The Orthopantomograph OP300 panoramic, cephalometric and cone beam computed tomography x-ray device is intended to image the head and neck areas for diagnostic support. This includes temporomandibular Joints (TMJs) and dentomaxillofacial areas, and with the 13x15 cm field of view (FOV) this additionally includes the ear. nose and throat (ENT) regions. The x-ray device produces conventional 2D x-ray images and x-ray projection images for the reconstruction of a 3D view. The device is operated and used by qualified healthcare professionals.

Device Description

Orthopantomograph OP300 x-ray unit is a software controlled diagnostic dental X-ray equipment for producing panoramic, cephalometric and 3D images of the dentomaxillofacial complex, ENT and airway regions of the head and neck. The Orthopantomograph OP300 is available in different configurations (panoramic, cephalometric, 3D) with different 3D Field of View configurations (6X4 cm, 6X8 cm, 5X5 cm, 8X8 cm, 8X15 cm, and 13X15 cm). The components of the device include column, carriage, rotating unit (containing tube head, sensors and collimator), top-level hanger, patient head support, software for image reconstruction, and an optional software package for image reviewing. The proprietary name of the optional image reviewing software is CLINIVIEW.

Cone Beam Volumetric Tomography is a medical imaging technique that uses X-rays to obtain crosssectional images of the head or neck. The proposed device utilizes cone beam X-ray technology, which generates conical x-ray beams that rotate around the patient's head and incident upon the receptor that generate sufficiently contrasted images. Quality of the images depends on the level and amount of X-ray energy delivered to the tissue. When interpreted by a trained physician, these images provide useful diagnostic information.

AI/ML Overview

The provided text describes the Orthopantomograph OP300, a dental X-ray device. The acceptance criteria and the study proving the device meets these criteria are mainly focused on demonstrating substantial equivalence to predicate devices, particularly the Scanora 3D (K110839), for expanded indications including ENT imaging.

Here's a breakdown of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state quantitative acceptance criteria in a table format with corresponding reported performance values for diagnostic accuracy or specific imaging quality metrics. Instead, it focuses on demonstrating substantial equivalence in diagnostic quality.

Acceptance Criteria (Implied)	Reported Device Performance
Image quality for proposed indications (head, neck, ENT, maxillofacial) is diagnostically acceptable.	Clinical images acquired with Orthopantomograph OP300 were reviewed by qualified clinicians and found to be of acceptable quality for the proposed indications for use.
Diagnostic quality of images is equivalent to predicate device Scanora 3D (K110839).	An image comparison study demonstrated that images from the Orthopantomograph OP300 from ENT, airway, and maxillofacial areas are of equivalent diagnostic quality as images from the predicate device Scanora 3D.
Adherence to relevant safety and performance standards (Biocompatibility, EMC, Electrical Safety).	Passed biocompatibility evaluation (ISO 10993-5, ISO 10993-10). Met requirements in IEC 60601-1, IEC 60601-1-6, IEC 62366, IEC 60601-2-63, IEC 60601-2-28, IEC 60601-1-2, and IEC 60601-1-3.
Minor differences in technical characteristics do not negatively affect device performance or raise new safety/effectiveness concerns.	Differences in technical characteristics are "so small that they do not have any effect on the device performance in practice." The slightly bigger Field-of-View "does not negatively affect imaging of the intended anatomical structures and does not affect substantial equivalence of the device."

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

The text mentions an "image comparison study" and "clinical images acquired using Orthopantomograph OP300." However, it does not specify the sample size for the test set or the provenance (country of origin, retrospective/prospective) of the data used in these studies.

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)

The text states that "clinical images acquired using Orthopantomograph OP300 were reviewed by qualified clinicians" and that the image comparison study involved "images from ENT, airway and maxillofacial areas." However, it does not specify the number of experts used or their specific qualifications (e.g., number of years of experience, specific board certifications).

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

The text does not provide any information about the adjudication method used for establishing ground truth or evaluating images in the mentioned studies. It simply states that images were "reviewed by qualified clinicians."

