(42 days)
Not Found
Yes
The device description mentions that the software "can then suggest points that represent the vertebral bodies in the image using a '6-point morphometry' protocol". While not explicitly stating AI/ML, the term "suggest points" implies an automated process that likely uses some form of pattern recognition or image analysis algorithm, which could be based on AI/ML techniques. The lack of explicit mention of AI/ML or performance data makes it difficult to definitively confirm, but the functionality described is consistent with AI/ML applications in medical imaging.
No
The device is intended for visualization and quantitative assessment of vertebral deformities to assist in diagnosis, not for direct treatment or intervention.
Yes
The device assists in the diagnosis of vertebral fracture and allows the qualified medical practitioner to use the information provided to make a diagnosis.
Yes
The device description explicitly states it is a "stand-alone software package" installed and used on a personal computer, with no mention of accompanying hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens derived from the human body. The Optasia Medical SpineAnalyzer analyzes images (X-ray and DXA) of the spine, which are not biological specimens.
- The device's function is image analysis and measurement, not the analysis of biological samples. It helps qualified medical practitioners assess vertebral deformities based on visual and quantitative analysis of images.
- The intended use clearly states it's for the visualization or quantitative assessment of vertebral body deformities in images. It does not involve testing or analyzing biological fluids, tissues, or other specimens.
Therefore, the Optasia Medical SpineAnalyzer falls under the category of medical imaging software or a medical device used for image analysis, not an In Vitro Diagnostic device.
No
The provided text does not contain any explicit statement that the FDA has reviewed and approved or cleared a Predetermined Change Control Plan (PCCP) for this specific device.
Intended Use / Indications for Use
The Optasia Medical SpineAnalyzer™ is intended for the visualization or quantitative assessment of vertebral body deformities between levels T4 and L4 of the thoracic and lumbar spine in adult patients at risk of osteoporotic fracture. The qualified medical practitioner uses the device to calculate vertebral deformity ratios derived from the interactive placement of morphometry markers. Deformity grades are then calculated using criteria published by Genant . Additionally, the qualified medical practitioner can record a manual Genant Semi-Quantitative score based on visual assessment.
The qualified medical practitioner may use the deformity ratios and deformity grades to assist in the diagnosis of vertebral fracture and may, along with knowledge of patient history, apply medical expertise and best practice clinical judgment to determine if therapeutic intervention is indicated.
Product codes
LLZ
Device Description
The Optasia Medical SpineAnalyzer is a stand-alone software package which can be installed and used on any "personal computer" meeting the minimum specification requirements defined in Tab 16, section 16.6. SpineAnalyzer is designed with context sensitive menus to guide the qualified medical practitioner through the vertebral assessment workflow of lateral spine xpractionel images from patients at risk of, or suffering from, osteoporosis.
The SpineAnalyzer allows visualization of the spine from lateral spine x-ray or DXA images, and hence identification of vertebral deformities. The SpineAnalyzer can then suggest points that represent the vertebral bodies in the image using a "6-point morphometry" protocol, for the vertebrae the image asing a - These points are then reviewed by a suitably qualified beedical practitioner who can adjust them using his/her clinical expertise to medical practicity. The spine in the spine in the region of interest.
A set of "tools" are provided within the SpineAnalyzer software to allow the A set of "tools" and peasure features on the digital image of cimical Specialist to announce es" which are derived from heights or ratios of spiric us "derormism" (1) in ther tools are provided to allow the neights of the vertebral boxed; allowing the physician to compare these measurements to be reported)
measurements against those made on previous occasions and hence infer improvement or deterioration in the condition of the area of interest of the spine.
The Optasia Medical SpineAnalyzer guides the qualified medical practitioner's workflow in the objective assessment of the vertebrae T4 through L4 captured in the image. In osteoporosis, a vertebral deformity may indicate an osteoporotic fracture. A qualified medical practitioner can use the information provided by SpineAnalyzer, together with other clinical information, to make a diagnosis.
