The sterEOS Workstation is intended for use in the fields of musculoskeletal radiology and orthopedics in both pediatric and adult populations as a general PACS 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 in patients with a Cobb's angle > 50 degrees and 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 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 patient younger than 15 years old.

Device Description

The sterEOS Workstation is a 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 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

Here's a breakdown of the acceptance criteria and study information for the sterEOS Workstation, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative "acceptance criteria" with specific thresholds for accuracy or precision. Instead, it describes a "performance data" section that generally asserts the device's capabilities and equivalence. The key performance claim is for the lower limb measurement tools.

Feature / Measurement	Acceptance Criteria (Implicit/General Statement)	Reported Device Performance
Accuracy and precision of 3D lower limb measurements	Not explicitly defined as a quantitative threshold. Implied as "validated" and "equivalent performance" to conventional methods.	"Accuracy and precision of the automatic measurements computed from the 3D model of the lower limbs have been confirmed with X-ray clinical images. Results validate the interactive 3D measurement tools for lower limb assessment and demonstrate the equivalent performance of the device with conventional measurement methods performed on native X-ray images."

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

Test Set Sample Size: The document does not explicitly state a separate "test set" sample size for the lower limb accuracy and precision validation.
- The "3D reconstruction method" for the lower limb mentions a "database of clinical descriptors measured in 45 lower limbs of healthy adult subjects." This dataset seems to be used for defining the statistical inference and forming a priori models, rather than a distinct testing set for device validation after model creation. It's unclear if these 45 limbs were also part of the "X-ray clinical images" used for performance confirmation.
Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). The text only mentions "X-ray clinical images."

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

The document does not provide details on the number of experts or their qualifications for establishing ground truth for the lower limb measurements. It only mentions "conventional measurement methods" as the comparison for "equivalent performance."

4. Adjudication Method for the Test Set

The document does not describe any adjudication method for the test set.

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

No multi-reader multi-case (MRMC) comparative effectiveness study is mentioned for the lower limb measurements, nor is any effect size of human readers' improvement with AI assistance discussed. The performance data focuses on the device's standalone measurements compared to conventional methods.

6. Standalone (Algorithm Only) Performance Study

Yes, a standalone performance assessment was done. The "Performance Data" section explicitly states: "Accuracy and precision of the automatic measurements computed from the 3D model of the lower limbs have been confirmed... Results validate the interactive 3D measurement tools for lower limb assessment and demonstrate the equivalent performance of the device with conventional measurement methods performed on native X-ray images." This indicates an evaluation of the algorithm's output against a reference standard.

7. Type of Ground Truth Used

The ground truth for evaluating the lower limb measurements seems to be based on:

"Conventional measurement methods performed on native X-ray images." This implies manual measurements made by experts directly on the images, which serves as a clinical reference.

8. Sample Size for the Training Set

Spine Model: 175 patients (91 normal, 47 moderate idiopathic scoliosis, 37 severe idiopathic scoliosis) and 1628 cadaveric vertebrae. This dataset was used to derive the "a priori image data set" for the spine's 3D model.
Lower Limb Model: 45 lower limbs of healthy adult subjects. This dataset was used to define the "statistical inference" for the parametric models of the tibia and femur.

9. How Ground Truth for the Training Set Was Established

The ground truth for the training sets (for both spine and lower limb models) was established through:

Clinical descriptors/measurements: Data was derived from patient populations (e.g., normal, moderate/severe idiopathic scoliosis, healthy adults) and cadaveric vertebrae. These "clinical descriptors" would have been established measurements or observations relevant to bone structures and deformities.
A priori image data set: This refers to the collection of pre-existing data from these patient populations that the models learned from.
Morpho-realistic models: These are meshed CT volumes of spine/lower limbs, regionalized according to the parametric models, likely serving as detailed anatomical references during model development.

Essentially, the models were developed using a database of known anatomical and pathological characteristics. The document doesn't detail the process of how each individual "clinical descriptor" was established for the training data (e.g., if it was expert consensus on each patient's image, or from medical records, etc.), but it clearly states these were "measured" or derived from a database.

Summary

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K101398

510(k) SUMMARY

FEB - 4 20il 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
Date Prepared:	Feb 01, 2011

Trade Name:	sterEOS Workstation
Common or Usual Name:	sterEOS Workstation

Classification:

21 CFR 892.2050; radiological image processing system

Product Code:

LLZ

Predicate Devices:

sterEOS Workstation (K080529; K090050)

Agfa Orthopedic Software for Impax Workstations (K071972)

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Device Description:

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

The sterEOS workstation is intended to be used by trained medical personnel, physicians and technologists. ········

· : : : : Additional details about the device can be found in the table presented below in the substantial equivalence section.