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

The document describes an "image comparison study of predicate device Scanora 3D and proposed device Orthopantomograph OP300 images." This suggests a comparative study between devices rather than a human-in-the-loop study with AI assistance. The device is an X-ray imaging system, not an AI-powered diagnostic tool. Therefore, an MRMC comparative effectiveness study involving AI assistance for human readers is not applicable and was not reported.

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

This point is not applicable as the Orthopantomograph OP300 is an imaging device, not an AI algorithm. Its performance is evaluated based on the quality of the images it produces for human interpretation, not as a standalone diagnostic algorithm.

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

The ground truth for the "acceptable quality" and "equivalent diagnostic quality" seems to be established through expert clinical review and comparison. There is no mention of pathology or outcomes data being used as ground truth for image quality assessments in the provided text.

8. The sample size for the training set

The document makes no mention of a "training set" as it describes an X-ray imaging device, not an AI model that requires training. The studies mentioned are focused on design verification, validation, and clinical image quality assessment.

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

As there is no mention of a training set, the establishment of ground truth for a training set is not applicable.

Summary

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Public Health Service

Image /page/0/Picture/2 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" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with a flowing, abstract design connecting them.

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

August 31, 2017

PaloDEx Group Oy % Mr. Eric Schwandt Regulatory Manager Nahkelantie 160 Tuusula. FI-04300 FINLAND

Re: K163423

Trade/Device Name: Orthopantomograph OP300 Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: OAS Dated: July 24, 2017 Received: August 3, 2017

Dear Mr. Schwandt:

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

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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.

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 (DICE) 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. 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 (DICE) 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,

Michael D. O'Hara

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) K163423

Device Name Orthopantomograph OP300

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)X Prescription Use (Part 21 CFR 801 Subpart 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.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

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Image /page/3/Picture/0 description: The image shows the words "Palodex Group" in a simple, sans-serif font. The word "Palodex" is in a larger font size and is positioned above the word "Group". The word "Group" is slightly offset to the right compared to "Palodex".

510(k) SUMMARY for Orthopantomograph OP300

Submitter Information:

Palodex Group Oy Nahkelantie 160 FI-04300 Tuusula Finland

Contact Person:	Eric Schwandt
Telephone Number:	+358 10 270 2000
Fax Number:	+358-10-270 5263

Date Prepared:	November 17, 2016
Updated:	July 21, 2017

Device Name:

Proprietary Name:	Orthopantomograph OP300
Common Name:	X-ray, Tomography, Computed, Dental
Classification Name:	Computed tomography x-ray system
CFR Number:	892.1750
Device Class:	II
Product Code:	OAS

Predicate Devices:

Proprietary Name:	Scanora 3D
510(k) Number	K110839
Common Name:	X-ray, Tomography, Computed, Dental
Classification Name:	Computed tomography x-ray system
CFR Number:	892.1750
Device Class:	II
Product Code:	OAS

Proprietary Name:	Orthopantomograph OP300
510(k) Number	K133544
Common Name:	X-ray, Tomography, Computed, Denta
Classification Name:	Computed tomography x-ray system
CFR Number:	892.1750
Device Class:	II
Product Code:	OAS

PaloDEx Group Oy

. Street address
Nahkelantie 160 04300 Tuusula Finland

Postal address
P.O. Box 64 ● FI-04301 Tuusula
Finland

Phone
+358 10 270 2000 VAT

BI code FI19774137 1977413-7

Bank Nordea Bank SWIFT NDEAFIHH

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Description of Device

Indications for Use:

