The KINEGRAPH VMA™ software is a quantitative imaging software application intended to be used to process digital image files. It is designed for physicians and clinical professionals who are interested in the analysis of motion in medical images, particularly in musculoskeletal images of the spine. KINEGRAPH VMA™ software permits users to review static and dynamic digital lumbar and cervical spine images acquired with the assistance of the MOTION NORMALIZER™ patient handling and data collection device, which is designed for use by imaging technicians and intended to assist with patient lumbar and cervical bending and data collection during imaging. KINEGRAPH VMA™ software also facilitates quantitative assessment of vertebral motion in digital medical images. Information about the motion of selected objects, such as bone structures, can be generated and presented in the form of a 'motion analysis' report containing graphics, charts, and text.

Device Description

The subject device consists of the KINEGRAPH VMA™ software that analyzes images from the MOTION NORMALIZER™ on an Off-the-Shelf ("OTS") imaging workstation. The MOTION NORMALIZER patient handling and data collection device is an accessory device to the KINEGRAPH VMA™ software that is used to assist with subject lumbar bending and data collection while images are captured with a standard fluoroscope. The MOTION NORMALIZER is comprised of two powered, electromechanical patient handling devices connected to and controlled by a console-mounted OTS computer running custom software connected to various OTS hardware accessories. The subject system is able to capture and record radiographic image data, as well as data from the patient handling devices, and to output this data into DICOM compatible digital image files for analysis using the KINEGRAPH VMA™ software. Once images have been created, they can be uploaded to online servers using running KINEGRAPH VMA™ software using an internet connected computer. All software operation and data storage that occurs subsequent to uploading occurs via online servers running KINEGARPH VMA software. Image processing operators, who are Ortho Kinematics, Inc. employees, operate the KINEGRAPH VMA™ software to process images and facilitate template placement for the prescriber. Prescriber users are able to access processed image and measurement results via an online account administered by Ortho Kinematics, Inc. Prescriber users are able to configure account settings that enable the prescriber to be alerted any time specific user-defined measurement thresholds are exceeded.

AI/ML Overview

The provided document, K133875, is a 510(k) summary for the KINEGRAPH VMA™ (Vertebral Motion Analyzer) Software and its accessory device, the MOTION NORMALIZER™ Patient Handling and Data Collection Device (Version 2.2). This special 510(k) is for a modification to a previously cleared device (Version 2.0).

Based on the provided text, the document states: "Validation and verification data (including software validation) demonstrate that the subject device functions as intended, and performs functions substantially equivalent to the predicate device." However, specific acceptance criteria and detailed study results meeting those criteria are not explicitly outlined in the provided pages of the 510(k) summary. The document mentions "repeatability and accuracy testing was performed for the integrated system" and concludes that "In all instances, the KINEGRAPH VMA ™ software and its accessory device, the MOTION NORMALIZER ™, functioned as intended." However, it does not specify what "intended" means in terms of quantifiable metrics or acceptance values.

Therefore, many of the requested details cannot be extracted directly from this summary.

Here's a breakdown of what can and cannot be derived from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Feature	Acceptance Criteria	Reported Device Performance
KINEGRAPH VMA™ software and MOTION NORMALIZER™ system functionality	The device functions as intended and performs substantially equivalent to the predicate device (K130743 version 2.0).	"In all instances, the KINEGRAPH VMA ™ software and its accessory device, the MOTION NORMALIZER ™, functioned as intended." "Validation and verification data (including software validation) demonstrate that the subject device functions as intended, and performs functions substantially equivalent to the predicate device."
Repeatability	Not explicitly stated in quantifiable terms in this document.	"repeatability... testing was performed for the integrated system."
Accuracy	Not explicitly stated in quantifiable terms in this document.	"accuracy testing was performed for the integrated system."

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

Sample Size (Test Set): Not specified in the provided 510(k) summary.
Data Provenance: Not specified in the provided 510(k) summary (e.g., country of origin, retrospective or prospective).