In patients who have been diagnosed with osteoporosis, a change in vertebral deformity over time may indicate an incident vertebral fracture. SpineAnalyzer facilitates the comparison of baseline and follow-up spine xray or DXA images which the qualified medical practitioner, together with other clinical information, can use to diagnose incident vertebral fracture.
The intended use of SpineAnalyzer™ is to facilitate the visual or quantitative assessment of vertebral body deformities in lateral DXA or digital/digitized X-ray images.
The Optasia Medical SpineAnalyzer will be delivered on a CD-ROM together with documentation containing operation manual, user installation instructions and release notes. The CD-ROM will auto-run an application installer and will contain the following files:
- An installer program which utilizes the "Windows Installer" on the . target system.
- A separate PDF (Portable Document Format) document which contains . user installation instructions and release notes.
- A separate PDF file containing the operation manual. .
- Additional system files associated with auto-run installation. .
The Optasia Medical SpineAnalyzer software does not contain any integrated "help" function. The user is guided through the workflow by a contextsensitive menu system available from a right-button mouse click at each stage.
Mentions image processing
Yes
Mentions AI, DNN, or ML
No
Input Imaging Modality
DXA, and digital or digitized X-ray
Anatomical Site
T4 and L4 of the thoracic and lumbar spine
Indicated Patient Age Range
Adult patients
Intended User / Care Setting
Qualified medical practitioner
Description of the training set, sample size, data source, and annotation protocol
Not Found
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)
No performance data (laboratory, animal or clinical) is included.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
K163475 P.
Center for Devices and Radiological Health
11/17/2010
JAN - 5 2011
Optasia Medical Haw Bank House, High Street Cheadle Cheshire, SK8 1AL United Kingdom Telephone: 011 44 161 4917860 Fax: 011 44 161 4917879
Optasia Medical
THE SCIENCE OF IMAGE UNDERSTANDING
510(k) Summary
As required by 21 CFR 807.92(c)
Owner's Name
Optasia Medical Haw Bank House High Street Cheadle Cheshire SK8 1AL United Kingdom
Tel:
Fax: Contact Person: e-mail :
011 44 161 4917860 011 44 161 4917879 Anthony Holmes anthony .holmes@optasiamedical.com
Date this Summary was Prepared
November 17, 2010
Classification name
Classification name: Requlation: Product Code: Requlatory Class:
Picture archiving and communications system 21 CFR 892.2050 LLZ II
Common/Usual Name
Spine Analysis Software
Proprietary Name
SpineAnalyzer
5 510(k) Summary
Page 5-2
1
11/17/2010
JAN - 5 2011
Establishment Registration Number
The SpineAnalyzer was manufactured by: Optasia Medical Limited Haw Bank House High Street Cheadle Cheshire SK8 1AL United Kingdom Establishment Registration Number: "to be applied for"
Substantial Equivalence
Optasia Medical believes that its SpineAnalyzer is substantially equivalent in design, use and materials to the GE LUNAR Dual-energy Vertebral Assessment View Software, K023554.
Description of Product
The Optasia Medical SpineAnalyzer is a stand-alone software package which can be installed and used on any "personal computer" meeting the minimum specification requirements defined in Tab 16, section 16.6. SpineAnalyzer is designed with context sensitive menus to guide the qualified medical practitioner through the vertebral assessment workflow of lateral spine xpractionel images from patients at risk of, or suffering from, osteoporosis.
The SpineAnalyzer allows visualization of the spine from lateral spine x-ray or DXA images, and hence identification of vertebral deformities. The SpineAnalyzer can then suggest points that represent the vertebral bodies in the image using a "6-point morphometry" protocol, for the vertebrae the image asing a - These points are then reviewed by a suitably qualified beedical practitioner who can adjust them using his/her clinical expertise to medical practicity. The spine in the spine in the region of interest.
