EOS is intended for use in general radiographic examinations and applications, excluding the evaluation of lung nodules and examinations involving fluoroscopy, angiography, and mammography. EOS 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 imaging with a patient entrance dose of 10 to 90 µGy for assessing global skeletal deformities in follow-up pediatric examinations. Micro Dose is not indicated for focal skeletal abnormalities and/or other pediatric abnormalities. Micro Dose is not indicated for use in patients with a Body Mass Index over 30.

Device Description

EOS is a digital radiography system in which two sets of xenon gas filled digital detectors and X-ray tubes are positioned orthogonally to generate frontal and lateral images simultaneously by scanning the patient over the area of interest. An acquisition feature named Micro Dose allows image acquisition with a patient entrance dose of 10 to 90 uGv for assessing global skeletal deformities in follow-up pediatric exams. The diagnostic images are stored in a local database and are displayed on a high-resolution, medical-quality monitor, where the diagnosis is performed. The diagnostic image can be transmitted through a DICOM 3.0 compatible digital network for printing and archiving.

AI/ML Overview

The provided text describes the EOS System, a stationary x-ray system, and states that it has been determined to be substantially equivalent to a legally marketed predicate device. However, this document does not contain details about specific acceptance criteria or an explicit study proving device performance against those criteria in the way you've outlined for clinical performance.

Instead, the document focuses on demonstrating substantial equivalence to an existing cleared device (K142773) based on:

Same Intended Use/Indications for Use: Both the modified and predicate EOS systems share the same intended use for general radiographic examinations, excluding lung nodules, fluoroscopy, angiography, and mammography. They both also offer the "Micro Dose" feature for assessing global skeletal deformities in follow-up pediatric examinations (with specific dose and BMI limitations).
Similar Technological Characteristics/Principles of Operation: The fundamental technological characteristics of the modified EOS are unchanged from the cleared EOS. Minor modifications (hardware component supplier changes, electrical component changes due to obsolescence, mirror sticker accessory, software modification related to a recall, optimization of default acquisition protocols, improvement of image processing, and addition of new features like Dose Structured Report and Reject and Repeat Analysis) are described as not altering the core function or safety.
Performance Data (Bench Testing): The document mentions "Performance data demonstrates that the modified EOS is as safe and effective as the cleared predicate device." This includes "bench testing to confirm appropriate dosing and image quality." It also states, "Performance testing has demonstrated that this modification allows reducing the entrance dose for the changed protocols, with maintaining equivalent or better image quality than the cleared EOS" (referring to the optimization of default acquisition protocols).

Therefore, I cannot fill in your requested table and many of the study details because the provided text does not describe a clinical performance study with defined acceptance criteria and results for the device itself, but rather an argument for substantial equivalence of a modified device to a predicate device based on technical performance and safety.

Here's what I can extract and state based on the provided text, while also noting what is not present:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Explicitly Stated in Doc)	Reported Device Performance (from Doc)
Not explicitly stated in terms of specific performance metrics (e.g., sensitivity, specificity, accuracy for a clinical task).	"Performance and functional testing has confirmed the equivalent performance of the modified EOS compared to the cleared predicate EOS."
"appropriate dosing"	"bench testing to confirm appropriate dosing"
"image quality"	"bench testing... to confirm image quality." "maintaining equivalent or better image quality than the cleared EOS" (for optimized acquisition protocols).
"reducing the entrance dose" (for modified protocols)	"Performance testing has demonstrated that this modification allows reducing the entrance dose for the changed protocols."
No new questions of safety or effectiveness.	"The minor differences... do not raise any new questions of safety or effectiveness."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not explicitly mentioned. The document refers to "bench testing" and "performance and functional testing," which typically involves phantoms or test objects, not patient datasets with "test sets" in the clinical sense.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable/Not mentioned. Since this was a substantial equivalence submission based on technical modifications and bench testing, there's no indication of expert review for clinical ground truth on a 'test set.'

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

Not applicable/Not mentioned.

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. This document describes an X-ray system, not an AI-powered diagnostic device. Therefore, no MRMC study or AI-related effectiveness is discussed.

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

Not applicable. As the device is an X-ray imaging system, "standalone" performance refers to its ability to acquire images, which is addressed by the "bench testing" and "performance and functional testing" mentioned. There is no algorithm performance discussed in the context of diagnostic interpretation.

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

Not applicable/Not mentioned for clinical ground truth. The "ground truth" for the performance claims appears to be based on physical measurements of dose and objective assessments of image quality (e.g., spatial resolution, contrast-to-noise ratio) from bench testing, rather than clinical outcomes or pathology.

