Ergon-X-HF is an extraoral X-ray source system intended to be used for dental radiographic examination and diagnosis of diseases of the teeth, jaws, and oral structures.

Device Description

VIVI Ergon-X HF is a device made up of a mobile and articulate double support arm. At the opposite ends of the arm are located respectively:

a central unit equipped with wall plate, extension and radio control device. This unit is the . interface on which the control panel is placed;
. the tube head with X-Ray Tube.

AI/ML Overview

The provided text describes the VIVI Ergon-X HF, an extraoral X-ray source system, and its 510(k) submission. However, it does not contain information about acceptance criteria or a study proving the device meets specific performance criteria related to the image quality or diagnostic accuracy of the device itself.

The "Performance Data" section primarily lists international standards the device was developed and tested according to. These standards relate to general safety, electromagnetic compatibility, radiation protection, and software life cycle processes, which are regulatory compliance requirements rather than acceptance criteria for diagnostic performance.

The text does mention a "comparative test was performed with the predicate device Endos DC (K030634) and this test demonstrated that the output to the patient is equivalent for both VIVI Ergon-X HF and Endos DC (K030634)." This is a comparison for patient output (likely radiation dose), not diagnostic performance.

Therefore, I cannot fulfill most of your request as the information is not present in the provided text. I will indicate where the information is missing.

Here's a breakdown of what can and cannot be answered based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not available in the provided text. The document lists regulatory standards the device complies with, but not specific performance acceptance criteria for diagnostic capability (e.g., resolution, contrast, accuracy of disease detection) or any reported device performance against such criteria.

Acceptance Criteria	Reported Device Performance	Comments
Not specified in the document for diagnostic performance.	Not specified in the document for diagnostic performance.	The document focuses on compliance with safety and electrical standards (IEC 60601 series, IEC 62304, ISO 14971) and a comparative test for patient output equivalency. No criteria for image quality or diagnostic accuracy are provided.
Example (patient output equivalency):
Patient Output equivalent to predicate device (Endos DC K030634)	"this test demonstrated that the output to the patient is equivalent for both VIVI Ergon-X HF and Endos DC (K030634)."	This criterion and performance relate to radiation dose, not diagnostic performance.

2. Sample size used for the test set and the data provenance

This information is not available in the provided text. The document mentions a "comparative test" for patient output but does not specify sample size or data provenance (country of origin, retrospective/prospective) for any test related to diagnostic performance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not available in the provided text. No details are given about any study involving expert review for establishing ground truth related to diagnostic performance.

4. Adjudication method for the test set

This information is not available in the provided text.

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

This information is not applicable/available. The VIVI Ergon-X HF is described as an "extraoral X-ray source system," which is a hardware device for generating X-rays for dental radiography. It is not an AI-powered diagnostic software, and therefore, an MRMC study comparing human readers with and without AI assistance would not be relevant to this product description.

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

This information is not applicable/available. As a hardware X-ray device, it does not involve an algorithm with standalone performance in the context of diagnostic interpretation.

7. The type of ground truth used

This information is not available in the provided text. Since no diagnostic performance study is described, the type of ground truth is not mentioned.

8. The sample size for the training set

This information is not applicable/available. As a hardware X-ray device, it does not use a training set in the context of machine learning.

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

This information is not applicable/available. As a hardware X-ray device, it does not use a training set in the context of machine learning.

Summary

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1412-0318

ERGON-X HF

VIVI S.R.L. 510(K) NOTIFICATION

MAR = 6 2012

510(k) Summary for the VIVI Ergon-X HF

This 510(k) Summary is submitted in accordance with the requirements of the SMDA 1990 and 21 CFR 807.92.

