Scanora 3Dx is a Cone Beam 3D x-ray system for imaging the head and neck areas, including the ENT and dentomaxillofacial areas, for use in diagnostic support. Dedicated panoramic imaging is an option. A flat panel detector is used to acquire 3D images and an optional CCD sensor to acquire panoramic images. The device is operated and used by qualified healthcare professionals.

Device Description

Scanora 3Dx is a Cone Beam Computerized Tomography x-ray system for Dentomaxillofacial and Head & Neck (ENT) imaging. Dedicated panoramic imaging is an option. In CT mode it generates a conical x-ray beam during rotation around a patient's head and produces two dimensional projection images on a flat panel detector. Three dimensional images are then reconstructed and viewed with 3rd party software. In panoramic mode panoramic and TMJ images can be taken in the classical way on a separate CCD detector.

AI/ML Overview

The provided text describes a 510(k) submission for the SCANORA 3Dx device, indicating that it is substantially equivalent to a predicate device (SCANORA 3D [K110839]). This type of submission relies on demonstrating similarity to an already approved device rather than presenting new clinical study data to establish effectiveness or meet novel acceptance criteria.

Therefore, the document does not contain a specific table of acceptance criteria and reported device performance based on a dedicated study proving these criteria. Instead, it focuses on comparative technological characteristics and a "preference study" for image quality.

Here's an breakdown of the information that can be extracted, and where information is missing based on your request:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria: Not explicitly stated as quantifiable metrics for a clinical study. The primary "acceptance" is demonstrated through substantial equivalence to the predicate device.
Reported Device Performance: The document highlights the technological characteristics of SCANORA 3Dx and compares them to the predicate device. The only "performance" comparison mentioned in a study context is a "preference study" for image quality, but specific metrics from this study are not provided.

Characteristic	SCANORA 3Dx (New Device)	SCANORA 3D [K110839] (Predicate Device)
X-ray source	3D mode: 90 kV, 4-10 mA, pulsed. Pan mode: 60-81 kV, 4-8 mA continuous. kV accuracy +/-5kV. Same x-ray source for 3D and Pan modes.	3D mode: 90 kV, 4-12.5 mA, pulsed. Pan mode: 60-81 kV, 4-8 mA continuous. kV accuracy +/-5kV. Same x-ray source for 3D and Pan modes.
Focal spot	0.5 mm	0.5 mm
Image detector(s)	Amorphous Silicon Flat Panel + CCD for panoramic imaging	CMOS Flat Panel + CCD for panoramic imaging
3D imaging technique	Reconstruction from 2D images	Reconstruction from 2D images
3D's Field Of View	H50 x Ø50 mm, H50 x Ø100 mm, H80 x Ø100 mm, H140 x Ø100 mm, H80 x Ø165 mm, H140 x Ø165 mm, H180x Ø165 mm - Stitched, H240x Ø165 mm - Stitched	H60 x Ø60 mm, H75 x Ø100 mm, H75 x Ø145 mm, H130xØ145 mm - stitched
3D's total viewing angle	360 degrees	360 degrees
Pixel size	Amorphous Silicon flat panel: 120 / 240 µm. CCD for panoramic imaging: 48 µm.	CMOS flat panel: 200 µm. CCD for panoramic imaging: 48 µm.
Voxel size	100/150/200/250/300/350/400/500 µm	133/200/250/300/350 µm
3D scan time	18 - 34 sec	10 - 26 sec
3D's effective exposure time	2.4 - 6 sec	2.25 - 6 sec
Indications for use	Scanora 3D is a Cone Beam 3D x-ray system for imaging the head and neck areas, including the ENT and dentomaxillofacial areas, for use in diagnostic support. Dedicated panoramic imaging is an option. A flat panel detector is used to acquire 3D images and an optional CCD sensor to acquire panoramic images. The device is operated and used by qualified healthcare professionals.	Scanora 3D is a Cone Beam 3D x-ray system for imaging the head and neck areas, including the ENT and dentomaxillofacial areas, for use in diagnostic support. Dedicated panoramic imaging is an option. A flat panel detector is used to acquire 3D images and an optional CCD sensor to acquire panoramic images. The device is operated and used by qualified healthcare professionals.
System footprint	H197cm x D140cm x W160cm	H197cm x D140cm x W160cm
Weight	310 kg	310 kg
Preference Study (Image Quality)	"Results were evaluated by internal reviewers." (No specific metrics or acceptance criteria reported for this study).	(Not applicable for this comparative preference study, as it was the comparison device)

2. Sample sized used for the test set and the data provenance:

Test Set Sample Size: "Same phantom" was used for the preference study. The number of images generated is not specified beyond this.
Data Provenance: The study was conducted by the manufacturer, PaloDEx Group Oy (Finland). The provenance of the phantom data (e.g., country of origin, retrospective/prospective) is not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Number of Experts: "Internal reviewers" evaluated the results of the preference study. The exact number is not stated.
Qualifications of Experts: Their qualifications are not specified.

