QRmaster-H/Revo is a dedicated X-ray imaging device that acquires a 360-degree rotational X-ray sequence of images for use as diagnostic support in radiology of the dento-maxillo-facial complex and in the field of maxillofacial surgery. The device accomplishes this task by reconstructing a three-dimensional matrix of the examined volume, producing two-dimensional views of this volume, and displaying both 2D images and 3D renderings. This technique is known as cone beam computed tomography, or CBCT.

Device Description

QRmaster-H/Revo is an extraoral 2D (panoramic) and 3D (CBCT) x-ray imaging system for use by dental professionals. The device is designed to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the body by lput the same axial plane taken at different angles. To accomplish this it uses a cone-shaped xray beam projected on a flat panel detector to capture a rapid series of 2D images using the standard narrow beam technique. Such images from a single 360° scan are reconstructed with special software to be viewed on 3D viewing stations (PCs) that are not part of the system.

The system makes use of a single flat panel detector for both panoramic and cone beam images. Three field of views (FOVs) provide targeted regions of interest that can be positioned by panoramic scout, two-dimensional scout, or four positioning laser beams.

QRmaster-H/Revo includes firmware to operate the device through a control panel attached to the main device. The device also includes image acquisition software that stores 3D images in standard DICOM format for export to third party viewing or image management software not part of the system. Users are expected to have or acquire such image management software for communication both with the device's image acquisition software and with third party 3D-viewing software. These latter applications are readily available in the domestic marketplace.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the QRmaster-H/Revo device, a Cone Beam Computed Tomography (CBCT) X-Ray System for dentistry. The document focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a standalone study with detailed performance metrics.

Therefore, the requested information regarding acceptance criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth data for a specific study is not explicitly available within this document. The document primarily relies on comparisons to predicate devices and general performance and safety assessments.

However, I can extract what is provided regarding performance and studies.

1. Table of Acceptance Criteria and Reported Device Performance

As specific, quantifiable acceptance criteria with corresponding performance metrics are not detailed in the provided document, I will summarize the general performance and conclusions drawn.

Acceptance Criteria (Implied)	Reported Device Performance
Diagnostic Relevance and Reliability of Images	Clinical images were examined by a qualified professor at Asahi University School of Dentistry and found to be diagnostically relevant and reliable. Sample 2D and 3D images utilizing test phantoms were also included in the submission.
Software Functionality and Safety (Risk Analysis)	A software level of concern analysis (including device risk analysis conforming to ISO 14971) determined "acceptable" residual risks. Verification and validation of the software included tests that confirmed its functionality.
Electrical and Laser Safety and Electromagnetic Compatibility (EMC)	Independent laboratory and in-house testing was performed to demonstrate conformance with recognized electrical (60601 et al) and laser device (60825-1) standards. Differences in technological features do not raise new issues of safety or effectiveness. Effective exposure (radiation dose) is equal to or lower than the predicates despite higher exposure times.
Substantial Equivalence to Predicate Devices	Both intended use and fundamental scientific technology are the same as predicate devices. The device and petition comply with relevant FDA guidance documents.

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

Test Set Sample Size: Not specified. The document mentions "clinical images" and "sample 2D and 3D images utilizing test phantoms," but no numerical sample size for either.
Data Provenance: The "qualified professor" mentioned is from Asahi University School of Dentistry, implying the clinical image evaluation data originates from Japan. The document does not specify if the data is retrospective or prospective.

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

Number of Experts: "A qualified professor" (singular) was involved.
Qualifications: "qualified professor at Asahi University School of Dentistry." Further specifics like years of experience or specialty (e.g., oral radiologist) are not provided.

4. Adjudication method for the test set

Adjudication Method: Not specified. With only one expert mentioned, a formal adjudication process (like 2+1 or 3+1) is unlikely to have been used for establishing ground truth, as there are no multiple readings to resolve. The single expert likely provided a direct assessment.

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

MRMC Study: No, an MRMC comparative effectiveness study is not mentioned. The device is described as an X-ray imaging system, not an AI software intended to assist human readers in interpretation. The document focuses on the device's image acquisition capabilities and safety/equivalence, not on reader performance improvement with AI assistance.

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

Standalone Performance: The core device is an imaging system. Its "performance" in this context is assessed by the diagnostic relevance and reliability of the images it produces, as evaluated by an expert, and by technical metrics (e.g., electrical safety, EMC). It's not an algorithm that outputs a diagnostic decision in a standalone manner. The software mentioned is for operation, image acquisition, and risk analysis, not for standalone diagnostic interpretation.

