The OPTEO digital system is used to provide instant digital images of human oral tissue and teeth without the use of a conventional x-ray film. It is used for diagnosis purpose, by dental practitioners. This is achieved by using the conventional xray tube, and placing an electronic sensor in the patient's mouth instead of conventional film. The sensor, upon radiation exposure, automatically captures the images into a computer. The computer, which is not provided by OWNDY, controls all aspects of image acquisition and image display, storage and printing. Additional software (after, and not part of, image capture software) is available on the market. They allow for enhancements such as zoom, contrasts controls, image inversion, and pseudo color renditions.

The Opteo digital system is designed to collect instant images of human oral tissue and teeth without the use of a conventional x-ray film. It is used with a conventional x-ray tube and a computer for dental radiographic imaging. The Opted is covered with a single use disposable sheath and positioned in the oral cavity opposite the tooth the dentist wishes to x-ray tube (which is not part of Opted) is pointed at the sensor and activated. The emitted radiation from the x-ray tube is detected by the sensor and transmitted as a data stream to the computer system that the device is connected to.

Device Description

Intraoral detector for capturing x-ray images from an extraoral source generator. Captured images are automatically transmitted in digital form via USB connection for display, storage, and printing on the practitioner's computer using imaging software. The device is a modified version of the predicate and is similar in terms of basic component materials, overall design, and labeling ... Both the original predicate and the 510(k) device are covered with a single-use disposable hygienic sheath and positioned in the patient's mouth for radiographic examination of areas of the oral region. An external x-ray generator emits radiation that is partially absorbed by bone areas and soft tissue. Unabsorbed x-rays strike a scintillator in the device which converts the x-ray energy beam into light. An optical fiber filters this stream of photons. The light then hits an electron light sensor (CMOS) that in turn reemits it in the form of an electrical pulse. The resulting pixel matrix is sent to a connected computer and saved as a gray-scale image. Imaging software on the PC processes the image and enables nearly instant viewing and storage of the x-ray image ... The only significant modification to the original Visteo was integration of control box electronics with sensor board electronics in order to eliminate the control box, as more fully discussed in Section 12.

AI/ML Overview

The provided 510(k) summary for the Owandy Opteo Intraoral Digital X-Ray Sensor (K133271) does not include information about acceptance criteria, a study proving the device meets those criteria, or details regarding AI/algorithm performance.

The document primarily focuses on demonstrating substantial equivalence to a predicate device (Visteo, K093105) based on:

Similar intended use.
Similar fundamental scientific technology.
Technological features comparison.
Risk analysis of modifications.
Electromagnetic compatibility (EMC) and electrical safety tests (IEC 60601-1 and 60601-1-2).

Therefore, I cannot provide the requested information about acceptance criteria, device performance tables, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or AI-related study details based solely on the provided text.

The document states:

"A comparison of the subject and predicate, which shows the devices have the same performance characteristics and equivalent safety and efficacy profiles, is provided in Section 12." However, Section 12 is not included in the provided text.
"EMC and Electrical Safety Testing: IEC 60601-1 and 6-0601-1-2 testing was performed to demonstrate continued conformance with recognized standards." These are safety and performance standards for medical electrical equipment, but they do not typically define clinical performance acceptance criteria in the way requested (e.g., sensitivity, specificity for a diagnostic task).

To answer your request thoroughly, I would need access to "Section 12" and potentially other parts of the original 510(k) submission that describe the performance characteristics and comparative studies in detail.

Summary

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APR 2 8 2014 1633271

510(k) Summary

510(k) Owner:	OwandyLe Coruscant, 2 rue des Vieilles Vignes77183 Croissy-BeaubourgFrance
Contact Person:	Olivier MaurierPhone: 0033-164-111818
Date Prepared:	October 21, 2013
Consultant:	Denterprise International, Inc.110 E. Granada Blvd., Suite 207Ormond Beach, FL 32176386-672-0450 (Voice)386-672-4402 (Fax)
Primary Contact:	Claude Berthoin, President (claude@510kfda.com)
Secondary Contact:	John Gillespy, VP Regulatory Affairs (john@510kfda)Holly Layne, Assistant (holly@510kfda)
Trade Name:	Opteo
Device Models:	Opteo T1, Opteo T2, Videograph HD #1, Videograph HD #2(Videograph HD is an OEM version of Opteo)
Common Name:	Intraoral Digital X-Ray Sensor
Classification Name:	Extraoral Source X-Ray System (Component); 21 CFR 872.1800;Product Code MUH
Predicate Device:	Visteo (Owandy)K093105
Device Description:	Intraoral detector for capturing x-ray images from an extraoral sourcegenerator. Captured images are automatically transmitted in digitalform via USB connection for display, storage, and printing on thepractitioner's computer using imaging software.

