The Cefla MyRay Hyperion is intended for use in producing panoramic-ray images of the maxillofacial region. It is used for the examination of teeth, the jaw, and oral structures.

Device Description

The MyRay Hyperion is a panoramic dental X-ray system which consists of a telescopic column, an overhead frame with a horizontal arm where an X-ray source and collimator and an X-ray image detector are mounted, and a console with a keyboard and display. The device includes a patient positioning system that consists of two handles which the patient grasps during exposures, a bite block, a frame for holding the head in the proper position and alignment with laser guide lights. The x-ray source and collimator generate a fan shaped x-ray beam which is projected through the patient's skull by the rotation of the imaging unit. The x-ray image detector allows reconstruction of the diagnostic image, storage of the image in the buffer memory, and transfer of the image to an external PC (not provided by Cefla).

AI/ML Overview

Here's an analysis of the provided text regarding the Cefla MyRay Hyperion, focusing on acceptance criteria and study details.

Important Note: The provided document is a 510(k) summary for the Cefla MyRay Hyperion, a dental panoramic X-ray system. This type of device is an imaging modality. The typical "acceptance criteria" and "studies" you're asking about (e.g., performance metrics like sensitivity/specificity, comparison to ground truth, reader studies) are primarily relevant for AI/CAD devices that provide diagnostic interpretations or assistance.

For a standard X-ray imaging system like the Cefla MyRay Hyperion, the "acceptance criteria" are generally related to its ability to produce clear, diagnostically acceptable images and its functional characteristics meeting established safety and performance standards for medical devices. The "study" for such a device is typically a demonstration of substantial equivalence to existing predicate devices, focusing on technical specifications, image quality, and safety rather than a clinical efficacy trial with human readers.

Therefore, many of your requested points will not be directly applicable or explicitly stated in this type of submission.

Acceptance Criteria and Device Performance for Cefla MyRay Hyperion

Based on the provided 510(k) summary, the device's "acceptance criteria" for regulatory clearance are primarily demonstrating substantial equivalence to predicate devices in terms of intended use, operational characteristics, and technological characteristics, as well as meeting general safety and performance standards. The "study" proving this is the 510(k) submission itself, which compares the new device to established predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category (Implied by 510(k))	Desired Performance (Implied from Predicate Comparison)	Reported Cefla MyRay Hyperion Performance (from Table 5-1)
Intended Use Equivalence	For producing panoramic X-ray images of the maxillofacial region for examination of teeth, jaw, and oral structures.	Same intended use: production of panoramic X-ray images of the maxillofacial region for examination of teeth, jaw, and oral structures.
Imaging Principle	Fan beam, High-Frequency Constant Potential X-ray source, CCD detector.	Fan beam, High-Frequency Constant Potential X-ray source, CCD detector.
X-ray Source Parameters	Focal spot (0.5mm), max energy (e.g., ~85-90 kVp).	Focal spot: 0.5mm, Max Energy: 85 kVp.
Detector Characteristics	CCD pixel size (e.g., ~48 microns), 12-bit grayscale.	CCD pixel size: 48 microns, Detector area: 147 x 6 mm, Grayscale: 12 bit.
Image Pixel Size	Typical for panoramic systems (e.g., ~96 x 96 microns).	Image pixel size: 96 x 96 microns.
Patient Positioning	Utilizes laser lines for accurate patient positioning.	3 laser lines for patient positioning.
Safety Standards	Compliance with relevant electrical safety, radiation safety, and electromagnetic compatibility standards (implied by general controls and submission for class II device).	Not explicitly detailed in the summary, but required for 510(k) clearance and covered under general controls provisions of the Act.
Image Quality (Diagnostic Acceptability)	Images produced by the device must be diagnostically acceptable for the intended use.	Not quantified in the provided text. Demonstrated by comparison to accepted predicate devices and implied by technical specifications.

