The DexTop Mammography Workstation is a mammography review workstation software package, which provides very high performance viewing, processing and analysis of multimodality two and three dimensional, as well as planar, medical image data.

The DexTop Workstation is designed to assist the radiologist in conducting screening and primary diagnosis through flexible, fast and efficient image hanging and processing of multimodality softcopy images with special emphasis and optimization for mammography.

When interpreted by a skilled physician, this software provides information that may be useful in screening and diagnosis. However, the final judgment must rely on the knowledge and skill of the physician.

Device Description

The DexTop Mammography Workstation is a software product, which runs on a high end personal computer, for the purpose of non-invasive multi-modality review. It provides very high performance viewing, processing and analysis of multimodality two and three dimensional, as well as planar medical image data.

The DexTop Mammography Workstation receives digital image data from various sources including a variety of diagnostic imaging systems, Hospital PACS, Electronic media and local file systems.

The architecture of the DexTop Workstation means that it can be deployed as a central base station with satellite workstations all using the same user configuration store and image data.

The Dexela DexTop Mammography Workstation supports the following image network communications:

Standard 10/100/1000 Base-T Ethernet protocols .
. DICOM 3.0 Storage SCP and Query/Retrieve SCU.
. TCP/IP network layer

The hardware configuration used with the software typically will include a PC, a single standard color monitor, a multi-function keypad (for increased productivity), and two high resolution monitors for mammographic Image review.

AI/ML Overview

The provided text is a 510(k) summary for the DexTop Mammography Workstation. It describes the device, its indication for use, and technological characteristics. However, it does not contain specific acceptance criteria, performance metrics, or details of a study that proves the device meets such criteria.

The document states:

"The non-clinical testing for the DexTop Workstation includes performance of system requirements testing according to the Software Testing Strategy and following the test cases as defined in the Software Requirements Test Specification Document."
"Therefore Dexela is confident that the system as developed will perform according to the specifications detailed in the User Requirements Specification and System Requirements Specification."

This indicates that internal system requirements testing was performed, but the results, acceptance criteria, or specifics of these tests are not included in the provided summary. There is no information regarding a clinical study or a comparative study against a predicate device in terms of diagnostic performance (e.g., sensitivity, specificity, reader performance).

Therefore, based only on the provided text, I cannot provide the requested information in detail. I will answer the questions to the best of my ability with the available text, noting where information is missing.

Here's an analysis based on the provided text:

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

The provided 510(k) summary does not include a table of acceptance criteria or specific reported device performance metrics related to diagnostic accuracy or clinical effectiveness. It focuses on the device's functional capabilities and compliance with DICOM standards and regulatory requirements for a workstation.

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

The document mentions "non-clinical testing for the DexTop Workstation includes performance of system requirements testing," but it does not specify a sample size for a test set (e.g., number of images or cases) or the data provenance (e.g., country of origin, retrospective/prospective nature). These tests appear to be internal system-level and software verification tests, not clinical performance studies.

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

This information is not provided in the 510(k) summary. Given that the testing described is non-clinical system requirement testing, the concept of "ground truth" derived from expert consensus for diagnostic performance is not applicable within the scope of the provided text.

4. Adjudication method for the test set

This information is not provided.

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

A multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned in the provided text. The device is a workstation for viewing and processing images, not an AI diagnostic tool. Therefore, an "effect size of how much human readers improve with AI vs without AI assistance" is not applicable to the description of this device.

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

A standalone performance study of an algorithm is not described in the provided text. The device is a workstation, intended to be used by a "skilled physician" who makes the "final judgment."

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

The specifics of "ground truth" are not mentioned as the described testing is non-clinical system testing related to software functions and specifications, not diagnostic accuracy.

8. The sample size for the training set

Given that this is a workstation software product, and not an AI/CADe device, the concept of a "training set" in the context of machine learning or deep learning is not applicable or mentioned in the provided document.

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

As there is no mention of a training set for an AI/CADe algorithm, how ground truth for such a set was established is not applicable or mentioned.

Summary

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5 510(k) Summary of Safety and Effectiveness

Ko80351

SUBMITTER:	Dexela Limited
CONTACT PERSON:	Michael Henry
	APR 22 2008
DATE PREPARED:	31 January, 2008
DEVICE TRADE NAME:	DexTop Mammography Workstation
COMMON NAME:	DexTop Mammography Workstation
CLASSIFICATION NAME:	Picture Archiving and Communication System
PREDICATE DEVICE(S):	General Electric Medical Systems: Seno Advantage (K033400)

DEVICE DESCRIPTION:

The DexTop Mammography Workstation receives digital image data from various sources including a variety of diagnostic imaging systems, Hospital PACS, Electronic media and local file systems.

The architecture of the DexTop Workstation means that it can be deployed as a central base station with satellite workstations all using the same user configuration store and image data.

The Dexela DexTop Mammography Workstation supports the following image network communications:

Standard 10/100/1000 Base-T Ethernet protocols .
. DICOM 3.0 Storage SCP and Query/Retrieve SCU.
. TCP/IP network layer

See the following table.

