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, 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. The 3D measurement tools include interactive analysis based either on identification of anatomical landmarks for postural assessment or 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 for spine modeling. The model of bone structures is not intended for use to assess individual vertebral abnormalities and is indicated only for patients 7 years and older. For postural assessment, a set of comparative tools is provided allowing the comparison of performed measurements to reference values for patients over 18 years old.
To aid in the analysis of lower limbs alignment and related disorders and deformities based on angle and length measurements. 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 (K123740), 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 is a 510(k) Summary for the sterEOS Workstation, which describes modifications to an already cleared device. It explicitly states, "Additional performance and functional testing has confirmed the equivalent performance of the modified sterEOS compared to the predicate sterEOS workstation." However, it does not provide specific acceptance criteria or detailed study results (like sensitivity, specificity, accuracy, or effect size for MRMC studies). It generally refers to verification and validation activities.

Therefore, many of the requested details about acceptance criteria, study specifics, and ground truth establishment are not present in the provided document.

Here's a breakdown of what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Not explicitly stated in the document	"Additional performance and functional testing has confirmed the equivalent performance of the modified sterEOS compared to the predicate sterEOS workstation."

Explanation: The document does not list specific numerical acceptance criteria (e.g., "accuracy > 90%"). Instead, it states that testing confirmed equivalent performance to the predicate device.

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

Sample Size: Not specified for performance testing. The "a priori image data set" used for model training includes 175 patients (91 normal, 47 moderate idiopathic scoliosis, 37 severe idiopathic scoliosis) but it's not explicitly stated this was the test set for the specific device modifications.
Data Provenance: Not specified for the performance testing. For the model training data, it comes from an "a priori image data set," but specific country of origin or whether it's retrospective/prospective is not mentioned.

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

Number of Experts: Not specified.
Qualifications of Experts: Not specified.

4. Adjudication Method for the Test Set

Adjudication Method: Not specified.

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

MRMC Study: No, an MRMC comparative effectiveness study is not mentioned. The document focuses on demonstrating substantial equivalence of the modified device to its predicate, rather than comparing human readers with and without AI assistance.

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

Standalone Performance: The description of "Performance Data" and "Software modifications have been verified at the unit level. After integration, system software V&V testing was performed..." implies standalone verification of the software's functionality. However, specific performance metrics for this standalone evaluation (e.g., accuracy of model-based measurements compared to ground truth) are not provided. The device itself is described as providing "interactive 3D measurement tools," suggesting a human-in-the-loop use case.

7. The Type of Ground Truth Used

Type of Ground Truth: Not explicitly stated for the device's performance testing. For the model of bone structures used in the 3D measurement tools, the data set included "dry isolated vertebrae data for spine modeling," which would serve as a form of anatomical ground truth for the model's development. However, how the ground truth for evaluating the measurements produced by the device was established is not detailed.

8. The Sample Size for the Training Set

Sample Size for Training Set: The "model of bone structures" used in the 3D measurement tools 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 for spine modeling." This dataset served for the development of the model, which is analogous to a training set.

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

Ground Truth for Training Set: For the "model of bone structures," the ground truth was established using an "a priori image data set" from 175 patients and "dry isolated vertebrae data." The "dry isolated vertebrae data" implies direct anatomical measurement as a ground truth for the morphology of individual vertebrae. For the patient image data, the method for establishing ground truth measurements (e.g., expert manual measurements) is not explicitly described, but the context implies that these images and associated clinical conditions (normal, moderate, severe scoliosis) served as the basis for model development.

Summary

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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

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

September 15, 2014

EOS Imaging % Mr. John J. Smith Regulatory Counsel Hogan Lovells US LLP Columbia Square 555 Thirteenth Street NW WASHINGTON DC 20004

Re: K141137

Trade/Device Name: sterEOS Workstation Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: August 18, 2014 Received: August 18, 2014

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. 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.

Smh.7)

for

Janine M. 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page

510(k) Number (if known) K141137

Device Name sterEOS workstation

Indications for Use (Describe)

The sterEOS Workstation is intended for use in the fields of musculoskeletal radiology and orthopediations of 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 Inaging EOS System, 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. O The 3D measurement tools include interactive analysis based either on identification of anatomical landmarks for postural assessment or on a model of bone structures derived from an a priori image data set from 175 patients, 47 patients with moderate idiopathic scoliosis with severe idiopathic scoliosis), and dry isolated vertebrae data for spine modeling. The model of bone structures is not intended for use to assess individual vertebral abnormalities and is indicated only for patients 7 years and older. For postural assessment, a set of comparative tools is provided allowing the comparison of performed measurements to reference values for patients over 18 years old.
O To aid in the analysis of lower limbs alignment and related disorders and deformities based on angle and length measurements. 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.

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

区 Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

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FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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510(k) SUMMARY

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

Contact Person:	Karine Chevrie, Quality and Regulatory Affairs Officer
Date Prepared:	August 15, 2014
Trade Name:	sterEOS Workstation
Common or Usual Name:	sterEOS Workstation
Classification:	21 C.F.R. § 892.2050; image processing radiological system
Product Code:	LLZ
Predicate Devices:	EOS imaging's sterEOS Workstation (K130395)

Purpose of the Traditional 510(k) notice:

The sterEOS workstation is a modification to the cleared sterEOS.

Device Description

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Indications for Use

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

To aid in the analysis of scoliosis and related disorders and deformities of the spine in o adult patients as well as pediatric patients. The 3D measurement tools include interactive analysis based either on identification of anatomical landmarks for postural assessment or 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 for spine modeling. The model of bone structures is not intended for use to assess individual vertebral abnormalities and is indicated only for patients 7 years and older. For postural assessment, a set of comparative tools is provided allowing the comparison of performed measurements to reference values for patients over 18 years old.
To aid in the analysis of lower limbs alignment and related disorders and deformities o based on angle and length measurements. 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.

Technological Characteristics

The technological characteristics of the modified sterEOS Workstation are essentially identical to the cleared sterEOS Workstation (K130395). Like the cleared sterEOS Workstation, the instant device is based on the Windows 7 operating system, runs on off-the-shelf hardware, supports DICOM 3.0 formatted images and its user interface follows typical clinical workflow patterns to process, review, and analyze digital images. The main differences with the cleared sterEOS Workstation consist of the following minor software modifications:

-Introduction of a new workflow dedicated to global postural assessment.
Improvement of the lower limb 3D modeling using automatic adjustment. -
-Addition of an export feature to allow for the transfer of sets of data for third-party applications.

Performance Data

Software modifications have been verified at the unit level. After integration, system software V&V testing was performed to ensure compliance with specifications, performance and nonregression. Additional performance and functional testing has confirmed the equivalent performance of the modified sterEOS compared to the predicate sterEOS workstation.

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Substantial Equivalence

The device has similar intended uses and 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.

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).