Indications for Use:

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 in patients with a Cobb's angle > 50 degrees and 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 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 patient younger than 15 years old.

Technological Characteristics:

The sterEOS Workstation supports DICOM 3.0 formatted images. The sterEOS Workstation is based on the Windows XP 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. and and the comments of the

A table setting forth the technological features of the sterEOS Workstation can be found in the substantial equivalence section below.

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Performance Data:

Accuracy and precision of the automatic measurements computed from the 3D model of the lower limbs have been confirmed with X-ray clinical images. Results validate the interactive 3D measurement tools for lower limb assessment and demonstrate the equivalent performance of the device with conventional measurement methods performed on native X-ray images.

Substantial Equivalence:

The sterEOS Workstation for the expanded indication for use in the lower extremities is as safe and effective as the company's cleared sterEOS device (K080529; K090050). The device has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate device. The minor technological 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.

	EOS Imaging Med	EOS Imaging Med	Agfa
	sterEOS Workstation	sterEOS WorkstationK090050	Orthopedic Software forImpax workstation K071972
Intended Use	Image processing systemaccessory to X-ray imager	Image processing systemaccessory to X-ray imager	Image processing systemaccessory X-ray imager
Indications forUse	The sterEOS Workstation isintended for use in the fieldsof musculoskeletal radiologyand orthopedics in bothpediatric and adultpopulations as a generalPACS device foracceptance, transfer,display, storage, and digitalprocessing of 2D X-rayimages of themusculoskeletal systemincluding interactive 2Dmeasurement tools.When using 2D X-rayimages obtained with theEOS Imaging EOS System(K071546), the sterEOSWorkstation providesinteractive 3D measurement	The sterEOS Workstation isintended for use in the fieldsof musculoskeletal radiologyand orthopedics in bothpediatric and adultpopulations as a generalPACS device foracceptance, transfer,display, storage, and digitalprocessing of 2D X-rayimages of themusculoskeletal systemincluding interactive 2Dmeasurement tools.When using 2D X-rayimages obtained with theEOS Imaging EOS System(K071546), the sterEOSWorkstation providesinteractive 3D measurementtools	Workstations are intended foruse in the acquisition, display,digital processing review,transfer, storage, archiving andprinting of medical images andpatient demographicinformation. They allow theuser to adjust image densities(window/level), perform basiclength and anglemeasurements and highlightregions of interest. They havethe ability to use 2D, 3D andtime series (cine) images anddata. They are intended foruse by physicians to aid indiagnosis, and by medicalprofessionals whenever theyrequire or desire access tomedical images and patientdemographic information.
	tools:- to aid in the analysis ofscoliosis and relateddisorders anddeformities of the spinein adult patients as wellas pediatric patients 7years and older. The3D measurement toolsinclude interactiveanalysis based on allmodel of bonestructures derived froman a priori image dataset from 175 patients(91 normal patients, 47	- to aid in the analysisof scoliosis andrelated disorders anddeformities of thespine in adult patientsas well as pediatricpatients 7 years andolder. The 3Dmeasurement tools:include interactiveanalysis based on amodel of bonestructures derivedfrom an a priori imagedata set from 175patients (91 normal	The software applicationallows orthopedic surgeonsand specialists to assessimages, plan surgicalprocedures, monitor patientprogress and educate patientsin a digital environment.It allows assessments to bemade of geometrical skeletalparameters with comparisonsagainst normative referencesfor adults and children in orderto draw therapeuticconclusions. It includesmodules for the hip, knee,spine, leg, hand, wrist, elbow,
	patients with moderateidiopathic scoliosis and37 patients with severeidiopathic scoliosis),and dry isolatedvertebrae data. Themodel of bonestructures is notintended for use inpatients with a Cobb'sangle > 50 degreesand is not intended foruse to assessindividual vertebralabnormalities- to aid in the analysis oflower limb alignmentand related disordersand deformities. The3D measurement toolsinclude interactiveanalysis based eitheron identification oflower limb alignmentlandmarks or as for thespine, on a model of,bone structures derivedfrom an a priori imagedata set. The model ofbone structures is notintended for use inpediatric patients andis not intended for useto assess individualbone abnormalities.	patients, 47 patientswith moderateidiopathic scoliosisand 37 patients withsevere idiopathicscoliosis), and dryisolated vertebraedata. The model ofbone structures is notintended for use inpatients with a Cobb'sangle > 50 degreesand is not intended foruse to assessindividual vertebralabnormalities	shoulder, foot, ankle andfractures (trauma planning).Users can access a library ofmanufacturers electronictemplates intended to assist inthe selection and positioning ofimplants and the marking oftissues prior to surgery
UserPopulation	Trained medical personnel,physicians, andtechnologists	Trained medical personnel,physicians, andtechnologists	Trained medical personnel,physicians, and technologists
Platform	Off the shelf hardware	Off the shelf hardware	Impax workstation
Operatingsystem	Windows XP	Windows XP
Imagingmodalities	Multimodality for 2D viewerEOS radiological images for3D visualization	Multimodality for 2D viewerEOS radiological images for3D visualization	Multimodality for 2D,3Dviewer.
DICOMConformance	DICOM 3.0	DICOM 3.0	DICOM 3.0
Image type	Monoframe image	Monoframe image
Hardware	Dell Precision hardware●Processor : Xeon ProcessorRAM: 2x1 GBHard Disk: 250 GoGraphic card: NVIDIAQuadro (NVS 295)16X DVD+/- RW DriveAt least 3 external USB portconnectorOne mouse	Dell Precision 390hardwareProcessor : Intel Core 2 DuoProcessorRAM: 2x1 GBHard Disk: 250 GoGraphic card: NVIDIAQuadro FX mid-range(FX 3450)16X DVD+/- RW Drive

