device is described as a viewing and manipulation tool, not a machine learning model that requires a "training set" in the conventional sense.

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

How Ground Truth for Training Set was Established: Not applicable. As noted above, the device does not appear to be an AI/ML model requiring a training set. Its functionality is based on established rendering and image processing algorithms.

Summary

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KOHINGI

JUL 1 3 2004

Image /page/0/Picture/2 description: The image shows the word "INFINITT" in white letters against a black background. The font is bold and sans-serif, giving the word a strong and clear presence. The letters are evenly spaced and aligned, creating a balanced and symmetrical appearance. The contrast between the white text and the black background makes the word highly visible and easy to read.

510(k) Summary of Safety and Effectiveness

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

Date Prepared:

May 20, 2004

Submitter's Information: 21 CFR 807.92(a)(1)

Mr. Samuel Choi, Director INFINITT CO.,LTD Taesuk Bldg. 9F, 275-5 Yangjae-Dong Seocho-Gu, Seoul, South Korea 137-943 Fax: 82-2-2194-1696 Email: switch@infinitt.com

Trade Name, Common Name and Classification: 21 CFR 807.92(a)(2)

Trade Name:	RapidiaColon™ System
Common Name:	Picture Archiving Communications System
Device Classification:	892.2050
Name:	System, Image Processing

Predicate Device: 21 CFR 807. 92(a)(3)

RapidiaColon ™ system is substantially equivalent to the:

Manufacturer:	Voxar LimitedBonnington Bond, 2 Anderson PlaceEdinburgh, UK EH6 5 NP
Device Name:	plug 'n view 3d, version 1.0
510(k) Number:	K 992654
Decision Date:	11/05/1999
Decision:	Substantially Equivalent
Panel Code reviewed by:	Radiology
Panel Code classified by:	Radiology
Product Code:	LLZ
Device Classification Name:	SYSTEM, IMAGE PROCESSING, RADIOLOGICAL
Regulation Number:	Class II - 892.2050

Device Description: 21 CFR 807 92(a)(4)

Indications for Use: 21 CFR 807 92(a)(5)

RapidiaColon ™ is a software application for the display and 3D visualization of medical data derived from digital modalities (CT and MRI scanners). It is intended

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Image /page/1/Picture/0 description: The image shows the word "INFINITT" in white letters against a black background. The letters are bold and sans-serif. The word appears to be a logo or brand name. The image is simple and high contrast.

for use by radiologists, clinicians and referring physicians to acquire, process, render, review, store, print, and distribute DICOM compliant image studies using standard PC hardware.

Technological Characteristics: 21 CFR 807 92(a)(6)

The proposed and predicate devices are both software programs that can be used for manipulation of DICOM-compliant CT 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.

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

Conclusion: 21 CFR 807 92(b)(1)

The 510(k) Pre-Market Notification for the RapidiaColon™ device contains adequate information and data to enable FDA - CDRH to determine substantial equivalence to the predicate device.

The RapidiaColon™ device has been and will be manufactured in accordance with the voluntary standards listed in the enclosed voluntary standard survey. The submission contains the results of a hazard analysis and the "Level of Concern for potential hazards has been classified as "minor".

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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circle around the eagle. The eagle is black, and the text is also black.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 3 2004

INFINITT Co., Ltd. % Mr. N. E. Devine, Jr. Responsible Third Party Official Entela, Inc. 3033 Madison Ave. SE GRAND RAPIDS MI 49548

Re: K041761 Trade/Device Name: RapidiaColon™ Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: 90 LLZ Dated: June 14, 2004

Received: June 30, 2004

Dear Ms. Devine:

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 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.

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 (OS) 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. Brygdon

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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Indications for Use

510(k) Number (if known): KOHI 76 |

Device Name: RapidiaColon TM

Indications for Use:

RapidiaColon ™ is a software application for the display and 3D visualization of medical data derived from CT and MRI scanners. It is intended for use by radiologists, clinicians and referring physicians to acquire, process, render, review, store, print, and distribute DICOM compliant image studies using standard PC hardware

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy C. Hogdon

(Division Sign Off) Division of Reproductive, Ab and Radiological Devices 510(k) Number

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).