(13 days)
Agfa's Orthopedic Software is indicated for use with Impax® Workstations in the acquisition, display, digital processing, review, transfer, storage, archiving and printing of medical images and patient demographic information. It is intended for use by physicians to aid in diagnosis, and by medical professionals whenever they require or desire access to medical images and patient demographic information.
The software application allows orthopedic surgeons and specialists to assess images, plan surgical procedures, monitor patient progress and educate patients in a digital environment.
It allows assessments to be made of geometrical skeletal parameters with comparisons against normative references for adults and children in order to draw therapeutic conclusions. It includes modules for the hip, knee, spine, leg, hand, wrist, elbow, shoulder, foot, ankle and fractures (trauma planning). Users can access a library of manufacturers electronic templates intended to assist in the selection and positioning of implants and the marking of tissues prior to surgery.
The new device is nearly identical to the Agfa predicate (OT-3000). It includes tools for performing common hip, knee and spine measurements, and provides access to orthopedic device manufacturers electronic templates. The measurements and tools enable planning of orthopedic procedures, monitoring patient progress and patient communications.
The orthopedic application is compatible with multiple workstations and Impax® software versions. User may purchase a complete set of tools or individual modules depending on their needs.
The basic principles of operation of the new and predicate devices are the same.
This 510(k) summary (K071972) indicates that the "Agfa Orthopedic Software for Impax Workstations" is nearly identical to a previously cleared device (OT-3000, K050751) with the addition of a spine-planning module, which is present in another predicate device (Cedara Software Corporation's I-SoftView Orthopedic Tools Set, K022881). The submission does not contain detailed acceptance criteria or a dedicated study report that explicitly proves the device meets specific performance metrics in a quantitative way. Instead, the focus is on demonstrating substantial equivalence based on technological characteristics and intended use.
However, based on the provided text, we can infer the acceptance criteria and the "study" that supports it:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Functional Equivalence: The new device should perform common orthopedic measurements and provide access to electronic templates similar to the predicate devices. | The device "includes tools for performing common hip, knee and spine measurements, and provides access to orthopedic device manufacturers electronic templates." The basic principles of operation are the same as predicate devices. The new spine module is functionally equivalent to the spine module in the Cedara predicate. |
| Compatibility: The revised orthopedic application should be compatible with Agfa's Impax® PACS Systems. | Agfa's Impax® PACS Systems "have been tested for compatibility with the revised orthopedic application." |
| Accuracy of New Spine Measurements: The new spinal measurements should operate correctly and accurately on medical images. | "Correct operation of the new spinal measurements has been confirmed with medical images in laboratory testing." |
| No Modification of Intended Diagnostic Effect: The change (addition of spine module) should not alter the intended diagnostic effect (assisting surgical planning, monitoring patient progress, communication). | "This change in indication does not modify the intended diagnostic effect." |
2. Sample Size Used for the Test Set and Data Provenance:
The document mentions "medical images" were used for testing the new spinal measurements, but does not specify the sample size (number of images or cases) or the data provenance (e.g., country of origin, retrospective or prospective nature) for this testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
The document mentions "medical images" and "laboratory testing" for confirming the correct operation of spinal measurements, but does not specify the number of experts involved or their qualifications (e.g., "radiologist with 10 years of experience") for establishing ground truth for any test set.
4. Adjudication Method for the Test Set:
The document provides no information about an adjudication method (e.g., 2+1, 3+1, none) for any test set. The confirmation of correct operation appears to be based on internal "laboratory testing."
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:
No, the document does not indicate that an MRMC comparative effectiveness study was done. The focus is on demonstrating substantial equivalence to predicate devices, not on quantifying improvement in human reader performance with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done:
The testing mentioned for the new spinal measurements ("Correct operation...has been confirmed with medical images in laboratory testing") likely refers to a standalone assessment of the algorithm's functionality. However, the document does not explicitly state it as a "standalone" study in the context of comparing it to human performance. The device itself is a software application intended to be used by physicians, so its performance is inherently human-in-the-loop.
7. The Type of Ground Truth Used:
The document refers to the "correct operation" of spinal measurements being confirmed. This implies that some form of expert knowledge or established anatomical/mathematical correctness was used as the ground truth against which the software's measurements were compared. However, the specific method of establishing this ground truth (e.g., expert consensus, pathology, other validated measurements) is not detailed. It's likely that clinicians or technical experts verified the accuracy of the software's calculated measurements against expected values or manual measurements on the "medical images."
8. The Sample Size for the Training Set:
The submission does not mention a training set or its sample size. This is common for software that is largely a re-implementation or slight modification of existing functional tools, rather than a novel algorithm requiring extensive machine learning training data. The device's operation is based on identifying physiological landmarks and calculating measurements, which implies programmed rules rather than a learned model from a large training dataset.
9. How the Ground Truth for the Training Set was Established:
Since a training set is not mentioned, the method for establishing its ground truth is not applicable.
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Agfa Corporation
Premarket Notification: Orthopedic Software For Impax® Workstations
L. Exhibit: 510(K) Summary
JUL 3 0 2007
.