A set of "tools" are provided within the SpineAnalyzer software to allow the A set of "tools" and peasure features on the digital image of cimical Specialist to announce es" which are derived from heights or ratios of spiric us "derormism" (1) in ther tools are provided to allow the neights of the vertebral boxed; allowing the physician to compare these measurements to be reported)
measurements against those made on previous occasions and hence infer
5 510(k) Summary
Page 5-3
2
$$\begin{array}{cccc} \text{15:} & \mathbf{5} - & \mathbf{N} \mathbf{\hat{k}} \ \hline \end{array}$$
11/17/2010
improvement or deterioration in the condition of the area of interest of the spine.
The Optasia Medical SpineAnalyzer guides the qualified medical practitioner's workflow in the objective assessment of the vertebrae T4 through L4 captured in the image. In osteoporosis, a vertebral deformity may indicate an osteoporotic fracture. A qualified medical practitioner can use the information provided by SpineAnalyzer, together with other clinical information, to make a diagnosis.
In patients who have been diagnosed with osteoporosis, a change in vertebral deformity over time may indicate an incident vertebral fracture. SpineAnalyzer facilitates the comparison of baseline and follow-up spine xray or DXA images which the qualified medical practitioner, together with other clinical information, can use to diagnose incident vertebral fracture.
The intended use of SpineAnalyzer™ is to facilitate the visual or quantitative assessment of vertebral body deformities in lateral DXA or digital/digitized X-ray images.
The indications for use are defined as:
- The Optasia Medical SpineAnalyzer™ is intended for the visualization . or quantitative assessment of vertebral body deformities between levels T4 and L4 of the thoracic and lumbar spine in adult patients at risk of osteoporotic fracture. The qualified medical practitioner uses the device to calculate vertebral deformity ratios derived from the interactive placement of morphometry markers. Deformity grades are then calculated using criteria published by Genant . Additionally, the qualified medical practitioner can record a manual Genant Semi-Quantitative score based on visual assessment.
- The qualified medical practitioner may use the deformity ratios and . deformity grades to assist in the diagnosis of vertebral fracture and may, along with knowledge of patient history, apply medical expertise and best practice clinical judgment to determine if therapeutic intervention is indicated.
- H K, et al. Vertebral Fracture Assessment Using a Semiquantitative Technique. Journal of Bone and Mineral Research. 8(9), pp1137-1148, 1993.
The Optasia Medical SpineAnalyzer will be delivered on a CD-ROM together with documentation containing operation manual, user installation instructions and release notes. The CD-ROM will auto-run an application installer and will contain the following files:
5 510(k) Summary
3
11/17/2010
- An installer program which utilizes the "Windows Installer" on the . target system.
- A separate PDF (Portable Document Format) document which contains . user installation instructions and release notes.
- A separate PDF file containing the operation manual. .
- Additional system files associated with auto-run installation. .
The Optasia Medical SpineAnalyzer software does not contain any integrated "help" function. The user is guided through the workflow by a contextsensitive menu system available from a right-button mouse click at each stage.
Technological Comparison to Predicate Devices
The table below provides a comparison of the SpineAnalyzer device and the predicate device. These differences raise no new types of safety or effectiveness questions.
| Feature | Optasia Medical SpineAnalyzer | GE Lunar Dual-energy Vertebral
Assessment View Software K023554 |
|------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Minimum
Specification
(Hardware) | Pentium IV-class processor with 1 GB RAM
1024 x 768 color display resolution | Greater than 900Mhz Pentium
512 MB RAM
Greater than 10GB hard disk
17" SVGA monitor (1024x768x32-bit color)
ZIP 250 drive
CD ROM
Audio capable with speakers
Modem
Fast Serial I/O board (GE MEDICAL
SYSTEMS part number 7151) - Prodigy only |
| Platform Software
Requirements | Windows XP Professional with SP2
.NET Framework 2.0
PDF Reader | Windows® XP Professional operating
system
Internet Explorer version 5.0 |
| Image Retrieval | Can load images from DICOM files and in TIFF
format | Works only with images generated on GE
Lunar scanners. |
| Image
Manipulation | Basic manipulations supported are brightness,
contrast, histogram equalization, invert, pan,
zoom | Basic manipulations supported are
brightness, contrast, clearview (edge
enhancement), pan, zoom |
| Image Annotation | Software overlays relevant annotation data for
clinician review, including vertebral outlines, 6-
point morphometry markers and height
markers | Software overlays relevant annotation data
for clinician review, including vertebral
outlines and 6-point morphometry markers.
