The DIGORA® Optime imaging system is indicated for capturing, digitization and processing of intra oral x-ray images stored in imaging plate recording media.

SOREDEX® DIGORA® Optime system is intended to be used only by dentist and other qualified dental professionals to process x-ray images exposed to the imaging plates from the intraoral complex of the skull.

Device Description

DIGORA® Optime (DXR-60) is a digital radiography system for intra oral imaging plates located in disposable bags. The system may be used with all x-ray equipment which is designed for intra oral radiography. The image is recorded on reusable imaging plate which substitutes for conventional xray film or digital sensor. The x-ray energy absorbed in the imaging plate remains stored as a latent image. When fed to the device the stored energy is released as an optical emission proportional to the stored energy when the imaging plate is stimulated pixel by a scanning laser. An optical system collects the emission for photo electronic system, which converts the emission to digital electronic signals. These signals are processed in a computer system which formats and stores the signals.

Further image processing, display and achieving are carried out with auxiliary software.

AI/ML Overview

Here is an analysis of the provided text regarding the DIGORA® Optime (DXR-60) device, focusing on acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document describes the DIGORA® Optime (DXR-60) as substantially equivalent to its predicate device, the DXR-50, based on design, composition, and function. The acceptance criteria essentially revolves around demonstrating that the new device is as safe and effective as the predicate, with modifications having no adverse impact.

Acceptance Criteria Category	Specific Criteria (Implicit or Explicit in Document)	Reported Device Performance (DXR-60)	Notes
Material Changes	Equivalence in functionality to DXR-50	Replaced machined aluminum with plastic components (chassis, plate carrier, door) providing equivalent functionality.	Verified/validated to have no impact on safety, effectiveness, image quality, or expected lifetime.
User Interface (UI)	Better visual communication and usability without affecting safety/efficacy	Modified control panel with relocated buttons, lighted numeric LEDs, and symbols for plate positioning, device status, and error codes.	Verified/validated to not affect safety or efficacy.
Image Processing Feature	Stitching two size 3 plates for occlusal view without affecting safety/effectiveness	"Comfort Occlusal 4C image processing ability" - two size 3 plates can be stitched; plates processed and supplied separately, then stitched.	Verified/validated to not affect safety or effectiveness, and makes the feature safe.
Safety and Effectiveness	No adverse impact on safety or efficacy from modifications	Design verification and validation demonstrated modifications did not affect safety and efficacy or raise new safety/efficacy questions.	Comprehensive testing on all applicable requirements per FDA guidance.
Image Quality	Diagnostic-quality images	Capable of providing diagnostic-quality images via anthropomorphic phantom images.	Considered appropriate due to primary target anatomy not involving moving or soft tissues of similar contrast.
Substantial Equivalence	Similar technological/performance characteristics to predicate	Deemed substantially equivalent to the predicate device (K041050) in clinical performance.	Based on similar characteristics and successful validation.

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

Test Set Sample Size:
- For the non-clinical testing, anthropomorphic phantoms were used as the "test set" to demonstrate image quality and system capability. No specific number of phantoms or images is provided, but it states "Anthropomorphic phantom images of perianical and bitewing views were provided."
- No human patient images were used for clinical testing.
Data Provenance: The testing was conducted by PaloDEx Group Oy (Manufacturer) in Tuusula, Finland. The data is non-clinical and derived from phantom images rather than retrospective or prospective human clinical data.

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

The document does not explicitly state the number of experts or their specific qualifications (e.g., radiologist with 10 years of experience) used to establish "ground truth" for the phantom images. It implies that the manufacturer's internal team determined the images were "diagnostic-quality." Given the non-clinical nature and the product (an imaging plate reader), the "ground truth" for image quality would likely be assessed against established imaging standards and anatomical correctness within the phantom.

4. Adjudication Method for the Test Set

No multi-expert adjudication method (e.g., 2+1, 3+1) is mentioned or implied, as the primary test involved non-clinical phantom images. The assessment of "diagnostic-quality" appears to be an internal verification by the manufacturer.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document explicitly states: "Clinical testing was not deemed necessary on DIGORA® Optime (DXR-60) device." Therefore, no effect size of human readers improving with AI vs. without AI assistance can be reported, as this study type was not performed and the device is an imaging plate reader, not an AI-assisted diagnostic tool.

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

The DIGORA® Optime (DXR-60) is an imaging plate reader, not an algorithm in the sense of a standalone AI diagnostic tool. Its performance is inherent in its ability to capture, digitize, and process x-ray images from imaging plates. The non-clinical tests on phantoms demonstrate this standalone functional performance (i.e., algorithm only in the sense of image processing capability, without human interpretation for diagnostic purposes as the primary outcome). The "algorithm" here refers to the system's image processing capabilities to produce an image, not an interpretative AI.