Indications For Use: The OPTEO digital system is used to provide instant digital images of human oral tissue and teeth without the use of a conventional x-ray film. It is used for diagnosis purpose, by dental practitioners. This is achieved by using the conventional xray tube, and placing an electronic sensor in the patient's mouth instead of conventional film. The sensor, upon radiation exposure, automatically captures the images into a computer. The computer, which is not provided by OWNDY, controls all aspects of

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image acquisition and image display, storage and printing. Additional software (after, and not part of, image capture software) is available on the market. They allow for enhancements such as zoom, contrasts controls, image inversion, and pseudo color renditions.

The main advantages of this digital imaging system are:

high definition ensuring high-value diagnostics
interface allowing image processing in the PC

In no case, it has to be used directly by the patient. So, it is used exclusively in a healthcare specific environment.

Technological Characteristics: The device is a modified version of the predicate and is similar in terms of basic component materials, overall design, and labeling ... Both the original predicate and the 510(k) device are covered with a single-use disposable hygienic sheath and positioned in the patient's mouth for radiographic examination of areas of the oral region. An external x-ray generator emits radiation that is partially absorbed by bone areas and soft tissue. Unabsorbed x-rays strike a scintillator in the device which converts the x-ray energy beam into light. An optical fiber filters this stream of photons. The light then hits an electron light sensor (CMOS) that in turn reemits it in the form of an electrical pulse. The resulting pixel matrix is sent to a connected computer and saved as a gray-scale image. Imaging software on the PC processes the image and enables nearly instant viewing and storage of the x-ray image ... A comparison of the subject and predicate, which shows the devices have the same performance characteristics and equivalent safety and efficacy profiles, is provided in Section 12. -
Device Modifications ... The only significant modification to the original Visteo was integration of control box electronics with sensor board electronics in order to eliminate the control box, as more fully discussed in Section 12. A risk analysis and electrical and EMC testing were performed on the device, as discussed below.
Safety Assessment: Device material safety and design have been established in 510(k) submission K093105 (Visteo). Biocompatibility testing is not warranted since both the subject and predicate devices are covered with disposable sheaths during use.
Risk Analysis: A risk analysis assessment of the impact of modifications on the device and its components was performed in conformance with ISO 14971:2009. Results of that analysis determined the residual risks inherent in the use of the Opteo are "acceptable."
EMC and Electrical Safety Testing: IEC 60601-1 and 6-0601-1-2 testing was performed to demonstrate continued conformance with recognized standards.

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Conclusions: Both intended use and fundamental scientific technology are the same in both the subject and predicate devices. A comparison of technological features, a risk analysis of modifications, and electromagnetic compatibility and electrical safety tests support the conclusions that the subject Opteo is safe for its intended use and is substantially equivalent to the predicate Visteo. ·

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird with three stylized lines representing its wings.

Public I fealth Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 28, 2014

OWANDY % Mr. Claude Berthoin President Denterprise International, Inc. 110 East Granada Blvd., Suite 207 ORMOND BEACH FL 32176

Re: K133271

Trade/Device Name: Opteo. Videograph HD Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: MUH Dated: March31, 2014 Received: April 3. 2014

Dear Mr. Berthoin:

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 r ou may, merely provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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 that I Dr. has mas and regulations administered by other Federal agencies. You must or any I ederal States and strequirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803): good manufacturing practice requirements as set ocentlated adverse erems) (2) Office on (2) 3) Street 820): and if applicable. the electronic form in the quality of the provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2-Mr. Berthoin

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803). please go to

http://www.fda.gov/Medicall.cevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

for

Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.

510(k) Number (if known) K133271

Device Name Opteo Intraoral X-Ray Sensor

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 807 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signalure)

Sm(n,p)

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This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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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.