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.

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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Optasia Medical SpineAnalyzer, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary explicitly states: "No performance data (laboratory, animal or clinical) is included." Therefore, there are no acceptance criteria or reported device performance metrics within this document. The submission relies on substantial equivalence to a predicate device.

Acceptance Criteria (e.g., Sensitivity, Specificity, Accuracy, F1 Score)	Reported Device Performance
Not specified in this document.	Not reported in this document.

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

Since no performance study was included, there is no test set sample size mentioned. Consequently, data provenance is also not applicable as no data was used in a performance study.

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

As there was no performance study, no experts were used to establish ground truth for a test set.

4. Adjudication Method for the Test Set

With no test set or performance data, no adjudication method was employed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No MRMC comparative effectiveness study was done and therefore no effect size of human readers improving with AI vs. without AI assistance is reported.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No standalone performance study was done. The device's description emphasizes a human-in-the-loop workflow where a "suitably qualified medical practitioner" reviews and adjusts the software's suggestions.

7. The Type of Ground Truth Used

Since no performance studies were conducted, no ground truth was used for evaluation.

8. The Sample Size for the Training Set

The document does not mention any training set or its sample size. This suggests that the device's development likely did not involve a supervised machine learning approach requiring a labeled training set in the context of this 510(k) submission.

9. How the Ground Truth for the Training Set Was Established

As no training set is mentioned, there is no information on how its ground truth would have been established.

Summary of the K163475 P. Submission:

The Optasia Medical SpineAnalyzer 510(k) submission focuses on demonstrating substantial equivalence to a predicate device (GE LUNAR Dual-energy Vertebral Assessment View Software, K023554) based on intended use and technological characteristics, rather than through a performance study with acceptance criteria and measured device performance. The submission explicitly states: "No performance data (laboratory, animal or clinical) is included." This means that for this particular submission, the FDA did not require or receive clinical performance data to support the device's function as described. The marketing authorization was granted based on the comparison of features and intended use to a previously cleared device.

Summary

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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

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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

5 510(k) Summary

Page 5-3

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11/17/2010

improvement or deterioration in the condition of the area of interest of the spine.

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

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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 VertebralAssessment View Software K023554
MinimumSpecification(Hardware)	Pentium IV-class processor with 1 GB RAM1024 x 768 color display resolution	Greater than 900Mhz Pentium512 MB RAMGreater than 10GB hard disk17" SVGA monitor (1024x768x32-bit color)ZIP 250 driveCD ROMAudio capable with speakersModemFast Serial I/O board (GE MEDICALSYSTEMS part number 7151) - Prodigy only
Platform SoftwareRequirements	Windows XP Professional with SP2.NET Framework 2.0PDF Reader	Windows® XP Professional operatingsystemInternet Explorer version 5.0
Image Retrieval	Can load images from DICOM files and in TIFFformat	Works only with images generated on GELunar scanners.
ImageManipulation	Basic manipulations supported are brightness,contrast, histogram equalization, invert, pan,zoom	Basic manipulations supported arebrightness, contrast, clearview (edgeenhancement), pan, zoom
Image Annotation	Software overlays relevant annotation data forclinician review, including vertebral outlines, 6-point morphometry markers and heightmarkers	Software overlays relevant annotation datafor clinician review, including vertebraloutlines and 6-point morphometry markers.Heights are calculated but not annotated onthe image
Patient contact &control of lifesustaining devices	No contact or control	No contact or control
ImageInterpretation	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 VertebralAssessment 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 VertebralLevels	Clinician manually labels vertebra	Clinician manually labels vertebra
Automatedannotation	Physician clicks approximate center ofvertebrae of interest; software returnssuggested vertebral body contour and 6-pointmorphometry placements	Physician clicks approximate center ofvertebrae of interest; software returnssuggested vertebral body contour and 6-point morphometry placements
Vertebral BodyContour Display	95-point, full contour capturing endplateprojections, anterior and posterior extent ofvertebral body. Used to suggest 6-pointplacements. Displayed but not shown on thereport.	Vertebra "ROI" (region of interest) definedby region enclosed by vertebral "boneedges". Displayed and shown on the report
Vertebral BodyContourPlacement	Clinician interactively adjusts contourcomponents; suggested 6-point placementsupdated accordingly (unless 6-pointplacements have been directly edited)	Clinician interactively adjusts contour bymoving 6-points
6-pt MorphometryPlacement	Initial placement derived from contour.Clinician manually adjusts point placements	Initial placement derived from contour.Clinician manually adjusts point placements
Vertebral Heights(anterior, mid andposterior)	Device computes heights from morphometrypoints (in pixels).	Device computes heights frommorphometry points (in cm).
Height ratio:Wedge	Device calculates Ha/Hp, which is same asmethod 2 in Black951. Reported as deformitypercentage (see below)	Device calculates Ha/Hp, which is same asmethod 2 in Black95. Reported as deformityratio percentage (see below)
Height ratio:Biconcavity	Device calculates Hm/Hp, which is same asmethod 2 in Black95 paper. Reported asdeformity percentage (see below)	Device calculates Hm/Hp, which is same asmethod 2 in Black95 paper. Reported asdeformity ratio percentage (see below)
Height ratio:Crush	Device calculates ratio according to method 2of Black95 paper. See labeling comparisonbelow for algorithmic details. Reported asdeformity percentage (see below)	Device calculates ratio of vertebral posteriorheight to average height of L2-L4 vertebraein same image. Reported as deformitypercentage (see below)
DeformityPercentage	Calculated as 1-height ratio and expressed aspercentage, as in Genant932 paper e.g. a ratioof 0.75 is a 25% deformity	Calculated as height ratio and expressed aspercentage e.g. a ratio of 0.75 is a 75%deformity ratio
Deformity Grade	Calculated from deformity percentages usingthe Genant height reduction thresholds i.e.normal <20%, mild <25%, moderate <40%,severe >=40%. Thresholds cannot be altered	Calculated from deformity percentagesusing Z-scores (number of SDs from meanof normative data) i.e. normal <2sd, mild<3sd, moderate <4sd, severe >=4sd.Thresholds cannot be altered.
Deformity GradeColor	Deformity grades are color-coded based upontheir values, to draw the eye. Mild - yellow,moderate - orange, severe - red.	Deformity grades are color-coded basedupon their values, to draw the eye. Mild -white, moderate - half-red/half-white,severe - red.
Feature	Optasia Medical SpineAnalyzer	GE Lunar Dual-energy VertebralAssessment View Software K023554
Genant SQ score	Device allows clinician to capture manual scoreof mild, moderate or severe wedge, biconcaveor crush deformity, or explicitly score vertebraas normal. Manual score is recorded separatelyfrom score derived from quantitativemorphometry.	Device allows clinician to capture manualscore of mild, moderate or severe wedge,biconcave or crush deformity, or implicitlyscore vertebra as normal. Manual scorereplaces score derived from quantitativemorphometry.
Report generation	Yes - includes annotated images, deformitypercentages, deformity classifications andmanual Genant SQ scores	Yes - includes annotated images, deformitypercentages, deformity classifications andmanual Genant SQ scores

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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.

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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).

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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

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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/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

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Indications for Use

510(k) Number (if known):	K163475
---------------------------	---------

Device Name: SpineAnalyzer SpineAnalyzer

JAN - 5 2011

JAN - 5 2C ..

Indications for Use:

†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

Page 4-2

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).