The ScanX Intraoral View is intended to be used for scanning and processing digital images exposed on Phosphor Storage Plates (PSPs) in dental applications.

Device Description

The ScanX Intraoral View is a dental device that scans photostimulable phosphor storage plates that have been exposed in place of dental X- Ray film and allows the resulting images to be displayed on a personal computer monitor and stored for later recovery. It will be used by licensed clinicians and authorized technicians for this purpose.

AI/ML Overview

The provided document is a 510(k) premarket notification for a dental imaging device called ScanX Intraoral View. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific acceptance criteria and a study proving the device meets those criteria from an AI/algorithm performance perspective.

Therefore, the document does not contain the information requested regarding acceptance criteria for an AI/algorithm, a study proving device performance against such criteria, sample sizes for test/training sets, expert involvement, adjudication methods, MRMC studies, standalone performance, or ground truth establishment in the context of an AI/algorithm.

The document describes the device as a scanner that processes digital images from Phosphor Storage Plates (PSPs) and displays them on a computer monitor. It is not an AI/ML powered device, but rather a digital radiography system. The performance testing summarized focuses on:

Safety testing: Electrical safety (IEC 61010-1), Electromagnetic Compatibility (EMC) (EN 61326-1), and Laser safety (IEC 60825-1).
Imaging performance: Theoretical resolutions, MTF (Modulation Transfer Function), and DQE (Detective Quantum Efficiency) were measured with reference to IEC 62220-1:2003, as recommended by the FDA guidance for Solid State X-ray Imaging Devices.
Software validation and risk analysis were performed.
Cybersecurity was addressed per FDA guidance.

The document explicitly states: "Summary of clinical performance testing: Not required to establish substantial equivalence." This further confirms that no clinical study (which would typically assess performance against clinical acceptance criteria) was conducted or presented in this 510(k) submission.

In summary, the provided text does not describe an AI/ML-based device or a study proving its performance against acceptance criteria in the way your detailed questions imply for an AI/ML product.

Summary

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

May 1, 2017

Duerr Dental AG % Daniel Kamm, P.E. Principal Engineer Kamm & Associates 8870 Ravello Ct NAPLES FL 34114

Re: K170733

Trade/Device Name: ScanX Intraoral View Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: MUH Dated: January 30, 2017 Received: March 10, 2017

Dear Mr. Kamm:

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.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. 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 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 Industry and Consumer Education 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,

Michael D. O'Hara

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)

K170733

Device Name ScanX Intraoral View

Indications for Use (Describe)

The ScanX Intraoral View is intended to be used for scanning and processing digital images exposed on Phosphor Storage Plates (PSPs) in dental applications.

Type of Use (Select one or both, as applicable)
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X Prescription Use (Part 21 CFR 801 Subpart D)

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

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Exhibit 5. 510(k) SUMMARY

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510(k) Summary, DUERR DENTAL AG, K170733

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR §807.92.

1. Date Summary Prepared:

April 12, 2017

2. Submitter's Identification:

DUERR DENTAL AG Höpfigheimer Strasse 17 74321 Bietigheim-Bissingen Deutschland/Germany Tel: +49 (0) 71 42 70 5-0 Fax: +49 (0) 71 42 705-500 E-Mail info@duerr.de Internet: www.duerrdental.com

Contact:

Oliver Lange Email: lange.o@duerr.de Quality Manager Durr Dental AG Höpfigheimer Strasse 17 D-74321 Bietigheim-Bissingen Deutschland / Germany Phone: + 49 (0) 7142 / 705-0 Fax: + 49 (0) 7142 / 705-500 Email: lange.o@duerr.de

U.S. Contact: Suzanne Lucas Tel: 516-214-5515 Email: slucas@airtechniques.com

3. Device Name:

Trade /Proprietary Name: ScanX Intraoral View Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: MUH

4. Legally Marketed Predicate Device Information:

Trade/Device Name: RIOScan (RPS500) Manufactured by RAY Co., Ltd. Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: MUH

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5. Device Description:

6. Intended Use/Indications for use:

The ScanX Intraoral View is intended to be used for scanning and processing digital images exposed on Phosphor Storage Plates (PSPs) in dental applications.

7. Safety and Effectiveness:

The ScanX Intraoral View is a device that scans photostimulable phosphor storage plates that have been exposed in place of x-ray film and allows the resulting images to be displayed on a personal computer monitor.

Safety concerns associated with the ScanX Intraoral View were addressed by safety testing the device with Intertek to IEC 61010-1 third edition (Electrical Safety), EN 61326-1:2013 (EMC) and IEC 60825-1 second edition (Laser safety). Design changes and risks associated with the introduction of the ScanX Intraoral View were properly mitigated by Duerr Dental's cGMP compliant Quality Management System, change control processes, risk assessments, and product validation.

The ScanX Intraoral View contains a Class 1 Laser Device as defined by 21 CFR 1040.10

Installation and operation manuals are provided with instructions for safe use and servicing of the ScanX Intraoral View. The ScanX Intraoral View is a non-patient contact Class II medical device.

8. Substantial Equivalence to Predicate Device Summary

Duerr Dental's ScanX Intraoral View is identical in function, and intended use to the RIOScan RPS500 Dental Radiography System manufactured by RAY Co., Ltd whose dental units are in commercial distribution and are FDA cleared under 510K # K160788. ScanX Intraoral View and the RIOScan RPS500 capture, digitize, and process intraoral x-ray images that are stored in imaging plate recording media.

