ORTHOPANTOMOGRAPH™ OP 3D is an x-ray device that is intended to be used for imaging of adult and pediatric patients. The device can be configured to take panoramic, cephalometric, or 3D images of the cranio-maxillofacial complex for use in diagnostic support. The device can also be configured to take carpus images.

ORTHOPANTOMOGRAPH™ OP 3D must only be used and operated by dentist and other qualified professionals.

Device Description

ORTHOPANTOMOGRAPH™ OP 3D x-ray unit is a software controlled diagnostic dental X-ray equipment for producing panoramic, cephalometric and 3D images of the cranio-dentomaxillofacial complex of patient head. The ORTHOPANTOMOGRAPH™ OP 3D has panoramic programs (adult, pediatric, TMJ, bitewing and partial), cephalometric programs (lateral and PA, also including carpus imaging) and 3D (CBCT) programs with different 3D Field of View configurations. The components of the device include column, carriage, rotating unit (containing tube head, sensors and collimator), upper shelf, patient head support, ceph attachment (containing ceph tube head and patient support) and driver software including image reconstruction. Workstation software for viewing the images is not included in this submission.

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 is a 510(k) summary for the ORTHOPANTOMOGRAPH™ OP 3D, a medical device. It focuses on demonstrating substantial equivalence to a predicate device (ORTHOPANTOMOGRAPH™ OP300) rather than presenting a study proving a device meets specific acceptance criteria based on its performance against a defined ground truth.

Therefore, the document does not contain the specific information required to complete the detailed table and answer most of your questions regarding acceptance criteria and performance studies where an AI or algorithm's diagnostic performance is being evaluated. The submission is for an imaging device, and the "performance data" mentioned refers to engineering and quality assurance testing (electrical, mechanical, safety, EMC, biocompatibility, software level of concern), and subjective review of bench test images, not a clinical diagnostic performance study of the images themselves.

Here's what can be extracted and what cannot:

What can be extracted:

1. A table of acceptance criteria and the reported device performance: This document does not provide a table of performance-based acceptance criteria for diagnostic accuracy (e.g., sensitivity, specificity, AUC) or human reader improvement with AI. Instead, it compares technical characteristics to a predicate device. The "performance" mentioned refers to engineering and quality assurance tests.
Conclusion as to Substantial Equivalence: The document states: "The proposed device does not introduce a fundamentally new scientific technology and the nonclinical tests demonstrate that the device is substantially equivalent with regards to safety and effectiveness. All internal verification and validation has been completed successfully." This is the general "acceptance" for the 510(k) submission: proving substantial equivalence, not meeting specific quantitative performance metrics for diagnostic accuracy.

What cannot be extracted (as per the document):

2. Sample sized used for the test set and the data provenance: Not applicable in the context of diagnostic performance. The document mentions "bench test images acquired using ORTHOPANTOMOGRAPH OP™ 3D." No sample size or provenance for this set is given, and it's for subjective quality review, not a formal test set for diagnostic accuracy.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: The document states "bench test images acquired using ORTHOPANTOMOGRAPH OP™ 3D was reviewed by qualified clinicians to be of acceptable quality for the proposed Intended Use." It does not specify the number or qualifications of these clinicians, and this is for subjective image quality, not establishing diagnostic ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done: "No clinical images were utilized for this submission. Clinical data was not needed to support substantial equivalence." This means no MRMC study or any clinical performance study was conducted or submitted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is an imaging device, not an AI/algorithm for diagnostic interpretation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. "Bench test images" were subjectively reviewed for "acceptable quality."
8. The sample size for the training set: Not applicable, as this is an imaging device, not an AI/algorithm that requires a training set.
9. How the ground truth for the training set was established: Not applicable.

