The OP300 dental panoramic, cephalometric and cone beam computed tomography x-ray device is intended for dental radiographic examination of teeth, jaw and TMJ areas by producing conventional 2D x-ray images as well as x-ray projection images of an examined volume for the reconstruction of a 3D view. The device is operated and used by qualified healthcare professionals.

Device Description

The Orthopantomograph OP300 is an extra oral source dental x-ray device that is softwarecontrolled which produces conventional digital 2D panoramic, cephalometric and TMJ x-ray images as well as digital x-ray projection images taken during cone beam rotations around a patient's head. The projection images are reconstructed to be viewed in 3D by a 3D viewing software.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a modified dental X-ray device, the OP300. The submission aims to demonstrate substantial equivalence to a predicate device (also an OP300, K122018) rather than presenting a novel device that requires extensive clinical studies. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are focused on engineering and bench testing, demonstrating that the modifications do not negatively impact safety or effectiveness.

Here's an analysis based on the provided text, recognizing that this is a 510(k) submission for a modification, not a de novo device requiring broad clinical trials:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by complying with recognized consensus standards and demonstrating equivalent image quality and performance to the predicate device through bench testing.

Acceptance Criteria Category	Specific Criteria / Standard	Reported Device Performance (Modified OP300)
Image Quality Equivalence	No significant differences in image quality compared to the predicate OP300 (K122018)	Concluded that there are no significant differences in image quality.
Sensor Performance Equivalence	Equivalent sensor performance to the predicate OP300 (K122018)	Concluded that there are no significant differences in sensor performance.
Compliance with Consensus Standards	IEC60601-1:1988 (Medical electrical equipment - Part 1: General requirements for safety)	Compliant
	IEC60601-1-2:2001 (Medical electrical equipment - Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests)	Compliant
	IEC 60601-1-3:1994 (Medical electrical equipment - Part 1-3: General requirements for safety - Collateral Standard: General requirements for radiation protection in diagnostic X-ray equipment)	Compliant
	IEC60601-1-4:1996 (Medical electrical equipment - Part 1-4: General requirements for safety - Collateral standard: Programmable electrical medical systems)	Compliant
	IEC 60601-2-7:1998 (Medical electrical equipment - Part 2-7: Particular requirements for the safety of high-voltage generators of diagnostic X-ray generators)	Compliant
	IEC 60601-2-28:1993 (Medical electrical equipment - Particular requirements for the safety of X-ray source assemblies and X-ray generators for medical diagnosis)	Compliant
	IEC 60601-2-32:1994 (Medical electrical equipment - Part 2-32: Particular requirements for the safety of associated equipment of X-ray equipment)	Compliant
Anthropomorphic Phantom Evaluation	Produce images without severe defects in 3D imaging mode.	Demonstrated capability of producing images without severe defects.
Software Validation	Successful validation of GUI software to incorporate new features (FOVs, low-dose mode).	Successfully verified and validated.
Safety and Effectiveness	Ensure the safety and effectiveness of the device (overall).	Successfully verified and validated.

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

Test Set Sample Size:
- For image quality and sensor performance, the testing involved comparing the modified OP300 against the predicate OP300 (K122018). The specific number of images or runs is not explicitly stated, but it was "in-house Performance (bench) testing."
- For the anthropomorphic phantom evaluation, it involved "images of an anthropomorphic phantom." The number of images is not specified.
- Clinical images of patients were explicitly not used to support substantial equivalence.
Data Provenance: The testing was "in-house" bench testing, conducted by the manufacturer (PaloDEx Group Oy) in Finland. This indicates internal, controlled testing, not necessarily independent third-party validation. The data is retrospective in the sense that it's comparing a new version to an existing (predicate) version's performance characteristics.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

No external experts or clinicians were explicitly stated as establishing ground truth for the bench test set. The evaluation of "image quality" and "sensor performance" likely relied on internal engineering and quality control staff, comparing objective metrics and potentially subjective assessments by qualified personnel. The statement "it was concluded that there is no significant differences in image quality" implies an internal assessment.