Heights are calculated but not annotated on
the image |
| Patient contact &
control of life
sustaining devices | No contact or control | No contact or control |
| Image
Interpretation | Manual by Clinician, captured as free text
"Impression" narrative on report | Manual by Clinician, captured as free text
"Comments" narrative on report |
| Feature | Optasia Medical SpineAnalyzer | GE Lunar Dual-energy Vertebral
Assessment View Software K023554 |
| Target Anatomy | Spine (Lateral) T4-L4 | Spine (Lateral & AP) T4-L4 |
| Modality | DXA, and digital or digitized X-ray | DXA, SXA |
| Label Vertebral
Levels | Clinician manually labels vertebra | Clinician manually labels vertebra |
| Automated
annotation | Physician clicks approximate center of
vertebrae of interest; software returns
suggested vertebral body contour and 6-point
morphometry placements | Physician clicks approximate center of
vertebrae of interest; software returns
suggested vertebral body contour and 6-
point morphometry placements |
| Vertebral Body
Contour Display | 95-point, full contour capturing endplate
projections, anterior and posterior extent of
vertebral body. Used to suggest 6-point
placements. Displayed but not shown on the
report. | Vertebra "ROI" (region of interest) defined
by region enclosed by vertebral "bone
edges". Displayed and shown on the report |
| Vertebral Body
Contour
Placement | Clinician interactively adjusts contour
components; suggested 6-point placements
updated accordingly (unless 6-point
placements have been directly edited) | Clinician interactively adjusts contour by
moving 6-points |
| 6-pt Morphometry
Placement | Initial placement derived from contour.
Clinician manually adjusts point placements | Initial placement derived from contour.
Clinician manually adjusts point placements |
| Vertebral Heights
(anterior, mid and
posterior) | Device computes heights from morphometry
points (in pixels). | Device computes heights from
morphometry points (in cm). |
| Height ratio:
Wedge | Device calculates Ha/Hp, which is same as
method 2 in Black951. Reported as deformity
percentage (see below) | Device calculates Ha/Hp, which is same as
method 2 in Black95. Reported as deformity
ratio percentage (see below) |
| Height ratio:
Biconcavity | Device calculates Hm/Hp, which is same as
method 2 in Black95 paper. Reported as
deformity percentage (see below) | Device calculates Hm/Hp, which is same as
method 2 in Black95 paper. Reported as
deformity ratio percentage (see below) |
| Height ratio:
Crush | Device calculates ratio according to method 2
of Black95 paper. See labeling comparison
below for algorithmic details. Reported as
deformity percentage (see below) | Device calculates ratio of vertebral posterior
height to average height of L2-L4 vertebrae
in same image. Reported as deformity
percentage (see below) |
| Deformity
Percentage | Calculated as 1-height ratio and expressed as
percentage, as in Genant932 paper e.g. a ratio
of 0.75 is a 25% deformity | Calculated as height ratio and expressed as
percentage e.g. a ratio of 0.75 is a 75%
deformity ratio |
| Deformity Grade | Calculated from deformity percentages using
the Genant height reduction thresholds i.e.
normal =40%. Thresholds cannot be altered | Calculated from deformity percentages
using Z-scores (number of SDs from mean
of normative data) i.e. normal =4sd.