7. The type of ground truth used

Type of Ground Truth: For the "clinical images," the ground truth appears to be expert consensus/opinion (from the "qualified professor"). For the "sample 2D and 3D images utilizing test phantoms," the ground truth would inherently be based on the known properties of the phantoms.

8. The sample size for the training set

Training Set Sample Size: Not applicable/not specified. The device is a hardware imaging system. While it has firmware and image acquisition software, the document doesn't describe a "training set" in the context of machine learning for image interpretation, as the device's function is image acquisition and reconstruction, not algorithm-based diagnosis.

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

Ground Truth for Training Set: Not applicable/not specified, as there's no mention of a machine learning model requiring a training set with associated ground truth for diagnostic interpretation.

Summary

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Image /page/0/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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines connecting them.

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

September 4. 2014

Telesystems Co., Ltd. % Mr. Claude Berthoin President Denterprise International, Inc. 110 East Granada Blvd. ORMOND BEACH FL 32176

Re: K133797

Trade/Device Name: Omaster-H/Revo Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: OAS Dated: August 1, 2014 Received: August 4, 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 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,

Smh.p)

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

510(k) Number (if known) K133797

Device Name QRmaster-H/Revo

Indications for Use (Describe)

All devices are sold by or on the order of a physician. They are not for use by the general public or over-the-counter.

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) (Signature)

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510(k) Summary

510(k) Owner:	Telesystems Co., Ltd.2-8-19, Ebisunishi, Naniwa-KuOsaka, Japan
Contact Person:	Yoshimitsu KobayashiGeneral ManagerPhone: +81-6-6631-0925Fax: +81-6-6631-5926
Date Prepared:	December 10, 2013
510(k) Preparer:	Denterprise International, Inc.110 E. Granada Blvd., Suite 207Ormond Beach, FL 32176386-672-0450 (Voice)386-672-4402 (Fax)
Primary Contact:	John Gillespy, VP Regulatory Affairs (john@510kfda.com)
Secondary Contact:	Claude Berthoin, President (claude@510kfda.com)Holly Layne, Assistant (holly@510kfda.com)
Trade Name:	QRmaster-H/Revo
Common Name:	Cone Beam Computed Tomography (CBCT) X-Ray System
Classification Name:	Dental Computed Tomography X-Ray System (21 CFR 892.1750, ProductCode OAS)
Predicate Devices:	Hyperion (K113497); Cefla Dental/MyRay, ItalyOrthophos XG (K103711); Sirona Dental, GermanyNewTom VG (K072357); Cefla Dental/QR, Italy
Device Description:	QRmaster-H/Revo is an extraoral 2D (panoramic) and 3D (CBCT) x-rayimaging system for use by dental professionals. The device is designed to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from

e body by lput the same axial plane taken at different angles. To accomplish this it uses a cone-shaped xray beam projected on a flat panel detector to capture a rapid series of 2D images using the standard narrow beam technique. Such images from a single 360° scan are reconstructed with special software to be viewed on 3D viewing stations (PCs) that are not part of the system.

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Indications For Use: ORmaster-H/Revo is a dedicated X-ray imaging device that acquires a 360-degree rotational X-ray sequence of images for use as diagnostic support in radiology of the dento-maxillo-facial complex and in the field of maxillofacial surgery. The device accomplishes this task by reconstructing a three-dimensional matrix of the examined volume, producing two-dimensional views of this volume, and displaying both 2D images and 3D renderings. This technique is known as cone beam computed tomography, or CBCT.
Comparison to Predicates QRmaster-H/Revo is intended for 2D panoramic diagnostic examination of dentition, jaws, and oral structures, the same as all three predicates. The device is also intended for 3D tomographic examination of dento-maxillo-facial areas and to support maxillofacial surgery, the same as two predicate devices with CBCT technology (Orthophos XG and NewTom VG).

Table 5 on the next page compares technological features between the subject and predicate devices. It shows the QRmaster-H/Revo and predicates share the same fundamental scientific technology. All are dedicated high-end x-ray imaging systems for dentistry.

More specifically, ORmaster-H/Revo is a PAN/CBCT x-ray system. All three predicates share the subject's 2D PAN technology, whereas two of the three share its 3D CBCT technology (Orthophos XG and NewTom VG). Two predicates also include CEPH technology for orthodontists (Hyperion and Orthophos XG), a feature not included in the subject device.

All devices feature similar x-ray generation technology, while QRmaster-H/Revo shares the same single-panel x-ray detector technology as NewTom VG.

