K080529 · Biospace Med · LLZ · Aug 29, 2008 · Radiology
Device Facts
Record ID
K080529
Device Name
STEREOS WORKSTATION
Applicant
Biospace Med
Product Code
LLZ · Radiology
Decision Date
Aug 29, 2008
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 892.2050
Device Class
Class 2
Attributes
Software as a Medical Device, Real-World Evidence, Pediatric
Real-World Evidence
Submission
Device
Sponsor
RWD Sources
RWE Use Summary
Key Tags
K080529 · Aug 29, 2008
STEREOS WORKSTATION
Biospace Med
Retrospective clinical image data set (175 patients)
The device uses a pre-existing clinical image data set from 175 patients (normal, moderate scoliosis, and severe scoliosis) to create a model of bone structures for 3D measurement analysis.
Retrospective data; Clinical image data; Model development
Clinical Evidence
Study Design
Population
Comparator
Key Endpoints
A priori image data set; Retrospective analysis of clinical image data
175 patients (91 normal, 47 moderate idiopathic scoliosis, 37 severe idiopathic scoliosis) and dry isolated vertebrae; Sample Size: 175
Not applicable for this study
Development of a model of bone structures for 3D measurement
AI Performance
Output
Algorithm
Acceptance
Observed
Dev DS
Dev Readers
Test DS
Test Readers
3D spinal measurement
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—
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175 patients (91 normal, 47 moderate idiopathic scoliosis, 37 severe idiopathic scoliosis) and dry isolated vertebrae data
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Comparative study in a clinical setting
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Indications for Use
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 scollosis and related disorders and deformities of the spine in adult patients as well as pediatric patients 16 vears 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 Story
sterEOS Workstation functions as a PACS for musculoskeletal 2D X-ray images; enables acceptance, transfer, display, storage, and digital processing. When paired with Biospace EOS System (K071546) images, provides interactive 3D measurement tools for spinal deformity and scoliosis analysis. Operates on off-the-shelf hardware using Windows XP. Clinicians use interactive tools to analyze bone structures based on a pre-existing model derived from 175 patient datasets and dry vertebrae. Output assists physicians in evaluating spinal alignment and deformities. Intended for clinical use in radiology and orthopedic settings. Does not assess individual vertebral abnormalities or patients with Cobb's angle > 50 degrees.
Clinical Evidence
Comparative study conducted in a clinical setting to validate 3D reconstruction software and accuracy of clinical parameters calculated in 3D space. Results demonstrated equivalent performance to predicate devices.
Technological Characteristics
Supports DICOM 3.0 images. Runs on off-the-shelf hardware with Windows XP operating system. Features interactive 2D and 3D measurement tools. User interface follows standard clinical workflow patterns.
Indications for Use
Indicated for musculoskeletal radiology and orthopedics in pediatric (≥16 years) and adult populations. Used for PACS functions (transfer, display, storage, processing) of 2D X-ray images. 3D measurement tools are indicated for analysis of scoliosis and spinal deformities. Contraindicated for patients with Cobb's angle > 50 degrees and for assessment of individual vertebral abnormalities.
Regulatory Classification
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.
Special Controls
*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).
Predicate Devices
Syngo Multimodality Workstation from Siemens Medical Systems, Inc. (K010938)
Agfa Orthopedic Software for Impax Workstations (K071972)
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K080529
Page 1 of 2
### 510(k) Summary
#### Biospace med's sterEOS Workstation
# Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
AUG 2 9 2008
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: August 21, 2008
### Trade Name:
sterEOS Workstation
### Common or Usual Name:
sterEOS Workstation for the EOS
#### Classification:
21 CFR 892.2050; radiological image processing system
#### Product Code:
LLZ
### Predicate Devices:
- Syngo Multimodality Workstation from Siemens Medical Systems, Inc. (K010938) ー
- -Agfa Orthopedic Software for Impax Workstations (K071972)
### 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.
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K08052°
Page 2 of 2
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.
