EOSedge is intended for use in general radiographic exams and applications, excluding the evaluation of lung nodules and exams involving fluoroscopy, angiography, and mammography. EOSedge allows the radiographic acquisition of either one or two orthogonal X-ray images, for diagnostic purposes, in one single body or a reduced area of investigation of a patient, in the upright or seated position.

The Micro Dose feature is indicated for assessing global skeletal deformities in follow-up pediatric exams.

Device Description

The EOSedge system is a digital radiography system comprised of an acquisition workstation, a gantry including an electrical cabinet housing the system power and communication controls, and an acquisition software to obtain diagnostic images. Two sets of detectors and X-ray tubes are positioned orthogonally to generate frontal and lateral images simultaneously by scanning the patient over the area of interest. If desired, the Micro Dose feature enables image acquisition for assessing global skeletal deformities in follow-up exams. The diagnostic images are stored in a local database and are displayed on a highresolution medical-quality non-diagnostic image can be transmitted through a DICOM compatible digital network for printing and archiving.

AI/ML Overview

The provided text is a 510(k) summary for the EOS imaging's EOSedge System. It describes the device, its intended use, and compares it to a predicate device (EOS System K152788) to demonstrate substantial equivalence.

However, the document does not contain information about acceptance criteria for an AI/algorithm's performance, nor does it describe a study that proves a device meets such criteria. It focuses on the substantial equivalence of an X-ray imaging system to its predecessor, based on design, technical specifications, and general performance testing (bench testing for dosing and image quality).

Therefore, I cannot fulfill your request for information regarding acceptance criteria and a study proving an AI device meets them based on the provided text. The document is about a conventional X-ray imaging system, not an AI-driven device with specific performance metrics like sensitivity, specificity, or AUC established through clinical studies with ground truth.

The "Performance Data" section (page 4) states: "Bench performance testing were conducted based on FDA's Guidance for the Submission of 510/k)'s for Solid-State X-ray Imaging Devices (September 1, 2016), to verify that EOSedge performs according to specifications and is as safe and effective as the predicate device." This refers to engineering and image quality tests common for X-ray hardware, not an AI algorithm evaluation.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font below.

November 27, 2019

EOS Imaging c/o Bernard Ismael Quality and Regulatory Affairs Director 10 rue Mercoeur Paris, 75011 FRANCE

Re: K192079

Trade/Device Name: EOSedge Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary X-Ray System Regulatory Class: Class II Product Code: KPR Dated: July 31, 2019 Received: August 2, 2019

Dear Bernard Ismael:

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

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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 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 (QS) 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,

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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510(k) Number (if known)

K192079

Device Name

EOSedge™

Indications for Use (Describe)

EOSedge is intended for use in general radiographic exams and applications, excluding the evaluation of lung nodules and exams involving fluoroscopy, and mammography. EOSedge allows the radiographic acquisition of either one or two orthogonal X-ray images, for diagnostic purposes, in one single body or a reduced area of investigation of a patient, in the upright or seated position.

The Micro Dose feature is indicated for assessing global skeletal deformities in follow-up pediatric exams.

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)

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510(k) SUMMARY

EOS imaging's EOSedge System

EOS imaging 10 Rue Mercoeur F-75011, Paris FRANCE

Phone: Facsimile: + 33 1 55 25 60 61

Contact Person: Bernard ISMAEL, Quality and Requlatory Affairs Director

Date Prepared: July 31, 2019

Name of Device:	EOSedge™
Common or Usual Name:	Digital Radiography System
Classification Name:	21 C.F.R §892.1680; Stationary X-ray System
Regulatory Class:	Class II
Product Code:	KPR - System, X-ray, Stationary
Predicate Device:	EOS imaging's EOS System (K152788)

Device Description

Intended Use / Indications for Use

EOSedge is intended for use in general radiographic exams and applications, excluding the evaluation of lung nodules and exams involving fluoroscopy, angiography, and mammography. EOSedge allows the radiographic acquisition of either one or two orthogonal X-ray images, for diagnostic purposes, in one single scan, of the whole body or a reduced area of investigation of a patient, in the upright or seated position.