	Proposed DeviceOrthopantomograph OP300	Predicate DeviceScanora 3D(K110839)	Predicate DeviceOrthopantomographOP300 (K133544)
Indications for use	The OrthopantomographOP300 panoramic,cephalometric and conebeam computed tomographyx-ray device is intended toimage the head and neckareas for diagnostic support.This includestemporomandibular Joints(TMJs) anddentomaxillofacial areas, andwith the 13x15 cm field ofview (FOV) this additionallyincludes the ear, nose andthroat (ENT) regions. The x-ray device producesconventional 2D x-ray imagesand x-ray projection imagesfor the reconstruction of a 3Dview. The device is operatedand used by qualifiedhealthcare professionals.	Scanora 3D is a ConeBeam 3D x-ray system forimaging the head and neckareas, including the ENTand dentomaxillofacialareas, for use in diagnosticsupport. Dedicatedpanoramic imaging is anoption. A flat paneldetector is used to acquire3D images and an optionalCCD sensor to acquirepanoramic images. Thedevice is operated andused by qualifiedhealthcare professionals.	The OP300 dentalpanoramic, cephalometricand cone beam computedtomography x-ray deviceis intended for dentalradiographic examinationof teeth, jaw and TMJareas by producingconventional 2D x-rayimages as well as x-rayprojection images of anexamined volume for thereconstruction of a 3Dview. The device isoperated and used byqualified healthcareprofessionals.

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Image /page/5/Picture/0 description: The image shows the text "Palodex Group". The word "Palodex" is in a larger font size and is placed above the word "Group". The word "Group" is in a smaller font size and is placed to the right of the word "Palodex".

Technological Characteristics Comparison

	Proposed Device	Predicate Device	Predicate Device
	Orthopantomograph OP300	Scanora 3D (K110839)	Orthopantomograph OP300 (K133544)
Imaging modes	Panoramic, Cephalometric, TMJ 3D	Panoramic, TMJ 3D	Panoramic, Cephalometric TMJ 3D
x-ray source	3D mode: 90kVPan mode: 57-90 kVCeph mode: 60-90 kVkV accuracy: +/-5kVmA range: 3.2-16 mA3D power mode: pulsed	3D mode: 85 kVPan mode: 60-81 kVkV accuracy:+/-5 kVmA range: 1-8 mAPower mode: pulsed	3D mode: 90kVPan mode: 57-90 kVCeph mode: 60-90 kVkV accuracy: +/-5kVmA range: 3.2-16 mA3D power mode: pulsed
Focal spot	0.5mm	0.5 mm	0.5mm
Image detector(s)	CMOS Flat Panel + CMOS for pan/ceph imaging	CMOS Flat Panel + CCD for panoramic imaging	CMOS Flat Panel + CMOS for pan/ceph imaging
3D imaging technique	Reconstruction from 2D images	Reconstruction from 2D images	Reconstruction from 2D images
3D's Field Of View	40 x 60 mm50 x 50 mm61 x 78 mm78 x 78 mm78 x 150 mm130 x 150 mm	50 x 50 mm60 x 60 mm75 x 100 mm75 x 145 mm130 x 145 mm	40 x 60 mm50 x 50 mm61 x 78 mm78 x 78 mm78 x 150 mm130 x 150 mm
Available 3D Programs	Field of View	Resolution	Field of View	Resolution	Field of View	Resolution
	40 x 60 mm50 x 50 mm	Low Dose, Standard, High, Endo	50 x 50 mm60 x 60 mm75 x 100 mm75 x 145 mm130 x 145 mm	Standard, High	40 x 60 mm50 x 50 mm	Low Dose, Standard, High, Endo
	61 x 78 mm78 x 78 mm78 x 150 mm130 x 150 mm	Low Dose, Standard, High			61 x 78 mm78 x 78 mm78 x 150 mm130 x 150 mm	Low Dose, Standard, High
3D's total viewing angle	212 degrees	360 degrees	200 degrees
Pixel size	CMOS flat panel for 3D: 200 μmCMOS for panoramic imaging: 100 μm	CMOS Flat panel for 3D: 200 μmCCD for panoramic imaging: 96 μm	CMOS flat panel for 3D: 200 μmCMOS for panoramic imaging: 100 μm
Voxel size	85-420 μm	133-350 μm	85-420 μm

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Image /page/6/Picture/0 description: The image shows the words "Palodex Group" in black font. The word "Palodex" is on the top line and is in a larger font than the word "Group" which is on the second line. The word "Group" is slightly offset to the right.

