The PracticeWorks TROPHYPAN/TROPHYPAN C System with the Orthoimaging/OMS Imaging System accessory is an extraoral source dental panoramic and optional cephalometric X-ray system intended to produce dental radiographic X-ray images of the dento-maxillo-facial area and store these images along with relevant patient examination information for use by dentists.

By using the TROPHYPAN/TROPHYPAN C System with the Orthoimaging/OMS Imaging System accessory, the dentist can acquire radiographic images of the dentomaxillofacial region, visualize anatomical structures through the use of a computer display and store the information electronically in a clinical software program that enables dental offices to keep records of hard and softcopy charts, treatment plans, clinical notes, and clinical exam data.

Device Description

The TROPHYPAN/TROPHYPAN C System is a panoramic extra-oral dental x-ray system, already marketed in the United States. Orthoimaging and OMS Imaging software consist of patient management software for dental, orthodontic, and oral surgery practices. By using the TROPHYPAN/TROPHYPAN C System with the Orthoimaging/OMS Imaging System accessory, the dentist can acquire radiographic images of the dentomaxillofacial region, visualize anatomical structures through the use of a computer display and store the information electronically in a clinical software program that enables dental offices to keep records of hard and softcopy charts, treatment plans, clinical notes, and clinical exam data.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the device K040556:

Executive Summary:

The provided 510(k) summary for the TROPHYPAN/TROPHYPAN C System with the Orthoimaging/OMS Imaging System accessory (K040556) does not contain information about specific performance acceptance criteria or a dedicated study demonstrating that the device meets such criteria.

Instead, the submission hinges on substantial equivalence to a previously cleared device. The "study" mentioned is the assertion that "The modifications to the TROPHYPAN/TROPHYPAN C do not affect the materials, intended use, operating principles, or manufacture of the system as previously cleared." The core modification is the addition of software for image archiving and management, not a change to the fundamental image acquisition capabilities. Therefore, specific performance metrics and their acceptance are implicitly covered by the predicate device's clearance.

Here's a breakdown based on your requested information, acknowledging the limitations of the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

No explicit acceptance criteria or reported device performance metrics are provided in the document. The submission relies on substantial equivalence to a predicate device.

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

No specific test set or sample size is mentioned for this 510(k) submission. The core assertion is that the modifications to the already cleared TROPHYPAN/TROPHYPAN C system (the addition of image archiving and management software) do not alter the performance of the image acquisition.
Data Provenance: Not applicable, as no new clinical or performance data is presented to support the modification.

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

Not applicable. No new ground truth establishment was described, as the submission relies on substantial equivalence for the core device functionality.

4. Adjudication Method for the Test Set

Not applicable. No test set or expert adjudication process is described in relation to the modifications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done (or at least not described in this submission). The device is an X-ray system with archiving software; the regulatory pathway chosen (substantial equivalence for a modification) generally does not require such studies unless the modification significantly impacts diagnostic accuracy or decision-making.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. The device is an imaging system and associated software, not primarily an "algorithm only" product in the sense of AI diagnostics without human involvement for which standalone performance would be a primary metric. Its function is to acquire and store images for human interpretation.

7. The Type of Ground Truth Used

Not explicitly described for this submission's modifications. For the underlying TROPHYPAN/TROPHYPAN C system, the ground truth would inherently be clinical diagnostic standards and pathologies confirmed through various means in dental practice. However, this submission focuses on the software's ability to archive and manage images, rather than its diagnostic performance.

8. The Sample Size for the Training Set

Not applicable. This submission describes a medical device, specifically an X-ray imaging system with accessory software for image management. It is not an AI/ML algorithm that would typically have a "training set" in the modern sense.

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

Not applicable. As above, there is no "training set" described for this type of device and submission.

Summary

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I KUPHYPAN/TROPHYPAN C System with the Orthoimaging/OMS Imaging System accessory

510(k) Summary
K040556

1. Company Identification

Eastman Kodak Company Health Imaging Group 343 State Street Rochester, NY 14650 Establishment Registration: 1317267

Practiceworks, Inc., an Eastman Kodak company 1765 The Exchange Atlanta, GA 30339 Establishment Registration: 1226003

2. Contact Person

Donald Ellis Director, Regulatory Affairs and Quality Systems

3. Device Name

TROPHYPAN/TROPHYPAN C System with the Orthoimaging/OMS Imaging System accessory

4. Device Classification

Class II Product Code: EHD

5. Intended Use

6. Device Description

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hard and softcopy charts, treatment plans, clinical notes, and clinical exam data.

7. Substantial Equivalence

The modifications to the TROPHYPAN/TROPHYPAN C do not affect the materials, intended use, operating principles, or manufacture of the system as previously cleared. The indications for use and labeling have been modified but are substantially equivalent to the original device. The modification to the TrophyPand C consists of the addition of Orthoimaging/OMS Imaging software accessory for image archiving and management.

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Image /page/2/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 department's name around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR - 7 2004

Mr. Donald Ellis Director, Regulatory Affairs & Quality Systems Eastman Kodak Company 343 State Street ROCHESTER NY 14650

Re: K040556

Trade/Device Name: TrophyPan C with Orthoimaging/OMSimaging Accessory Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: 90 EHD

Dated: March 1, 2004 Received: March 17, 2004

Dear Mr. Ellis:

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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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):

The PRACTICEWORKS, TROPHYPAN/TROPHYPAN C System with the Orthoimaging System accessory is an extraoral source dental panoramic and optional cephalometric X-ray system intended to produce dental radiographic X-ray images of the dento-maxillo-facial area and store these images along with relevant patient examination information for use by dentists.

2040586

By using the TROPHYPAN/TROPHYPAN C System with the Orthoimaging System accessory, the dentist can acquire radiographic images of the dentomaxillofacial region, visualize anatomical structures through the use of a computer display and store the information electronically in a clinical software program that enables dental offices to keep records of hard and softcopy charts, treatment plans, clinical notes, and clinical exam data

Concurrence of CDRH, Office of Device Evaluation

Prescription Use_ (Per 21 CFR 801.109)

Over-The-Counter

Nancy Chogdon
(Division Sign-Off)

Division of Reproducti vé, Abdor and Radiological Devices 510(k) Number

Regulation Number and Section

§ 872.1800 Extraoral source x-ray system.

(a)
Identification. An extraoral source x-ray system is an AC-powered device that produces x-rays and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The x-ray source (a tube) is located outside the mouth. This generic type of device may include patient and equipment supports and component parts.(b)
Classification. Class II.