### Indications for Use:
The sterEOS Workstation is intended for use in the fields of musculoskeletal radiology and orthonedics in both pediatic 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 scollosis and related disorders and deformities of the spine in adult patients as well as pediatric patients 16 vears 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
### Technological Characteristics:
The sterEOS Workstation supports DICOM 3.0 formatted images. The 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:
A comparative study was conducted in a clinical setting to demonstrate accuracy of clinical parameters calculated in the 3D space. The results of this study validate the 3D reconstruction software and demonstrate the equivalent performance of the device.
#### Substantial Equivalence:
The sterEOS Workstation, when used as a general picture archiving and communications storage system, including the interactive 2D measurement tools, and when used with 2D X-ray images obtained with the Biospace EOS System (K071546), is as safe and effective as the Siemens Syngo Multimodality Workstation and the Agfa Orthopedic Software for Impax Workstation. The sterEOS Workstation, when used as a general PACS and with the 3D measurement tools available for use with the 2D X-ray images from the EOS System, has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate devices. The minor technological differences between the sterEOS Workstation and its predicate devices raise no new questions of safety or effectiveness. Thus, the sterEOS Workstation is substantially equivalent.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three bars extending from its head, representing health, human services, and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle symbol. The logo is presented in black and white.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
/AUG 2 9 2008
Biospace Med Incorporated % John J. Smith, M.D., J.D., Partner Hogan & Hartson, LLP Columbia Square 555 Thirteenth Street, N.W. WASHINGTON DC 20004
Re: K080529
Trade/Device Name: stereos Workstation Regulation Number: 21 CFR §892.2050 Regulation Name: Picture archiving and communications systems Regulatory Class: II Product Code: LLZ Dated: August 21, 2008 Received: August 21, 2008
### 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 (Premarket Approval), it may be subject to such 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.
Image /page/2/Picture/10 description: The image shows a circular logo with the letters "FDA" in the center. Above the letters, the years "1906-2006" are printed. Below the letters, the word "Centennial" is written in cursive. Three stars are below the word "Centennial". The logo is surrounded by a circular border with text and star shapes.
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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); 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.
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 Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliary, prome of the following numbers, based on the regulation number at the top of this letter.
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRF's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 24/1276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You max 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html .
Sincerely yours.
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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### Indications for Use Statement
## 510(k) Number (if known): K080529
#### Device Name: sterEOS Workstation
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 scollosis and related disorders and deformities of the spine in adult patients as well as pediatric patients 16 vears 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
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 Evaluation (ODE)
Arnal M. Whang
and Radiological Devic 510(k) Number
Two short videos show you everything — or skip straight to the written tutorial if you'd rather read. You can reopen this any time from the Tutorial button in the top bar.
Part 1 — Search, results, and everyday workflows 16 min
Part 2 — Embeddings: the galaxy map 3 min
1. Search: exact and fuzzy
Type a phrase like "coronary artery calcification" into the search box. You get two kinds of results. Exact results match the literal phrase — prefix searches work ("coronary artery calcificati") but suffix searches do not. Fuzzy results match on the meaning and intent of your phrase rather than the exact words, and are sorted by relevance score. Hover over the Exact or Fuzzy badge on any row to see exactly why it matched.
Use the checkboxes above the results to narrow: SaMD keeps only software-only devices, AI / ML keeps only devices with AI.
Exact vs. fuzzy search: what's the difference?
Exact matches on the literal phrase (prefix search works, suffix does not). Fuzzy matches on the meaning and intent of the phrase rather than the exact words. Hover over the badge on any row to see why it matched.
You search "coronary artery calcification" and want only software devices with AI. What two filters do you apply?
Narrow by SaMD (software-only devices), then narrow by AI/ML (devices with AI).
2. The results table
Scroll right in the results table. The intended use is extracted for you — no need to open the PDF. The device story gives a high-level snapshot of what the device does and how it's used. The AI Performance sub-table shows each output name, acceptance criteria, observed values, and development/test dataset descriptions — the same format Innolitics uses for regulatory strategy outputs, and the fastest high-level fingerprint of an AI device. It is AI-generated but has been very reliable in practice.
Where do you find a device's intended use without opening the PDF?
Scroll right in the search results table. The intended use column is extracted for you; no need to dig into the 510(k) summary PDF.
What does the AI Performance sub-table show, and why is it useful?
