The VISTEO 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 x-ray 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 OWANDY, 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, 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.

Device Description

The VISTEO system consists of the following components: the sensor and its cable, a USB/data box, with sensor adapter. The sensor body is made hermitically sealed shell which encapsulates a black and white CMOS chip. The sensor attaches the USB/data box (processing unit) via a 1 meter removable cable.
The sensor, when exposed to radiation, captures image in the form of a charge pattern on its surface (CMOS). The resulting electronic signals are digitised and sent to a computer for image presentation.
According to the 2 different models, there are two possible sizes:
D001 model (size 1): the outer dimensions are approximately 1.5 x 1.0 x 0.3 inches (38,9 x 24,9 x 7,4mm) with rounded edges.
D002 model (size 2): the outer dimensions are approximately 1.7 x 1.2 x 0.3 inches (42.9 x 30.9 x 7,4mm) with rounded edges.
The USB/data box relays the data from to the computer for display. The data box is a 5.4 x 1.8 x 0.7 inches (13.8x 1.8 x 0.7 cm) box with an USB cable connection.
Positioner accessories : 2 bite blocks (bitewing and endo) + 1 aiming ring

AI/ML Overview

The provided 510(k) summary for the VISTEO device does not contain a specific study proving the device meets particular acceptance criteria in terms of diagnostic performance or accuracy. Instead, the submission focuses on substantial equivalence to a predicate device (UNIVERSAL-X, K053172) based on technological characteristics and intended use.

Here's an analysis of what is and isn't available in the document regarding acceptance criteria and performance:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not provide a table of acceptance criteria for diagnostic performance outcomes (e.g., sensitivity, specificity, image quality metrics) or any reported device performance against such criteria. The focus is on demonstrating that the VISTEO device functions similarly to its predicate in capturing digital dental X-ray images.

Acceptance Criteria	Reported Device Performance
Not specified for diagnostic performance or image quality.	Not reported as per a specific study with defined metrics.
(Implicit) Image Acquisition and Display Functionality	"The VISTEO digital system is used to provide instant digital images of human oral tissue and teeth..." and "...high definition ensuring high-value diagnostics." (These are descriptive statements, not quantified performance criteria.)

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

No specific test set or associated sample size for evaluating clinical performance (e.g., diagnostic accuracy) is mentioned. The submission describes the device's components and its function in capturing images but does not detail a study where these images were evaluated against a ground truth.

Sample Size (Test Set): Not specified.
Data Provenance: Not specified.

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

Since no test set for evaluating diagnostic performance is described, there's no mention of experts used to establish ground truth or their qualifications.

Number of Experts: Not applicable.
Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set:

Not applicable, as no test set for clinical performance evaluation is described.

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

No MRMC study is mentioned in the provided text. The submission focuses on substantial equivalence based on technological characteristics and intended use, not on comparative effectiveness for diagnostic tasks.

MRMC Study: No.
Effect Size (AI vs. without AI assistance): Not applicable.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

The VISTEO is a hardware device (sensor) that captures raw image data. It interfaces with a computer for display and storage. The document explicitly states: "Additional software (after, and not part of, image capture software) is available on the market. They allow for enhancements such as zoom, controls, image inversion, and pseudo color renditions." This indicates that the VISTEO itself is not an "algorithm" as typically referred to in AI/ML, but rather an imaging sensor. Therefore, a standalone algorithm performance study is not relevant to this device's description.

Standalone Study: Not applicable (device is a sensor, not an algorithm).

7. The Type of Ground Truth Used:

Not applicable, as no study evaluating diagnostic performance against a ground truth is described.

Type of Ground Truth: Not specified.

8. The Sample Size for the Training Set:

The device is an imaging sensor, not an AI/ML algorithm that requires a training set. Therefore, there is no mention of a training set or its sample size.

Sample Size (Training Set): Not applicable.

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

Not applicable, as the device does not involve a training set for an AI/ML algorithm.

