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 extraoral source, software-controlled dental x-rav device 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 does not contain detailed information about specific acceptance criteria (performance metrics with thresholds) for the OP300 device, nor does it detail a comprehensive study designed to prove the device meets such criteria. Instead, it focuses on demonstrating substantial equivalence to a predicate device.

Here's an analysis based on the available text:

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

The document does not explicitly state quantitative acceptance criteria in terms of performance metrics with specific thresholds (e.g., accuracy > 90%, sensitivity > 85%). Instead, it establishes "substantial equivalence" based on similar technological characteristics. The table provided focuses on comparing the design and function of the modified OP300 to its predicate (OP300 [K093683]).

Concept	OP300 (Modified) Performance	Acceptance Criteria (Implicit: Substantial Equivalence to Predicate)
Indications for Use	Dental radiographic examination of teeth, jaw, and TMJ areas; produces conventional 2D x-ray images and x-ray projection images for 3D reconstruction.	Same as predicate
Imaging modes	Panoramic, Cephalometric, TMJ, 3D	Same as predicate
X-ray source	3D: 90kV; Pan: 57-90 kV; Ceph: 60-90 kV; kV accuracy: +/-5kV; mA range: 3.2-16 mA; 3D power: pulsed	Close match to predicate (mA range for predicate is 2-16 mA, modified is 3.2-16 mA, which is within the predicate's range)
Focal spot	0.5mm	Same as predicate
Image detector(s)	CMOS Flat Panel + CMOS for pan/ceph imaging	Same as predicate
3D imaging technique	Reconstruction from 2D images	Same as predicate
3D's Field Of View	61 x 41 mm, 61 x 78 mm	Same as predicate
3D's total viewing angle	200 degrees	Same as predicate
Pixel size	CMOS flat panel for 3D: 200 um; CMOS for panoramic imaging: 100 um	Same as predicate
Voxel size	80-350 µm	Same as predicate
Reconstruction Software	Filtered Back Projection (FBP) or Algebraic Reconstruction Technique (ART)	Predicate used Algebraic Reconstruction Technique (ART). The modified device includes FBP as an additional option, which is noted in the non-clinical data as widely used.
3D's effective exposure time	2.3 - 12.5 sec	Predicate: 2 - 20 sec (modified device falls within this range)
3D Reconstruction Time	1-3 min	Same as predicate
Patient's Position	Standing and wheelchair	Same as predicate
System footprint	H161-241cm x D1390cm x W97-193 cm	Same as predicate
Weight	Pan/3D 205 kg; Ceph 250 kg	Same as predicate

The "acceptance criteria" here are largely based on the new device having "Same" or "similar" (within a specified range) technological and performance characteristics as the predicate device, which is a common approach for 510(k) submissions.

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

Sample size: The document mentions a "Preference study as an image quality comparison." It states that "Same patient data was used for the reconstructions." It does not specify the number of patients or images used in this preference study.
Data provenance: Not explicitly stated. The manufacturer is based in Finland. The study is referred to as a "preference study" implying image review, but the source of the patient data (country, retrospective/prospective) is not detailed.

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)

Number of experts: The preference study involved "internal reviewers and external dental professionals." The exact number of these professionals is not specified.
Qualifications of experts: The document only refers to them as "external dental professionals" and "internal reviewers." No specific qualifications (e.g., years of experience, specialization) are provided.

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

The document does not describe the adjudication method for the preference study. It simply states that images were "evaluated by internal reviewers and external dental professionals."

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

No, an MRMC comparative effectiveness study, particularly one measuring the improvement of human readers with AI assistance, was not conducted. This device is a pure imaging system, not an AI diagnostic tool.
The "preference study" compares images from the new OP300 with its predicate. It's a reader study, but not an MRMC for AI assistance. It aims to show equivalent image quality between the devices, not human performance improvement with AI.

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

This question is less relevant to the OP300, as it is an imaging device, not an AI algorithm intended for standalone diagnostic performance.
The "standalone" performance in this context would refer to the image quality produced by the system itself. The preference study was designed to compare the image quality of the modified OP300 to the predicate, effectively assessing its standalone imaging performance.

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

For the preference study, the "ground truth" was subjective expert preference/evaluation of image quality. It was not based on objective clinical ground truth like pathology or outcomes data. This is appropriate for an image quality comparison study rather than a diagnostic accuracy study.