Scan performance is continuous for both ORmaster-H/Revo and Hyperion. Exposure times are higher for the subject device, but measured effective exposure is equal to or lower than the predicates (as discussed in Section 12, Substantial Equivalence Discussion).

None of the differences in technological features between the subject and predicate devices raise new issues of safety or effectiveness.

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Devices	QRmaster-H/Revo(Subject)	Hyperion	Orthophos XG	NewTom VG
510(k) Number	NA	K113497	K103711	K072357
Manufacturer	Telesystems(Japan)	Cefla Dental/MyRay(Italy)	Sirona Dental(Germany)	Cefla Dental/QR(Italy)
Device Photo	Image: QRmaster-H/Revo	Image: Hyperion	Image: Orthophos XG	Image: NewTom VG
Common Name	PAN & CBCTX-Ray System	PAN & CEPHX-Ray System	PAN, CEPH &CBCTX-RaySystem	PAN & CBCTX-Ray System
X-Ray Generator
X-Ray Source	High Frequency,Rotating Anode	High Frequency, RotatingAnode	High Frequency,Rotating Anode	High Frequency,Rotating Anode
Shape of X-RayBeam	Fan-shaped x-raybeam and conebeam fortomography x-ray	Fan-shaped x-ray beam	Fan-shaped x-raybeam and conebeam fortomography x-ray	Cone beam fortomography x-ray
X-Ray Detector
Single ImageDetector?	YES	NO	NO	YES
Image Detector(PAN)	Amorphous siliconflat panel detector(Hamamatsu)	Digital CCD linear detector,repluggable for CEPHexposure	Digital CCD lineardetector,repluggable forPAN exposure	Amorphous siliconflat panel detector(Varian)
Image Detector(CBCT)	Amorphous siliconflat panel detector(Hamamatsu)	NA	Digital FPD withCMOS technology,integrated for 3Dexposure technique	Amorphous siliconflat panel detector(Varian)
Scintillator(CBCT)	Csl	NA	Not documented	Csl
Scan Performance
Type of X-RayEmission	Continuous for PANand CBCT exams	Continuous for PAN andCEPH exams	Not documented	Pulsed for CBCTexams
Exposure Time(Standard Pan)	12 s, continuedexposure	9.3 s, continued exposure	14.1 s	NA
Exposure Time(CBCT)	18 s, effectiveradiation time	NA	3.2-5.0 s, effectiveradiation time	3.6 s - 5.4 s,effective radiationtime
FOV (CBCT -Voxel Size - O X Hcm)	5.0 X 4.5 cm9.5 X 4.5 cm9.5 X 9.0 cm	7 cm (H.R. Zoom 4")11 cm (6" detector)15 cm (9" detector)	8.0 X 8.0 cm	8.0 X 10.0 cm

Table 5 - Comparison of Technological Features

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Performance Data: Clinical images were examined by a qualified professor at Asahi University School of Dentistry and found to be diagnostically relevant and reliable. Sample 2D and 3D images utilizing test phantoms are also included in the submission.
Biocompatibility Assessment: Biocompatibility testing is not warranted since surfaces in contact with users are covered with single-use protective barriers during use.
Software and Risk Analysis: A software level of concern analysis that included a device risk analysis in conformance with ISO 14971 was performed. Results of that analysis determined the residual risks inherent in the use of QRmaster-H/Revo are "acceptable." Verification and validation of the software included tests that confirmed its functionality.
EMC and Electrical Safety Testing: Independent laboratory and in-house testing was performed to demonstrate conformance with recognized electrical (60601 et al) and laser device (60825-1) standards.
FDA Guidance Compliance: The subject device and this petition comply with the following FDA guidance documents: (a) Pediatric Information for X-Ray Imaging Device Premarket Notifications, draft guidance issued on May 10, 2012; (b) Guidance for the Submission of 510(k)s for Solid State X-Ray Imaging Devices, issue on August 6, 1999; (c) Laser Products – Conformance with IEC 60825-1 and IEC 60601-2-22, issued on June 24, 2007; and (d) Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, issued on May 11, 2005.
Conclusions: Both intended use and fundamental scientific technology are the same in the subject and predicate devices, and any differences in technological features do not raise new issues of safety or effectiveness. A comparison of such features, combined with performance data that includes clinical evaluation of device images, a software and device risk analysis, and electromagnetic compatibility as well as electrical and laser safety tests support the conclusions that ORmaster-H/Revo is safe for its intended use and is substantially equivalent to the predicate devices.

Regulation Number and Section

§ 892.1750 Computed tomography x-ray system.

(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.