1. General Information

Submitter:

Contact Person:

VIVI S.r.l. is located at: Via dei Lavoratori, 3/K 20090 - Buccinasco (Milano) ITALY

Guido Bonapace (consultant) ISEMED sri Via Borgo Santa Cristina 12 40026 Imola (BO) Italy Mob.phone: +39-335-5378686 Telephone: +39-0542-683803 Fax: +39-0542-698456 Email: gbonapace@isemed.eu

Summary Preparation Date:

11,04,2011

Names 2.
VIVI Ergon-X HF Device Name: Common Name: Unit, x-ray, extraoral with timer Product Code: EHD Classification: ll

3. Predicate Devices

The VIVI Ergon-X HF is substantially equivalent to the following devices:

Applicant	Device name	510(k) Number
Sirona Dental Systems GmbH	HELIODENT Plus	K083344
Villa Sistemi	ENDOS DC	K030634
Progeny Inc	PREVA	K043092

Page 21

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VIVI S.R.L. 510(K) NOTIFICATION

VIVI Ergon-X HF and its predicate devices are indicated for the same intended use and have equivalent design solutions .

They have the same operating principle (X-ray tube) and equivalent technical characteristics. Moreover, a comparative test was performed with the predicate device Endos DC (K030634) and this test demonstrated that the output to the patient is equivalent for both VIVI Ergon-X HF and Endos DC (K030634).

4. Device Description

VIVI Ergon-X HF is a device made up of a mobile and articulate double support arm. At the opposite ends of the arm are located respectively:

a central unit equipped with wall plate, extension and radio control device. This unit is the . interface on which the control panel is placed;
. the tube head with X-Ray Tube.

5. Indications for Use

Ergon-X-HF is an extraoral X-ray source system intended to be used for dental radiographic examination and diagnosis of diseases of the teeth, jaws, and oral structures.

6. Performance Data

VIVI Ergon-X HF device has been developed and tested according to the following international standards:

. IEC 60601-1 - Medical Electrical Equipment Part.1: General requirements for safety. 1: Collateral standard: safety requirements for Medical Electrical Systems. FDA Recognition number 5-4
IEC 60601-1-2 Medical Electrical Equipment Part.1: General requirements for safety. 2-. Collateral standard: electromagnetic compatibility - requirements and tests. FDA Recognition number 5-28
. IEC 60601-1-3 Medical Electrical Equipment - Part.1: General requirements for safety, 3: Collateral standard: general requirements for radiation protection in diagnostic X-ray equipment. FDA Recognition number 12-199
IEC 60601-2-7 Medical Electrical Equipment Part.2-7: particular requirements for high . voltage generators safety in diagnostic X-ray equipment. FDA Recognition number 12-34
IEC 60601-2-28 Medical Electrical Equipment Part.2: particular requirements for safety of . X-ray generators assembled in diagnostic X-ray equipment. FDA Recognition number 12-126
IEC 62304 , Medical device software Software life cycle processes. FDA Recognition . number 13-8
IEC 60601-1-4, Medical electrical equipment Part 1-4: General requirements for safety --● Collateral standard: Programmable electrical medical systems, edition 1.1. FDA Recognition number 5-41
ISO 14971 Medical Devices Application of risk management to medical devices. FDA ● Recognition number 5-40

Page 22

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it, representing medicine and healing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus symbol. The logo is black and white.

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

VIVI S.r.l. % Mr. Guido Bonapace Consultant ISEMED S.r.1. Via Borgo Santa Cristina 12 40026 Imola (BO) ' ITALY

Re: K120318

Trade/Device Name: Ergon-X HF Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: MUH, EHD Dated: January 4, 2012 Received: February 1, 2012

MAR - 6 2012

Dear Mr. Bonapace:

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, additional corral 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 I that FDA has made a determination that your device complies with other requirements of the Act that I Drinas Intactions and regulations administered by other Federal agencies. You must or any I odotal 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,

Janine M. Morris

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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VIVI S.R.L. 510(K) NOTIFICATION

Indications for Use

510(k) Number (if known):	K120318
Device Name:	Ergon-X HF

Indications for Use:

Ergon-X-HF is an extraoral X-ray source system intended to be used for dental radiographic examination and diagnosis of diseases of the teeth, jaws, and oral structures.

. Prescription Use x (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mary Scott

(Division Sign-Off) Division of Radiological Devices Division of Hadlologiour So Rose.
Office of In Vitro Diagnostic Device Evaluation and Safety

510K. K120318

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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.