REX™ 1.0 is a software package intended for viewing and manipulating DICOM-compliant medical images acquired from CT scanners. REX™ 1.0 can be used for real-time image viewing, image manipulation, 3D volume rendering, virtual endoscopy, and issuance of reports.

Device Description

REX™ 1.0 is a tool for 3D (three dimensional) and 2D (two dimensional) viewing and manipulation of DICOM compliant CT images. The proposed software provides real-time image viewing, image manipulation, 3D volume rendering, virtual endoscopy, and issuance of reports.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the REX™ 1.0 device:

Important Note: The provided document is a 510(k) Premarket Notification Summary from 2002. At that time, the regulatory requirements and expectations for demonstrating substantial equivalence, particularly for software devices, were different from current standards, especially for AI/ML-driven devices. This document focuses on demonstrating equivalence to a predicate device rather than presenting extensive performance studies against defined acceptance criteria in the way a modern AI/ML device would.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of quantitative acceptance criteria and corresponding reported device performance metrics in the way modern AI/ML device submissions typically do (e.g., sensitivity, specificity, AUC, etc.). Instead, the performance is framed in terms of substantial equivalence to a predicate device and adherence to functional requirements and standards.

Acceptance Criteria (Inferred from Substantial Equivalence and Validation)	Reported Device Performance (REX™ 1.0)
Functional Equivalence to Predicate Device (Rapidia® V 2.0):
- DICOM 3.0 Compliance	Conforms to DICOM Version 3.0 (Explicitly stated).
- Real-time image viewing	Yes (Matches predicate)
- Image manipulation	Yes (Matches predicate)
- 3D volume rendering	Yes (Matches predicate)
- Virtual endoscopy	Yes (Matches predicate) - specifically: instant access to lesions by single click, real-time display of endoscopic view, internal and external viewing of any hollow structures.
- Issuance of reports	Yes (Matches predicate)
- Operating System compatibility (Windows 2000)	Yes (Matches predicate)
- Patient demographics display	Yes (Matches predicate)
- TCP/IP networking	Yes (Matches predicate)
- PNG (Lossless) Image Compression	Yes (Feature present, predicate unspecified, but deemed acceptable for equivalence due to REX™ being a subset of features and no new safety risks)
- Annotations - marker	Yes (Matches predicate)
- Image Review (Still, Window, Level, Zoom, Pan, Flip)	Yes (Matches predicate)
- 2D Measurements (Length, Area)	Yes (Matches predicate)
- Image Source (CT only for REX™)	Yes (Supports CT, unlike predicate which also supports MR; REX™ is a subset of features and thus acceptable)
- Image Input (DICOM 3.0)	Yes (Matches predicate)
- Image Output (PNG lossless snapshots)	PNG (lossless snapshots) (Predicate outputs JPEG, BMP, DICOM; considered acceptable due to REX™ being a subset of features and no new safety risks)
- Use Standard Monitor	Yes (Matches predicate)
- Patient and Study Browser	Yes (Matches predicate)
- Measure CT Numbers (ROI)	Yes (Matches predicate)
- Standalone Software Type	Yes (Matches predicate)
- Local Image Storage	Yes (Matches predicate)
- True Color	Yes (Matches predicate)
- User Login	Yes (Predicate unspecified, but this is a security/access feature and does not introduce new safety risks that would preclude equivalence)
- Preset Window and Level	Yes (Matches predicate)
- Image Conversion (for viewing in browser)	Yes (Matches predicate)
- Trained Physicians as Users	Yes (Matches predicate)
- Volume Rendering algorithms	Yes (Matches predicate)
- Reporting algorithms	Yes (Matches predicate)
Adherence to Internal Requirements and Regulatory Practices:
- Performance to functional requirements specified in SRS	Validation testing confirms REX™ 1.0 performs all input, output functions, and required actions according to the Software Requirements Specification.
- Adherence to Software Development Practices	Followed specified Software Development Practices and Validation and Verification Process. Procedures specify individuals responsible for developing/approving specs, coding/testing, validation, and maintenance.
- Hazard Control	Potential hazards identified in Hazard Analysis and controlled by designing controls, introducing protective measures, and warning users.
- No new potential safety risks	Concluded that REX™ 1.0 "does not result in any new potential safety risks and performs in accordance with its intended use as well as the Rapidia® V 2.0 device currently on the market."
- Substantial Equivalence to Predicate	PointDx considers features of REX™ 1.0 to be substantially equivalent to the subset of features in common with Rapidia® V 2.0. The FDA ultimately agreed and determined the device to be substantially equivalent.

