The ScanX Edge 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. The device is an intraoral Plate Scanner, which is designed to read out intraoral Plates of the sizes 0, 1 and 2. intraoral plate Scanners are state of the art since 2002 and are available in various designs from many companies around the world. The intraoral Plates are put into the mouth of the patient, exposed to X-rays and then are read out with the device. The read-out-process is carried out with a 635nm Laser. The laser beam is moved across the surface of the plate by an oscillating MEMS mirror. The laser beam stimulates the top coating of the plates, which consists of x-ray sensitive material. Depending on the exposed dose, the coating emits different levels of light. These light particles are then requisitioned by an optical sensor (Photo Multiplier Tube/ PMT) and transferred into an electrical output signal is digitalized and is the data for the digital X-ray image. The data is transmitted via an Ethernet link to a computer. Before the plate is discharged, the remaining data is erased by a LED-PCB. The user chooses which size of plate he has to use and prepares the device by inserting the appropriate plate insert into the device. He then exposes the plate and then puts the plate directly into the insert by pushing it out of the light protection envelope. The user closes the light protection cover and starts the read out process. After the read out process the picture is transmitted to the connected PC, the picture can be viewed and the IP is erased and ready to use for the next acquisition.

AI/ML Overview

The provided text describes the Dürr Dental SE ScanX Edge device (K202633) and its substantial equivalence to a predicate device, the ScanX Intraoral View (K170733). However, it does not contain a study that establishes acceptance criteria and then proves the device meets those criteria with performance data from a specific study.

Instead, the document focuses on demonstrating that the ScanX Edge maintains similar performance characteristics and safety profiles compared to a previously cleared device. It references technical testing and standards compliance rather than a clinical performance study with defined acceptance criteria and performance metrics for the device itself.

Therefore, I cannot provide a table of acceptance criteria and reported device performance from a dedicated study as that information is not present in the provided text. I will extract the available performance specifications and the context of their assessment.

Here's a breakdown of the information that can be extracted from the document, with explanations for what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

As noted above, the document does not present a specific study that defines acceptance criteria and then reports performance against those criteria. Instead, it compares the ScanX Edge's technical specifications to those of its predicate device, often stating that the values are "similar." These comparisons are made against established standards for general X-ray imaging devices.

Metric (Acceptance Criteria are inferred as being "Similar" or "More than XX% at YY lp/mm" to the predicate)	Predicate Device (ScanX Intraoral View) Performance	Subject Device (ScanX Edge) Performance
Image quality - Theoretical resolutions	10, 20, 25 or 40 LP/mm	Max. theoretical resolution Approx. 16.7 Lp/mm
MTF (Modulation Transfer Function) at 3 lp/mm	More than 45%	More than 40%
DQE (Detective Quantum Efficiency) at 3 lp/mm	More than 7.5%	More than 3.4%
Image data bit depth	16 bits	16 bits

Note: The document states that the "lower DQE did not adversely affect image quality as shown by our SSD testing," implying that despite a numerically lower DQE, the overall image quality was deemed acceptable, likely within the context of substantial equivalence to the predicate in dental applications.

2. Sample size used for the test set and the data provenance

Sample Size for Test Set: Not specified. The document refers to "MTF and DQE image performance testing" and "SSD testing" but does not provide details on the number of images or cases used for these tests.
Data Provenance: Not specified. The document does not mention the country of origin of the data or whether it was retrospective or prospective. Implicitly, as Dürr Dental SE is a German company, some testing might have occurred in Germany, but this is not stated for the performance data.

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

Number of Experts: Not specified.
Qualifications of Experts: Not specified.

The performance testing referenced (MTF, DQE, noise power spectrum) are objective technical measurements performed on the device itself, often using phantoms or controlled inputs, not human interpretation of clinical images. Therefore, the concept of "ground truth established by experts" as typically applied in diagnostic AI studies is not directly applicable here for these specific technical metrics. The "SSD testing" mentioned in relation to DQE might involve human assessment, but details are not provided.

4. Adjudication method for the test set

Not applicable/Not specified for the referenced technical performance tests (MTF, DQE). These are objective measurements rather than subjective assessments requiring adjudication.

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

MRMC Study: No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or reported in this document.
Effect Size: Not applicable, as no MRMC study was performed.

This device is described as an "Extraoral source x-ray system" for scanning phosphor plates and displaying digital images. It is not an AI algorithm intended to assist human readers in diagnosis. Therefore, an MRMC study assessing AI assistance is outside the scope of this device's function as described.

