The sterEOS Workstation is intended for use in the fields of musculoskeletal radiology and orthopedics in both pediatric and adult populations as a general device for acceptance, transfer, display, storage, and digital processing of 2D X-ray images of the musculoskeletal system including interactive 2D measurement tools.

When using 2D X-ray images obtained with the EOS Imaging EOS System (K071546), the sterEOS Workstation provides interactive 3D measurement tools:

To aid in the analysis of scoliosis and related disorders and deformities of the spine in adult patients as well as pediatric patients 7 years and older. The 3D measurement tools include interactive analysis based on a model of bone structures derived from an a priori image data set from 175 patients (91 normal patients, 47 patients with moderate idiopathic scoliosis and 37 patients with severe idiopathic scoliosis), and dry isolated vertebrae data. The model of bone structures is not intended for use to assess individual vertebral abnormalities.

To aid in the analysis of lower limbs alignment and related disorders and deformities based on angle and length measurement . The 3D measurement tools include interactive analysis based either on identification of lower limb alignment landmarks or as for the spine, on a model of bone structures derived from an a priori image data set. The model of bone structures is not intended for use to assess individual bone abnormalities. The 3D package including model-based measurements and torsion angles is indicated only for patients 15 years or older. Only the 2D/3D ruler is indicated for measurements in patients younger than 15 years old.

Device Description

The sterEOS Workstation is a general system for acceptance, transfer, display, storage, and digital processing of 2D X-ray images of the musculoskeletal system, including interactive 2D measurement tools.

When used with 2D X-ray images obtained with the EOS imaging's EOS System (K071546), the sterEOS Workstation provides interactive 3D measurement tools to aid in the analysis of skeletal deformities in spine and lower limbs.

AI/ML Overview

The provided text describes the sterEOS Workstation, a device for processing 2D X-ray images, and its 3D measurement tools for spine and lower limb deformities. The performance data section is brief and focuses on the validation for severe scoliosis, but it does not specify clear acceptance criteria or detailed study methodologies beyond what is presented below.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implicit)	Reported Device Performance
Equivalent performance with conventional measurement methods on native X-ray images for scoliosis assessment.	"Accuracy and precision of the automatic measurements computed from the 3D model of the spine in patients with Cobb’s angle > 50° have been confirmed with X-ray clinical images. Results validate the interactive 3D measurement tools for a severe scoliosis assessment and demonstrate the equivalent performance of the device with conventional measurement methods performed on native X-ray images."
Safety and effectiveness as the predicate device (sterEOS Workstation, K080529, K090050, K101398) for expanded indications (Cobb's angle > 50°).	"Performance data demonstrate that the device is as safe and effective as the company's cleared sterEOS device and, thus, is substantially equivalent."

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

The document does not explicitly state the sample size used for the performance evaluation of the interactive 3D measurement tools for Cobb's angle > 50°. It only refers to "X-ray clinical images."

The provenance of the data (e.g., country of origin, retrospective or prospective) for this specific validation is not mentioned.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

The document does not provide details on the number of experts used or their qualifications for establishing ground truth specifically for the test set used to validate the performance for Cobb's angle > 50°. It only refers to "conventional measurement methods performed on native X-ray images" as the comparison.

4. Adjudication Method for the Test Set

The adjudication method for the test set is not described in the provided text.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. The performance evaluation focuses on comparing the device's automatic measurements with "conventional measurement methods," implying a comparison against established, presumably manual, measurement techniques rather than an AI-assisted human reader study.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, a standalone performance evaluation appears to have been done. The text states: "Accuracy and precision of the automatic measurements computed from the 3D model of the spine...have been confirmed." This indicates that the algorithm's performance (automatic measurements) was evaluated against conventional methods. While the tool is interactive, the reported performance is for the "automatic measurements."

7. The Type of Ground Truth Used

The ground truth used for the performance evaluation of the 3D measurements for scoliosis appears to be based on conventional measurement methods performed on native X-ray images. This implies expert-derived measurements using traditional techniques as the reference standard.

8. The Sample Size for the Training Set

The model of bone structures for the spine and lower limbs was derived from an "a priori image data set from 175 patients (91 normal patients, 47 patients with moderate idiopathic scoliosis and 37 patients with severe idiopathic scoliosis), and dry isolated vertebrae data." This describes the data used to develop the underlying 3D models which the interactive tools use. It can be considered the training data for the model generation.

