axis PACS is a software application intended to perform operations relating to acquisition, display, digital processing, review, transfer, archive, measurements, teleradiology exchange of medical images and patient demographic information. axis PACS receives digital images and data from various modalities, including but not limited to; Computed Radiography (CR), Computed Tomography (CT), Magnetic Resonance (MR), Ultrasound (US), Fluoroscopy (RF), secondary screen captures devices, scanners, digitizers, or other imaging sources.

It is intended for use by the physician to aid diagnosis and used by medical professionals whenever they require access to medical images and patient demographic information. Users have access to a variety of measurement tools and image processing to aid them in viewing digital images.

This device may be used to archive mammography images (MG) but is not intended for primary diagnostic viewing of mammography images.

axis PACS can integrate with a health care institution's or physician's office Health Information System (HIS) or a Radiology Information System (RIS) for a fully integrated electronic patient record.

Device Description

axis PACS is a Picture Archiving and Communication System (PACS) designed for the management, and Procession, manipulation, and processing of DICOM 3.0 images from modalities in a diagnostic viewing, artiming, axis PACS consists of the axis PACS Web software application on a server and the axis imaging secting. "Alle Prob on client computers connecting to the Server via the HTTPS protocol. axis PACS r Nos viewer ver DICOM 3.0 images over a medical imaging network, as well as export images to other applications.

AI/ML Overview

Here's an analysis of the acceptance criteria and study information for the axis PACS device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document describes a PACS (Picture Archiving and Communication System) device. For such devices, acceptance criteria are typically related to their functionality, image quality, comparison to a predicate device, and compliance with regulations.

Acceptance Criteria Category	Specific Criteria (Inferred/Stated)	Reported Device Performance
Functional Equivalence	Perform operations related to acquisition, display, digital processing, review, transfer, archive, measurements, teleradiology exchange of medical images and patient demographic information.	"axis PACS performed as intended and performed to substantial equivalence (SE) to the predicate device."
	Receive digital images and data from various modalities (CR, CT, MR, US, RF, etc.).	Stated as a core function and confirmed implicitly by successful comparison to predicate device.
	Integrate with HIS/RIS.	Directly stated: "axis PACS can integrate with a health care institution's or physician's office Health Information System (HIS) or a Radiology Information System (RIS)."
Image Quality & Processing	Enable viewing of digital images with measurement tools and image processing.	Directly stated: "Users have access to a variety of measurement tools and image processing to aid them in viewing digital images."
	Not intended for primary diagnostic viewing of mammography images.	Directly stated limitation: "This device may be used to archive mammography images (MG) but is not intended for primary diagnostic viewing of mammography images."
Safety and Effectiveness	Be as safe and effective as the predicate device.	"It was concluded the axis PACS is as safe and effective, performed as well as or exceeded, the predicate device..."
Technological Equivalence	Same technological characteristics as predicate (operating system, functionality, standards conformance, presentation).	"Compared to the predicate device, axis PACS has the same technological characteristics. These include operating system, functionality, conformance with voluntary standards, and presentation characteristics."
Regulatory Compliance	Meets voluntary standards (21 CFR 892.2050(b)).	"axis PACS was tested to validate and verify that the device meets voluntary standards specified in 21 CFR 892.2050(b)..." and "axis PACS is manufactured according to the voluntary standards, 21 CFR 892.2050(b)..."
	Complies with 21 CFR 820 Quality System Regulations.	Directly stated.
	Complies with 21 CFR Part 807 Subpart B (registration/listing).	Directly stated.
	Complies with 21 CFR Part 801 (labeling).	Directly stated.

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

Sample Size for Test Set: The document mentions "DICOM calibration images and actual patient images" were used for non-clinical testing. For the clinical test, it states "DICOM images were already obtained by the modalities." However, specific numbers for the test set sample size (i.e., how many cases or images) are not provided in the document.
Data Provenance:
- Non-clinical tests: "DICOM calibration images and actual patient images." The source of these "actual patient images" is not specified beyond being "used in both systems during the comparison testing."
- Clinical tests: "DICOM images were already obtained by the modalities." These tests were conducted at Bedford Medical Center in Bedford, Indiana. The data appears to be retrospective as the images were already obtained.

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

Number of Experts: For the clinical test, it states the test was conducted "under the supervision of the hospital's radiologist." This implies at least one radiologist was involved in the clinical comparison.
Qualifications of Experts: "hospital's radiologist." No specific experience level (e.g., "10 years of experience") is mentioned.

4. Adjudication Method for the Test Set

The document describes a "side-by-side" comparison of axis PACS with the predicate device (e-Film Workstation) during both non-clinical and clinical tests. The clinical test involved direct supervision by a radiologist. This suggests a direct comparative assessment rather than a formal adjudication method like 2+1 or 3+1. The adjudication method appears to be a direct comparison by the supervising radiologist(s) to determine if axis PACS "performed as well as or exceeded" the predicate device.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Was an MRMC study done? No.
Effect Size: Since no MRMC study was performed to assess human reader improvement with AI assistance (as axis PACS is a PACS, not an AI diagnostic tool in this context), there is no reported effect size for human readers improving with AI vs. without AI assistance. The study focuses on the PACS system's performance relative to a predicate PACS.

