The Veraviewepocs Panoramic/Cephalometric X-ray Unit With Digital Image Function is an extraoral source X-ray unit that is used for dental radiographic examination and diagnosis of teeth, jaw, and oral structure by exposing an X-ray image receptor to ionizing radiation, with an optional cephalometric capability, and a digital imaging capability for taking both panoramic and cephalometric images.

Device Description

AI/ML Overview

The provided text describes the 510(k) summary for the "J. Morita Manufacturing Corporation's Veraviewepocs Panoramic/Cephalometric X-ray Unit With Digital Image Function". However, this document does not contain specific acceptance criteria, performance data, or details of a study that directly proves the device meets acceptance criteria.

Instead, the document focuses on:

Substantial Equivalence: It claims substantial equivalence to previously cleared predicate devices based on intended use, principle of operation, and technological characteristics.
Compliance with Standards: It states that the device was tested and complied with UL2601-1 and IEC 60601-1, and will comply with 21 C.F.R. Subchapter J and successfully passed image quality testing.
Software Validation: It mentions a software validation report describing development processes, requirements, hazard analysis, and certification of adherence to procedures.
Biocompatibility: It addresses the use of biocompatible materials.

This 510(k) summary is a regulatory submission demonstrating substantial equivalence, not a detailed study report for meeting specific performance acceptance criteria. Therefore, most of the requested information cannot be extracted directly from the provided text.

Here is what can be inferred or stated based on the document:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria: The document implies acceptance criteria are related to compliance with safety standards (UL2601-1, IEC 60601-1, 21 C.F.R. Subchapter J), successful software validation, and image quality testing. However, specific quantitative acceptance criteria (e.g., minimum resolution, SNR, DQE values, tolerance for geometric distortion) are not provided.
Reported Device Performance: The document states the device "complied with the applicable requirements" for safety standards and "passed the image quality testing." No specific performance metrics or values are reported.

Acceptance Criteria	Reported Device Performance
Compliance with UL2601-1 and IEC 60601-1 (electrical, thermal, mechanical safety)	Device "complied with the applicable requirements."
Compliance with 21 C.F.R. Subchapter J (radiation control provisions)	Device "will comply with the applicable requirements... prior to marketing."
Software Validation	Software "successfully validated by Morita."
Image Quality	Device "passed the image quality testing."
Biocompatibility	Uses "biocompatible metals and plastics" widely used in medical applications.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Not provided. The document states "The modified Veraviewepocs was tested" and "passed the image quality testing," but gives no details about the sample size (e.g., number of images, number of patients, number of components tested) or the provenance of any data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Not provided. The document does not mention the use of experts for establishing ground truth, as it is primarily focused on technical compliance and substantial equivalence rather than diagnostic performance evaluation by experts.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not provided. This information is typically relevant for studies involving human interpretation and consensus, which is not described here.

5. 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, an MRMC comparative effectiveness study was not done or reported. This device is an X-ray unit, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Irrelevant/Not applicable. This device is an imaging hardware unit, not a standalone algorithm. The software mentioned is for controlling the device and processing the images, not for automated diagnostic interpretation.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not provided/Implicit through compliance standards. For "image quality testing," the ground truth would likely be defined by objective metrics and technical specifications (e.g., MTF, spatial resolution, contrast-to-noise ratio measured against phantoms or reference images) rather than medical interpretations like expert consensus or pathology. No details are given.

8. The sample size for the training set

Not applicable. This device is a hardware X-ray unit with associated operational software, not a machine learning model that requires a "training set" in the conventional sense. The "software validation" refers to verifying that the software meets its specified requirements and functions correctly, not to training an AI model.

9. How the ground truth for the training set was established

Not applicable. See point 8.