8. The sample size for the training set

This device does not involve a "training set" in the context of machine learning. It's an X-ray imaging device. Its algorithms (Filtered Back Projection or Algebraic Reconstruction Technique) are established methods, not 'trained' in the same way an AI model is.

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

Not applicable, as no machine learning training set is mentioned or implied for this device.

Summary

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

K122018

Attachment 7

510(k) Summary

DEC 1 0 2012

Date: November 2, 2012

Manufacturer:

PaloDEx Group Ov Nahkelantie 160 04300 Tuusula, Finland

Tel: +358 10 270 2000 Fax: +358 9 851 4048

Contact person: Mr. Matti Tulikoura, Tel +358 400 609 507

Trade Name:

OP300

Common Name:

Dental panoramic, cephalometric and cone beam computed tomography xray device

Classification Name:

Computed tomography x-ray system (21 CFR § 892.1750, product code OAS)

Description:

Intended Use:

The unit must only be used and operated by dentist and other qualified professionals. The unit must only be used to take panoramic. cephalometric and 3D images of the dento-maxillofacial complex of the human skull. It must not be used to take images of any other part of the human body.

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

Summary of Technological Characteristics:

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

··

.
1992 – 1992 – 1992 – 1992 – 1992 – 1992 – 1992 – 1992 – 1992 – 1992 – 1992 – 1992 – 1992 – 1992 – 1992 – 1992 – 1992 – 1992 – 1992 – 1992 – 1992 – 1992 – 1992 – 1992 – 199

. .

... ...

. ·

. .

. •

Concept		OP300 (Modified)	OP300 [K093683]
1.	Indications for Use	The OP300 dental panoramic,cephalometric and cone beam computedtomography x-ray device is intended fordental radiographic examination of teeth,jaw and TMJ areas by producingconventional 2D x-ray images as well as x-ray projection images of an examinedvolume for the reconstruction of a 3Dview.	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	3D mode: 90kVPan mode: 57-90 kVCeph mode: 60-90 kVkV accuracy: +/-5kVmA range: 2-16 mA3D power mode:pulsed/continuous ·
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	Same
8.	3D's total viewing angle	200 degrees	Same
9.	Pixel size	CMOS flat panel for 3D: 200 umCMOS for panoramic imaging: 100 um	Same
10.	Voxel size	80-350 µm	Same
11.	Reconstruction Software	Filtered Back Projection (FBP) orAlgebraic Reconstruction Technique (ART)	Algebraic ReconstructionTechnique (ART)
12.	3D's effective exposure time	2.3 - 12.5 sec	2 - 20 sec
13.	3D Reconstruction Time	1-3 min	Same
14.	Patient's Position	Standing and wheelchair	Same
15.	System footprint	H161-241cm x D1390cm x W97-193 cm	Same
16.	Weight	Pan/3D 205 kgCeph 250 kg	Same

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

Non-clinical Test Data:

Preference study as an image quality comparison between OP300 and the predicate device was performed. Same patient data was used for the reconstructions and the images were evaluated by internal reviewers and external dental professionals. Validations have been performed successfully to ensure the safety and effectiveness of the OP300 system.

Clinical Test Data:

Clinical testing has not been conducted on OP300 device because CBCT imaging technique and FBP algorithm are widely used. Only a preference study was conducted.

Conclusion:

Based upon the similar technological/performance characteristics to the predicate device [OP300, K093683] and the successful validation of the OP300 software, the clinical performance of the OP300 is deemed to be substantially equivalent to the predicate devices.

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird symbol. The text is in all caps and is smaller than the bird symbol.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

December 10, 2012

PaloDEx Group OY C/O Mr. Matti Tulikoura Regulatory Manager Nahkelantie 160 TUUSULA 04300 FINLAND

Re: K122018

Trade/Device Name: OP300 Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: OAS Dated: November 5, 2012 Received: November 7, 2012

Dear Mr. Tulikoura:

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.

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

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Janine M. Morris -S

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

Enclosure

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

Indications for Use

510(k) Number (if known): . K122018

Device Name: OP300

Indications for Use:

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 In Vitro Diagnostics and Radiological Health (OIR) Janine M. Morris -S 2012.12.10 12:34:35 -05'00'

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

K122018 __ 510(k)________________________________________________________________________________________________________________________________________________________________________

Page 1 of

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.