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

The document only states "results were evaluated by internal reviewers." No specific adjudication method (like 2+1 or 3+1 where disagreements are resolved by a third party) is mentioned. It implies a qualitative "preference" rather than a quantitative ground truth establishment.

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 MRMC study was done. The described "preference study" was an image quality comparison between the new device and the predicate device using a phantom, judged by internal reviewers. This is not a comparative effectiveness study involving human readers with and without AI assistance.
Effect Size: Not applicable as no such study was performed.

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

The device is a hardware system (Cone Beam 3D X-ray system) that generates images. The document does not describe any specific algorithm or AI component that would have standalone performance measured without a human-in-the-loop. The mention of "FBP algorithm" refers to a standard image reconstruction technique, not a diagnostic AI algorithm.

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

For the "preference study," the ground truth was based on the qualitative "preference" of internal reviewers regarding image quality from a phantom. This is not expert consensus on diagnostic findings, pathology, or outcomes data. It's a subjective assessment of image quality.

8. The sample size for the training set:

Not applicable. The document describes a medical imaging device (hardware) undergoing a 510(k) process based on substantial equivalence. It does not refer to a machine learning or AI algorithm that would require a "training set" in the context of diagnostic performance evaluation.

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

Not applicable. As above, no training set for an AI algorithm is mentioned or implied.

Summary

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K130297
Page 1 of 4

PALODEX GROUP

MAY 2 9 2013

510(k) Summary

Date: February 4th, 2013

PalaDEx Group Ox

. palodex group. com

Street addre Nahkelantie 160 04300 Tuusuta Finland

Postal address P.O. Box 64 FI-0430 | Tuusula Finland

+358 10 270 2000

Fas +358 9 851 4048

VAT F119774137

BI code 1977413-7

Bank Nordea Bank SWIFT NDEAFIHH Account F19015963000046864

Manufacturer:

PaloDEx Group Oy Nahkelantie 160 Tuusula, Finland 04300

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

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

Trade Name: SCANORA 3Dx

Common Name: Cone beam 3D X-ray system

Classification Name:

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

Description:

Intended Use:

The unit must only be used to take 3D and (optional) panoramic images of the dento-maxillo-facial complex and the head and neck areas, including the ear, nose and throat (ENT) areas of the human skull. The unit must not be used to take images of any other part of the human body.

Note that panoramic and 3D exposures should not be used if conventional intraoral radiographic images (bitewing exposures) would suffice. Note that cone beam computerized tomography images are not adequate for the analysis of soft tissue.

Always use the lowest possible exposure values that will allow you to take an image of sufficient quality for you to perform the required diagnostic examination.

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PaloDEx Group

Indication For Use

SCANORA 3Dx is a Cone Beam 3D x-ray system for imaging the head and neck areas, including the ENT and dentomaxillofacial areas, for use in diagnostic support. Dedicated panoramic imaging is an option. A flat panel detector is used to acquire 3D images and an optional CCD sensor to acquire panoramic images. The device is operated and used by qualified healthcare professionals.

PaloDEx Group Oy

www.pzlodexgroup.com

Street address Nahkelantic 160 04300 Tuusula Finland

Postal address P.O. Box 64 Fi-04301 Tuusula Finland

Phone +358 10 270 2000

Fax 4.350 9 B51 4048

VAT F119774137

Bi code 1977413-7

Bank Nordea Bank SWIFT NDEAFIHH Account F19015963000046864

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PALODEX GROUP

Summary of Technological Characteristics:

SCANORA 3Dx is substantially equivalent in design, composition and function to the current SCANORA 3D unit [K110839].