Summary based on the provided text:

This 510(k) pertains to a Computed Tomography X-ray system (ORTHOPANTOMOGRAPH™ OP 3D). The acceptance criteria for this type of submission are primarily demonstrating substantial equivalence to a predicate device (ORTHOPANTOMOGRAPH™ OP300) in terms of intended use, technological characteristics, and safety/effectiveness through non-clinical (engineering, design verification, and validation) testing. It explicitly states that no clinical performance data or images were utilized for this submission and "Clinical data was not needed to support substantial equivalence." Therefore, the document does not describe a study proving the device meets acceptance criteria related to diagnostic performance, AI accuracy, or human reader improvement with AI assistance.

The closest thing to "acceptance criteria" and "performance" described are:

Acceptance Criteria Category (Implied by 510k)	Reported Device Performance (as stated)
Safety & Electrical Standards:	Successfully passed internal design verification and validation. Electrical, mechanical, safety testing (IEC 60601-1, -1-6, -2-63, -2-28, -1-3) and EMC testing (IEC 60601-1-2:2014) were performed by a 3rd party test house. Result: The proposed ORTHOPANTOMOGRAPH™ OP 3D has passed all tests.
Biocompatibility:	Biocompatibility evaluation conducted on patient contacting accessory parts and their material. Result: Found to be in conformance with ISO 10993-1.
Software Quality:	Software categorized as Moderate Level of Concern and documented according to Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.
Image Quality (Subjective Review):	Bench test images acquired using ORTHOPANTOMOGRAPH OP™ 3D was reviewed by qualified clinicians. Result: Found to be of acceptable quality for the proposed Intended Use.
Substantial Equivalence:	No significant differences between proposed and predicate device. Minor differences shown not to affect substantial equivalence. Proposed device does not introduce fundamentally new scientific technology. Nonclinical tests demonstrate substantial equivalence with regards to safety and effectiveness. Result: All internal verification and validation has been completed successfully, leading to a finding of substantial equivalence to ORTHOPANTOMOGRAPH™ OP300 (K133544).

The document does not relate to an AI device or a comparative effectiveness study involving human readers and AI assistance. It describes the regulatory submission for an X-ray imaging system.

Summary

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June 7th, 2018

PaloDEx Group Oy % Terho Turkumaki QA&RA Manager Nahkelantie 160 Tuusula. 04300 FINLAND

Re: K180947

Trade/Device Name: ORTHOPANTOMOGRAPH OP 3D Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: Class II Product Code: OAS Dated: April 6, 2018 Received: April 11, 2018

Dear Terho Turkumaki:

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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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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K180947

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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice

(https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Jeff Balyer

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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Indications for Use

510(k) Number (if known) K180947

Device Name ORTHOPANTOMOGRAPH™ OP 3D

Indications for Use (Describe)

ORTHOPANTOMOGRAPH™ OP 3D is an x-ray device that is intended to be used for imaging of adult and pediatric patients. The device can be configured to take panoramic, or 3D images of the cranio-maxillofacial complex for use in diagnostic support. The device can also be configured to take carpus images.

ORTHOPANTOMOGRAPH™ OP 3D must only be used and operated by dentist and other qualified professionals.

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

☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image shows the logo for Palodex Group. The word "Palodex" is written in a large, bold, sans-serif font. Below and to the right of "Palodex" is the word "Group" in a smaller font. The logo is simple and clean, with a focus on the company name.

510(k) SUMMARY for ORTHOPANTOMOGRAPH™ OP 3D

Submitter Information:

Palodex Group Oy Nahkelantie 160 FI-04300 Tuusula Finland

Contact Person:	Terho Turkumäki
Telephone Number:	+358 10 270 2000
Fax Number:	+358 50 320 9113
Date Prepared:	April 6, 2018

Device Name:

Proprietary Name: Common Name: CFR Number: Device Class: Product Code:

ORTHOPANTOMOGRAPH™ OP 3D X-ray, Tomography, Computed, Dental Classification Name: Computed tomography x-ray system 892.1750 -OAS

Predicate Device:

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

Description of Device

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The following guidances were followed when preparing this 510k submission:

-Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, May 11, 2005

-Guidance for Industry and FDA Staff: Premarket Assessment of Pediatric Medical Devices, November 28, 2017.

-Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices, September 1, 2016 -Guidance for Industry and Food and Drug Administration Staff: Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically-Powered Medical Devices. July 11, 2016. -Guidance for Industry, FDA Reviewers and Compliance on Off-The-Shelf Software Use in Medical Devices, September 9, 1999

-Guidance for the Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, October 2, 2014"

-FDA Guidance "Use of International Standard ISO 10993-1, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a Risk management process".

	Concept	Proposed device(ORTHOPANTOMOGRAPHTMOP 3D)	Predicate device(ORTHOPANTOMOGRAPHTMOP300, K133544)
1.	Indications for Use/Intended Use	ORTHOPANTOMOGRAPHTM OP 3Dis an x-ray device that is intended tobe used for imaging of adult andpediatric patients. The device can beconfigured to take panoramic,cephalometric, or 3D images of thecranio-maxillofacial complex for usein diagnostic support. The device canalso be configured to take carpusimages.ORTHOPANTOMOGRAPHTM OP 3Dmust only be used and operated bydentist and other qualifiedprofessionals.	The OP300 dental panoramic,cephalometric and cone beamcomputed tomography x-ray device isintended for dental radiographicexamination of teeth, jaw and TMJareas by producing conventional 2D x-ray images as well as x-ray projectionimages of an examined volume for thereconstruction of a 3D view. Thedevice is operated and used byqualified healthcare professionals.
2.	Imaging modes	Panoramic, TMJ, BW, 3D (CBCT),cephalometric	Panoramic, TMJ,BW, 3D (CBCT),Cephalometric
3.	X-ray source	3D mode: 95kVPan mode: 60-90 kVCeph mode: 60-95kVkV accuracy: +/-5kVmA range: 1-16 mA3D power mode: continuous/pulsed	3D mode: 90kVPan/ceph mode: 57-90 kVkV accuracy: +/-5kVmA range: 3.2-16 mA3D power mode: continuous/pulsed
4.	Focal spot	0.5mm	0.5mm
5.	Image detector(s)	three detectors (3D flat panel, panand ceph)	three detectors (3D flat panel, pan andceph)
5.1	CBCT imagingmode	3D CMOS Flat Panel	3D CMOS Flat Panel
5.2	Panoramic imagingmode	3D CMOS Flat Panel / CMOS pan &ceph detectors	CMOS pan & ceph detectors
5.3	Cephalometricimaging mode	CMOS ceph detector	CMOS ceph detector
6.	3D imagingtechnique	Reconstruction from 2D images	Reconstruction from 2D images
7.	3D's Field Of View	5 x 56 x 99 x 119 x 14 (optional)	5x56x88x88x1513x15 (optional)
8.	3D's total viewingangle	360°	360 °
9.	Pixel size	CMOS PAN & 3D combo flat panel:3D pixel size: 198 µmpan/ceph pixel size: 99µm	CMOS flat panel for 3D: pixel size 200 µmCMOS for pan/ceph imaging: pixel size100 µm
10.	Voxel size	80-400 µm	85-420 µm
11.	ReconstructionSoftware	Filtered Back Projection (FBP)	Filtered Back Projection (FBP)
12.	3D's effectiveexposure time	1,7 - 20 s	1.2 - 12.5 s
13.	Ceph exposuretime Time	8.1-10.5 s	6.9-20s
14.	Patient's Position	Standing and wheelchair	Standing and wheelchair
15.	System footprint(includes theoperator)	H167-247cm x D124-149cm x W167cm	H161-241cm x D139cm x W97-193 cm
16.	Weight	App. Pan/3D 120 kgCeph 155 kg	App. Pan/3D 205 kgCeph 240 kg
17	Classification	OAS	OAS
18	3D resolution	Low, standard, high, endo	Low, standard, high, endo
19	2D imagingprograms	Adult Pan, Pediatric Pan, TMJ, BW,Segmented Pan, ceph PA/LAT,carpus	Adult Pan, Pediatric Pan, TMJ, BW,Segmented Pan, ceph PA/LAT
20	MTF @10% (5x5HiRes)	2.2lp/mm	2.25lp/mm

Description of Substantial Equivalence

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Indications for Use

ORTHOPANTOMOGRAPH™ OP 3D must only be used and operated by dentist and other qualified professionals.