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Component	Quantity
SYSTEM: Multi-core (>2) 64-bit processor	1
Memory: Minimum 2GB RAM	NA
STORAGE: DVD Drive SONY DDU1615 or equivalent	1
RAM: Minimum 80 GB (MAXTOR ATLAS SCSI drive or equiv)	NA
DISPLAYS: Any HIPAA approved display monitors	1 or 2 depending on configuration
PERIPHERALS: Standard keyboardStandard mouseX-KEYS SE USB - LCD keypad	1 each
SOFTWARE: Windows XP Professional X64Dexela Mammography Workstation Software	1 each

INDICATION FOR USE:

Hardware
64 bit Windows Operating System	More memory for larger data sets and increasespeed of workflow
Multi-core processor	Makes full use of new multi core CPUs tomaximize throughput
Remote workstation configuration	Multiple workstations can view the same data.
Easy to use shortcut keypad	Shortcut keys to often used functions arepresented on a separate keypad for ease of use
Communications
DICOM	DICOM compliant communications
Software
Modalities	MG,MR,CR,US
Multi-vendor imaging	Fully IHE and DICOM compliant image displayallows any vendor image to be displayedcorrectly
Window centre and width adjustment	Window centre and width can be freely adjusted
Hardware
	for any image maintaining the predefined curveif it exists
Use of imbedded VOI LUTs	Correct implementation of the DICOM LUTSimbedded in the image file, including the abilityfor the user to adjust the image maintain the
Linear and Sigmoid LUTs	same curveSwitch between the use of a linear or a sigmoid
Pull-scale function	curve for the display of gray scale imagesFunction allowing the user to focus on a specificarea with regard to window centre and width
User specific window center and width	The system can remember the individual'spreference for an image with regard to changesmade to its default window centre and width
Highly flexible patient and technicalinformation display	The user can specify which pieces of patient andtechnical information should appear on whichscreen
XML based annotation	Allows the radiologist to annotate the images ina very flexible way. The annotation can behidden and deleted as required
Flip, Zoom, Invert and Pan	The images can be manipulated on screen in allthe usual ways
Tiling	Images series or planar images can be tiled tothe screen allowing some or all of the frames toviewed at the same time.
Shutter-View	A type of shutter view of the image where twosynchronized images have a mask overlaid soonly the same small portion of each image isvisible.
1:1 view	Display of the image data at one pixel per imagedata.
Life-size view	Display of the image at life size
Magnifying glass	A zoomed in portion of the image at the currentcursor position
Hot lamp / Bright Light	A portion of the image is displayed as if abrighter light had been applied to that area ofthe screen.
CLAHE and Un-sharp Mask	Image processing techniques can be applied tosharpen and equalize the images
Highly configurable hanging	Hanging protocols are designed per user withunlimited categories and limitless flexibility withrespect to screen use and positioning
Smart-Merge Protocol	Specific technology that brings together userpreferences from different aspects of film typeand screen use and combines them to form anew hanging from images that are only looselyspecified.
DICOM printing	DICOM printing
Data export	Export data to CD or for presentations

TECHNOLOGICAL CHARACTERISTICS:

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NON-CLINICAL REQUIREMENTS TEST:

The non-clinical testing for the DexTop Workstation includes performance of system requirements testing according to the Software Testing Strategy and following the test cases as defined in the Software Requirements Test Specification Document.

CONCLUSIONS:

Software Development for the DexTop workstation has been performed in accordance with the Software Development Plan and following the guidance of the Dexela Design and Development Procedures, and which includes, in addition to other documents, a Product Risk Analysis, Software Requirements, Design and Development Plan, detailed Architecture documents , Testing Strategy, and Software Requirements Test Specification. Therefore Dexela is confident that the system as developed will perform according to the specifications detailed in the User Requirements Specification and System Requirements Specification.

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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 stylized eagle with three stripes representing the three branches of government. The eagle is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the logo.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 22 2008

Dexela, Ltd. % Mr. Barry Sall, RAC Principal Consultant Parexel Consulting 200 West St. WALTHAM MA 02451

Re: K080351

Trade/Device Name: Dexela DexTop Mammography Workstation Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: March 28, 2008 Received: March 31, 2008

Dear Mr. Sall:

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, Rarts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2

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.

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter,

21 CFR 876.xxxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 892.xxxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrb/industry/support/index.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

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510(k) Number (if known): K080351

Device Name: Dexela DexTop Mammography Workstation

The DexTop Workstation is designed to assist the radiologist in conducting screening and primary diagnosis through flexible, fast and efficient image hanging and processing of multimodality soft-copy images with special emphasis and optimization for mammography.

Dexela DexTop Mammography Workstation will display the full fidelity DICOM image in a non-compressed format. Lossy compressed mammography images and digitized film screen images must not be used for the purpose of primary diagnosis. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 megapixel resolution and meets other technical specifications reviewed and accepted by the FDA

The device will display only DICOM "For Presentation" images for primary image diagnosis. The device does not perform any image processing (except simple manipulation such as gray scale changes by window level and window width) of the proprietary image processing algorithm of the FFDM manufacturers.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)

Over-the-Counter Use (21 CFR 807 Subpart C) AND/OR

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number K080351

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).