The Agfa IMPAX OT3000 Orthopedic Workstation is designed as an x-ray imaging system software option, which allows the planning of orthopedic surgeries on a workstation. Along with basic diagnostic display station functionality the software is intended to read in diagnostic images (c.g. digitized x-rays) for use with a database of orthopedic implant geometries and dimensions. This provides a constructed image of this data, to use in conjunction with the Agfa Impax OT3000 software to overlay the constructed images to aid surgeons in their planning of orthopedic surgeries.

The Agfa IMPAX OT3000 Orthopedic workstation is designed to help orthopedic surgeons and specialists access images, plan surgical procedures, educate patients and monitor patient progress in a digital environment.

As an add-on component to the IMPAX client, the OT3000 orthopedic application provides digital planning to images acquired through the PACS system. These images can be utilized to place digital templates that reflect actual prosthetic implants on patients' images helping the surgeon plan the surgical placement of the implant. These plans can be shown to patients to explain the procedure they will undergo and to help them understand the pathology present.

The application consists of the following components:

Hip Prosthetic Planning .
Knee Prosthetic Planning ●
Biometry Planning takes into account patient motion and metrics .
Coxometry tracking of known measurement values in pediatrics to determine surgical . intervention
Osteotomy determines optimum osteotomy locations .
Impax Diagnostic Workstation ●

Device Description

Concentrating within the specialty of joint replacement, the IMPAX® OT3000 will provide an orthopedic surgeon with the ability to produce presurgical plans and distribute those plans for intra operative guidelines. It will also support the proper workflow necessary to effectively compare pre and post operative radiograph studies for a unique understanding of the patient's surgical outcome. Integrating this workflow with the orthopedic surgeons existing workflow and combining it with the data produced from the patient physical exam, provides a comprehensive data set for the continued prescription of a patient's relevant treatment and therapy.

The proper choice of prosthesis implant, size and placement is critical to postoperative success and minimizing intra operative complications. Proper pre-surgical planning is key for identifying the correct choices and decisions an orthopedic surgeon makes.

AI/ML Overview

Here's an analysis of the provided text regarding the Agfa IMPAX® OT3000 Orthopedic Workstation, focusing on the acceptance criteria and study information:

Based on the provided 510(k) summary, there is no detailed information regarding specific acceptance criteria or an explicit study proving the device meets them. The document primarily focuses on establishing substantial equivalence to a predicate device.

Here's a breakdown of the requested information based on the text:

Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: Not explicitly stated in the document. The submission is based on substantial equivalence, implying that the device's performance aligns with that of the predicate device (Siemens' EndoMap).
- Reported Device Performance: Not explicitly enumerated in performance metrics. The document states that the "Technological and functional characteristics of the Agfa's IMPAX® OT3000 software are identical to those of the predicate devices."
Sample Size Used for the Test Set and Data Provenance:
- This information is not provided in the document. No specific test set or study data is mentioned.
Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- This information is not provided in the document. No information on ground truth establishment for a test set is present.
Adjudication Method for the Test Set:
- This information is not provided in the document. No test set or related adjudication method is mentioned.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No MRMC study is mentioned or referenced. The document does not discuss human reader performance with or without AI assistance.
Standalone (Algorithm Only) Performance Study:
- No standalone performance study for the algorithm is described. The focus is on the software's functionality and its substantial equivalence to a predicate device, not on specific performance metrics of the algorithm itself.
Type of Ground Truth Used:
- This information is not provided. As no specific study or test set is detailed, the type of ground truth used is not mentioned.
Sample Size for the Training Set:
- This information is not provided. There is no mention of a training set or its size.
How Ground Truth for the Training Set Was Established:
- This information is not provided. As no training set is mentioned, the method for establishing its ground truth is also absent.

Summary of what the document does provide:

Intended Use: The workstation is designed for orthopedic surgical planning, accessing images, educating patients, and monitoring progress. It allows for placing digital templates of orthopedic implants on patient images to aid in surgical planning.
Predicate Device: The Agfa IMPAX® OT3000 is deemed substantially equivalent to the Siemens' EndoMap (K014113).
Technological Identity: The document explicitly states, "Technological and functional characteristics of the Agfa's IMPAX® OT3000 software are identical to those of the predicate devices." This is the primary "proof" of its suitability for market, based on the 510(k) pathway for substantial equivalence.

Conclusion:

The provided 510(k) summary is typical for a substantial equivalence submission, where detailed performance studies with acceptance criteria, sample sizes, and ground truth establishment are often not included if the device is found to be sufficiently similar to an already cleared predicate device. The "proof" the device meets acceptance criteria essentially relies on its "identical" technological and functional characteristics to a legally marketed predicate. It does not contain the granular study details typically found for novel devices or those undergoing more rigorous performance testing.

Summary

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510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

Submitted by: Agfa Corporation 10 South Academy St. Greenville, SC 29602-9048

K040344
ruge/of

Date Prepared February 5, 2004

1. Contact Person Phil Cuscuna Phone: (519) 746-2900 FAX: (519) 746-3745 Email: pcuscuna@mitra.com

3. Device Name and Classification

Trade Name: Classification Name:

Classification Panel: CFR Section:

Device Class: Device Code:

IMPAX® OT3000 Orthopedic Workstation PACs system. Template for Clinical Use Radiology 21 CFR § 892.2050 21 CFR 888.4800 Class II LLZ and HWT

4. Intended Use

5. Substantial Equivalence

The IMPAX® OT3000 orthopedic component is substantially equivalent to the Siemens' EndoMap (FDA Clearance # K014113; Clearance Date: 06/14/2002).

The Diagnostic Workstation was previously submitted for FDA approval (K022292; Clearance Date: September 12, 2002) by Agfa Corporation and (K993532; Clearance Date: December 15, 1999) by Impax Technology. The workstation component is considered here in this submission for its

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The workstation component is considered here in this submission for its integration with the OT3000 orthopedic software.

K040344
Риге горс

6. Device Description

7. Comparison of Technological Differences:

Technological and functional characteristics of the Agfa's IMPAX® OT3000 software are identical to those of the predicate devices.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three curved lines representing its wings. The eagle faces to the left. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 2 2004

Agfa Corporation % Mr. Phil Cuscuna Official Correspondent Agfa HealthCare 455 Philip Street Waterloo, Ontario, N2L 3X2 CANADA

Re: K040344

Trade/Device Name: IMPAX® OT3000 Orthopedic Workstation Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulation Number: 21 CFR 888.4800 Regulation Name: Template for clinical use Regulatory Class: II Product Code: 90 LLZ and 87 HWT Dated: February 3, 2004 Received: February 12, 2004

Dear Mr. Cuscuna:

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, 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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Page 2

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. Brydon

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: IMPAX® OT3000 Orthopedic Workstation

Indications For Use:

The application consists of the following components:

Hip Prosthetic Planning .
Knee Prosthetic Planning ●
Biometry Planning takes into account patient motion and metrics .
Coxometry tracking of known measurement values in pediatrics to determine surgical . intervention
Osteotomy determines optimum osteotomy locations .
Impax Diagnostic Workstation ●

Prescription Use
(Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use

(21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy C Broadon

(Division Sign Division of Reproductiv and Radiological D 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).