The Hologic DR ImagePro is a Windows-based software application acting as a Picture Archiving and Communications System (PACS). It is intended to be used by clinical professionals to view, manipulate, transmit, print, and store DICOM compliant digital radiographic image data. It provides standard tools for image zoom, rotation, enhancement, smoothing, and sharpening. Hologic DR ImagePro also provides software tools for merging two to five DICOM image files of an individual patient together to aid visualization of large areas of interest. The software assists users in merging, or "stitching," the separate images together manually and allows users to draw lines and angles within the images to obtain measurements. The software runs on standard, off-the-shelf PC components.

Device Description

AI/ML Overview

The provided text is a 510(k) Premarket Notification for the Hologic DR ImagePro, a Picture Archiving and Communications System (PACS) software. This type of document focuses on establishing substantial equivalence to a predicate device, rather than presenting a detailed study with specific acceptance criteria and performance metrics of the new device itself.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets them, in the typical sense of a clinical or performance validation study with quantitative metrics for accuracy, sensitivity, or specificity.

The document primarily focuses on:

Device Description and Intended Use: Explaining what the Hologic DR ImagePro is and what it does (view, manipulate, transmit, print, store DICOM images, provide tools like zoom, rotation, enhancement, smoothing, sharpening, image stitching, line/angle measurement).
Substantial Equivalence to a Predicate Device: Comparing its features and technical characteristics to a previously cleared device (Accuview Diagnostic Imaging Software Package with Plug-ins).
Risk Analysis: Assessing the potential risks associated with the software, concluding a "minor" level of concern.
Compliance with Regulations: Stating that the software was developed and validated in accordance with 21 CFR 820.

Here's what can be extracted based on the nature of this submission:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Implied by Substantial Equivalence): The primary "acceptance criterion" for this 510(k) is that the Hologic DR ImagePro software is substantially equivalent to the predicate device (Accuimage Diagnostics Corp. AccuView Diagnostic Imaging Software Package with Plugins) in terms of intended use, technological characteristics, and safety and effectiveness.
Reported Device Performance: The document provides a detailed comparison of features between the Hologic DR ImagePro and the predicate device in a table, demonstrating that the Hologic device offers similar or enhanced functionalities without raising new questions of safety or effectiveness. For example:
- Image Processing: Both offer window/level, pan, zoom. Hologic DR ImagePro adds grayscale invert, contrast enhance, sharpen, blur, rotate, crop, side-by-side display; the predicate offers variable smooth filter, cine display.
- Image Stitching: Both merge images from the same patient/study using manual selection of common stitch points.
- Measurement Tools: Both offer line and angle measurement tools derived from DICOM header pixel size.

Feature	Hologic DR ImagePro Performance	Implied Acceptance Criterion (Equivalence to Predicate)
Intended Use	View, manipulate, transmit, print, and store DICOM compliant digital radiographic image data. Aids visualization of large areas by merging 2-5 DICOM images (stitching), allows line/angle measurements.	Equivalent to predicate's intended use of a PACS for viewing, manipulating, and managing images, and providing advanced tools like stitching and measurements.
Computer Platform	Standard PC, Windows XP OS, >2.0GHz processor, ≥ 512 MB RAM.	Compatible with standard PC hardware and operating systems, similar to or improved upon the predicate's requirements (Windows 95/98/NT OS, 400MHz processor, 512MB RAM).
Communications	TCP/IP Ethernet.	Utilizes standard network protocols like the predicate (TCP/IP Ethernet, GPIB).
Image Format (input)	DICOM 3.0.	Supports standard medical image formats, similar to the predicate (DICOM 3.0, ACR NEMA 2.0).
Image Format (output)	DICOM 3.0.	Outputs in standard medical image formats, similar to the predicate (DICOM 3.0, BMP, TIFF).
Storage Media	PACS/Ethernet Network, Local Disk.	Supports networked and local storage solutions, similar to the predicate (PACS/Ethernet Network, Local Disk, CD-ROM).
Display/Monitor Req.	> 18" Color, CRT or LCD, SXGA 1280 X 1024.	Compatible with common display standards, similar to or improved upon the predicate (Color/Grayscale, CRT or Laptop LCD, Up to 1024 X 768).
Image Processing Tools	Window/Level, Pan, Zoom, Grayscale Invert, Contrast Enhance, Sharpen, Blur, Rotate, Crop, Side-by-side Display.	Provides core image processing functionalities (Window/Level, Pan, Zoom), and potentially enhanced features, comparable to or exceeding the predicate's (Window/Level, Pan, Zoom, Variable Smooth Filter, Cine Display).
Image Stitching	Merges 2-5 images from the same patient/study using manual selection of common stitch points; software stitches user-placed common points.	Performs image merging based on user-defined stitch points, functioning equivalently to the predicate ("Manual selection of common stitch points within images. Software stitches user-placed common points or lines.").
Line Measurement Tool	Measures distances from user-placed points, derived from pixel size in DICOM header.	Measures distances accurately based on DICOM pixel size, equivalent to the predicate.
Angle Measurement Tool	Measures angles from user-placed points.	Measures angles accurately, equivalent to the predicate.
Risk Level (FDA)	Level of Concern: "minor."	No new risks or higher risk level than the predicate device. Ensures patient safety and device effectiveness, similar to predicate's risk profile. Software designed, developed, verified, and validated per 21 CFR 820 procedures.