6. Standalone (Algorithm Only) Performance Study

Was a standalone study done? Yes, in a sense. The entire evaluation of axis PACS is a standalone performance study in relation to its predicate. The device itself (the software) is evaluated for its functionality and capabilities without being solely an "AI algorithm." The "algorithm" here essentially refers to the PACS software's core functions. The non-clinical and clinical tests described are evaluations of the device's standalone performance in comparison to a predicate device.

7. Type of Ground Truth Used

The ground truth for the comparison was primarily based on:

Functional Equivalence: Assessing if axis PACS could perform the same operations and display information comparably to the predicate device. This is a functional ground truth checked against expected PACS behavior and predicate performance.
Expert Comparison: The radiologist's assessment during the "side-by-side" clinical test served as the ground truth for performance and equivalence in a clinical setting. This falls under expert comparison/assessment.
DICOM Standards: The use of "DICOM calibration images" suggests adherence to DICOM standards as part of the ground truth for image processing and handling.

8. Sample Size for the Training Set

The document does not specify a training set size. PACS systems, like axis PACS, are generally conventional software applications for image management and display, not AI/machine learning models that typically require explicit training data sets in the same manner. Its development would involve software engineering and testing cycles, rather than data-driven machine learning training.

9. How the Ground Truth for the Training Set Was Established

As axis PACS appears to be a conventional PACS software and not an AI/ML diagnostic algorithm, the concept of "ground truth for a training set" as typically understood for AI models is not directly applicable. The "ground truth" for the development and verification of such software would be defined by engineering specifications, user requirements, and adherence to established medical imaging standards (like DICOM). This would be established through a combination of:

Software requirements specifications.
Industry standards (DICOM 3.0).
User feedback and operational needs.
Benchmarks against existing, legally marketed predicate devices.

Summary

{0}------------------------------------------------

axis Health C

Image /page/0/Picture/1 description: The image shows the letters "AHC" in white font on a black rectangular background. The letters are capitalized and appear to be a sans-serif font. The black background provides a strong contrast, making the letters stand out prominently.

5. 510(k) Summary

5.1 510(k) Summary of Safety and Effectiveness

This summary of safety and effectiveness is provided as part of the Premarket Notification for axis PACS and HMS PACS, in accordance with 21 CFR 807 Subpart E.

5.1.1. Submitted By
Business Name:	axis Health Care, LLC5755 Carmichael ParkwayMontgomery, Alabama 36117
Contact Name:	William D. Henderson, President
Contact E-mail:	dwight.henderson@hcsinc.net
Telephone:	334-279-9711
Fax:	334-279-0711
Registration Number:	Not assigned
Small Business Decision Number:	SBD 118249
Date Prepared:	December 16, 2010
5.1.2. Device Trade Name
Proprietary Name of Device:	axis PACS
Other Proprietary Name of Device:	HMS PACS
Classification:	Picture Archiving and Communication System (PACS)
Device Classification:	Class II Medical Device
Product Code:	LLZ
21 CFR Regulation	892.2050
5.1.3. Predicate Device
Predicate Device:	e-Film Workstation with Modules
Predicate Device Manufacturer:	Merge eFilm Medical, Inc. (Merge Healthcare)
Predicate Device 510(k) Number:	K020995
Date Received:	March 28, 2002
Decision Date:	April 12, 2002
Decision:	Substantially Equivalent
Device Classification:	Class II Medical Device
Product Code:	LLZ
21 CFR Regulation	892.2050

5.1.4. Device Description

5.1.4. Device Desertproin
axis PACS is a Picture Archiving and Communication System (PACS) designed for the management, and Procession, manipulation, and processing of DICOM 3.0 images from modalities in a diagnostic viewing, artiming, axis PACS consists of the axis PACS Web software application on a server and the axis imaging secting. "Alle Prob on client computers connecting to the Server via the HTTPS protocol. axis PACS r Nos viewer ver DICOM 3.0 images over a medical imaging network, as well as export images to other applications.

{1}------------------------------------------------

axis Healt

Image /page/1/Picture/1 description: The image shows the letters "AHC" in a bold, sans-serif font. The letters are white against a black background, creating a high-contrast effect. The letters are tightly spaced, almost touching each other. The overall impression is simple and clean.

5.1.5. Indications for Use

axis PACS is a software application intended to perform operations relating to acquisition, display, digital processing, review, transfer, archive, measurements, teleradiology exchange of medical images and patient demographic information. axis PACS receives digital images and data from various modalities, including but not limited to, Computed Radiography (CR), Computed Tomography (CT), Magnetic Resonance (MR), Ultrasound (US), Fluoroscopy (RF), secondary screen captures devices, scanners, digitizers, or other imaging sources.

lt is intended for use by the physician to aid diagnosis and used by medical professionals whenever they require access to medical images and patient demographic information. Users have access to a variety of measurement tools and image processing to aid them in viewing digital images.