7. The Type of Ground Truth Used

The ground truth for evaluating the device's performance was:

Engineering/Technical Specification Comparisons: Comparing the DXR-60's specifications (e.g., theoretical resolution, pixel size, bit depth) against the predicate DXR-50 and demonstrating either equivalence or improvement where relevant.
Physical Phantom Images: For image quality assessment, anthropomorphic phantom images were used, with the "ground truth" being the expected anatomical structures and image characteristics represented by the phantom for "diagnostic quality."
Functional Verification/Validation: For material changes and UI modifications, the ground truth was that the changes had "no impact on safety, effectiveness, and overall performance."

8. The Sample Size for the Training Set

The concept of a "training set" is not applicable here in the context of machine learning. The DIGORA® Optime is a physical medical device (an imaging plate reader) and not an AI/ML algorithm that requires a training set of data. Its development involves traditional engineering design, testing, and validation processes, not machine learning model training.

9. How the Ground Truth for the Training Set Was Established

As explained above, there is no "training set" in the machine learning sense for this device. Therefore, no ground truth was established for a training set. The device's "training" refers to its design and manufacturing processes ensuring it meets its intended specifications and performance.

Summary

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KB3231
Page 1 of 4.

PALODEX GROUP

510(k) Summary

Date: October 10, 2013, revised February 4, 2014

PaloDEx Group O

ww.palodexeroup.com

Street nodress Nahkelantie 160 04300 Tuusula Finland

Posta! address P.O Box 6-Fl-04301 Tuusula Fininne

Phone +358 10 270 2000

Fax +358 & 851 +048

VAT F119774137

BI code 1977413-7

Barch Nordea Sank SWIFT NDEAFIHH Account F19015963000046864

Manufacturer: PaloDEx Group Oy 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: DIGORA® Optime

Common Name: Imaging plate reader

Classification Name:

872.1800 Extraoral source x-ray system. Product Code MUH.

Description:

Further image processing, display and achieving are carried out with auxiliary software.

Indications for Use:

The DIGORA® Optime imaging system is indicated for capturing, digitization and processing of intra oral x-ray images stored in imaging plate recording media.

Intended Use:

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PALODEx GROUP

Summary of Technological Characteristics:

DIGORA® Optime (DXR-60) is substantially equivalent in design, composition and function to the current DIGORA Optime unit (K041050).

PaloDEx Group Oy

www.palodexgroup.com

Streer address Nahkelantie 160 04300 Tuusula Fieland
Postal address P.O Box 64 FI-04301 Tuusula Finland

Ріюль +358 ID 270 2000

Fax +158 9 851 4048

VAT FII 977 4137

BI (ode 1977413-7

Bank Nordes Bank 5WIFT NDEAFIHH Aとくのいか F19015963000046864

	Concept	Proposed DXR-60	Predicate DXR-50(Cleared Under K041050)
1.	Theoretical resolution	16,7 lp/mm	12,5 lp/mm
2.	Image data bit depth	14-bit	14-bit
3.	Image scanning time(size 2)	6,8 s	5,1 s
4.	Pixel size (selectable)	30 µm (Super resolution)60 µm (High resolution)	40 µm (Super resolution)64 µm (High resolution)
5.	Imaging plates	0,1,2,3	0,1,2,3
6.	Operating voltage	24 VDC (External PSU100-250 V, 50/60Hz)	24 VDC (External PSU100-250 V, 50/60Hz)
7.	Laser safetyclassification	Class 1 laser productEN 60825-1:2007	Class 1 laser productEN 60825-1:2007
8.	Interface	Ethernet RJ-4510/100 Mbs LAN	Ethernet RJ-4510/100 Mbs LAN
9.	Operating environment	+10°C - +40°C, 30 - 90RH%, 700 - 1060 mbar	+10°C - +40°C, 30 - 90RH%, 700 - 1060 mbar
10.	Storage / Transportationenvironment	-10°C - +50°C, 0-90RH%, 500 - 1080 mbar	-10°C - +50°C, 0 - 90RH%, 500 - 1080 mbar
11.	IEC60601-1classification	Class 2	Class 1
12.	IP classification	IPX0	IPX0
13.	Applied part	None	None
14.	Dimensions	152 mm x 227 mm x 308mm(6.0 x 8.9 x 12.1 inches)	191 mm x 221 mm x 394mm(7.5 x 8.7 x 15.5 inches)
15.	Indications for use	The DIGORA® Optimeimaging system isindicated for capturing,digitization andprocessing of intra oral x-ray images stored inimaging plate recordingmedia.	The DIGORA® Optimeimaging system isindicated for capturing,digitization and processingof intra oral x-ray imagesstored in imaging platerecording media.
16.	Intended use	SOREDEX® DIGORA®Optime system isintended to be used onlyby dentist and otherqualified dental	The DIGORA Optimeimaging system isindicated for capturing,digitization and processingof intra oral x-ray images
		professionals to processx-ray images exposed tothe imaging plates fromthe intraoral complex ofthe skull.	stored in imaging platerecording media.
17.	Weight	3,5 kg (7.7 lb)	7 kg (15.5lb)