4. Adjudication Method for the Test Set

No formal adjudication method (like 2+1 or 3+1 by multiple experts) is mentioned, as clinical data was not used. The determination of "no significant differences" in image quality and sensor performance appears to be a conclusion drawn from the in-house bench testing results.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

No MRMC comparative effectiveness study was conducted. The submission explicitly states: "Sample clinical images of patients were not used to support substantial equivalence of the OP300 device." This means there was no human reader component to the "effect size of how much human readers improve with AI vs without AI assistance" as there is no AI assistance feature discussed in the submission, and no human reader study.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

The device is an imaging system, not an algorithm being validated in isolation. The "standalone" performance relates to its ability to produce images compliant with standards and equivalent to the predicate, which was assessed through bench testing. The reconstruction software (FBP or ART) operates in a "standalone" fashion to generate the 3D view from 2D projections, but its performance was evaluated in terms of image quality metrics from the phantom, not through a separate algorithm-only study.

7. The Type of Ground Truth Used

The "ground truth" for this 510(k) submission primarily relies on:

Engineering benchmarks and specifications: Adherence to the technical parameters and performance characteristics established for the predicate device.
Consensus Standards: Compliance with recognized international standards (IEC 60601 series).
Anthropomorphic phantom images: The "truth" for these images is the known anatomical/radiological features within the phantom, and the assessment looked for "severe defects" rather than diagnosing a specific condition.

8. The Sample Size for the Training Set

This submission is for a device modification (hardware and GUI changes), not a new algorithm that requires a separate training set. The device uses established image reconstruction techniques (FBP, ART) which do not involve deep learning or AI requiring a "training set" in the modern sense. Therefore, there is no mention of a training set sample size.

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 to this submission.

Summary

{0}------------------------------------------------

MAR 2 6 2014

Page 1 of 4
K133544

510(k) Summary

Date: October 25th, 2013 Revised: 4th Febuary, 2014

Manufacturer:

PaloDEx Group Ov Nahkelantie 160 Tuusula, Finland 04300

Tel: +358 10 270 2000 Fax: +358 9 701 5263

Contact person: Mr. Terho Turkumäki, Tel +358 50 320 9113

Trade Name:

OP300

Common Name:

Dental panoramic, cephalometric and cone beam computed tomography x-ray device

Classification Name:

x-ray, tomography, computed, dental (21 CFR § 892.1750, product code OAS)

Description:

Indication for Use:

Intended Use:

The intended use of the OP300 is for dental radiographic examination of teeth, jaw and TMJ areas by producing conventional 2D x-ray images as well as x-ray projection images of an examined volume for the reconstruction of a 3D view.

{1}------------------------------------------------

Summary of Technological Characteristics:

OP300 is substantially equivalent in design, composition and function to the current OP300 unit.

	Concept	OP300 (K122018)	OP300 (Modified)
1.	Indications for use	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.	Same
2.	Imaging modes	Panoramic, Cephalometric, TMJ, 3D	Same
3.	X-ray source	3D mode: 90kVPan mode: 57-90 kVCeph mode: 60-90 kVkV accuracy: +/-5kVmA range: 3.2-16 mA3D power mode: pulsed	Same
4.	Focal spot	0.5mm	Same
5.	Image detector(s)	CMOS Flat Panel+ CMOS for pan/ceph imaging	Same
6.	3D imaging technique	Reconstruction from 2D images	Same
7.	3D's Field Of View	61 x 41 mm61 x 78 mm	50 x 50 mm61 x 78 mm78 x 78 mm78 x 150 mm130 x 150 mm
8.	3D's total viewing angle	200 degrees	Same
9.	Pixel size	CMOS flat panel for 3D: 200 μmCMOS for panoramic imaging: 100 µm	Same
10	Voxel size	80-350 µm	80-600 µm
11	Reconstruction Software	Filtered Back Projection (FBP) orAlgebraic Reconstruction Technique(ART)	Same
12	3D's effective exposure time	2 - 20 sec	Same
13	3D Reconstruction Time	1-3 min	Same
14	Patient's Position	Standing and wheelchair	Same
15	System footprint	H161-241cm x D1390cm x W97-193cm	Same
16	Weight	Pan/3D 205 kg	Same