8. The sample size for the training set

Not applicable/Not mentioned. This is not an AI/machine learning device that would require a training set in the typical sense.

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

Not applicable/Not mentioned.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.

October 21, 2015

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

EOS Imaging % John J. Smith, M.D., J.D Partner Hogan Lovells US LLP 555 Thirteenth Street, NW WASHINGTON DC 20004

Re: K152788 Trade/Device Name: EOS System Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: KPR Dated: September 25, 2015 Received: September 25, 2015

Dear Dr. Smith:

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/Resourcesfor You/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,

Robert Oals

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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510(k) Number (if known)

K152788

Device Name

EOS System

Indications for Use (Describe)

EOS is intended for use in general radiographic examinations and applications, excluding the evaluation of lung nodules and examinations involving fluoroscopy, and mammography. EOS 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 imaging with a patient entrance dose of 10 to 90 µGy for assessing global skeletal deformities in follow-up pediatric examinations. Micro Dose is not indicated for focal skeletal abnormalities and/or other pediatic abnormalities. Micro Dose is not indicated for use in patients with a Body Mass Index over 30.

Type of Use (Select one or both, as applicable)

X 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)

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510(k) SUMMARY

EOS imaginq's EOS System

EOS imaqing 10 rue Mercoeur PARIS F-75011 FRANCE

Phone: + 33 1 55 25 60 60 Facsimile: + 33 1 55 25 60 61

Contact Person: Mathias Breuil, Regulatory Affairs Project Leader

Date Prepared: October 13, 2015

Name of Device and Name/Address of Sponsor:

EOS System EOS imaging 10 rue Mercoeur PARIS F-75011 FRANCE Common or Usual Name: Digital Radiography System 21 CFR 892.1680; Stationary X-ray System Classification Name: Product Code KPR - System, X-Ray, Stationary Predicate Devices: K142773 cleared on January 22, 2015 Trade/Device Name: EOS System Regulation: 21 CFR 892.1680; Stationary X-Ray System Regulatory Class: II; Product Code: KPR, MQB

Intended Use/ indication for use

The Micro Dose feature is indicated for imaging with a patient entrance dose of 10 to 90 µGv for assessing global skeletal deformities in follow-up pediatric examinations. Micro Dose is not indicated for focal skeletal abnormalities and/or other pediatric abnormalities. Micro Dose is not indicated for use in patients with a Body Mass Index over 30.

Technological Characteristics

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Performance Data

EOS is designed to conform to IEC 60601-1 and collateral standards. A CB (certification body) test certificate has been issued. Software verification and validation testing was also conducted. Additional performance and functional testing has confirmed the equivalent performance of the modified EOS compared to the cleared predicate EOS. This testing included bench testing to confirm appropriate dosing and image quality.

Substantial Equivalence

The modified EOS has the same intended use and similar indications, principles of operation, and technological characteristics as the cleared predicate device.

	Modified EOS System(K152788)	Comparison with cleared Predicate EOS System(K142773)
Intended Use/Indications for Use	Both devices have the same intended use.
TechnologicalCharacteristics /Principles ofOperation	The fundamental technological characteristics of the modified EOS are unchanged fromthe cleared EOS. The modified EOS contains the following minor modifications that havebeen implemented following the last clearance:
• HardwareModifications	Component Supplier Changes	The change in suppliers has not resulted in anychanges to the design or manufacturingspecifications of the system. Performance andfunctional testing has confirmed non-regression.
	Modification to electricalcomponents followingobsolescence	Components have been replaced with iso-functionalcomponents.
	Mirror Sticker Accessory	New optional accessory kit
• SoftwareModifications	Software modification related to arecall action.	The acquisition software has been modified in orderto improve the detection of a dysfunction of thespectral filter and to prevent the use of the systemafter the alert message on spectral filtrationappears.
	Optimization of default acquisitionprotocols	Performance testing has demonstrated that thismodification allows reducing the entrance dose forthe changed protocols, with maintaining equivalentor better image quality than the cleared EOS.
	Improvement of imageprocessing.	The aim of this optimization is to increase the imagecontrast and dynamic during the image processing.
	Addition of a new features likeDose Structured Report andReject and Repeat Analysis(

Conclusions

The minor differences in the modified EOS's technological characteristics do not raise any new questions of safety or effectiveness. Performance data demonstrates that the modified EOS is as safe and effective as the cleared predicate device. Thus, the modified EOS is substantially equivalent to its predicate device.

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.