RX DC x-ray unit is designed for use in the dental surgery to make endo-oral x-rays for diagnostic purposes. This equipment can be used to produce traditional x-rays developed using chemicals or, alternatively, it can be used with digital x-ray sensors.

Device Description

The subject device RX DC, in the new 65/70 kV version, is an extraoral source dental X-ray system intended for intraoral imaging. The subject device is a device comprises a double mobile and articulate support arm. At the opposite ends of the arm are located, respectively:

. A control unit equipped with wall plate, extension arm and wired/wireless control device;
A tube head with x-ray tube; .
X-rays are produced using the high frequency and constant potential generators with a built in round collimator with the high frequency (HF) technology, X-ray emission at 70 kV and 8 mA (maximum power), and x-ray unit automatically calculates the best exposure time (from 0.02 s to 1.00 s) based on the selected tooth and patient size, as well as an adjustable arm allows for easy positioning. The system can be used either with conventional film or a digital imaging system. RX DC, 65/70 kV version, is manufactured by CEFLA S.C. and available in several versions, and it can be sold under different brands and commercial names for commercial needs, as well as with different type of installation, and also different types of maximum anode voltage (65 kV or 70 kV). To identify the different variants of the RX DC product, CEFLA S.C. designed a reference system to identify any variant via the REF code.

AI/ML Overview

Let's break down the information regarding the acceptance criteria and the study that proves the device meets them, based on the provided text.

This document describes the 510(k) premarket notification for the RX DC dental X-ray unit. It focuses heavily on demonstrating substantial equivalence to predicate devices rather than setting specific, numerical acceptance criteria for a diagnostic performance study. The "acceptance criteria" here largely revolve around compliance with established standards and comparable physical measurements.

Here's the breakdown of the information you requested:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't present a table with explicit numerical acceptance criteria for diagnostic accuracy, sensitivity, or specificity commonly associated with AI/CAD devices. Instead, the acceptance criteria are implicit in demonstrating compliance with safety and performance standards, and showing equivalent dosimetric output to a predicate device.

Acceptance Criteria (Implicit)	Reported Device Performance
Safety and EMC Compliance: Device meets all requirements of the specified international standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-2-65, IEC 62366).	"For all consensus standards here above all requirements have been met." (Section 7.A) This indicates full compliance with these safety, EMC, basic safety, essential performance, and usability standards.
Dosimetric Equivalence: The device emits a comparable quantity of X-ray dose to the predicate device (K080076) for various loading factors, patient sizes, and anatomical shapes.	"The test results demonstrated that RX DC, in the new 65/70 kV version, emits the same quantity of x-ray than the predicate device K080076." (Section 7.B) This indicates the device's radiation output is equivalent to the legally marketed predicate, meaning it performs similarly in terms of dose delivery.
Technological Equivalence: The device's technological characteristics (e.g., intended use, principle of use, generator type, anode material) are substantially similar to predicate devices.	The extensive comparison table in Section 6 demonstrates that the RX DC shares almost all key technological characteristics with K080076 and K120318, with minor differences (e.g., higher kV options, different arm lengths) that were addressed in subsequent tests. The software changes were validated to maintain the same performance.
Indication for Use Equivalence: The device is intended for the same diagnostic purposes as the predicate devices.	The "Indications for Use" for the subject device are identical to the predicate device K080076. (Section 5 and comparison table in Section 6).

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

Sample Size for Test Set: Not applicable in the context of this 510(k) submission. There is no "test set" in the sense of a dataset for evaluating diagnostic performance (e.g., images for classification). The "tests" performed were non-clinical engineering and dosimetric tests.
Data Provenance: The tests were conducted by CEFLA S.C. (the manufacturer) or their contracted labs. The company is based in Italy. The document doesn't specify if the dosimetric tests involved actual patient data or were conducted in a controlled laboratory environment with phantoms. Given the nature of dosimetric testing for X-ray units, it's highly likely to be laboratory-based and controlled.

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)

This information is not applicable as there was no ground truth determination by experts for a diagnostic performance test set. The evaluation focused on physical and electrical device characteristics and dosimetric output.

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

This information is not applicable as there was no diagnostic performance test set requiring adjudication.

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. This submission is for an X-ray imaging device itself, not an AI/CAD system designed to assist human readers. The clinical utility is in producing the images, not in interpreting them.

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

No, a standalone algorithm performance study was not done. This device is an X-ray unit, not a diagnostic algorithm.

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

This information is not applicable as there was no diagnostic performance evaluation requiring ground truth. The "ground truth" equivalent for the dosimetric test would be the established and verified output of the predicate device.

