Acquire, store, transmit, and display medical images and patient reports of various types. Teleradiology image acquisition, distribution, archive and viewing.

Device Description

The IiVS™ Integrated image Viewing Station is a product family, which comes in two different versions: DiVS: a DICOM viewer IiVS: a 3D viewer. The intended use of the devices is to provide solutions to various medical image-viewing problems, which come about as the modalities generate more and more images. They also support image distribution over networks, and are DICOM conformant. Finally, the IIVS™ Integrated image Viewing Station family supports the radiologist in writing a report, and transmitting and storing this report in digital form.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the TeraRecon IiVS™ Integrated Image Viewing Station (K994329). This document primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving the device meets specific acceptance criteria with quantifiable performance metrics.

Therefore, much of the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, and MRMC studies is not explicitly available in the provided text.

However, I can extract and infer some information based on the document's content, particularly from the "Performance Standards" section and the "Comparison Table."

Here's the information that can be extracted and inferred:

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

The document does not explicitly present a table of acceptance criteria with corresponding reported performance metrics in the way a typical clinical study would. Instead, it relies on demonstrating compliance with standards and comparing features to a predicate device.

Inferred "Acceptance Criteria" (based on compliance and comparison):

Acceptance Criteria Category	Specific Criteria (Inferred from documentation)	Reported Device Performance (Inferred from documentation)
Voluntary Standards	Compliance with DICOM 3 Query and Retrieve	"Compliance with DICOM 3 Query and Retrieve"
	Compliance with ISO/IEC 12207:1995 (Software Life Cycle)	Software designed to control and manipulate images follows this standard.
Hardware Requirements	Execute on Silicon Graphics SGI-320 and 540 and VW 320/540 workstations	Device is configured to run on these specified workstations with detailed CPU, RAM, and storage.
	Memory requirement of 640 MB	VW 320/540 configurations specify 640 MB of SDRAM.
User Interface	Standard keyboard and wheel-mouse input	"User interacts with the system through a standard keyboard and a wheel-mouse."
	Buttons marked with commonly understood symbols or English	"All buttons are marked with commonly understood symbols or English language notation."
Data Input	Max. file size: 512 MB or 1000 slices	"Max. file size: 512 MB or 1000 slices"
	NTSC video input at 30 frames per second	"NTSC video input signals at 30 frames per second."
Data Output	User defined output as DICOM file	"Data output is user defined and is one of 3 options: 1. DICOM file"
	User defined output as JPEG compressed image file	"Data output is user defined and is one of 3 options: 2. JPEG compressed image file"
	User defined output as BMP file	"Data output is user defined and is one of 3 options: 3. BMP file"
Video Output	NTSC-compatible video output as an option	"NTSC-compatible video output as an option."
Report Functionality	Provide preset image format for included images, easily modifiable	"Provide preset image format for included images. This format has to be easily modified."
	Overlay of figures and characters to annotate findings	"Overlay of figures and characters on top of the images to annotate findings."
	Placing report on a network as DICOM, BMP, or JPEG	"Provide for placing the report on a network as DICOM files or BMP or JPEG format."
	Provide a print function	"Provide a print function."
Comparison to Predicate	Teleradiology image acquisition, distribution, archival and 3D viewing	"SAME" as predicate AccuImage™ Viewer Products.
	Network Connectivity: Ethernet 100 Base T	Different from predicate (GPIB IEEE488), but considered equivalent ("Yes" in SE column).
	Computer Platform: SGI VW-320 and -540	Different from predicate (PC), but considered equivalent ("Yes" in SE column).
	Lossy Image Compression: JPEG	Different from predicate (BMP), but considered equivalent ("Yes" in SE column).
	DICOM Compliant: YES	"YES" (same as predicate)
	Image Display: Color, Grey scale, 1600x1200	Higher resolution than predicate (512x512), considered equivalent ("Yes" in SE column).
	Image Edit: 8 object segmentation clipping planes in double oblique orientation	More advanced than predicate (Manual and threshold segmentation), considered equivalent ("Yes" in SE column).
	Volume Rendering: Voxel transmission, parallel and perspective ray casting	Different algorithms than predicate (MIP, Surface rendering, Depth encoded surface), considered equivalent ("Yes" in SE column).
	2D/3D Integration: Automatic display of orthogonal planes	More advanced than predicate (Display of basic 2D views), considered equivalent ("Yes" in SE column).
	Operating System: SGI320, SGI-540 Windows NT	Different from predicate (Win95/Win98), but considered equivalent ("Yes" in SE column).