Reconstructiontechnique	Filtered Back Projection(FBP) orAlgebraic ReconstructionTechnique (ART)	Filtered Back Projection(FBP) orAlgebraic ReconstructionTechnique (ART)	Filtered Back Projection(FBP) orAlgebraic ReconstructionTechnique (ART)
3D's effectiveexposure time	1.2 - 12.6 sec	2.25 - 6 sec	1.2 - 12.5 sec
3D reconstructiontime	1-3 min	1 - 5 min	1-3 min
Software Version	OP300 Firmware: 1.28OP300 GUI: 1.9	Not Known	OP300 Firmware: 1.21OP300 GUI: 1.9
Patient's position	Standing and wheelchair	Sitting	Standing and wheelchair
System footprint	H161-241cm x D1390cm xW97-193 cm	H 196 cmD 110 cmW 154 cm	H161-241cm x D1390cm xW97-193 cm

The proposed Orthopantomograph OP300 also shares the same architectural components and principle of operation as the predicate device Scanora 3D (K110839) including:

An X-ray source on a motorized rotating unit a.
b. Collimation of X-ray
2D and 3D image detection C.
Image reconstruction techniques ರ.
Interfaces to 2D and 3D (3rd party) image acquisition software e.

The technical characteristics of the proposed device and predicate devices, including imaging technology, available Field of Views, technical resolution and other basic technological characteristics are substantially equivalent. Differences in technical characteristics are so small that they do not have any effect on the device performance in practice. As evidenced through the design verification and validation, the proposed Orthopantomograph OP300 can produce 3D images of the maxillofacial (including ENT and airway) areas and the images are of equivalent diagnostic quality as the images with the predicate device Scanora 3D. The slightly bigger Field-of-View of the proposed Orthopantomograph OP300 compared to predicate device Scanora 3D does not neqatively affect imaging of the intended anatomical structures and does not affect substantial equivalence of the device.

Non-Clinical Performance Data

As part of the design control activities, the Orthopantomograph OP300 device has successfully passed design verification and validation. The substantial equivalence of the proposed Orthopantomograph OP300 for the proposed indications for use has been substantiated via an image comparison study of predicate device Scanora 3D and proposed device Orthopantomograph OP300 images from ENT, airway and maxillofacial areas.

Biocompatibility evaluation was conducted on patient contacting accessory parts and their material and found to be in conformance with ISO 10993-5 and ISO 10993-10.

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Image /page/7/Picture/0 description: The image shows the words "Palodex Group" in black font. The word "Palodex" is on the top line and is in a larger font than the word "Group" which is on the second line. The word "Group" is slightly offset to the right compared to the word "Palodex".

EMC and Electrical Safety testing were performed by 30 party test house and found to meet all the requirements in standards IEC 60601-1: 2005. IEC 60601-1-6:2013. IEC 62366:2014. IEC 60601-2-63:2012. IEC 60601-2-28:2010. IEC 60601-1-2:2007. and IEC 60601-1-3:2013.

Clinical Performance Data:

Clinical images acquired using Orthopantomograph OP300 were reviewed by qualified clinicians to be of acceptable quality for the proposed indications for use.

Conclusion as to Substantial Equivalence

The indications for use for the proposed device Orthopantomograph OP300 include imaging of head and neck, and ENT. The proposed device has been verified and validated to satisfy the requirements derived from the proposed indications for use. Indications for use of proposed device Orthopantomograph OP300 including imaging of head and neck, and ENT are similar to predicate device Scanora 3D (K110839). As evidenced through the design verification and validation, the proposed Orthopantomograph OP300 can produce 3D images of the maxillofacial (including ENT) areas and the images are of equivalent diagnostic quality as the images with the predicate device Scanora 3D.

Based on the comparison of intended use, principles of operation, technological characteristics, nonclinical and clinical performance data, the minor differences between the proposed Orthopantomograph OP300 with expanded indications for use, and the predicate devices. Scanora 3D (K110839) and Orthopantomograph OP300 (K133544), do not raise new concerns regarding safety and effectiveness for the proposed indications of use. We conclude that the proposed device Orthopantomograph OP300 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.