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

A "standalone" performance assessment was done in the sense that the intrinsic physical image quality metrics (MTF, DQE, theoretical resolution) of the device were measured and reported. These metrics reflect the device's inherent capability to produce high-quality images, independent of human interpretation or assistance. However, it's not an algorithm that performs a diagnostic task.

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

The ground truth for the MTF, DQE, and theoretical resolution measurements are based on physical properties and standardized test methods as outlined in IEC 62220-1:2003 ("Medical electrical equipment - Characteristics of digital X-ray imaging devices - Part 1: Determination of the input properties of digital X-ray imaging devices"). This typically involves using phantoms and known physical inputs rather than clinical ground truth like pathology or expert consensus.

8. The sample size for the training set

Not applicable. This device is a hardware imaging system, not an artificial intelligence algorithm that requires a training set.

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

Not applicable, as there is no training set for this hardware device.

Summary

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October 7, 2020

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Dürr Dental SE % Mr. Daniel Kamm Principal Engineer Kamm & Associates 8870 Ravello Ct NAPLES FL 34114

Re: K202633

Trade/Device Name: ScanX Edge Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: Class II Product Code: MUH Dated: September 1, 2020 Received: September 11, 2020

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

For

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K202633

Device Name ScanX Edge

Indications for Use (Describe)

The ScanX Edge 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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510(k) Summary, DÜRR DENTAL SE K202633

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

Date Summary Prepared: August 14, 2020

1. Submitter's Identification:
  DÜRR DENTAL SE 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

Submitter Contact: Mr. Oliver Lange Director of Quality Management DÜRR DENTAL SE Höpfigheimer Str. 17 74321 Bietigheim-Bissingen, Germany Phone: + 49 (0) 7142 70 5-190 Email: oliver.lange@duerrdental.com

U.S. Agent and Contact: Mr. Joseph Latkowski Director of Quality and Regulatory Air Techniques, Inc. 1295 Walt Whitman Road Melville, NY 11747, USA U.S. Phone: 516-214-5574 E-Mail: Joseph.Latkowski@airtechniques.com

1. Device Name:
  Trade /Proprietary Name: ScanX Edge Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: MUH
1. Legally Marketed Predicate Device Information: Trade/Device Name: ScanX Intraoral View K170733 Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: MUH

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4. Device Description:

1. Intended Use/Indications for use:
  The ScanX Edge is intended to be used for scanning and processing digital images exposed on Phosphor Storage Plates (PSPs) in dental applications.
1. Safety and Effectiveness:
  The Edge 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 Edge were addressed by safety testing the device with Intertek to IEC 60601-1:2005 (Third Edition) + CORR. 1:2006 + CORR. 2:2007 +A1:2012 (Electrical Safety), IEC 60601-1-2:2014 (EMC) and IEC 60825-1 second edition (Laser safety). Design changes and risks associated with the introduction of the ScanX Edge were properly mitigated by DÜRR Dental's cGMP compliant Quality Management System, change control processes, risk assessments, and product validation. The ScanX Edge contains a Class 1 Laser Device as defined by 21 CFR 1040.10 The ScanX Edge is a non-patient contact Class II medical device.
1. Substantial Equivalence to Predicate Device Summary
  DÜRR Dental's ScanX Edge is identical in function, and intended use to the DÜRR Dental ScanX Intraoral View K170733. Both units capture, digitize, and process intraoral x-ray images that are stored in imaging plate recording media.