:
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510(k) Summarv
Agfa Orthopedic Tools
Common/Classification Name: Picture Archiving and communications system (PACS), 21 CFR 892.2050 Proprietary Name: Agfa Orthopedic Software for Impax Workstations
Agfa HealthCare Corporation 10 South Academy Street Greenville, SC 29602-9048
Contact: Tom Holbrook, Prepared: June 29, 2007 Telephone: (519) 746-6210 ext. 3297 Facsimile: (519) 746-3745
A. LEGALLY MARKETED PREDICATE DEVICES
This is a 510(k) for Agfa's Orthopedic Software for Impax Workstations. The predicate devices are Agfa's previous orthopedic workstation, the OT-3000 (K050751) and Cedara Software Corporation's I-SoftView Orthopedic Tools Set (K022881). The new device is nearly identical to Agfa's previous version, except for the addition of a spine-planning module. The Cedara predicate includes a spine module.
B. DEVICE DESCRIPTION
The new device is nearly identical to the Agfa predicate (OT-3000). It includes tools for performing common hip, knee and spine measurements, and provides access to orthopedic device manufacturers electronic templates. The measurements and tools enable planning of orthopedic procedures, monitoring patient progress and patient communications.
The orthopedic application is compatible with multiple workstations and Impax® software versions. User may purchase a complete set of tools or individual modules depending on their needs.
The basic principles of operation of the new and predicate devices are the same.
C. INTENDED USE
Workstations are intended for use in the acquisition, display, digital processing, review, transfer, storage, archiving and printing of medical images and patient demographic information. They allow the user to adjust image densities (window/level), perform basic length and angle measurements and highlight regions of interest. They have the ability to use 2D, 3D and time series (cine) images and data. They are intended for
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use by physicians to aid in diagnosis, and by medical professionals whenever thev require or desire access to medical images and patient demographic information.
The software application allows orthopedic surgeons and specialists to assess images, plan surgical procedures, monitor patient progress and educate patients in a digital environment.
It allows assessments to be made of geometrical skeletal parameters with comparisons against normative references for adults and children in order to draw therapeutic conclusions. It includes modules for the hip, knee, spine, leg, hand, wrist, elbow, shoulder, foot, ankle and fractures (trauma planning). Users can access a library of manufacturers electronic templates intended to assist in the selection and positioning of implants and the marking of tissues prior to surgery.
SUBSTANTIAL EQUIVALENCE SUMMARY D.
Agfa's Orthopedic Software for Impax Workstations have the same indications for use as the legally marketed predicate devices. It is nearly identical to the Agfa predicate (the OT-3000, K050751) except for the new spine module, which is included in the Cedara predicate (K022881).
This change in indication does not modify the intended diagnostic effect: To assist in surgical planning; monitor patient progress and communicate with the patient.
The new device has the same control methods and operating principles as the predicates. Descriptive characteristics and data provided in this submission are sufficiently precise to assure substantial equivalence.
TECHNOLOGICAL CHARACTERISTICS ய்
The technological characteristics are the same in the proposed and predicate devices. Users identify physiological landmarks on medical images. The software calculates commonly used measurements based on those landmarks. The software also allows the user to overlay electronic templates of orthopedic implants provided by implantable device manufacturers.
F. TESTING
Aqfa's Impax® PACS Systems have been tested for compatibility with the revised orthopedic application.
Correct operation of the new spinal measurements has been confirmed with medical images in laboratory testing.
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G. CONCLUSIONS
This 510(k) has demonstrated Substantial Equivalence as defined and understood in the Federal Food Drug and Cosmetic Act and various guidance documents issued by the Center for Devices and Radiological Health.
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Image /page/4/Picture/0 description: The image shows a logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "U.S. DEPARTMENT OF HEALTH & HUMAN SERVICES" written around it. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or movement.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
Agfa Healthcare Corporation % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313
30 2007
Re: K071972
Trade/Device Name: Agfa Orthopedic Software for Impax® Workstations Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications systems Regulatory Class: II Product Code: LLZ Dated: July 16, 2007 Received: July 17, 2007
Dear Mr. Job:
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 (Premarket Approval), 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, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Image /page/4/Picture/10 description: The image is a black and white circular logo. The logo has the text "1906-2006" at the top, and the text "Centennial" at the bottom. In the center of the logo are the letters "FDA" in a stylized font. There are three stars below the word "Centennial".
wint and Premoting Public
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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 Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
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 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/cdrl/industry/support/index.html.
Sincerely yours,
Nancy C. Hogdon
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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Indications for Use
510(k) Number (if Known):
Device Name: Agfa Orthopedic Software for Impax® Workstations
Indications for Use:
Agfa's Orthopedic Software is indicated for use with Impax® Workstations in the acquisition, display, digital processing, review, transfer, storage, archiving and printing of medical images and patient demographic information. It is intended for use by physicians to aid in diagnosis, and by medical professionals whenever they require or desire access to medical images and patient demographic information.
The software application allows orthopedic surgeons and specialists to assess images, plan surgical procedures, monitor patient progress and educate patients in a digital environment.
It allows assessments to be made of geometrical skeletal parameters with comparisons against normative references for adults and children in order to draw therapeutic conclusions. It includes modules for the hip, knee, spine, leg, hand, wrist, elbow, shoulder, foot, ankle and fractures (trauma planning). Users can access a library of manufacturers electronic templates intended to assist in the selection and positioning of implants and the marking of tissues prior to surgery.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Lora Mz Wh
(Division Sian-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
N-2
§ 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).