This device may be used to archive mammography images (MG) but is not intended for primary diagnostic viewing of mammography images.

Typical users of axis PACS are trained medical professionals including radiologists, physicians, radiology technologists, and other clinicians.

5.1.6. Technological Characteristics and Substantial Equivalence Compared to the predicate device, axis PACS has the same technological characteristics. These include operating system, functionality, conformance with voluntary standards, and presentation characteristics. Both predicate device and axis PACS can transmit images and information over a medical imaging network and to remote viewing stations.

axis PACS does not physically come in contact with a patient nor does it control any life sustaining device. A physician has ample öpportunity to provide competent human intervention and interpretation of images and medical information as displayed or printed via axis PACS.

5.1.7. Performance Testing

axis PACS was tested to validate and verify that the device meets voluntary standards specified in 21 CFR 892.2050(b), with defined design and performance specifications. The results of the testing confirmed that axis PACS performed as intended and performed to substantial equivalence (SE) to the predicate device. The application is as safe and effective in the performance as a PACS as compared to the predicate device.

Testing is an integral part of axis PACS development process as outlined and supported by information provided in Section 11, 12 and 16 of this submission.

Nonclinical tests: (i)

A final non-clinical test with the predicate device was conducted November 22, 2010 at the axis Health Care office in Montgomery, AL. axis PACS was tested side-by-side with the predicate device, e-Film

{2}------------------------------------------------

axis Health C

Image /page/2/Picture/1 description: The image shows the letters "AHC" in a bold, sans-serif font. The letters are white against a black background, creating a high-contrast visual. The letters are stacked vertically, with "A" on top, followed by "H" and then "C". The overall impression is simple and clear.

Workstation with Modules version 2.1. DICOM calibration images and actual patient images were used in both systems during the comparison testing.

Clinical tests: (ii)
- a.) Subjects tested
- b.) Safety and Effectiveness
- c.) Adverse Effects and Complications

A clinical test at Bedford Medical center in Bedford, Indiana was conducted Oct. 1-3, 2010 under the supervision of the hospital's radiologist. The facility has the predicate software and has been using it for 3+ years. The products were compared side-by-side and the results are included in:

Attachment 19 Application Test Script axis PACS Radiologist Workstation (RW) o
(Note: Radiologist Workstation – This term is used interchangeably within this document and supporting documents with Diagnostic Station, Diagnostic Workstation, Read.Station, Diagnostic Read Workstation. All terms mean the workstation used by the radiologist to view digital images from the axis PACS archive.)

No subjects were directly included in the clinical test. All tests were indirect as DICOM images were already obtained by the modalities.

It was concluded the axis PACS is as safe and effective, performed as well as or exceeded, the predicate device, e-Film Workstation with Modules.

5.1.8. Conclusion

The axis PACS 510(k) premarket notification contains adequate information and data to enable FDA-CDRH to determine substantial equivalence (SE) to the predicate device.

axis PACS is manufactured according to the voluntary standards, 21 CFR 892.2050(b), and in 0 compliance with 21 CFR 820 Quality System Regulations.
This submission contains the results of the software validation and verification along with the o risk analysis. The risks have been classified as moderate level of concern and the submission provides solutions to mitigate those risks.
axis PACS complies with 21 CFR Part 807 Subpart B associated with registration and listing. o
axis PACS complies with 21 CFR Part 801 associated with proper labeling of the device. o

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

Mr. Ronald W. Graham Vice President Operations axis Health Care, LLC 5755 Carmichael Parkway MONTGOMERY AL 36117

MAR - 3 2011

Re: K103679 ·

Trade/Device Name: axis PACS and HMS PACS Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: December 16, 2010 Received: December 22, 2010

Dear Mr. Graham:

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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of

{4}------------------------------------------------

medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (OS) regulation (2) CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely Yours.

Mary Postel

Mary Pastel, ScD. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

Image /page/5/Picture/0 description: The image contains the words "axis Health Care" in a simple, sans-serif font. The text is black against a white background, and the words are evenly spaced. To the right of the words is a black and white graphic of the letter A.

4. FDA Indications for Use Statement

FDA Indications for Use Form

510(k) Number: K103679

Device Name: axis PACS and HMS PACS

Indications For Use:

This device may be used to archive mammography images (MG) but is not intended for primary diagnostic viewing of mammography images.

Typical users of axis PACS are trained medical professionals including radiologists, physicians, radiology technologists, and other clinicians.

Prescription Use:

AND/OR

Over-The-Counter Use: _

(Part 21 CFR 801 subpart D)

(21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of D

Page 1 of 1

May S Post
(Division Sign-Off)

Division of Radiological Devices
Office In Vitro Diagnostic Device Evaluation and Safety

This document is confidential

510K K103679

Page 16

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).