8. The sample size for the training set

This information is not applicable as there is no AI/machine learning component requiring a training set mentioned in this 510(k) summary.

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

This information is not applicable as there is no AI/machine learning component or training set mentioned.

Summary

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

January 13, 2017

CEFLA S.C. % Maurizio Pantaleoni CEO Isemed Srl Via Argentina Altobelli Bonetti 3A Imola, BO 40026 ITALY

Re: K163519 Trade/Device Name: RX DC Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: EHD Dated: November 24, 2016 Received: December 15, 2016

Dear Maurizio Pantaleoni:

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. 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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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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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" (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 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.

Michael D.'Hara

For

Robert Ochs, Ph.D. 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: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K163519

Device Name RXDC

Indications for Use (Describe)

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

IZJ Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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

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FORM FDA 3881 (8/14)

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510(k) Summary

This 510(k) Summary is being submitted as required by 21 CFR 807.92.

1. General Information

Submitter :	CEFLA S.C.Via Selice Prov.le 23/aImola, BO 40026 ITALYTel. +39 0542 653441Fax +39 0542 653607
Consultant/ Contact:	Maurizio PantaleoniISEMED srlVia Altobelli Bonetti 3/aImola, BO 40026 ITALYMob. +39 348 4435155Tel. +39 0542 683803Fax +39 0542 698456Email: regulatory@isemed.eu

Summary Prepared Date:

November 24, 2016

2. Names

Device Name:	RX DC
Common Name:	Unit, X-Ray, Extraoral with timer
Regulation Name:	Extraoral Source X-Ray System
Product Code:	EHD
Classification:	21CFR 872.1800; Class II

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Predicate Devices 3.

Applicant	Device name	510(k) Number
CEFLA S.C.	RXDC	K080076
VIVI S.r.l.	VIVI Ergon-X HF	K120318

The RX DC, in the new 65/70 kV version, is substantially equivalent to the following device:

4. Device Description

. A control unit equipped with wall plate, extension arm and wired/wireless control device;
A tube head with x-ray tube; .

X-rays are produced using the high frequency and constant potential generators with a built in round collimator with the high frequency (HF) technology, X-ray emission at 70 kV and 8 mA (maximum power), and x-ray unit automatically calculates the best exposure time (from 0.02 s to 1.00 s) based on the selected tooth and patient size, as well as an adjustable arm allows for easy positioning. The system can be used either with conventional film or a digital imaging system. RX DC, 65/70 kV version, is manufactured by CEFLA S.C. and available in several versions, and it can be sold under different brands and commercial names for commercial needs, as well as with different type of installation, and also different types of maximum anode voltage (65 kV or 70 kV). To identify the different variants of the RX DC product, CEFLA S.C. designed a reference system to identify any variant via the REF code.

5. Indications for Use

6. Comparison of technological characteristics with the predicate device

The RX DC, in the new 65/70 kV version, represents a development of the cleared RX DC (K080076), which has a fixed x-ray tube potential 60kV. In addition, concerning the maximum voltage of 70KV, this parameter is identical to that of the other predicate device K120318.

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CEFLA S.C. 510(K) PREMARKET NOTIFICATION

All relevant characteristics of the subject device are side-by-side compared with those of the predicate devices in the Comparison table.

	Subject Device	Predicate Devices
	CEFLA S.C.RX DC	CEFLA S.C.RX DC	VIVIVivi Ergon- X HF
		K 080076	K 120318
General Features
Classification	II	II	II
Product Code	EHD	EHD	EHD
Intended use	This x-ray unit is designed for usein the dental surgery to make endo-oral x-rays for diagnosticpurposes. This equipment can beused to produce traditional x-raysdeveloped using chemicals or,alternatively, it can be used withdigital x-ray sensors.	This x-ray unit is designed for usein the dental surgery to make endo-oral x-rays for diagnosticpurposes. This equipment can beused to produce traditional x-raysdeveloped using chemicals or,alternatively, it can be used withdigital x-ray sensors.	Ergon-X-HF is an extraoral X-ray source system intended tobe used for dentalradiographic examination anddiagnosis of diseases of theteeth, jaws, and oralstructures.
Principle of use	X-Ray Tube	X-Ray Tube	X-Ray Tube
Mechanical Features
Installationconfiguration	Wall-mounted standard versionStand mobile version	Wall-mounted standard version	Wall-mounted standardversionFixed floor StandStand mobile version
X-ray emissioncontrol	Wired controlWireless Remote control	Remote control	Wired controlWireless remote control
Extension arm	90 cm (standard)40 cm (optional)60 cm (optional)	90 cm (standard)40 cm (optional)60 cm (optional)	30 cm (standard)60 cm (optional)80 cm (optional)
Radiological characteristics
HV generator	High frequencyConstant potential	High frequencyConstant potential	High FrequencyConstant potential
Anode material	Tungsten	Tungsten	Tungsten
Tube Voltage (KV)	60, 63, 65 kV60,65, 70 kV	60 kV	60, 65 or 70 kV
Tube current (mA)	6, 7 mA @65kV4, 8 mA @ 70 kV	7mA3.5mA	7 mA
Exposure time	0.02s-1s (R 20 steps)	0.01sec. - 1sec. (in R20 steps)	0.01 - 2.0 sec
X-ray tube & anodeangle	• From 12.5° to 16°	12.5°	19°
Focal spot size	• 0.4mm / 0.7mm	0.4mm	0.5mm
Leakage radiation	< 0.25 mGy/h	< 0.25 mGy/h	< 0.25 mGy/h