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PALODEX GROUP

PaloDEx Ciroup Or

.palodegroup.com

Street address Nahkelantis 160 04300 Tuusula Finland

Postal Address P.C) Box 54 FLO4301 Tuusula Furtame

Phone +358 10 270 2000

Fax +358 9 851 4048

VAT F119774137

BI code 1977413.7

Bank Nordea Bank SWIFT NDEAFIHH Account F19015963000046864

In DXR-60, representative machined aluminium components in the predicate device DXR-50 have been replaced by equivalent plastic components. This has been done as part of device evolution to support modern manufacturing techniques. The most significant components that have been modified to plastic are device chassis, plate carrier and the door. All replaced components provide equivalent functionality to the predicate device DXR-50. This functionality has undergone design verification / validation, and system testing where applicable to ensure that the material change has no impact on safety, effectiveness, and overall performance of the device including image quality and expected lifetime of the device

In DXR-60, the User interface Control Panel has been modified from DXR-50 (the predicate device) for better visual communication and usability. In addition to relocating the power and start buttons, the modifications to the User Interface control panel consist of lighted numeric LED's and other relevant symbols which depict plate positioning, device status and error codes. It has been verified and validated that this change does not affect safety or efficacy of the device.

DXR-60 has Comfort Occlusal 4C image processing ability. In DXR-60 this ability means that two size 3 plates can be stilched together to form a larger image for an occlusal view. Image plates are processes and supplied separately to the user, and also stitched together to form a single Comfort Occlusal 4C projection image. This makes this feature safe. It has been verified and validated that this feature does not affect safety or effectiveness of a device.

The results of the design verification and validation demonstrated that modifications did not affect safety and efficacy of the device or raise any new questions of safety or efficacy.

Non-clinical Test Data:

Testing was conducted to all applicable requirements according to FDA's guidance ""Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices".

Comparison between DIGORA® Optime (DXR-60) and the predicate device was performed with the same technical phantoms. Anthropomorphic phantom images of perianical and bitewing views were provided to demonstrate the system is capable of providing diagnostic-quality images. Anthropomorphic phantom images were deemed appropriate instead of human patient images because the primary target anatomy does not involve moving tissue or soft tissues of similar contrast.

Validations have been performed successfully to ensure the safety and effectiveness of the DIGORA® Optime (DXR-60) system.

Clinical Test Data:

Clinical testing was not deemed necessary on DIGORA® Optime (DXR-60) device.

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K133231
Page 4 of 24

PaloDEx Group

Conclusion:

PaloDEx Croup Oy

www.palodexg: oup.com

Street address Nahkelantie 160 04300 Tuusula Finland

Postal address P.C) Box 64 FI-04301 Tuusula Finl.ind

የነው። የ • 358 10 7 /D 2000

ﺮ ﺩﺭ +358 9 851 4048

VAT F119774137

BI ८००८: 1977413-7

Bank Nordea Bank SWJFT NDEAFIHH Account F19015963000046864 Based upon the similar technological/performance characteristics to the predicate device and the successful validation of the DIGORA Optime (K041050), the clinical performance of the DIGORA® Optime (DXR-60) is deemed to be substantially equivalent to the predicate device.

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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three wing-like shapes extending upwards. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird-like figure.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

March 20, 2014

Instrumentarium Dental, PaloDEx Group Oy % Mr. Terho Turkumaki Quality & Regulatory Manager Nahkelantie 160 Tuusula. 04300 FINLAND

Re: K133231 Trade/Device Name: DIGORA® Optime Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: MUH Dated: February 17, 2014 Received: February 19, 2014

Dear Mr. 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 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 forlannual registration. Iisting 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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Page 2-Mr. Turkumaki

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.fda.gov/MedicalDevices/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/MedicalDevices/Safety/ReportaProblem/delault.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/Industrv/default.htm.

Sincerely yours.

Smh7)

for

Janine M. Morris j 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 SERVICESFood and Drug Administration		Form Approved: OMB No. 0910-0120Expiration Date: January 31, 2017See PRA Statement below.
Indications for Use
510(k) Number (if known)	K133231
Device Name	DIGORA® Optime
Indications for Use (Describe)	The DIGORA® Optime imaging system is indicated for capturing, digitization and processing of intra oral x-ray images stored in imaging plate recording media.
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)
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)
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.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
	Department of Health and Human Services
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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (1/14)	Page 1 of 1	PSC Publishing Services (301) 443-6740

FORM FDA 3881 (1/14)

: :

Regulation Number and Section

§ 872.1800 Extraoral source x-ray system.

(a)
Identification. An extraoral source x-ray system is an AC-powered device that produces x-rays and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The x-ray source (a tube) is located outside the mouth. This generic type of device may include patient and equipment supports and component parts.(b)
Classification. Class II.