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DescriptiveInformation:	Predicate Device:ScanX Intraoral Viewas cleared via 510(k) K170733	Subject Device:ScanX Edge	Change Impact Analysis:
Device Photo	Image: ScanX Intraoral View	Image: ScanX Edge	Different look, samefunctionalities.
Indications forUse	The ScanX Intraoral View isintended to be used forscanning and processingdigital images exposed onPhosphor Storage Plates(PSPs) in dental applications.	The ScanX Edge is intendedto be used for scanning andprocessing digital imagesexposed on PhosphorStorage Plates (PSPs) indental applications.	No change.
Mechanicaldesign	The exposed and unwrappedplates are scanned in twoorthogonal directions using alaser with a wavelength ofapproximately 650 nm.	The exposed andunwrapped plates arescanned using a laser with awavelength of 650nm. Thescan pattern is not line byline but follows a certaingeometrical figure.	Similar technology.The ScanX Edge showsdifferent constructivesolutions for theperformance itself,without influencing theintended use or safety.The operating principle isstill the same. The imageplates are scanned by alaser light.
Electrical design	Light with a wavelength ofapproximately 380 nm isfrom the plate in proportionto the number of captured x-ray photons. This light iscollected and formed into animage that may be viewed ona video display and stored forlater recovery in a computermemory.	Same principle.	Slightly differentimplementation.The difference lies withinthe used laser diode. Thediode used in the ScanXEdge is a fiber pigtaileddiode and the one used inthe ScanX Intraoral View isa standard diode. Bothhave identicalspecifications concerningthe wavelength.
DescriptiveInformation:	Predicate Device:ScanX Intraoral Viewas cleared via 510(k) K170733	Subject Device:ScanX Edge	Change Impact Analysis:
Image scanning	Laser / Photomultiplier Tube.Components :PHOTOMULTIPLIER 5 »HAMAMATSU (Part-No. :2151-150-50)DIODE, LASER- 635nm/15mWTO9 (Art-Nr.: 9135-80-002)	Laser / Photomultiplier TubeComponents :Photomultiplier 2 »Hamamatsu (Part-Nr. : 2160-100189)Diode, Laser 639nm/10mWPigtail (Art-Nr. :9135100003)	No change: A laser andphotomultiplier tube(PMT) is used for imagescanning. Differentcomponents are used. TheScanX Edge has a differentLaser Module and PMTModule. The diode used inthe ScanX Edge is a fiberpigtailed diode and theone used in the ScanXIntraoral View is astandard diode.
Erasing theresidual imagefollowingscanning forplate reuse	The residual image is erasedin the scanner by an inlineerasing function.	The residual image is erasedin the scanner by an inlineerasing function.	No change.
Viewing theimage	4.3" Touch Screen. The touchscreen only shows a previewwhich serves to provide aninitial impression of the finalx-ray image. For the purposesof diagnosis, the x-ray imagemust be viewed on adiagnostic monitor. Thescanned images are displayedon an internal LCD or anexternal monitor using acomputer and user softwareincluding image storage,retrieval and manipulation.	The ScanX Edge does nothave a screen.	Different.The ScanX Edge does nothave a screen. Thisdifference does notinfluence the intended usefor scanning andprocessing digital imagesexposed on PhosphorStorage Plates (PSPs) indental applications.
Transport / feedmechanism	The plates are transported by"beltways" down the axis ofthe cylinder past the slot. Themotion of the laser andplates provides the twoorthogonal scan directions.This is a continuous feeddevice that allows successiveplates to be loaded as soonas the previous plates havemoved past the slot.	The plates are inserted intoa size specificinterchangeable insert. If theuser wants to scan adifferent plate size, theinsert needs to beexchanged. The insert isused to transport the plateinto the scanning position.During the scanning processthe plate is not move. Uponcompletion of the scanningprocess the plate is movedtowards the dischargingposition Afterwards the	Different.The ScanX Edge showsdifferent constructivesolutions for theperformance itself,without influencing theintended use or safety.The operating principle isstill the same by means ofthat the image plate istransported in the scanposition. After thescanning procedure theimage plate is ejectedfrom the device.
DescriptiveInformation:	Predicate Device:ScanX Intraoral Viewas cleared via 510(k) K170733	Subject Device:ScanX Edge	Change Impact Analysis:
		plate is ejected from thedevice.
Plates to beused with thedevice	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	Dental IntraoralSize 0: 22 x 35 mmSize 1: 24 x 40 mmSize 2: 31 x 41 mm	Similar.The ScanX Edge is usedwith the smaller phosphorplates only: Size 0, 1 and 2.The phosphor plate sizesare within the IntendedUse as defined by thepredicate device.
Image quality	Theoretical resolutions:10, 20, 25 or 40 LP/mm	Max. theoretical resolutionApprox. 16.7 Lp/mm	Similar.
MTF	More than 45% at 3 lp/mm	More than 40% at 3 LP/mm	Similar. The measurementwas done on the basis ofIEC 62220-1 with minor
DQE	More than 7.5% at 3 lp/mm	More than 3,4% at 3 LP/mm	IEC 62220-1 with minordeviations due to thedental application of theradiography device. Thelower DQE did notadversely affect imagequality as shown by ourSSD testing.
Image databit depth	16 bits	16 bits	No change.
Product sizeand weight	380 x 410 x 450 [mm];(W x L x H)19.5 [kg] (42.99 lbs.)	167x231x216(W x L x H)Approx. 4 Kg (8,82 lbs.)	Different. No impact onsafety/effectiveness.
ImagingSoftware	• DBSWIN/VistaEasy	• DBSWIN/VistaEasy,K190629• VisionX K192743	The ScanX Edge can beused with the imagingsoftware DBSWIN andVisionX.
Energy SourceAC	100 to 240VAC, 50/60 Hz	100 to 240VAC, 50/60 Hz	No change.
PatientContaminationprevention	Single patient use barrierenvelope encloses theimaging plate while in thepatient's mouth.	Single patient use barrierenvelope encloses theimaging plate while in thepatient's mouth.	No change. (Cleared inK190949)
DescriptiveInformation:	Predicate Device:ScanX Intraoral Viewas cleared via 510(k) K170733	Subject Device:ScanX Edge	Change Impact Analysis:
RFID	The ScanX Intraoral Viewdoes not support the RFIDfunction	The ScanX Edge supportsimage plates with RFID Tags.The RFID tag is programmedwith the followinginformation:- Brandname DD, AT,- OEM.- HIBC- Date of production- Type of image plate	Different. The RFIDperformance has no influenceon the intended use or safetyof the device.The information on the RFIDTag is used to identify theimage plate as a specificplate.
Electronic UserManual	User manual is provided inprinted form to the user.	The user manual is providedin electronic form to theuser.	Different. In accordance withthe FDA Guidance"Acceptable Media forelectronic Product UserManuals" issued on 18 March2010, the user manual can beprovided in electronic formonly. No additional storagemedium (DVD, or USB-Stick)will be provided. The usermanual can be downloadedfrom the website of AirTechniques. Paper copies willbe provided upon request.
StandardsCompliance	US Performance Standard forLasers 21CFR1040IEC 60825-1 Edition 2.0 2007-03,safety of laser products - part I:equipment classification, andrequirementsIEC 61010-1 :2010 (ThirdEdition), Safety Requirementsfor Electrical Equipment forMeasurement,Control and Laboratory Use Part1: General RequirementsEN 61326-1 :2013, ElectricalEquipment for Measurement,Control and Laboratory Use,EMC requirements	US Performance Standard forLasers 21CFR1040IEC 60825-1 - TEST REPORTSafety of laser products - Part1: Equipment classification andrequirementsIEC 60601-1 Medical electricalequipmentPart 1: General requirementsfor basic safety and essentialperformanceIEC 60601-1-2:2014, EN 60601-1-2:2015 EMC Professionalhealthcare facility environment/ Emission class B)	Standards chosen are moresuitable for use in thehealthcare environment