The following points cannot be answered from the provided text:

Sample size used for the test set and the data provenance: No information on a specific test set for performance evaluation is provided, as this is a PACS software substantial equivalence submission rather than an AI/CAD performance study.
Number of experts used to establish the ground truth for the test set and qualifications: Not applicable, as there's no clinical test set for diagnostic accuracy in this submission.
Adjudication method for the test set: Not applicable.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and effect size: This is not an AI-assisted diagnostic device, so an MRMC study comparing human readers with and without AI assistance is not relevant or reported here.
If a standalone performance (algorithm only without human-in-the-loop performance) was done: Not applicable, as this is PACS software and not a standalone diagnostic algorithm. Its function is to support human interpretation.
The type of ground truth used: Not applicable, as there's no diagnostic accuracy study with a "ground truth." The "ground truth" for this type of device relates to its technical functionality (e.g., does it correctly display DICOM images, does the stitching work as designed given user input). The document states software was "designed, developed, verified, and validated in accordance with written procedures as required by 21 CFR 820."
The sample size for the training set: Not applicable; this is not an AI/Machine Learning device that undergoes training.
How the ground truth for the training set was established: Not applicable.

In summary, this 510(k) submission primarily relies on demonstrating that the Hologic DR ImagePro PACS software offers similar features and capabilities to a legally marketed predicate device, thereby meeting the "substantial equivalence" criterion for market clearance, rather than providing a detailed clinical performance study with specific acceptance criteria and performance metrics.

Summary

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OCT 1 6 2003

Hologic, Inc. August 15, 2003

Hologic DR ImagePro 510(k) Premarket Notification

H. 510(k) Summary

H.1 Company Identification

Hologic, Inc. 35 Crosby Drive Bedford, MA 01730 781-999-7300

H.2 Contact Information

Daniel F. Phelan Senior Regulatory Affairs Specialist

H.3 Date of Submission

August 13, 2003

H.4 Device Identification

Proprietary Name Hologic DR ImagePro Classification Name: Picture Archiving and Communications System Regulation Number: 21 CFR 820.2050 Product Code: 90 LLZ Common/Usual Name Medical Image Management Device

H.5 Predicate Device Information

K990241 Acculmage Diagnostics Corp. AccuView Diagnostic Imaging Software Package with Plugins.

H.6 Device Description and Intended Use

H.7 Software

Hologic, Inc. certifies that the DR ImagePro software package is designed, developed, verified, and validated in accordance with written procedures as required by 21 CFR 820 and Hologic's quality system.

000336

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H.8 Hazard/Risk Analysis

The DR ImagePro does not contact the patient and is not intended to sustain life or control lifesustaining devices. Risk analysis has been performed throughout the development process in accordance with design control procedures. Particular attention has been paid to identifying potential hazards, assessing any potential effect on the safety of patients and the effectiveness of the device, determining the causes and effects of potential hazards, implementing mitigation measures, and to maintaining records of risk analysis and mitigation measures.

The potential risks identified through risk analysis activities are no different that those of other PACS devices. None of the risks is expected to cause or contribute to patient death or serious injury. Hologic therefore concludes that the Level of Concern posed by DR ImagePro is "minor."

Manufacturer	Hologic, Inc.	Acculmage Diagnostics Corp
510(k) Number		K990241
Proprietary Name	DR ImagePro	Accuview Diagnostic ImagingSoftware Package with Plug-ins.
Computer Platform	Standard PC, Windows XP OS, >2.0GHz processor, ≥ 512 MB RAM.	Standard PC, Windows 95/98/NT OS,400MHz processor, 512 MB RAM
Communications	TCP/IP Ethernet	TCP/IP Ethernet, GPIB
Image Format (input)	DICOM 3.0	DICOM 3.0, ACR NEMA 2.0
Image Format (output)	DICOM 3.0	DICOM 3.0, BMP, TIFF
Storage Media	PACS/Ethernet Network, Local Disk.	PACS/Ethernet Network, Local Disk,CD-ROM
Display / MonitorRequirements	> 18" Color, CRT or LCD, SXGA 1280X 1024	Color/Grayscale, CRT or Laptop LCD,Up to 1024 X 768
Image Processing	Window/Level, Pan, Zoom, GrayscaleInvert, Contrast Enhance, Sharpen,Blur, Rotate, Crop, Side-by-sideDisplay.	Window/Level, Pan, Zoom, VariableSmooth Filter, Cine Display
Image Stitching	Merge images from the samepatient/study. Manual selection ofcommon stitch points within images.Software stitches user-placedcommon points.	Merge images from the samepatient/study (patient/study dataobtained from DICOM header).Manual selection of common stitchpoints within images. Softwarestitches user-placed common pointsor lines.
Line Measurement Tool	Measures distances from user-placedpoints on image Measurementsderived from pixel size specified inDICOM header.	Measures distances from user-placedpoints on image Measurementsderived from pixel size specified inDICOM header..
Angle MeasurementTool	Measures angles from user-placedpoints on image.	Measures angles from user-placedpoints on image.

H.9 Substantial Equivalence

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 6 2003

Mr. Daniel F. Phelan Senior Regulatory Affairs Specialist HOLOGIC, Inc. 35 Crosby Drive BEDFORD MA 01730

Re: K032546 Trade/Device Name: Hologic DR ImagePro Software Package Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and

communications system

Regulatory Class: II Product Code: 90 LLZ Dated: August 15, 2003 Received: August 18, 2003

Dear Mr. Phelan:

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 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. 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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B.2 Indications for Use

Prescription Use

NancyC Srodon
(Division Sign-Off)

Division of Reproduct Yve. Abdom and Radiological Device 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).