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Comparison criteria	Predicate Device: RIOScanRPS500 K160788, RAY Co. Ltd.	New Device ScanX IntraoralView
Photo	Image: RIOScan RPS500 K160788, RAY Co. Ltd.	Image: ScanX Intraoral View
Indications for Use	This system is a digital intraoraldental radiographic imagingsystem intended for use bydentists and dental sub-specialists.The system captures, digitizes,displays and stores diagnosticintraoral radiographic images.	The ScanX Intraoral View isintended to be used for scanningand processing digital imagesexposed on Phosphor StoragePlates (PSPs) in dental applications.
Mechanical design	The exposed and unwrappedplates are scanned using a laserwith a certain wavelength.	The exposed and unwrappedplates are scanned in twoorthogonal directions using alaser with a wavelength ofapproximately 650 nm.
Electrical design	Light with a certain wavelengthfrom the plate in proportion tothe number of captured x-rayphotons. This light is collectedand formed into an image thatmay be viewed and stored on anexternal display/computer.	Light with a wavelength ofapproximately 380 nm is from theplate in proportion to thenumber of captured x-rayphotons. This light is collectedand formed into an image thatmay be viewed on a video displayand stored for later recovery in acomputer memory.
Image scanning	Laser/Photomultiplier Tube	SAME
Erasing the residualimage followingscanning for platereuse.	Automatic plate erasing	The residual image is erased inthe scanner by an inline erasingfunction.
Comparison criteria	Predicate Device: RIOScanRPS500 K160788, RAY Co. Ltd.	New Device ScanX IntraoralView
Viewing the image	The scanned images can bedisplayed on an integrated LCDpanel, a 4.3" Touch Screen	4.3" Touch Screen. The touchscreen only shows a previewwhich serves to provide an initialimpression of the final x-rayimage. For the purposes ofdiagnosis, the x-ray image mustbe viewed on a diagnosticmonitor. The scanned images aredisplayed on an internal LCD oran external monitor using acomputer and user softwareincluding image storage,retrieval and manipulation.
Transport/feedmechanism	Gravity scan	The plates are transported by"beltways" down the axis of thecylinder past the slot. The motionof the laser and plates providesthe two orthogonal scandirections. This is a continuousfeed device that allows successiveplates to be loaded as soon as theprevious plates have moved pastthe slot.
Phosphor Plates	Dental intraoralSize 0: 22 x 35 mmSize 1: 24 x 40 mmSize 2: 31 x 41 mmSize 3: 27 x 54 mmSize 4: 57 x 76 mm	Same as predicate device.
Image Quality	Theoretical resolutions:9, 16, or 21 lp/mm	Theoretical resolutions:10, 20, 25 or 40 LP/mm
MTF	More than 35% at 3 lp/mm	More than 45% at 3 lp/mm
DQE	More than 10% at 3 lp/mm	More than 7.5% at 3 lp/mm
Image databit depth	14 bits	16 bits
Body size andweight	170 x 260 x 278 [mm];3.6 [kg]	380 x 410 x 450 [mm];(W x L x H)19.5 [kg] (42.99 lbs.)
Imaging Software	"RIOView"	DBSWIN/VistaEasy as cleared inK161444
User interface	It will be used by dentists andauthorized dental auxiliarypersonnel.	Same as predicate device.
Energy Source AC	100 to 240VAC, 50/60 Hz	Same as predicate device.
Comparison criteria	Predicate Device: RIOScanRPS500 K160788, RAY Co. Ltd.	New Device ScanX IntraoralView
Electrical safetystandards	IEC 60601-1 Electrical SafetyMedical Devices	EN 61010-1:2010 SafetyRequirements for ElectricalEquipment for Measurement,Control, and Laboratory Use - Part 1:General Requirements
EMC Testing	IEC 60601-1-2 EMC Medical Devices	EN 61326-1:2013 Electricalequipment for measurement, controland laboratory use. EMCrequirements. General requirements
Patient Contaminationprevention	Single patient use barrier envelopeencloses the imaging plate while inthe patient's mouth.	Same as predicate device

9. Table of comparison to Legally Marketed Device:

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The technological characteristics, including design, materials, composition, and energy source, are substantially the same, so there are no issues impacting safety and effectiveness.

10. Summary of non-clinical performance testing:

Risk analysis and software validation was successfully performed. EMC Testing according to EN 61326-1:2013 was successfully performed. Electrical safety testing according to EN 61010-1:2010 was successfully performed. We chose safety standards that were more closely aligned with where the device is to be used: Equipment for Measurement, Control, and Laboratory Use. FDA guidance documents utilized in the development of the device:

a) Imaging performance evaluation according to the recommendations in the FDA guidance document: Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices Document issued on: September 1, 2016.

b) Software development: Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.

c) Cybersecurity: Content of Premarket Submissions for Management of Cybersecurity in Medical Devices.

MTF and DQE image performance testing was performed with reference to IEC 62220-1:2003. Noise power spectrum measurements were documented.

11. Summary of clinical performance testing:

Not required to establish substantial equivalence.

12. Conclusion

In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification, Duerr Dental AG concludes that the ScanX Intraoral View is safe and effective and substantially equivalent to the predicate device as described herein.

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.