The "study" proving the device meets these criteria is the non-clinical performance data and substantial equivalence comparison presented in the 510(k) summary.

Detailed Breakdown of the Study/Evidence:

2. Sample Size Used for the Test Set and Data Provenance:

Test Set Sample Size: Not explicitly stated as a separate "test set" with image counts. The validation testing mentioned refers to internal software validation. The comparison for substantial equivalence does not involve a specific clinical image dataset for performance metrics, but rather a feature-by-feature comparison against the predicate device.
Data Provenance: Not applicable in the context of a clinical test set. The validation would have been performed on internally generated or standard DICOM test files to verify functionality.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Number of Experts/Qualifications: Not applicable. This submission predates the common requirement for human-in-the-loop or standalone clinical performance studies with expert ground truth for imaging software that provides basic viewing and manipulation functionalities. Substantial equivalence was primarily based on functional comparison.

4. Adjudication Method for the Test Set:

Adjudication Method: Not applicable. There was no "test set" requiring adjudication in the way modern AI performance studies do. The equivalence was determined by comparing features and functionality to the predicate device.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and effect size:

MRMC Study: No, an MRMC comparative effectiveness study was not done. The device is a "PACS / Image Processing Software" that provides viewing and manipulation tools, not an AI diagnostic aid requiring assessment of human reader improvement.

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

Standalone Performance: Not applicable in the context of a diagnostic algorithm. The device itself is a standalone software, but its "performance" is about its functionality (e.g., can it render 3D, can it measure length) rather than a diagnostic output that would have standalone metrics like sensitivity/specificity. The validation testing ensured the software functions as designed.

7. The Type of Ground Truth Used:

Type of Ground Truth: For the functional validation, the "ground truth" would be the software requirements specification (SRS) and DICOM 3.0 standard compliance. For the substantial equivalence, the "ground truth" was the features and specifications of the predicate device (Rapidia® V 2.0). There was no clinical ground truth (like pathology or outcomes data) used as this device is a viewing/manipulation tool, not a diagnostic algorithm.

8. The Sample Size for the Training Set:

Training Set Sample Size: Not applicable. REX™ 1.0 is described as PACS/Image Processing Software. It's a deterministic software program for viewing and manipulation, not an AI/ML algorithm that requires a "training set" in the modern sense.

9. How the Ground Truth for the Training Set was Established:

Ground Truth for Training Set: Not applicable, as there is no "training set" for this type of software.

Summary

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JUN 2 7 2002

Section II - Section 510(k) Premarket Notification Summary (as required by 807.92 (j))

Submitter:

PointDx, Inc. 635 West Fourth Street, Suite 200 Winston-Salem. NC 27101 Phone: 336.723.1450 Fax: 336.723.1458

Date Prepared:

April 2, 2002

Contact Person(s):

Francis Bonk, Director of Quality Assurance and Regulatory Affairs 336-723-1450 (v) 336-723-1458 (f)

Device Trade Name:

REXTM

Device Common Name:

PACS / Image Processing Software

Classification Name:

Class II - System, Image Processing, RA (90) LLZ

Substantially Equivalent To:

Rapidia® V 2.0 (K012290) 3D Med Co. Ltd. 940-319 Research Park SNU. San 4-8 Bongcheon-dong, Gwanak-gu Seoul 151-818 Republic of Korea

Device Description:

Indications for Use:

REX™ 1.0 is a software package intended for viewing and manipulating DICOM-compliant medical images acquired from CT scanners. REX™ 1.0 can be used for real-time image viewing. image manipulation, 3D volume rendering, virtual endoscopy, and issuance of reports.

Technological Comparison to Predicate Device:

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. REX™ 1.0 is a subset of the Rapidia® V 2.0 features with an added monitor to allow a Radiologist the convenience of using two monitors, one for image viewing, and the other for report viewing. The REX ™1.0 software has substantially equivalent features and

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specifications versus the existing Rapidia® V 2.0, for those features and specifications the two devices have in common.

Non-Clinical Performance Data:

The proposed REX™ 1.0 software conforms to DICOM (Digital Imaging and Communications in Medicine) Version 3.0. Validation testing was provided that confirms that REX™ 1.0 performs all input functions, output functions, and all required actions according to the functional requirements specified in the Software Requirements Specification.

To ensure performance to specifications, Federal Regulations and User Requirements:

Software Development Practices and .
The Validation and Verification Process .

have been followed. Procedures specify individuals within the organization responsible for developing and approving product specifications, coding and testing, validation and maintenance.

Adverse Effects on Health:

The potential hazards are identified in the Hazard Analysis and are controlled by:

. Designing controls directed at the cause and/or
il
Introducing protective measures and/or ●
. Warning the Users.