The proposed ORTHOPANTOMOGRAPH™ OP 3D has similar Intended Use/Indications for Use as the predicate device ORTHOPANTOMOGRAPH™ OP300 (K133544) and is based on the already cleared ORTHOPANTOMOGRAPH™ OP 3D (K170813) intended Use statement with the addition of cephalometric imaging and the related carpus imaging is used to define the bone age and skeletal maturity for the timing of orthodontic treatment to the pubertal growth spurt.

Reference device ORTHOPHOS SL (K150217) is included to justify the usage of carpus imaging as an application of the cephalometric imaging for orthodontics.

Principle of Operation

The proposed ORTHOPANTOMOGRAPH™ OP 3D shares similar architectural components and principle of operation as the predicate device ORTHOPANTOMOGRAPH™ OP300 (K133544). Both devices utilize cone beam x-ray technology to acquire volumetric data. Conical x-ray beam rotates around the patient's head and incident upon the receptor and the system generates volumetric data from the 2D projection images, similarly to the predicate device.

The reconstruction of 3D images from 2D image data in the proposed device is made using the same reconstruction techniques as in the predicate device. Additionally the interfaces to 2D/3D image viewing software are similar. There is no substantial difference in the functionality for the data acquisition, data/image display nor integration with 2D/3D imaging software of ORTHOPANTOMOGRAPH™ OP 3D, when compared to the predicate device. The proposed and the predicate device utilize the similar format for interfacing with the 2D and/or 3D imaging software.

Technological Characteristics

The technical characteristics of the proposed device and predicate device, including imaging technology (X-ray sources and image detectors), available Field of Views, technical resolution (MTF) and other basic technological characteristics are substantially equivalent to the predicate device ORTHOPANTOMOGRAPH™ OP300. The proposed ORTHOPANTOMOGRAPH™ OP 3D can produce 2D and 3D images of the cranio-maxillofacial areas of equivalent diagnostic quality as the images with the predicate device ORTHOPANTOMOGRAPH OP300 (K133544). Differences in technical characteristics are minor and the device performance is equivalent as evidenced through verification and validation testing.

Non-Clinical Performance Data

As part of the design control activities, the ORTHOPANTOMOGRAPH™ OP 3D device has successfully passed internal design verification and validation.

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Electrical, mechanical, safety and performance testing according to standards IEC 60601-1: 2005, IEC 60601-1-6:2013, IEC 62366:2014, IEC 60601-2-63:2012, IEC 60601-2-28:2010, and IEC 60601-1-3:2007 were performed, and EMC testing was conducted in accordance with standard IEC 60601-1-2:2014. Testing was completed by 3rd party test house, and the proposed ORTHOPANTOMOGRAPH™ OP 3D has passed all tests.

Biocompatibility evaluation was conducted on patient contacting accessory parts and their material and found to be in conformance with ISO 10993-1.

Software for ORTHOPANTOMOGRAPH™ OP 3D has been categorized as Moderate Level of Concern and documented according to Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.

Bench test images acquired using ORTHOPANTOMOGRAPH OP™ 3D was reviewed by qualified clinicians to be of acceptable quality for the proposed Intended Use.

Clinical Performance Data

No clinical images were utilized for this submission. Clinical data was not needed to support substantial equivalence.

Conclusion as to Substantial Equivalence

There are no significant differences between the proposed ORTHOPANTOMOGRAPH™ OP 3D and predicate ORTHOPANTOMOGRAPH™ OP300 (K133544). Minor differences have been shown not to affect the substantial equivalence of the device.

The proposed device does not introduce a fundamentally new scientific technology and the nonclinical tests demonstrate that the device is substantially equivalent with regards to safety and effectiveness. All internal verification and validation has been completed successfully.

In summary, the proposed ORTHOPANTOMOGRAPH™ OP 3D device is substantially equivalent to the predicate ORTHOPANTOMOGRAPH™ OP300 device.

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.