The Micro Dose feature is indicated for assessing global skeletal deformities in follow-up pediatric exams.

Performance Data

EOSedge is designed and has been certified to conform to IEC 60601-1 and collateral standards. Software verification and validation testing was also conducted. Additional performance and functional

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testing have confirmed the equivalent performance of EOSedge compared to the cleared predicate EOS System. This included bench testing to confirm appropriate dosing and image quality. Bench performance testing were conducted based on FDA's Guidance for the Submission of 510/k)'s for Solid-State X-ray Imaging Devices (September 1, 2016), to verify that EOSedge performs according to specifications and is as safe and effective as the predicate device.

Substantial Equivalence

EOSedge has the same intended use and similar indications, principles of operation, and technological characteristics as the cleared predicate device. EOSedge is an updated version of the cleared EOS System (K152788) with the main modification being a change in the type of detector used, namely, solid state photon counting detectors rather than gaseous detectors. Although the design of the equipment is being updated to accommodate the new detector, there are no major changes to the tube assembly and beam-limiting features. Both systems have two sets of detectors and X-ray tubes positioned orthogonally to generate frontal and lateral images simultaneously by scanning the patient over the area of interest. The two orthogonal acquisition chains consist of HV generators, X-ray tubes, collimators and detectors, positioned on C-shaped arms translating along a vertical axis. The software for the two systems are also fundamentally the same.

A substantial equivalence table summarizing the similarities and differences between EQSedge and its predicate device is provided below.