Output name, acceptance criteria, observed values, development dataset description, and test dataset description. It's the same format we use for regulatory strategy output and Fast 510(k) input, and the fastest high-level fingerprint of an AI device. AI-generated but reliable in practice.
3. Judging fuzzy relevance
Fuzzy results trail off in relevance as you scroll. Use three signals to decide how far down to go: the fuzzy badge explanations, the intended use column, and whether your target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, you're past the relevant zone. A top hit with a low score (~0.4) and a stretched explanation is a hint the closest predicates are far away — the project may be headed for De Novo. Note the fuzzy search is a pattern match: it doesn't handle negation ("not") well, and hardware devices can appear — filter by SaMD/AI ML to cut them.
How do you judge how far down fuzzy search results to go?
Use the relevancy signals: the fuzzy badge explanations, the intended use column, and whether the target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, results are trailing off in relevancy.
4. Device detail page: chat and citations
Click a device name to open its detail page: device facts on the left, a chat window on the right. Ask something like "Describe the training data". The answer carries little citation bubbles — click one to jump to the highlighted passage in the source PDF, so you can verify every AI answer against the document. There's also a Download PDF button for sharing.
How do you verify an AI chat answer on the device detail page?
Click the citation bubbles to jump to the relevant highlight in the source document.
Reading rule for every project: how many summaries do you read in full?
At least the three most relevant 510(k) or De Novo summaries, in full. After that, use targeted chat questions to confirm your memory quickly. The tool supports this professional habit — it doesn't replace it.
5. Side-by-side comparison
Select multiple rows in the results table (aim for under ~10), then open the PDF Viewer tab. Ask one question — it goes to all selected devices in parallel, each with citations. This is the fastest way to compare and contrast devices: training data, PCCP scope, how they handled adding new scanners, and so on.
What does the side-by-side PDF viewer mode do?
Select multiple devices, open the PDF viewer tab, and ask one question (e.g., "Describe the training data"). It queries all selected devices simultaneously with citations, so you can compare and contrast quickly.
6. Collections
With rows selected, go to the Collections tab and create a labeled collection (e.g., "Cobb Angle Project"). Reload that selection any time — before a client call, pull up the collection and ask questions across all of its devices at once.
How do you save a set of selected devices for later use?
Select the rows, go to the Collections tab, and create a labeled collection (e.g., "Cobb Angle Project"). You can reload the selection anytime and carry it into the PDF viewer and other tabs that support selections.
7. Product codes and the regulations tree
Click a product code in the results to jump to it in the regulations tree — identification text, sibling product codes, and devices you can open in a PDF viewer on the right. Click a regulation number to see its identification, special controls, and related product codes. You can also search by product code or regulation number at the top of the tree. Always read the special controls if any exist for your device — it broadens your search and sharpens pre-kickoff research.
What can you do from the regulations tree view?
Browse product codes and regulation numbers, read the identification text and special controls, browse sibling product codes, open device PDFs on the right, and search by product code or regulation number at the top of the tree.
8. Chart view
Click Show Chart and segment by regulation number (or product code) to see which regulations dominate your result set. Clicking a regulation takes you into the regulations tree. Great for spotting that most matches are, say, hardware laparoscopic devices — a cue to go back and filter.
How do you see which regulations dominate a search result set?
Click "Show Chart" and segment by Regulation Number. Clicking a regulation takes you to the regulations tree.
9. The predicate graph
Open the Predicates tab for a family-tree view of predicate relationships. Click a node to trace its parents and children; selections from search carry over pre-selected. Commonly predicated devices are worth reading — a lot of people predicated them for a reason. The visual lineage is also handy on client calls, e.g. to show how a predicate family evolved and justify why your predicate still holds.
In the predicate graph, why are commonly predicated devices worth reading?
A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
10. Embeddings: the galaxy map
The Embeddings tab plots every matching document in a 2-D "galaxy map" where semantically similar devices cluster together. Hover or click clusters to explore, and let AI label the clusters for you. Embeddings beat product codes for grouping: two devices can carry different product codes (LLZ vs. QIH) yet do the same thing — the embedding captures the meaning of the intended use and device story. This is also exactly how retrieval-augmented generation (RAG) works under the hood, and it makes a great visual on client calls.
Try it yourself
Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