1. 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.

1. Summary of non-clinical performance testing:
  Risk analysis and software validation was successfully performed. Cybersecurity issues were addressed by observance of the recommendations in the FDA Guidance Content of Premarket Submissions for Management of Cybersecurity in Medical Devices Guidance for Industry and Food and Drug Administration Staff Document Issued on: October 2, 2014

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This device meets the applicable portions of the following international standards:

IEC 60601-1:2005 (Third Edition) + CORR. 1:2006 + CORR. 2:2007 + A1:2012 (or IEC 60601-1: 2012 reprint) Medical electrical equipment Part 1: General requirements for basic safety and essential performance.

IEC 60601-1-2:2014, (Professional healthcare facility environment / Emission class B) Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance -Collateral Standard: Electromagnetic disturbances - Requirements and tests.

IEC-60825-1 Safety of laser products - Part 1: Equipment classification and requirements Ed.2. The laser aspects of this device comply with the US Performance Radiation Safety Standard in 21CFR1040.

MTF and DQE image performance testing was performed with reference to IEC 62220-1:2003. Noise power spectrum measurements were documented. The following FDA Guidance Document was consulted during the development of this device: Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices, Guidance for Industry and Food and Drug Administration Staff, Document issued on: September 1, 2016.

The development of labeling was done in accordance with the FDA Guidance Pediatric Information for X-ray Imaging Device Premarket Notifications, Guidance for Industry and Food and Drug Administration Staff Document issued on November 28, 2017. Because the modified unit employs RFID, we also consulted the FDA Guidance Radio Frequency Wireless Technology in Medical Devices Guidance for Industry and Food and Drug Administration Staff Document issued on: August 14, 2013

1. Summary of clinical performance testing: Not required to establish substantial equivalence.
1. 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, DÜRR Dental SE concludes that the ScanX Edge 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.