Note on "Reported Device Performance": For a 510(k) submission like this, "reported performance" often means demonstrating that the device meets its design specifications, is compliant with relevant standards, and is substantially equivalent to a legally marketed predicate device. Actual quantitative performance metrics from a dedicated study are typically not included unless addressing a specific performance claim.

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

The document does not describe a specific "test set" for performance evaluation in the context of a clinical study or image dataset. The submission focuses on technical specifications, compliance with standards (DICOM, ISO/IEC 12207), and a feature-by-feature comparison to a predicate device. Therefore, information about sample size, data provenance, and retrospective/prospective nature is not provided.

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)

Since there is no described "test set" or clinical study involving image interpretation, there is no information about experts establishing ground truth.

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

As no test set involving expert review is described, there is no information on an adjudication method.

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

The document does not describe an MRMC comparative effectiveness study, nor does it refer to AI assistance. This device is an image viewing and communication system, not an AI-powered diagnostic aid.

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

The device is an image viewing and communication system designed to be used by human radiologists. It is not an algorithm intended for standalone diagnostic performance. Therefore, analysis of "standalone" algorithm performance is not applicable or described.

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

Since no clinical performance study involving diagnostic interpretation is described, there is no mention of the type of ground truth used. The ground truth for this type of device relates to its technical functionality (e.g., a DICOM file is correctly transferred and displayed, a report is correctly generated).

8. The sample size for the training set

The document does not describe a "training set" as it is not an AI/machine learning device. The software development follows ISO/IEC 12207, implying standard software testing and validation, but not machine learning training.

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

As there is no "training set" in the context of machine learning, this question is not applicable and no information is provided.

Summary

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K994329
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Device Name:

Trade Name: Common Name: Classification Name: Teleradiology System DIVS & IiVS™ Integrated image Viewing Stations Image communication and storage system System, Digital Image Communication

Establishment Name & Registration Number:

Name: TeraRecon, Inc. Number: Pending

Classification:

Title 21, Code of Federal Regulations, § 892.2020 & § 892.2050. Now proposed exempt, final rule pending.

90-LMD & 90-LLZ ProCode:

Equivalent Device(s):

Acculmage™ Viewer Products, K961023, by Acculmage, Inc.

The referenced systems are equivalent to the DVS and IiVS™ Integrated image Viewing Stations in terms of basic design, features and intended use.

Description of the Device:

The IiVS™ Integrated image Viewing Station is a product family, which comes in two different versions:

DiVS: a DICOM viewer liVS: a 3D viewer

The intended use of the devices is to provide solutions to various medical image-viewing problems, which come about as the modalities generate more and more images. They also support image distribution over networks, and are DICOM conformant.

Finally, the IIVS™ Integrated image Viewing Station family supports the radiologist in writing a report, and transmitting and storing this report in digital form.

Applicant / Sponsor Name / Address:

TeraRecon, Inc. 2955 Campus Drive, Suite 325 San Mateo, CA 94403 650.372.2669

Contact Person:

Horst Brüning, Ph.D. VP Engineering TeraRecon, Inc. 2955 Campus Drive, Suite 325 San Mateo, CA 94403 650.372.2669

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K994329
Page 2 of 3

Submission Correspondent:

Mr. David W. Schlerf Buckman Company, Inc. 200 Gregory Lane, Suite C-100 Pleasant Hill, CA 94523-3389 925.356.2640 / 925.356.2654 FAX

Manufacturing Facility:

Manadalanting I dolling.
At the present time, the DVS & IiVS™ Integrated image Viewing Station is manufactured by TeraRecon, Inc.

Performance Standards:

There are no applicable FDA mandated performance standards for this device. However, voluntary standards such as DICOM, various in-house Standard Operating Procedures and vendor qualification procedures are in place and utilized in the production of the software.

The software designed to control and manipulate the diagnostic images follows the international standard ISO/IEC 12207: 1995 Informatin technology - Software Life Cycle Processes. In accordance with that standard, the level of concern relative to this software has been determined using the decision tree provided in Version 1 of the FDA Software Guidance.