Thresholds cannot be altered. |
| Deformity Grade
Color | Deformity grades are color-coded based upon
their values, to draw the eye. Mild - yellow,
moderate - orange, severe - red. | Deformity grades are color-coded based
upon their values, to draw the eye. Mild -
white, moderate - half-red/half-white,
severe - red. |
| Feature | Optasia Medical SpineAnalyzer | GE Lunar Dual-energy Vertebral
Assessment View Software K023554 |
| Genant SQ score | Device allows clinician to capture manual score
of mild, moderate or severe wedge, biconcave
or crush deformity, or explicitly score vertebra
as normal. Manual score is recorded separately
from score derived from quantitative
morphometry. | Device allows clinician to capture manual
score of mild, moderate or severe wedge,
biconcave or crush deformity, or implicitly
score vertebra as normal. Manual score
replaces score derived from quantitative
morphometry. |
| Report generation | Yes - includes annotated images, deformity
percentages, deformity classifications and
manual Genant SQ scores | Yes - includes annotated images, deformity
percentages, deformity classifications and
manual Genant SQ scores |
4
JAN - 5 2011 11/17/2010
1 Black D M, Palermo L, Nevitt M C, Genant H K, Epstein R, San Valentin R, Cummings S R Compatison of S Black D M, L alching prevalent vertebral deformities: the Study of Osteoporotic Fractures. J Bone Miner Res. 10(6): 890-902. 1995.
2 Genant H K, et al. Vertebral Fracture Assessment Using a Semiquantitative Technique. Journal of Bone and Mineral Research. 8(9): 1137-1148. 1993.
5
JAN - 5 2011 11/17/2010
Performance Testing
No performance data (laboratory, animal or clinical) is included.
Conclusion
Optasia Medical believes the SpineAnalyzer is substantially equivalent to the predicate device on the basis of intended use and technological characteristics. Further that the descriptive characteristics contained in the PreMarket Notification are sufficient to assess equivalence without comparison of performance data (laboratory, animal or clinical).
6
Image /page/6/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird symbol, with three curved lines representing the body and wings. The bird is facing to the right. Encircling the bird is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room – WO66-G609 Silver Spring, MD 20993-0002
Mr. Anthony Holmes Vice President of Technical Services Optasia Medical Haw Bank House, High Street Cheadle, Cheshire, SK8 1AL UNITED KINGDOM
JAN - 5 2011
Re: K103475
Trade/Device Name: SpineAnalyzer Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications systems Regulatory Class: II Product Code: LLZ Dated: November 17, 2010 Received: November 24, 2010
Dear Mr. Holmes:
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 of
7
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/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 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,
signature
David G. Brown, Ph.D. Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
8
11/17/2010
Indications for Use
| 510(k) Number (if known): | K163475 |
|---|---|
| --------------------------- | --------- |
Device Name: SpineAnalyzer SpineAnalyzer
JAN - 5 2011
JAN - 5 2C ..
Indications for Use:
The Optasia Medical SpineAnalyzer™ is intended for the visualization or quantitative assessment of vertebral body deformities between levels T4 and L4 of the thoracic and lumbar spine in adult patients at risk of osteoporotic fracture. The qualified medical practitioner uses the device to calculate vertebral deformity ratios derived from the interactive placement of morphometry markers. Deformity grades are then calculated using criteria published by Genant . Additionally, the qualified medical practitioner can record a manual Genant Semi-Quantitative score based on visual assessment.
The qualified medical practitioner may use the deformity ratios and deformity grades to assist in the diagnosis of vertebral fracture and may, along with knowledge of patient history, apply medical expertise and best practice clinical judgment to determine if therapeutic intervention is indicated.
†Genant H K, et al. Vertebral Fracture Assessment Using a Semiquantitative Technique. Journal of Bone and Mineral Research. 8(9), pp1137-1148, 1993.
Prescription Use _ X _ (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use __ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1 _
(Posted November 13, 2003) Michael D'O'hm
(Division Sign-Off)
510K.
Office of In Vitro Diagnosti
Indications for Use Statement ব
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