Summary of 510(k) Approach for VISTEO:

The 510(k) submission for VISTEO is based on demonstrating substantial equivalence to an existing legally marketed predicate device (OWANDY UNIVERSAL-X, K053172). This approach typically relies on comparing the new device's technological characteristics and intended use to the predicate, rather than conducting new clinical performance studies with specific acceptance criteria and ground truth evaluations.

Technological Characteristics Comparison: The document highlights the change from CCD technology in the predicate to CMOS technology in VISTEO, but asserts that both are X-ray sensitive solid-state imaging arrays.
Intended Use Comparison: Both devices are stated to be for digital dental radiography, intended for diagnosis by dental practitioners.

The FDA's clearance (K093105) indicates that they agreed the VISTEO device is substantially equivalent to the predicate, implying that it is as safe and effective as the predicate without requiring new clinical performance data.

Summary

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VISTEO 510(k)

510(K) SUMMARY

Premarket Notification for VISTEO Device

K093105

Submitter OWANDY 6 Allee Kepler 77420 Champs sur Marne France Tel : +33 1 64 11 18 18 Fax : +33 1 64 11 18 10

Application correspondent

Jay Mansour 845 Aronson Lake Court Roswell GA 30075 Tel : 678-908-8180 Fax: 678-623-3765

Device name

Proprietary name: VISTEO Classification name : Extra oral source X-Ray System accessory Common name : Digital dental imaging device

Predicate devices

Manufacturer/Applicant = OWANDY UNIVERSAL-X : K053172

Device description

The sensor, when exposed to radiation, captures image in the form of a charge pattern on its surface (CMOS). The resulting electronic signals are digitised and sent to a computer for image presentation.

According to the 2 different models, there are two possible sizes:

D001 model (size 1): the outer dimensions are approximately 1.5 x 1.0 x 0.3 inches (38,9 x 24,9 x 7,4mm) with rounded edges.

D002 model (size 2): the outer dimensions are approximately 1.7 x 1.2 x 0.3 inches (42.9 x 30.9 x 7,4mm) with rounded edges.

The USB/data box relays the data from to the computer for display. The data box is a 5.4 x 1.8 x 0.7 inches (13.8x 1.8 x 0.7 cm) box with an USB cable connection.

Positioner accessories : 2 bite blocks (bitewing and endo) + 1 aiming ring

OCT 1 8 2010

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OWANDY

VISTEO 510(k)

Intended use

This is achieved by using the conventional x-ray 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 OWANDY, 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, 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.

Substantial equivalence and technological characteristics

The VISTEO device is substantially equivalent to the UNIVERSAL-X predicate device , legally marketed in the United States (K053172) by OWANDY in 2006.

The VISTEO and the predicate devices are intended to be used with Dental X-ray source, Dental Image Management Application Software and standard computer hardware for the capture, evaluation and storage of high quality digital dental X-ray mages using existing X-ray equipments.

The system and its predicates all consists of a X-ray sensitive solid state imaging array (CCD technology for the predicate, CMOS technology for the VISTEO) installed in the Dental X-ray device in place of the traditional photographic film, connected via cable to digitizing and control electronics which, in turn, interface to a computer via a standard interface. The proposed and predicate devices are intended for patients receiving routine dental radiography, in a clinical environment by dental professionals.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

OWANDY % Mr. Jay Mansour, MSQA, BE, RAC, LA President Mansour Consulting 845 Aronson Lake Court ROSWELL GA 30075

Re: K093105

OCT 1 8 2010

Trade/Device Name: Visteo Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: EHD Dated: August 23, 2010 Received: August 26, 2010

Dear Mr. Mansour:

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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/MedicalDevices/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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

signature

David G. Brown, Ph.D. Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use Form

OCT 1 8 2010

510(k) Number (if known): K093105

VISTED Device Name:

Indications for Use:

The VISTEO 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 VISTEO is covered with a single use disposable sheath and positioned in the oral cavity opposite the tooth the dentists wishes to X-Ray.

The dental X-ray tube (which is not part of VISTEO) 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

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

Prescription Use ============================================================================================================================================================= (21 CFR 801 Subpart Ci

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510[k] K092105

Page 1 of

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.