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

Test Set Description: This 510(k) pertains to a medical imaging device itself, not an AI or diagnostic software. Therefore, there isn't a "test set" in the sense of a dataset of images used to evaluate diagnostic performance. The "test" for this device involved comparing its technical specifications and image acquisition capabilities to legally marketed predicate devices.
Provenance: Not applicable in the context of diagnostic performance data. The device was manufactured in Italy.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not Applicable (N/A): For a panoramic X-ray machine itself, "ground truth" as it applies to diagnostic accuracy of an AI algorithm is not relevant. The device's "ground truth" is its ability to produce images that are physically accurate representations of the maxillofacial anatomy, which is assessed through engineering testing and comparison to functional specifications, not expert consensus on diagnostic findings.

4. Adjudication Method for the Test Set

N/A: No "adjudication method" for diagnostic interpretation of a test set was performed as this is an imaging device, not a diagnostic AI.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No: An MRMC comparative effectiveness study was not done. These studies are typically conducted for AI/CAD systems to demonstrate improvement in human reader performance with aid. This submission is for an imaging acquisition device.

6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance)

N/A: This is an imaging device, not a standalone diagnostic algorithm. Its "performance" is its ability to acquire images, not to interpret them without human intervention.

7. Type of Ground Truth Used

Physical and Technical Specifications: The "ground truth" for this device's evaluation is primarily its adherence to established engineering, safety, and performance specifications for dental panoramic X-ray systems, as well as its ability to produce images comparable in quality to predicate devices. This includes measurements of factors like focal spot size, kVp output, detector characteristics, and image resolution.

8. Sample Size for the Training Set

N/A: The concept of a "training set" is relevant for machine learning algorithms. This is a medical device for image acquisition, not an AI algorithm, so no training set was used.

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

N/A: As there's no training set, this question is not applicable.

Summary

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510(k) Summary for the Cefla, s.c. - Cefla Dental Group Cefla MyRay Hyperion

1101661

1. SPONSOR

SEP 1 G 2010

Cefla, s.c. - Cefla Dental Group via Selice Prov. le 23/a Imola, BO 40026 Italy

Contact:	Simona Daidone
Telephone:	+39 0542 653111

Date Prepared: June 11, 2010

2. DEVICE NAME

Proprietary Name: Common/Usual Name: Classification Name:

MyRay Hyperion Dental Panoramic X-ray system System, x-ray, extraoral, source, digital

3. PREDICATE DEVICES

· Instrumentarium Dental Inc., Orthopantomograph OP200D (K043612)
Sirona Dental System GmbH, Orthophos XG DS (K033073) .
Gendex, Orthoralix 9200 DDE (K032355) .

4. INTENDED USE

The Cefla MyRay Hyperion is intended for use in producing panoramic-ray images of the maxillofacial region. It is used for the examination of teeth, the jaw, and oral structures.

5. DEVICE DESCRIPTION

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imaging unit. The x-ray image detector allows reconstruction of the diagnostic image, storage of the image in the buffer memory, and transfer of the image to an external PC (not provided by Cefla). A detailed description of the components is provided below.

Telescopic Column

The telescopic column supports the patient arm at which the patient stands during X-ray exposures. It also includes the patient handles which the patient holds during imaging and a plate which contains the mid-sagittal laser beam, the bite block and chin rest. The telescopic column allows adjustment of the patient arm to the patient's height.

Overhead Assembly

The overhead assembly supports the main horizontal and rotating arm. The rotating arm holds the x-ray generator and the collimator in a fixed position opposite to the x-ray image detector.

Console

The console allows the user to select the projection mode and the exposure factors, view the machine status information, control the height of the telescopic column, adjust the reset of the Y-axis, and turn on the laser guide lights. A system emergency stop button is included on the console so the user can immediately stop the procedure.

Control Panel

The control panel serves as the user interface with the electronic control system. The layout of the controls has been designed to split the panel into 2 sections. The "Procedure programming" area is found on the left side from which the user selects the type of procedure to be performed and technical settings. The "Assisted positioning" area is found on the right side of the panel which contains the controls to move the unit to position the patient. In addition, a port for an SD card (Secure Digital Memory Card) is provided at the bottom of the control panel. If this card is inserted, the images can be saved without having to connect the unit to a computer.

