When used for diagnostic purposes, the patient population will be the general public, and the diseases/conditions that the device will be used to diagnose are; dental caries, periodontal disease and bone loss, tooth fractures, jaw misalignment, and other diseases and conditions that are encountered by general practitioners and specialists in the dental care field.

Device Description

The KODAK DIGITAL SCIENCE™ Dental Image Viewer is a software package designed to provide full resolution digitized images of a dental x-ray film for diagnostic review, insurance adjudication and patient consultation. The KODAK DIGITAL SCIENCE™ Dental Image Viewer is designed to operate on a standard PC-compatible computer.

KODAK DIGITAL SCIENCE™ Dental Image Viewer features the display of full-mouth sets and other mounts, high-resolution image display and manipulation, and interfaces with practice management systems.

AI/ML Overview

The provided text is a 510(k) summary for the KODAK DIGITAL SCIENCE™ Dental Image Viewer. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain any information about acceptance criteria, device performance studies, or clinical validations.

Therefore, I cannot provide the requested information regarding:

A table of acceptance criteria and the reported device performance: This information is not present in the document. The submission focuses on substantial equivalence based on functional and technical specifications, not performance against specific acceptance criteria.
Sample size used for the test set and the data provenance: No test set is described.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth establishment for a test set is mentioned.
Adjudication method for the test set: No test set or adjudication is mentioned.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: No MRMC study is described. The device is an image viewer and manipulation tool, not primarily an AI-assisted diagnostic tool in the modern sense.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No standalone performance study is mentioned.
The type of ground truth used: No specific ground truth is mentioned in relation to performance studies.
The sample size for the training set: No training set is mentioned as this device predates widespread machine learning applications in medical imaging.
How the ground truth for the training set was established: Not applicable, as no training set is mentioned.

The document primarily focuses on demonstrating substantial equivalence to a predicate device (TAU Corporation TigerScan/TigerView) by comparing technical and functional specifications. It does not include data from performance studies or clinical trials that would typically establish acceptance criteria and verify device performance against them.

Summary

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NOV 1 1 1) 1697

. )

510(k) SUMMARY OF SAFETY AND EFFECTIVE NESS

I. Date Prepared:

September 12, 1997

ll. Submitter:

Eastman Kodak Company Health Imaging Division Dental Business unit 343 State Street Rochester, New York 14650

III. Contact Person:

Judith A. Wallace Regulatory Affairs (716) 724-2314

IV. Device Name:

Kodak Digital Science Dental Image Viewer Trade Name

Dental x-ray image enhancement system Common Name

V. Device Classification:

FDA has classified the predicate device as Regulatory Class II under CFR 892.1750

VI. Predicate Device:

TAU Corporation TigerScan/TigerView -- 510(k) No. K955237

VII. Description of Device:

KODAK DIGITAL SCIENCE™ Dental Image Viewer features the display of full-mouth sets and other mounts, high-resolution image display and manipulation, and interfaces with practice management systems.

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VIII. Indications for Use:

Intended uses in the dental industry include the following:

Radiograph viewing and manipulation for insurance claims adjudication. .
Radiograph viewing and manipulation for diagnostic purposes ●
Radiograph viewing for patient education and consultation. .

IX. Substantial Equivalence:

The purpose and functionality of the KODAK DIGITAL SCIENCE™ Dental Image Viewer is substantially similar to the TAU Corporation TigerView system (K955237), as well as numerous other x-ray viewers currently on the market. The basis for the equivalence is that both systems consist of software which will enhance images for diagnosis. The following table summarizes the two products functional equivalence

Description	Kodak Dental ImageViewer	TAU TigerView
Host Platform:	Pentium Processor basedPersonal Computer	IBM - CompatibleComputer
Operating System:	Windows 95	Windows 3.1. Windows forWorkgroups 3.11 orWindow 95
Host RAM:	32 MB	16 MB
Host Magnetic Storage:	10 MB	at least 400 MB
Host Floppy Drives:	3.5 inches	3.5 inches
Host Processor Speed:	Any Pentium speed	486 66Mhz or better CPU
Host Monitor Size:	15" diagonal minimum
Display resolution	800 X 600 at 24 bit colorminimum	800 X 600
Open Case Preview:	No	Yes
User Display Preferences:	Yes	No
Receive Images from otherSystems:	Yes	Yes

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Description	Kodak Dental ImageViewer	TAU TigerView
Patient List TransmissionStatus:	No	Receiving status isdisplayed.
Image Manipulation:	Rotate, Zoom, Flip,Contrast, Brightness	Rotate, Zoom, Flip,Contrast, Brightness,Negative Image
Monitor Calibration:	Yes

KODAK DIGITAL SCIENCE - Dental Image Viewer 510(k) Submission

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 100 1997

Judith A. Wallace Regulatory Affairs Associate Eastman Kodak Company Health Imaging Division, Dental Business 343 State Street Rochester, NY 14650-1122

Re: K973476

Kodak Digital Science - Dental Image Viewer Dated: September 12, 1997 Received: September 15, 1997 Regulatory class: II 21 CFR 872.1800/Procode: 90 EHD

Dear Ms. Wallace:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, 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 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for question 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours.

hJliau Yu
Lillian Yin, Ph.D.

Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(K) Number (if known):

Device Name: KODAK DIGITAL SCIENCE - Dental Image Viewer Indication of use: Viewing of dental radiographic film

Concurrence of CDRH, Office of Device Evaluation

Prescription Use (Per 21 CFR 801.109)	✓
	OR
Over-The-Counter	____

KODAK DIGITAL SCIENCE - Dental Image Viewer
510(k) Submission

(Division Sign-Off)
	9/12/97
Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number	K973476

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.