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

The document does not explicitly state how the ground truth for the 175-patient a priori image data set was established. It only mentions the composition of the dataset (normal, moderate idiopathic scoliosis, severe idiopathic scoliosis). It can be inferred that these classifications would have been based on clinical assessment and measurements by medical professionals.

Summary

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113344

510(k) SUMMARY

NOV 1 6 2012

EOS imaging's sterEOS Workstation

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

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 Contact Person:

Date Prepared: November 14, 2011

Trade Name:

sterEOS Workstation

Common or Usual Name:

sterEOS Workstation

Classification:

21 C.F.R. § 892.2050; radiological image processing system

Product Code:

LLZ

Predicate Devices:

sterEOS Workstation (K080529; K090050; K101398)

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Device Description:

Indications for Use:

When using 2D X-ray images obtained with the EOS imaging System (K071546), the sterEOS Workstation provides interactive 3D measurement tools:

To aid in the analysis of scoliosis and related disorders and deformities of the spine in adult ◆ patients as well as pediatric patients 7 years and older. The 3D measurement tools include interactive analysis based on a model of bone structures derived from an a priori image data set from 175 patients (91 normal patients, 47 patients with moderate idiopathic scoliosis and 37 patients with severe idiopathic scoliosis), and dry isolated vertebrae data. The model of bone structures is not intended for use to assess individual vertebral abnormalities.
To aid in the analysis of lower limb alignment and related disorders and deformities. The 3D . measurement tools include interactive analysis based either on identification of lower limb alignment landmarks or as for the spine, on a model of bone structures derived from an a priori image data set. The model of bone structures is not intended for use in pediatric patients and is not intended for use to assess individual bone abnormalities. The 3D package including model-based measurements and torsion angles is indicated only for patients 15 years or older. Only the 2D/3D ruler is indicated for measurements in patients younger than 15 years old.

Technological Characteristics:

The sterEOS Workstation supports DICOM 3.0 formatted images. The sterEOS Workstation is based on the Windows 7 operating system and runs on off-the-shelf hardware. The sterEOS Workstation user interface follows typical clinical workflow patterns to process, review, and analyze digital images.

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Performance Data:

Accuracy and precision of the automatic measurements computed from the 3D model of the spine in patients with Cobb's angle > 50° have been confirmed with X-ray clinical images. Results validate the interactive 3D measurement tools for a severe scoliosis assessment and demonstrate the equivalent performance of the device with conventional measurement methods performed on native X-ray images.

Substantial Equivalence:

The sterEOS Workstation expands the indications for use of the company's cleared sterEOS device to include patients with Cobb's angle > 50°. The sterEOS Workstation for the expanded indication for use is as safe and effective as the company's cleared sterEOS device (K080529, K090050, K101398). The device has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate device. The minor differences between the device and its predicate devices raise no new issues of safety or effectiveness. Performance data demonstrate that the device is as safe and effective as the company's cleared sterEOS device and, thus, is substantially equivalent.

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health and 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 image of a caduceus, a symbol often associated with medicine and healthcare, featuring a staff with a serpent entwined around it.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

EOS Imaging C/O Hogan Lovells US LLP 555 Thirteenth Street, NW WASHINGTON DC 20004

NOV 1 6 2012

Re: K113344

Trade/Device Name: Stereos Workstation Regulation Number: 21 CFR 892.2050 Regulation Name: Picture Archiving and Communications System Regulatory Class: Class II Product Code: LLZ Dated: October 25, 2012 Received: October 25, 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 - John 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,

Michael D. O'Hara 2012.11.16
11:38:07 -05'00'

Janine Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

510(k) Number (if known): K113344

Device Name: sterEOS Workstation

When using 2D X-ray images obtained with the EOS Imaging EOS System (K071546), the sterEOS Workstation provides interactive 3D measurement tools:

Prescription Use (Part 21 C.F.R. § 801 Subpart D) AND/OR

Over-The-Counter Use (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)	Page ___ of ___
Division of Radiological Health
Office of In Vitro Diagnostics and Radiological Health
510(k)	K113344

Regulation Number and Section

§ 892.2050 Medical image management and processing system.

(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).