Control System

The electronic components which control the system operation consist of the following:

· Main unit- providing real-time system control as well as motor drive;
· Power unit- connecting to the mains power supply and providing the 400 VDC bus for the system;
· Converter unit- controlling the power to the x-ray generator;

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· Sensor unit- controlling the x-ray image detector

6. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE

The Cefla MyRay Hyperion dental x-ray system is similar in design and materials to the Instrumentarium OP200D, subject of K043612, the Sirona Orthophos XG DS, subject of K033073, and the Gendex Orthoralix 9200 DDE subject of K032355. The similarities in intended use, operational characteristics, and functional technological characteristics between the MyRay Hyperion, OP 200D, and Orthophos XG DS dental x-ray systems lead to a conclusion of substantial equivalence between the proposed and predicate devices. A comparison between the features of the proposed device and those of the predicate devices is shown in Table 5-1 below:

Comparison Chart	Hyperion	Instrumentarium OP200 D	SironaOrthophos XG 5	GendexOrthoralix 9200
Maximum total weight	145 kg	175 kg	183 kg	115-212 kg
Nominal voltage	230/115 VAC	230/115 VAC	230/115 VAC	250-115 VAC
Nominal frequency	60 Hz	60 Hz	60 Hz	60 Hz
X-ray source: geometryand type	Fan beam, HighFrequencyConstant Potential	Fan beam, HighFrequency ConstantPotential	Fan beam, HighFrequencyConstant Potential	Fan beam, HighFrequencyConstant Potential
X-ray source: focal spot	0.5mm	0.5mm	0.5mm	0.5 mm
X-ray source: max.energy	85 kVp	85 kVp	90 kVp	84 kVp
Exposure Time (std.panoramic)	9.3 s	17.6 s	14.2 s	12 s
Patient position	Lateral	Frontal	Frontal	Frontal
Detector: type	CCD	CCD	CCD	CCD
CCD pixel size	48 microns	48 microns	27 microns	48 microns
Detector area	147 x 6 mm	147 x 6 mm	N.A.	147 x 6 mm
Detector: gray scale	12 bit	12 bit	16 bit	12 bit
Image pixel size	96 x 96 microns	96 x 96 microns	N.A.	96 x 96 microns
Computer interface	LAN	Proprietary (PCI slot)	LAN	LAN
Patient positioning	3 laser lines	3 laser lines	2 laser lines	3 laser lines

Table 5-1. Comparison Table for Determination of Substantial Equivalence

NA=Not available, LAN=Local area network, PCI=Personal Computer Instrumentation

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a human figure embracing or supporting three wavy lines, which may represent people or services.

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

Cefla Dental Group % Ms. Mary McNamara-Cullinane Senior Regulatory Consultant Medical Device Consultants, Inc. 49 Plain Street NORTH ATTLEBORO MA 02760

SEP 1 6 2010

Re: K101661

Trade/Device Name: Cefla MyRay Hyperion Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: MUH Dated: June 11, 2010 Received: June 14, 2010

Dear Ms. McNamara-Cullinane:

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 220). This letter will allow you to begin marketing your device as described in your Section 5100%) premarket. notification. The FDA finding of substantial equivalence of your device to a legal y renatisted 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 vours.

Donald J. Trump

Donald J. St.Pierre 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

510(k) Number (if known): K161661

Device Name:

Cefla MyRay Hyperion

SEP 1 6 2010

Indications for Use:

The Cefla MyRay Hyperion is indicated for use in producing panoramic X-ray images of the maxillofacial region. It is used for the examination of teeth, the jaw, and oral structures.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (00) C

Division Sign Only

ion Sian-O Division of Radiological Dev Office of In Vitro Diagnostic Device Eva

510K KIOKIOI

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.