PatoDEx Group Oy

www.patodexgroup.com

Street address Nahkelantie | 60 04300 Tuusula Finland
Postal address P.O. Box 64 FI-04301 Tuusula Finland

Phone +350 10 270 2000

Fax +356 9 851 4048

VAT FI19774137

BI code
1977413-7

Bank Nordea Bank swift NDEAFIHH Account F190 | 5963000046864

Concept		SCANORA 3Dx	SCANORA 3D [K110839]
1.	X-ray source	3D mode: 90 kV, 4-10 mA, pulsed.	3D mode: 90 kV, 4-12.5 mA, pulsed.
		Pan mode: 60-81 kV, 4-8 mA continuous.	Pan mode: 60-81 kV, 4-8 mAcontinuous.
		kV accuracy +/5kV,	kV accuracy +/5kV,
		Same x-ray source for 3D and Panmodes.	Same x-ray source for 3D and Panmodes.
2.	Focal spot	0.5 mm	0.5 mm
3.	Imagedetector(s)	Amorphous Silicon Flat Panel	CMOS Flat Panel
		+ CCD for panoramic imaging	+ CCD for panoramic imaging
4.	3D imagingtechnique	Reconstruction from 2D images	Reconstruction from 2D images
5.	3D's Field OfView	H50 x Ø50 mmH50 x Ø100 mmH80 x Ø100 mmH140 x Ø100 mmH80 x Ø165 mmH140 x Ø165 mmH180x Ø165 mm - StitchedH240x Ø165 mm - Stitched	H60 x Ø60 mmH75 x Ø100 mmH75 x Ø145 mmH130xØ145 mm - stitched
6.	3D's totalviewing angle	360 degrees	360 degrees
7.	Pixel size	Amorphous Silicon flat panel: 120 / 240µmCCD for panoramic imaging: 48 µm	CMOS flat panel: 200 µmCCD for panoramic imaging: 48 µm
8.	Voxel size	100/150/200/250/300/350/400/500 µm	133/200/250/300/350 µm
9.	3D scan time	18 - 34 sec	10 - 26 sec
10.	3D's effectiveexposure time	2.4 - 6 sec	2.25 - 6 sec
11.	Indications foruse	Scanora 3D is a Cone Beam 3D x-raysystem for imaging the head and neckareas, including the ENT anddentomaxillofacial areas, for use indiagnostic support. Dedicated panoramicimaging is an option. A flat panel detectoris used to acquire 3D images and anoptional CCD sensor to acquirepanoramic images. The device isoperated and used by qualified healthcareprofessionals.	Scanora 3D is a Cone Beam 3D x-raysystem for imaging the head and neckareas, including the ENT anddentomaxillofacial areas, for use indiagnostic support. Dedicatedpanoramic imaging is an option. A flatpanel detector is used to acquire 3Dimages and an optional CCD sensor toacquire panoramic images. The deviceis operated and used by qualifiedhealthcare professionals.
12.	Systemfootprint	H197cm x D140cm x W160cm	H197cm x D140cm x W160cm
13.	Weight	310 kg	310 kg

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PALODEX GROUP

Non-clinical Test Data:

Preference study as an image quality comparison between Scanora 3Dx and the predicate device was performed. Same phantom was imaged with Scanora 3Dx and the predicate Scanora 3D. The results were evaluated by internal reviewers. Validations have been performed successfully to ensure the safety and effectiveness of the Scanora 3Dx system.

Clinical Test Data:

Clinical testing has not been conducted on Scanora 3Dx 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 and the successful validation of the SCANORA 3D software, the clinical performance of the SCANORA 3Dx is deemed to be substantially equivalent to the predicate devices.

PaloDEx Graup Oy www.palodexgroup.com

Screet address Nahkelande 160 04300 Tuusula Finland

Postal address P.O. Box 64 FI-0430! Tuusula Finland

Phone +358 10 270 2000

Fax +358 9 851 4048

VAT F119774137

ફા દર્ભવ 1977413-7

Bank Nordea Bank swift NDEAFIHH Account £19015963000046864

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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 a stylized symbol that resembles a caduceus, a traditional symbol of medicine, but with three wavy lines instead of snakes.

Public Health Service

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

May 29, 2013

PaloDEx Group Ov % Mr. Matti Tulikoura Regulatory Manager Nahkelantie 160 Tuusula 04300 FINLAND

Re: 510(k) Number: K130297 Trade/Device Name: SCANORA 3Dx Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: Class II Product Code: OAS Dated: April 21, 2013 Received: April 29, 2013

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

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Page 2 – Mr. Tulikoura

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.

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/ReportalProblem/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/ResourcesforYou/Industrv/default.htm.

Sincerely yours,

Sm.h.f.)

for

Janine M. Morris 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): K130297

Device Name: SCANORA 3Dx

Indications for Use:

Scanora 3Dx is a Cone Beam 3D x-ray system for imaging the head and neck areas, including the ENT and dentomaxillofacial areas, for use in diagnostic support. Dedicated panoramic imaging is an option A flat panel detector is used to acquire 3D images and an optional CCD sensor to acquire panoramic images- The device is operated and used by qualified healthcare professionals.

Prescription Use × (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 (OlR)

: Smh7)

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

K130297 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.