(262 days)
Unknown
The description mentions "statistical inference defined from database" for the 3D reconstruction process, which could potentially involve ML techniques, but it doesn't explicitly state the use of AI or ML.
No
The device is described as a workstation for processing and analyzing 2D X-ray images and providing 3D measurement tools, primarily for diagnostic and analytical purposes related to musculoskeletal deformities, rather than directly treating or preventing a disease.
Yes
The device aids in the analysis of medical conditions (scoliosis, spinal deformities, lower limb alignment disorders) by providing 3D measurement tools based on X-ray images, which directly supports diagnosis.
No
The device description explicitly states it is a "system" and is used "with 2D X-ray images obtained with the EOS Imaging EOS System (K071546)". While the core functionality described is software-based image processing and measurement, its operation is tied to and dependent on the specific hardware of the EOS Imaging EOS System. This suggests it is not a standalone software-only device.
Based on the provided information, the sterEOS Workstation is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- sterEOS Workstation Function: The sterEOS Workstation processes and analyzes medical images (2D X-ray images) of the musculoskeletal system. It does not interact with or analyze biological specimens from the patient.
The device is clearly described as a PACS device and a tool for analyzing medical images to aid in the diagnosis and assessment of musculoskeletal conditions. This falls under the category of medical imaging software or a medical image analysis system, not an IVD.
N/A
Intended Use / 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 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.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
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.
The sterEOS workstation is intended to be used by trained medical personnel, physicians and technologists.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
2D X-ray images, EOS radiological images
Anatomical Site
musculoskeletal system, spine, lower limbs
Indicated Patient Age Range
pediatric and adult populations.
scoliosis and related disorders and deformities of the spine in adult patients as well as pediatric patients 7 years and older.
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.
Intended User / Care Setting
trained medical personnel, physicians and technologists
Description of the training set, sample size, data source, and annotation protocol
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).
Database of clinical descriptors measured in 45 lower limbs of healthy adult subjects (for lower limbs).
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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:
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)
: 上一篇: 上一篇:
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1
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.
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:
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.
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.
2
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 Workstation | ||
| K090050 | Orthopedic Software for | ||
| Impax workstation K071972 | |||
| Intended Use | Image processing system | ||
| accessory to X-ray imager | Image processing system | ||
| accessory to X-ray imager | Image processing system | ||
| accessory X-ray imager | |||
| 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 | |||
| EOS Imaging EOS System | |||
| (K071546), the sterEOS | |||
| Workstation provides | |||
| interactive 3D measurement | 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 | Workstations are intended for | ||
| use in the acquisition, display, | |||
| digital processing review, | |||
| transfer, storage, archiving and | |||
| printing of medical images and | |||
| patient demographic | |||
| information. They allow the | |||
| user to adjust image densities | |||
| (window/level), perform basic | |||
| length and angle | |||
| measurements and highlight | |||
| regions of interest. They have | |||
| the ability to use 2D, 3D and | |||
| time series (cine) images and | |||
| data. They are intended for | |||
| use by physicians to aid in | |||
| diagnosis, and by medical | |||
| professionals whenever they | |||
| require or desire access to | |||
| medical images and patient | |||
| demographic information. | |||
| 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 all
model of bone
structures derived from
an a priori image data
set from 175 patients
(91 normal patients, 47 | - 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 | The software application
allows orthopedic surgeons
and specialists to assess
images, plan surgical
procedures, monitor patient
progress and educate patients
in a digital environment.
It allows assessments to be
made of geometrical skeletal
parameters with comparisons
against normative references
for adults and children in order
to draw therapeutic
conclusions. It includes
modules for the hip, knee,
spine, leg, hand, wrist, elbow, |
| | 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 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. | 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 | shoulder, foot, ankle and
fractures (trauma planning).
Users can access a library of
manufacturers electronic
templates intended to assist in
the selection and positioning of
implants and the marking of
tissues prior to surgery |
| User
Population | Trained medical personnel,
physicians, and
technologists | Trained medical personnel,
physicians, and
technologists | Trained medical personnel,
physicians, and technologists |
| Platform | Off the shelf hardware | Off the shelf hardware | Impax workstation |
| Operating
system | Windows XP | Windows XP | |
| Imaging
modalities | Multimodality for 2D viewer
EOS radiological images for
3D visualization | Multimodality for 2D viewer
EOS radiological images for
3D visualization | Multimodality for 2D,3D
viewer. |
| DICOM
Conformance | DICOM 3.0 | DICOM 3.0 | DICOM 3.0 |
| Image type | Monoframe image | Monoframe image | |
| Hardware | Dell Precision hardware
●
Processor : Xeon Processor
RAM: 2x1 GB
Hard Disk: 250 Go
Graphic card: NVIDIA
Quadro (NVS 295)
16X DVD+/- RW Drive
At least 3 external USB port
connector
One mouse | Dell Precision 390
hardware
Processor : Intel Core 2 Duo
Processor
RAM: 2x1 GB
Hard Disk: 250 Go
Graphic card: NVIDIA
Quadro FX mid-range
(FX 3450)
16X DVD+/- RW Drive | |
3
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. : .
4
| | EIZO Radiforce LCD
screen size >21",
resolution >2 million
pixels, luminance > 200
cd/m², response time
21",
resolution >2 million
pixels, luminance > 200
cd/m², response time
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