	EOS imaging's EOSedge	EOS imaging's cleared EOS System(K152788)
Intended UseIndications for Use	General X-ray imaging systemEOSedge is intended for use in generalradiographic exams and applications,excluding the evaluation of lung nodules andexams involving fluoroscopy, angiography,and mammography. EOSedge allows theradiographic acquisition of either one or twoorthogonal X-ray images, for diagnosticpurposes, in one single scan, of the wholebody or a reduced area of investigation of apatient, in the upright or seated position.The Micro Dose feature is indicated forassessing global skeletal deformities infollow-up pediatric examinations.	General X-ray imaging systemEOS is intended for use in generalradiographic examinations and applications,excluding the evaluation of lung nodules andexaminations involving fluoroscopy,angiography, and mammography. EOSallows the radiographic acquisition of eitherone or two orthogonal X-ray images fordiagnostic purposes, in one single scan, ofthe whole body or a reduced area ofinvestigation of a patient in the upright orseated position.The Micro Dose feature is indicated forimaging with a patient entrance dose of 10to 90 µGy for assessing global skeletaldeformities in follow-up pediatricexaminations. Micro Dose is not indicatedfor focal skeletal abnormalities and/or otherpediatric abnormalities. Micro Dose is notindicated for use in patients with a BodyMass Index over 30.
Contraindications	EOSedge is not designed to performfluoroscopy, angiography or mammographyexams.The Micro Dose feature is not designed formorphological analysis of bone structures andlesions.The Micro Dose feature is not indicated:• for analysis of spine static in the	This system was not designed to performmammograms, angiograms or fluoroscopyexaminations.The Micro Dose functionality is not designedfor morphological analysis of bonestructures and lesions. It is not indicated foranalysis of spine static in the presence offusion material or for analysis of the bone-
	EOS imaging's EOSedge	EOS imaging's cleared EOS System(K152788)
	presence of fusion material or foranalysis of the bone-implant interfacein the case of focal skeletal anomalies•and/or other pediatric abnormalities•for use in patients with a Body MassIndex over 30	implant interface.
User Population	Trained medical personnel	Trained medical personnel
TechnologicalCharacteristics	Digital radiography system in which two setsof detectors and X-ray tubes are positionedorthogonally to generate frontal and lateralimages simultaneously by scanning thepatient over the area of interest. The 2orthogonal acquisition chains consist of HVgenerators, X-ray tubes, collimators anddetectors, positioned on C-shaped armstranslating along a vertical axis.	Digital radiography system in which two setsof detectors and X-ray tubes are positionedorthogonally to generate frontal and lateralimages simultaneously by scanning thepatient over the area of interest. The 2orthogonal acquisition chains consist of HVgenerators, X-ray tubes, collimators anddetectors, positioned on C-shaped armstranslating along a vertical axis.
Dimensions (I x w xh)	2.58 m x 2.58 m x 2.706 m(8.5 ft x 8.5 ft x 8.9 ft)	2 m x 2 m x 2.7 m(7.9 ft x 7.9 ft x 10.44 ft)
Weight	2 005 kg (4 420 lb)	1 623 kg (3579 lb)
Accessories	Laser safety barriersMotorized lifting platformGantry consoleLaser positioning systemAccess and stabilization barsBar code reader	Mechanical platformLaser positioning systemAccess and stabilization bars
Principles ofOperation	Tube preheatingSelection of the patient, the acquisitionplanes, and the anatomical area, as well aspatient positioningSelection of either automatic mode or manualmodeSelection of patient morphotypeImage previewDisplay of the exposure area, configuration ofthe reference planes, and verification andvalidation of the acquisition parametersImage analysis and export of the exam	Tube preheatingDaily detector calibrationSelection of the patient, the acquisitionplanes, and the anatomical area, as well aspatient positioningSelection of patient morphotypeImage previewDisplay of the exposure area, configurationof the reference planes, and verification andvalidation of the acquisition parametersDisplay of unprocessed images andreprocessing with various optionsImage analysis and export of the examPrinting
Permanentminimum total	1.7 mm Al at 75 kV	1.5 mm Al at 75 kV
filtration(Al equivalent)	Additional filtrations:• 0.1 mm copper thickness (used forimages with or without Micro-Dose)	Additional filtrations:• 0.1 mm Cu copper thickness (used forimages with or without Micro-Dose)
	EOS imaging's EOSedge	EOS imaging's cleared EOS System(K152788)
	◦ 0.5 mm copper thickness (used for theScout View)	◦ 1 mm aluminum thickness (used forlarge patient with LF and power > 28kW)
Detectors	Direct conversion device - solid statedetector	Direct conversion device - gaseous detector
Pixel Depth	17 bits (> 131 000 grey levels)	16 bits (> 65 000 grey levels)
Pixel Size	100 μm	254 μm
Resolution	3.7 lp/mm	1.6 - 1.7 lp/mm
Typical DynamicRange	> 100 dB	> 90 dB
SoftwareSpecifications	Patient information managementImage acquisitionDisplay imagesSend exam to the PACSMaintenance managementAccess management to the systemSystem acquisition configuration.	Patient information managementImage acquisitionDisplay imagesSend exam to the PACSMaintenance managementAccess management to the systemSystem acquisition configuration.
Focal Spot	Large focal spot:0.6 x 1.3 at 120 kV - 100 mA	Large focal spot:0.6 x 1.3 at 120 kV - 100 mASmall focal spot:0.4 x 0.7 at 120 kV - 50 mAUse of the two focal spot sizes enabled
Linear ScanningSpeed (cm/s)	From 4.1 to 32.5	From 3.8 to 30.5
AverageAcquisition Time	8 seconds for a spine and 15 seconds for anentire body	5 to 10 seconds for a spine and 20 secondsfor an entire body

Table 1: EOS IMAGING'S EOSEDGE - SUBSTANTIAL EQUIVALENCE CHART

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Conclusion

EOSedge has the same intended use and similar indications for use, technological characteristics, and principles of operation as its predicate device, the EOS System (K152788). The minor differences in indications for use and technology between EOSedge and its predicate device raise no new questions of safety or effectiveness. Performance data further demonstrates that EOSedge is as safe and effective as the cleared EOS System (K152788). Thus, EOSedge is substantially equivalent.

Regulation Number and Section

§ 892.1680 Stationary x-ray system.

(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.