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. : .

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	EIZO Radiforce LCDscreen size >21",resolution >2 millionpixels, luminance > 200cd/m², response time<100 ms.	At least 3 external USB portconnectorOne mouseEIZO Radiforce LCDscreen size >21",resolution >2 millionpixels, luminance > 200cd/m², response time<100 ms.
Imagemanipulationfunctions	ZoomMagnifying glassPanGrayscale inversionRotating flippingDistanceAngle	ZoomMagnifying glassPanGrayscale inversionRotating flippingDistanceAngle	ZoomMagnifying glassPanGrayscale inversionRotating flippingDistanceAngle
Measurementfunctions
Workflowfeatures	DICOM query/retrieve fromarchives	DICOM query/retrieve fromarchives	DICOM query/retrieve fromarchives
	Multiple series loading	Multiple series loading	Multiple series loading
	annotation	annotation	annotation
	DICOM print	DICOM print	DICOM print
3Dreconstructionmethod	Lower limb 3Dreconstruction processis based on:- Parametric models oftibia and femur- Statistical inferencedefined from databaseof clinical descriptorsmeasured in 45 lowerlimbs of healthy adultsubjects.- One morphorealistmodel of lower limbwhich is a meshed CTvolume of lower limbregionalized as theparametric models.After identifying basicanatomical landmarks,corresponding to somepoints of the parametricmodels, on frontal andlateral EOS X-ray images,the others points of theparametric models arecalculated by linearregression with theknowledge included in the apriori data base. Thispersonalized parametricmodel is used for adaptingthe morpho-realisticparametric meshed modeland provides a first 3Dmodel as close as possibleto the native X-ray contours.This 3D model is deformedmanually by the operatorthrough control points up to	Spine 3D reconstructionprocess is based on:- parametric models ofspine and vertebrae- Statistical inferencedefined from databaseof clinical descriptorsmeasured in 175subjects with scoliosisand 1628 cadavericvertebrae.- One morphorealistmodel of spine which isa meshed CT volume ofspine regionalized asthe parametric models.After identifying basicanatomical landmarks,corresponding to somepoints of the parametricmodels, on frontal andlateral EOS X-ray images,the others points of theparametric models arecalculated by linearregression with theknowledge included in the apriori data base. Thispersonalized parametricmodel is used for adaptingthe morpho-realisticparametric meshed modeland provides a first 3Dmodel as close as possibleto the native X-ray contours.This 3D model is deformedmanually by the operatorthrough control points up tomatching accurately the X-

. . . . .

: 上一篇:

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matching accurately the Xray contours. This deformation is performed by using common linear least squares estimation
algorithm.

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ray contours. This deformation is performed by using common linear least squares estimation algorithm.

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Image /page/6/Picture/0 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

Public Health Service

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

Biospace Med % Mr. John J. Smith Regulatory Counsel Hogan & Hartson L.L.P. 555 Thirteenth Street, NW WASHINTON DC 20004

FEB - 4 201

Re: K101398

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: January 14, 2011 Received: January 14, 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 comply with all 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

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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/ReportalProblem/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.

Mary Postel

Mary Pastel. ScD. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Image /page/8/Picture/0 description: The image shows a grainy, black and white picture of what appears to be a cluster of objects. The objects are small and irregularly shaped, and they are grouped together in the center of the image. The background is a uniform white color. Due to the image quality, it is difficult to determine the exact nature of the objects.

Indications for Use Statement

510(k) Number (if known): K101398

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:

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 in patients with a Cobb's angle > 50 degrees and is not intended for use to assess individual vertebral abnormalities.
to aid in the analysis of lower limbs alignment and related disorders and deformities ﺍ 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 patient vounger than 15 years old.

Prescription Use	X
(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 Evarration (OD ///DC - 026967/000001 - 3203067 v1

510K. K101398

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).