Hardware requirements

The DiVS will execute on Silicon Graphics SGI-320 and 540 workstations under Windows NT4.0. Memory requirements are 640 MB.

User interface

The user interacts with the system through a standard keyboard and a wheel-mouse. All buttons are marked with commonly understood symbols or English language notation.

Data input:

DTCOM file transfer: Compliance with DICOM 3 Query and Retrieve Max. file size: 512 MB or 1000 slices

Video Input: NTSC video input signals at 30 frames per second. Data output: Data output is user defined and is one of 3 options:

1. DICOM file
1. JPEG compressed image file
1. BMP file

Video output:

NTSC-compatible video output as an option.

The Report Function

Provide preset image format for included images. This format has to be easily modified. Overlay of figures and characters on top of the images to annotate findings. Provide for placing the report on a network as DICOM files or BMP or JPEG format. Provide a print function.

Hardware Information:

The liVS will execute on Silicon Graphics Visual Workstations VW 320 or VW 540. The following configuration is used:

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K 994329
Page 3 of 3

VW 320

Silicon Graphics 320 Base Model Dual Pentium 111 500 MHz 640 MB of SDRAM 14.4.GB hard disc 32x CD-ROM Silicon Graphics 1600 SW flat panel monitor MS IntelliMouse with wheel USB keyboard

VW 540

Silicon Graphics 540 Base Model Quad Pentium III Xeon 550 MHz 640 MB of SDRAM 9.1 GB Ultra 2 SCSI hard disc e.-h. same as model 320

Comparison Table:

FEATURE	DIVS & liVS™	Acculmage™	SE?
Intended Use:	Teleradiology image acquisition,distribution, archival and 3Dviewing.	SAME	Yes
NetworkConnectivity:	Ethernet 100 Base T	General Purpose InterfaceProtocol - GPIB IEEE488	Yes
ComputerPlatform:	SGI VW-320 and -540	PC	Yes
Lossy ImageCompression:	JPEG	BMP	Yes
DICOMCompliant:	YES	YES	Yes
Image Display:	Color, Grey scale, 1600x1200	Color, Grey scale, 512x512	Yes
Image Edit:	8 object segmentation clippingplanes in double obliqueorientation	Manual and thresholdsegmentation	Yes
VolumeRendering:	Voxel transmission, parallel andperspective ray casting	MIP, Surface rendering, Depthencoded surface,	Yes
2D/3DIntegration:	Automatic display of orthogonalplanes	Display of basic 2D views	Yes
OperatingSystem:	SGI320 , SGI-540 Windows NT	Win95/Win98	Yes

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 6 2000

Terarecon, Inc. c/o David W. Schlerf Buckman Company, Inc. 200 Gregory Lane Suite C-100 Pleasant Hill, CA 94523 Re:

K994329 IiVS™ Integrated Image Viewing Station Dated: April 14, 2000 Received: May 1, 2000 Regulatory class: II 21 CFR 892.2050/Procode: 90 LMD/90 LLZ

Dear Mr. Schlerf:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices uevice is Substantally Quirient (10 the Medical Device Amendment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmelic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include manked the done, valier of the general post post manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

lf your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to n your dovice a controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Starraditional online. Externination assumes compliance with the Current Good Manufacturing Proclice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might the reductions 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of r rios to the new 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 and additionally 809.10 for in vito diagnostic devices), please contact the Office of Compliance at (301) 594-4591. 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 entitiled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,

Daniel G. Schultz, M.D. Captain, USPHS Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure(s)

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K994321 510(k) Number (if known):_

IiVS™ Integrated image Viewing Station Device Name:

Indications For Use:

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Acquire, store, transmit, and display medical images and patient reports of various types. Teleradiology image acquisition, distribution, archive and viewing.

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

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use J (Optional format 1-2-96)

David A. Seymore
Division Sign Off

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devic 510(k) Number

IiVS.doc

Regulation Number and Section

§ 892.2020 Medical image communications device.

(a)
Identification. A medical image communications device provides electronic transfer of medical image data between medical devices. It may include a physical communications medium, modems, and interfaces. It may provide simple image review software functionality for medical image processing and manipulation, such as grayscale window and level, zoom and pan, user delineated geometric measurements, compression, or user added image annotations. The device does not perform advanced image processing or complex quantitative functions. This does not include electronic transfer of medical image software functions.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 892.9.