The 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.

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. 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. The fundamental technological characteristics of the modified EOS are unchanged compared to the cleared EOS.

AI/ML Overview

The provided text describes a 510(k) submission for a modified EOS digital radiography system. However, it does not contain detailed information about acceptance criteria for performance, a specific study proving those criteria were met, or any of the detailed aspects like sample sizes, ground truth establishment, or expert qualifications that your request specifies.

The document states that the fundamental technological characteristics of the modified EOS are unchanged compared to the cleared EOS (K071546). The "Performance Data" section primarily focuses on ensuring the modified device maintains equivalent performance to the predicate device.

Here's a breakdown of what can be extracted based on your request, and what is missing:

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

Acceptance Criteria	Reported Device Performance
Equivalent resolution to predicate device (K071546)	Confirmed through bench testing
Equivalent accuracy to predicate device (K071546)	Confirmed through bench testing
Acceptable mechanical resistance of stabilization accessory	Confirmed through testing
Acceptable software performance	Confirmed as equivalent to predicate through verification testing
Conformity with IEC 60601-1 and collateral standards	IECEE CB test certificate issued

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

Not specified. The document mentions "bench testing," "mechanical resistance testing," and "software verification testing" but provides no details on the sample sizes of images or devices used, nor the provenance of any data (e.g., country of origin, retrospective/prospective clinical data).

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 based on the provided text. The performance data described is primarily engineering/bench testing and software verification, not a clinical study involving experts establishing ground truth for diagnostic accuracy.

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

Not applicable based on the provided text. See point 3.

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 mentioned. This device is described as a "Digital Radiography System," implying it's an imaging acquisition device, not an AI-powered diagnostic aide for human readers.

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

Not applicable. The device itself is the imaging system; there's no "algorithm only" performance reported in the context of diagnostic interpretation. The performance data relates to the physical and software functioning of the imaging system.

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

Not specified/Applicable to the type of testing described. The "ground truth" for the tests mentioned (resolution, accuracy, mechanical resistance, software) would be established by engineering specifications, calibration standards, and functional requirements, not clinical ground truths like pathology or expert consensus.

8. The sample size for the training set

Not applicable. This document describes a modification to an existing digital radiography system, not the development or training of an AI algorithm. Therefore, there's no "training set" in the context of machine learning.

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

Not applicable. See point 8.

Summary

{0}------------------------------------------------

510(k) SUMMARY

APR - 6 2012

EOS imaging's EOS

Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared:

EOS imaging 10 rue Mercoeur PARIS F-75011 FRANCE

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

Contact Person: Karine Chevrie, Quality and Regulatory Affairs Officer

April 4, 2012 Date Prepared:

Name of Device and Name/Address of Sponsor:

EOS EOS imaging 10 rue Mercoeur PARIS F-75011 FRANCE

Digital Radiography System Common or Usual Name:

Classification Name: Radiology

Predicate Devices: EOS imaging's EOS (K071546)

Purpose of the Special 510(k) notice.

The modified EOS is a modification to the cleared EOS.

Intended Use

{1}------------------------------------------------

Technological Characteristics

Performance Data

EOS is designed to conform with IEC 60601-1 and collateral standards. An IECEE CB (certification body) test certificate has been issued. Additional performance and functional testing has confirmed the equivalent performance of the modified EOS compared to the EOS. This testing included bench testing to confirm equivalent resolution and accuracy of the modified EOS, and mechanical resistance testing of the stabilization accessory. Software verification testing was also conducted.

Substantial Equivalence

The modified EOS has the same intended use and similar indications, principles of operation, and technological characteristics as the cleared EOS. 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 EOS. Thus, the modified EOS is substantially equivalent to its predicate devices.

{2}------------------------------------------------

Image /page/2/Picture/0 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 human figure embracing or supporting another figure, represented by three curved lines.

DEPARTMENT OF HEALTH & HUMAN SERVICES

) L

Public Health Service

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

APR - 6 2012

EOS Imaging % Mr. John Smith Regulatory Counsel Hogan Lovells US L.L.P. 555 Thirteenth Street, NW WASHINGTON DC 20004

Re: K120721

Trade/Device Name: EOS Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: MQB Dated: March 8, 2011 Received: March 8, 2011

Dear Mr. 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.

If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 or any I vathan the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of

{3}------------------------------------------------

Page 2

medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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 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/cdrh/industry/support/index.html.

Sincerely Yours,

Janine M. Morris

Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

Indications for Use Statement

510(k) Number (if known):_

Device Name: EOS

Indications for Use:

Prescription Use __ x (Per 21 C.F.R. 801.109) AND/OR

Over-The-Counter Use_ (Per 21 C.F.R. 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety

510K

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.