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Collimators
Focus film distance	• Short round (fix): 200 mm (8'')• Long rectangular (removable): 300mm (12'')• Round (removable): 300mm (12'')	• Short round (fix): 200 mm (8'')• Long rectangular (removable): 300mm (12'')	200 mm
Diameter of X-ray beam cone	• Short round (fix): Ø 60 mm• Long rectangular (removable): Ø 45x35mm• Round (removable): Ø 55 mm	• Short round (fix): Ø 60 mm• Long rectangular (removable): Ø 45x35mm	Ø 60 mm
Radiological parameters
Exposure times control	Microprocessor controlled exposure timespreset loading factorsorManual mode	Microprocessor controlled exposure timespreset loading factors	Microprocessor controlled exposure timesautomatic exposureormanual exposure
Exposure modes
Selectable parameter	Patient type, anatomical position,	Patient type, anatomical position,	Patient size, anatomical position, film type
Patient type	Adult-child	Adult -child
Tooth type	Molar (upper and lower)Premolars (upper and lower)Incisors/canines (upper and lower)Bite wing	Molar (upper and lower)Premolars (upper and lower)Incisors/canines (upper and lower)Bite wing	Molar (upper and lower)Premolars (upper and lower)Incisors/canines (upper and lower)Bite wing
Film type	Sensor or photostimulated plate	Sensor or photostimulated plate	Class E - F - D (selectable)
Standards
Standards	IEC 60601-1IEC 60601-1-2IEC 60601-1-3IEC 62304	IEC 60601-1IEC 60601-1-2IEC 62304	IEC 60601-1IEC 60601-1-2IEC 60601-1-3IEC 62304

According to table above, the subject device has similar technology and features than the predicate devices K080076 and K120318, pointing out only few differences.

The differences like the highest energy available is 70 keV or the necessity to manage a wired controller together an others, together with some electronic changes introduced in the subject device, as indicated in the table, have caused the need for software changes in order to allow the firmware porting, but the two mains parts of the software, that consist of the user interface management and the control algorithms that manage the x-ray tube remained substantially the same. Finally this modification has been validated in compliance with the same standard used in the predicate device as indicated in the comparison table

Furthermore all these differences have been addressed by dedicated performance tests demonstrating that the technical differences have the equivalent results concerning the performance of the dose released during the radiographic exposition. Therefore, the subject device is able to produce comparable performances in term of emitted dose respect the correspondent dose emitted by RX DC cleared by FDA with K080076.

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7. Performance Data

The following tests were performed for determination of substantial equivalence:

Non clinical tests performed on the subject device:

A. Safety and EMC tests conducted in compliance with the declared standards:

IEC 60601-1:2005 ●
IEC 60601-1-6:2013 ●
IEC 62366: 2014 ●
IEC 60601-1-3:2013 ●
IEC 60601-2-65:2012
IEC 60601-1-2:2007 (EMC) ●

For all consensus standards here above all requirements have been met.

B. Comparative dosimetric test:

The test purpose is to measure the air kerma emitted by the subject device and RX DC (K080076), for each combination of loading factors accordingly to patient size and anatomical shape of the tooth, in order to verify that the technical differences have the equivalent results concerning the performance of the dose released during the radiographic exposition

The test results demonstrated that RX DC, in the new 65/70 kV version, emits the same quantity of x-ray than the predicate device K080076.

8. Conclusions

In light of evidence discussed above and underlining similar technological features for these three compared devices as well as pointing out the compliance with the same safety-related standards and the similar performance as demonstrated by dedicated performance test, the subject device may be found substantially equivalent to the predicate devices K080076, and 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.