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 Biospace 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.

Device Description

The sterEOS Workstation is a general picture archiving and communications storage 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 Biospace 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.

AI/ML Overview

The provided text indicates that the sterEOS Workstation is a general PACS device with 2D and 3D measurement tools, particularly for scoliosis and spinal deformities. The performance data section broadly mentions "Accuracy studies of the 3D measurements were performed by using either anthropomorphic phantoms or patient images acquired with EOS system in hospitals. Results of these studies validate the 3D measurement tools of the software and demonstrate the equivalent performance of the device in both adult and pediatric populations."

However, the input does not contain specific acceptance criteria (e.g., minimum accuracy percentages, confidence intervals, comparison to a gold standard with numerical thresholds) or the detailed results of these studies. It also lacks information on sample sizes for test sets, data provenance, expert qualifications, adjudication methods, details of MRMC studies, standalone performance specifics, training set size, or how its ground truth was established.

Therefore, many parts of your request cannot be directly answered from the provided text.

Here's a summary of what can be extracted or inferred based on the given document, and where information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Not specified in document	"Accuracy studies of the 3D measurements... validate the 3D measurement tools of the software and demonstrate the equivalent performance of the device in both adult and pediatric populations."

2. Sample size used for the test set and the data provenance

Sample Size for Test Set: Not specified. The document mentions an "a priori image data set from 175 patients" used for a model of bone structures, but this is explicitly not the test set for performance evaluation of the 3D measurement tools themselves. This 175-patient dataset likely contributed to the development of the model, not necessarily the independent verification of its accuracy against new data.
Data Provenance: "patient images acquired with EOS system in hospitals." The country of origin is not specified.
Retrospective or Prospective: Not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not specified. The document does not mention the use of experts for ground truth establishment in the performance studies.

4. Adjudication method for the test set

Not specified.

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

Not mentioned. The document focuses on the software's 3D measurement accuracy rather than its impact on human reader performance.

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

The performance studies seem to focus on the accuracy of the "3D measurement tools of the software," implying a standalone evaluation of the algorithm's output for these measurements. However, the exact methodology (e.g., whether a human user manually applied the tools, or if it was fully automated) is not detailed. The device is described as having "interactive 3D measurement tools," which might suggest human interaction is part of its intended use and thus part of its performance.

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

For studies using anthropomorphic phantoms, the ground truth would be based on the known, precise dimensions of the phantom.
For studies using patient images, the type of ground truth is not explicitly stated. Given it's measuring 3D anatomical structures from 2D X-rays, the ground truth would likely involve highly precise 3D imaging (e.g., CT, MRI) or a manual gold standard obtained by expert measurement using high-resolution 3D data if available, or direct measurements on the phantoms.

8. The sample size for the training set

The document mentions "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." This 175-patient dataset, along with dry isolated vertebrae data, served as the basis for developing the bone structure model used by the 3D measurement tools. This would be considered the data used for training/development of the model.

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

For the "a priori image data set from 175 patients," the method for establishing ground truth for training the bone structure model is not detailed.
For "dry isolated vertebrae data," the ground truth would likely be established through precise physical measurements of these specimens.

Summary

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K090050

510(k) SUMMARY

Biospace Med's sterEOS Workstation

MAR - 5 2010

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

Biospace Med 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: December 31, 2008

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)

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Device Description:

ﺮ:

Indications for Use:

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.

Performance Data:

Accuracy studies of the 3D measurements were performed by using either anthropomorphic phantoms or patient images acquired with EOS system in hospitals. Results of these studies validate the 3D measurement tools of the software and demonstrate the equivalent performance of the device in both adult and pediatric populations.

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Substantial Equivalence:

The sterEOS Workstation expands the indications for use of the company's cleared sterEOS device (K080529) to include patients 7 years and older. Performance data demonstrate that use of the device in the expanded patient population does not impact the sterEOS's safety. The modified sterEOS Workstation is otherwise identical to the cleared sterEOS Workstation. Accordingly, the sterEOS 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 & 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 another person, or possibly a stylized representation of an eagle.

Public Health Service

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

MAR - 5 2010

Biospace Med., Inc. % John J. Smith, M.D., J.D. Regulatory Counsel Hogan & Hartson LLP 555 Thirteen Street, N.W. WASHINGTON DC 20004

Re: K090050

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: November 18, 2009 Received: November 18, 2009

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 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,

Donald J. Bohn

Donald J. St.Pierre Acting 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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Indications for Use Statement

510(k) Number (if known):

Device Name: sterEOS Workstation

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

signature

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

17 510(k) Number

\DC - 026967/000001 - 2838917 v2

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).