{2}------------------------------------------------

The differences between the Predicate Device OP300 (K122018), and the modified device are the following:

New panel and Field of Views: The small size 3D CMOS flat panel sensor (10x7) used in the Predicate Device OP300 (K122018) is replaced with a medium size CMOS flat panel sensor (12x12), This brings new bigger Field of View (FOV) sizes for the user. The new 3D programs to support the new FOV -sizes are: 50 x 50 mm. 61 x 78 mm (as in the Predicative Device), 78 x 78 mm. 78 x 150 mm and 130 x 150 mm.

Modified beam-limiting device is introduced to support the new FOV -sizes. Sliding aperture plate has been modified to consist of 3 apertures to allow the usage of new FOVs, instead of 1 aperture in the Predicative Device. Control principle remains the same as the predicate device.

The GUI software that is operated through the touch screen control panel has been modified to incorporate the changes to the imaging programs. Each new FOV -size has a new selection button in the updated GUI.

Following the ALARA (As Low As Reasonably Achievable) principle, a very low radiation dose mode for 3D imaging is introduced. The low radiation dose mode can be used for example in treatment follow-up cases where the most accurate image quality is not needed. As the radiation dose is lower, the voxel size needs to be bigger (lower resolution) in order to keep the dose per voxel in adequate level. Voxel size is an input parameter for the 3D reconstruction calculation.

Design verification and validation has been performed to ensure the safety and effectiveness of the device.

Performance (bench) Test Data:

In- house Performance (bench) testing has been conducted to compare the image quality and the sensor performance of the proposed OP300 and the predicate OP300 according to the recommendations in the "Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices". As a result of the performance test it was concluded that there is no significant differences in image quality between the proposed and the predicate device.

The modified OP300 has been tested against FDA Recognized Consensus Standards (IEC60601-1:1988, IEC60601-1-2:2001, IEC 60601-1-3:1994, IEC60601-1-4:1996, IEC 60601-2-7:1998, IEC 60601-2-28:1993 and IEC 60601-2-32:1994). The standards used are the same standards as with the Predicate Device.

Images of an anthropomorphic phantom image for the 3D imaging mode were evaluated for the OP300 device and the predicate to demonstrate the modified device was capable of producing images without severe defects.

The modified OP300 has been successfully verified and validated to ensure the safety and effectiveness of the device.

{3}------------------------------------------------

K133544
Page 4 of 4

Clinical Test Data:

Sample clinical images of patients were not used to support substantial equivalence of the OP300 device because the primary change to the imaging chain was a change in the detector size (other detector characteristics remained the same); the bench performance testing demonstrated that the new detector options had equivalent laboratory image quality performance to the predicate.

Conclusion:

Based upon the similar technological/performance characteristics to the predicate device and the successful validation of the OP300 software, the clinical performance of the OP300 is deemed to be substantially equivalent to the predicate devices.

The OP300 has been successfully verified and validated to ensure the safety and effectiveness of the device.

{4}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/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 an abstract symbol resembling an eagle or bird in flight, composed of three stylized lines.

Public Health Service

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

March 26, 2014

PaloDex Group Oy % Mr. Terho Turkumäki OA&RA Manager Nahkelantie 160 O4300 Tuusula FINLAND

Re: K133544 Trade/Device Name: OP300 Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: OAS Dated: February 20, 2014 Received: February 24, 2014

Dear Mr. Turkumäki:

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 10 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.

{5}------------------------------------------------

Page 2-Mr. Turkumäki

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.lda.gov/Medicall.cevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/McdicalDevices/Safety/ReportaProblem/dcfault.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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

for

Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

{6}------------------------------------------------

Indications for Use

510(k) Number (if known): K133544

Device Name: OP300

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

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

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

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

$(m,h,7)$

(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health

K | 33544 510(k) =======================================================================================================================================================================

Page 1 of 1

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.