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 510(k) summary for EOS imaging's EOS (K123740) is a Special 510(k) notification, which means it addresses a modification to a previously cleared device (K120721; K071546). Due to this, the performance data section focuses on demonstrating equivalence to the predicate device rather than establishing new acceptance criteria or a comprehensive de novo validation study.

Here's an analysis based on the provided text, addressing your points where possible:

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided text, specific quantifiable acceptance criteria and directly "reported device performance" against those criteria are not explicitly stated in a systematic table format. The submission focuses on demonstrating that the modified EOS has "equivalent performance" to the predicate.

Acceptance Criteria (Implied)	Reported Device Performance
Conformance with IEC 60601-1 and collateral standards	CB (certification body) test certificate has been issued.
Appropriate dosing	Bench testing confirmed appropriate dosing.
Image quality	Bench testing confirmed appropriate image quality.
Software functionality and reliability	Software verification and validation testing was conducted.
No new questions of safety or effectiveness compared to predicate	Performance data demonstrates safety and effectiveness equivalent to predicate.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: The document does not specify a distinct "test set" with a particular sample size for clinical evaluation of diagnostic performance. The testing described (bench testing, software V&V) is primarily engineering and regulatory compliance focused.
Data Provenance: Not applicable, as a clinical test set is not explicitly mentioned.

3. Number of Experts and Qualifications for Ground Truth

Not applicable. The submission does not describe a study involving expert readers establishing ground truth for a clinical test set. The focus is on technical equivalence.

4. Adjudication Method

Not applicable, as a clinical study with expert readers and ground truth establishment is not described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not done according to the provided text. The submission aims to show technical equivalence to a predicate device, not an improvement in human reader performance with AI assistance.

6. Standalone Performance Study (Algorithm Only)

No, a standalone performance study was not done. The EOS device itself is a digital radiography system, not an AI algorithm. The performance data refers to the overall system's technical operation and image output, not an AI component.

7. Type of Ground Truth Used

The term "ground truth" as typically understood in AI/clinical performance studies (e.g., pathology, clinical outcomes) is not applicable here. The "truth" being established is that the modified device's technical characteristics (dosing, image quality, software) are equivalent to its predicate and meet relevant safety standards.

8. Sample Size for the Training Set

Not applicable. As this is not an AI device, there is no "training set" in the context of machine learning.

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no training set for an AI algorithm.

Summary of the Study that Proves Acceptance Criteria:

The study proving the device meets its (implied) acceptance criteria is a technical and regulatory compliance assessment rather than a clinical performance study. The key elements are:

Bench Testing: To confirm appropriate dosing and image quality. This likely involved phantoms and standardized measurements.
Software Verification and Validation: To ensure the software performs as intended and is free from defects.
Conformance with Standards: Demonstrated by a CB (certification body) test certificate for IEC 60601-1 and collateral standards.

The essence of the K123740 submission is to show that the modifications to the EOS system (which are not detailed in this summary but are implicit given it's a Special 510(k)) do not alter the fundamental safety or effectiveness of the device compared to its already cleared predicate. It relies on the predicate's prior clearance and the demonstration that the modified device remains technically equivalent.

Summary

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K123740

510(k) SUMMARY

EOS imaging's EOS

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

FEB 2 2 2013

EOS imaging 10 rue Mercoeur PARIS F-75011 FRANCE

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

Karine Chevrie, Quality and Regulatory Affairs Officer Contact Person:

Date Prepared: December 5, 2012

Name of Device and Name/Address of Sponsor:

EOS EOS imaging 10 rue Mercoeur PARIS F-75011 FRANCE

Common or Usual Name: Digital Radiography System

Classification Name: Radiology

Predicate Devices: EOS imaging's EOS (K120721; K071546)

Purpose of the Special 510(k) notice:

The EOS is a modification to the cleared EOS.

Intended Use

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.

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Technological Characteristics

Performance Data

EOS is designed to conform with IEC 60601-1 and collateral standards. A 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 appropriate dosing and image quality. Software verification and validation 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.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, symbolizing protection and service. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

February 22, 2013

EOS Imaging C/O John J. Smith, M.D., J.D. Hogan Lovells US L.L.P. 555 Thirteenth Street, NW Washington, DC, 20004

Re: K123740

Trade/Device Name: EOS Regulation Number: 21 CFR 892.1650 Regulation Name: Image Intensified Fluoroscopic X-Ray system Regulatory Class: Class II Product Code: MQB Dated: December 5, 2012 Received: December 5, 2012

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.

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

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Page 2 -- [Dr. Smith]

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.

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 Diagnostics and Radiological Health 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,

Image /page/3/Figure/5 description: The image shows a logo with the letters "FDA" in a stylized, interconnected design. The letters are formed by a series of parallel lines that create a three-dimensional effect. The overall design is intricate and abstract, with the letters blending together to form a cohesive shape.

for

Janine M. Morris Director Division of Radiolgoical 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): K123740

Device Name: EOS

Indications for Use:

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

FSA

(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health

K123740 510(k)

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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.