Conclusions:

The REX™ 1.0 does not result in any new potential safety risks and performs in accordance with its intended use as well as the Rapidia® V 2.0 device currently on the market. PointDx considers features of the REX™ 1.0 to be substantially equivalent to the subset of features in common with Rapidia® V 2.0 (K012290) device.

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Substantial Equivalence Chart

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System	REX™	Rapidia®
Version	1.0	2.0
Manufacturer	PointDx, Inc.	3D Med Co., Ltd.
510(k) Number		K012290
Classification	Class II892.205090 LLZ	Class II892.205090 LLZ
Intended Use	REX™ 1.0 is a software package intended forviewing and manipulating DICOM-compliant medical images acquired from CTscanners. REX™ 1.0 can be used for real-time image viewing, image manipulation, 3Dvolume rendering, virtual endoscopy, andissuance of reports.	Rapidia® is a software packageintended for viewing andmanipulating DICOM-compliantmedical images from CT and MRscanners. Rapidia® can be used forreal-time viewing, imagemanipulation, segmentation, 3Dvolume and surface rendering, virtualendoscopy, and issuing reports.
Graphical User Interface	Yes	Yes
Platform
PC	Yes	Yes
Operating System
Windows 2000	Yes	Yes
Windows XP	No	Yes
Windows NT	No	Yes
Image Display Monitor	1	1
Report Display Monitor	1	Unspecified
Patient Demographics	Yes	Yes
Networking
TCP/IP	Yes	Yes
Image Communication
DICOM 3.0 compliant	Yes	Yes
Image Compression
PNG (Lossless)	Yes	Unspecified
Image Processing
Annotations - marker	Yes	Yes
3D Image Processing
Volume rendering	Yes	Yes
Image Review
Still	Yes	Yes
Window	Yes	Yes
Level	Yes	Yes
Zoom	Yes	Yes
Pan	Yes	Yes
Flip	Yes	Yes
2D Measurements
Length	Yes	Yes
Area	Yes	Yes
System	REX™	Rapidia®
Image Source
CT	Yes	Yes
MR	No	Yes
Image Input
DICOM 3.0	Yes	Yes
Image Output	PNG (lossless snapshots)	JPEG, BMP, DICOM
Use Standard Monitor	Yes	Yes
Patient and Study Browser	Yes	Yes
Multi Planer Reformatting	No	Yes
Measure CT Numbers
ROI	Yes	Yes
Type of Software
Standalone	Yes	Yes
Virtual Endoscopy
Instant access to lesions by singleclick	Yes	Yes
Real time display of endoscopic view	Yes	Yes
Internal and external viewing of anyhollow structures	Yes	Yes
Fly-through	No	Yes
Real time interactive correlationamong 3D image, endoscopic imageand MPR images with respect to thepoint of view, viewing area and lesionlocalization	No	Yes
Display multiple objects in differentcolor and opacity	No	Yes
Local Image Storage	Yes	Yes
True Color	Yes	Yes
User Login	Yes	Unspecified
Preset Window and Level	Yes	Yes
Image Conversion	Yes (for viewing in browser)	Yes
Device Users
Trained Physicians	Yes	Yes
Compliance Standards
DICOM 3.0	Yes	Yes
Algorithms
Volume Rendering	Yes	Yes
Reporting	Yes	Yes
Physical Characteristics	Software Package● Operates on off-the-shelf hardware● (multiple vendors)● Windows 2000 operating system● DICOM compatible	Software PackageOperates on off-the-shelfhardware (multiple vendors)Windows 2000, XP, or NToperating systemDICOM compatible
Safety	● Clinician interactive review/editing ofdata integral to use of tool	Unspecified

Tabular Comparison of Features and Specifications of the REX™ 1.0 and the Rapidia® V2.0

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Table 1. Substantial Equivalence

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Image /page/4/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 an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 7 2002

Re: K021099

Mr. Robert Anderson Chief Operating Officer PointDX, Inc. 635 West Fourth Street, Suite 200 WINSTON-SALEM NC 27101

Trade/Device Name: REX™ 1.0 PACS / Image Processing Software Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II

Product Code: 90 LLZ Dated: April 3, 2002 Received: April 4, 2002

Dear Mr. Anderson:

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 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 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 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 vours.

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): K_KO2/099

Device Name: REX™ 1.0 PACS / Image Processing Software

INDICATIONS FOR USE:

Intended Use:

Indications for Use:

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use X Per 21 CFR 801.109

Over-The-Counter Use)

Nancy C brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K021099

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).