Summary

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MAY 2 9 2003

K030699

510(k) SUMMARY

J. Morita Manufacturing Corporation's Veraviewepocs Panoramic/Cephalometric X-ray Unit With Digital Image Function

Name of Device and Name/Address of Sponsor

	Trade or Proprietary Name: Veraviewepocs Panoramic/Cephalometric X-ray UnitWith Digital Image Function
Common Name:	Extraoral Source X-ray with Cephalometric Capability
Classification Name:	Extraoral Source X-ray System and Cephalometer
Product Code :	EHD (Extraoral Source X-ray System)EAG (Cephalometer)MUH (Extraoral Source Digital X-ray System)

J. Morita Mfg. Corp. 680 Higashihama Minami-cho, Fushimi-ku, Kyoto 612-8533, Japan

Contact Person: Hideaki Okuda, Senior Executive Director Date Prepared: February 28, 2003

Intended Use

Technological Characteristics and Substantial Equivalence

The Veraviewepocs Panoramic X-ray Unit is an FDA-cleared extraoral source X-ray unit that is used for dental radiographic examination and diagnosis of teeth, jaw, and oral structure by exposing an X-ray image receptor to ionizing radiation (K#013955). A cephalometric capability was added to this device in 2002 (K#021372). The device is now being modified to add a digital imaging capability.

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The modified Veraviewepocs is substantially equivalent, for purposes of the FDA's medical device regulations, to Instrumentarium Corporation Imaging Division's (i) Orthoceph OC100 extraoral x-ray unit for cephalometric radiography (K#930338 and K#973642) (ii) Orthopantomograph OP100 extraoral x-ray unit for cephalometric radiography (also cleared under K#973642), and (iii) Orthoceph OC100 D for digital panoramic and cephalometric radiography (K#001439). The modified Veraviewepocs has the same general intended use, similar principles of operation, and similar technological characteristics as the previously cleared predicate devices. Although there are minor difference in the characteristics of the modified Veraviewepocs and the predicate devices, these differences do not raise new questions of safety or efficacy.

The software used in the modified Veraviewepocs has been successfully validated by Morita. The software validation report describes the development process for the device's software/firmware: the software change control and code revision procedures; the system and software requirements; the software handling and storage procedures; a hazard analysis; and a software/firmware certification that the company followed the above-described procedures and policies.

The modified Veraviewepocs was tested to ensure compliance with UL2601-1 and IEC 60601-1, and it complied with the applicable requirements. The modified Veraviewepocs will be tested and will comply with the applicable requirements of 21 C.F.R. Subchapter J prior to marketing. The modified Veraviewepocs also passed the image quality testing.

The modified Veraviewepocs complies with the applicable thermal, mechanical, and electrical safety requirements of UL2601-1 and IEC 60601-1, and will comply with the applicable requirements of 21 C.F.R. Subchapter J prior to marketing.

The modified Veraviewepocs uses biocompatible metals and plastics on any body contacting surfaces, such as the temple stabilizers and covers, ear rods, chin rests, patient handles, and front/rear head stabilizers. The metals and plastics have been widely used in other medical applications in which the metal or plastic is in body contact, including oral contact.

40143822.doc

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Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular in shape, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. Inside the circle is a stylized image of an eagle, with its wings spread and its head facing to the left.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 9 2003

J. Morita Manufacturing Corporation % Mr. Keith A. Barritt Regulatory Attorney Fish & Richardson P.C. 1425 K Street, N.W., 11th Floor WASHINGTON DC 20005

Re: K030699 Trade/Device Name: Veraviewepocs Panoramic/ Cephalometric X-Ray Unit Regulation Number: 21 CFR 872.1830 Regulation Name: Cephalometer Regulatory Class: II Product Code: 90 EAG Dated: March 5, 2003 Received: March 6, 2003 .

Dear Mr. Barritt:

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 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. Brogdon

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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KD30699 510(k) Number (if known): Device Name: Veraviewepocs Panoramic/Cephalometric X-ray Unit With Digital Image Function Indications For Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use	✓
	OR
Over-The-Counter Use
(Per 21 CFR 801.109)

40143820.doc

David R. Byrom

(Division Sign-Off Division of Reproductive, A and Radiological Devic 510(k) Numbe

Regulation Number and Section

§ 872.1830 Cephalometer.

(a)
Identification. A cephalometer is a device used in dentistry during x-ray procedures. The device is intended to place and to hold a patient's head in a standard position during dental x-rays.(b)
Classification. Class II.