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

Number of Experts: Not specified.
Qualifications of Experts: Not specified.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not specified.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance:

The document describes the KINEGRAPH VMA™ as a quantitative imaging software application that assists physicians and clinical professionals, and "Image processing operators, who are Ortho Kinematics, Inc. employees, operate the KINEGRAPH VMA™ software to process images and facilitate template placement for the prescriber." Prescriber users access processed images and measurement results. This implies a human-in-the-loop system where human operators use the software.
However, no MRMC comparative effectiveness study is mentioned, nor is any effect size for human improvement with AI assistance. The submission focuses on demonstrating substantial equivalence to a previous version of the device.

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

The text indicates that "Image processing operators... operate the KINEGRAPH VMA™ software to process images and facilitate template placement." This suggests a human-in-the-loop scenario rather than a standalone algorithm performance evaluation. No standalone performance metrics are provided.

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

Not specified. The summary mentions "repeatability and accuracy testing" but does not detail how the "true" values for these tests were established.

8. The sample size for the training set:

Not specified. The document describes a "verification and validation testing" process, but does not provide details about a training set, which is more relevant for machine learning systems. This device processes images but isn't explicitly described as a machine learning/AI device in the sense of needing a distinct "training set" in the context often associated with such algorithms. It's more about image processing and measurement.

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

Not applicable/Not specified, as no training set details are provided.

Summary of Limitations:

This 510(k) summary is for a modification (version 2.2) of an already cleared device (version 2.0) and focuses heavily on demonstrating substantial equivalence rather than providing detailed performance studies with explicit acceptance criteria and extensive ground truth details for a novel device. The "Performance Data" section is very high-level, stating the device "functioned as intended" without quantifying what "intended" means in terms of performance metrics. The details typically requested for AI/ML device evaluations regarding training data, ground truth establishment, expert involvement, and rigorous statistical studies (like MRMC) are not present in this document.

Summary

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K133875
Page 1 of 5

JAN 1 7 2014

510(k) SUMMARY

ORTHO KINEMATICS, INC.

INTEGRATED SYSTEM COMPRISED OF THE KINEGRAPH VMA™ (VERTEBRAL MOTION ANALYZER) SOFTWARE AND ITS ACCESSORY DEVICE, THE MOTION NORMALIZER IMAGE™ PATIENT HANDLING AND DATA COLLECTION DEVICE (VERSION 2.2)

SUBMITTED BY	John Smith, M.D, J.D.Hogan Lovells US LLP555 13th Street, NWWashington, DC 20004
CONTACT PERSON	Primary:John Smith, M.D, J.D.PartnerHogan Lovells US LLPPhone: (202) 637-5600Fax: (202) 637-5910	Alternate:Adam DeitzChief Technology OfficerOrtho KinematicsPhone: (415) 699-1736Fax: (512) 334-5500
DATE PREPARED	December 20, 2013
DEVICE PROPRIETARY NAME	The integral system comprised of:- the KINEGRAPH VMA™ (VERTEBRAL MOTIONANALYZER) software (version 2.0), and its accessorydevice,- the MOTION NORMALIZER™ patient handling and datacollection device (version 2.0)
DEVICE COMMON NAME	The VMA system; the MOTION NORMALIZER device
CLASSIFICATION NAME /PRODUCT CODE	System, Image Processing, Radiological / LLZ
DEVICE CLASS	Class II
REGULATION NUMBER	21 C.F.R. 892.2050
PREDICATE DEVICE	Version 2.0 of the VMA system (K130743)

PURPOSE OF THE SPECIAL 510K NOTICE

Version 2.2 of the VMA system is a modification to version 2.0 of the system, which was the originally cleared version.

7004 Bee Caves Road Building Three, Suite 315 Austin, Texas 78746 Fax: (512) 334-5500 Ortho Kinematics

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INTENDED USE

TECHNOLOGICAL CHARACTERISTICS

The subject device consists of the KINEGRAPH VMA™ software that analyzes images from · the MOTION NORMALIZER™ on an Off-the-Shelf ("OTS") imaging workstation. The MOTION NORMALIZER patient handling and data collection device is an accessory device to the KINEGRAPH VMA™ software that is used to assist with subject lumbar bending and data collection while images are captured with a standard fluoroscope. The MOTION NORMALIZER is comprised of two powered, electromechanical patient handling devices connected to and controlled by a console-mounted OTS computer running custom software connected to various OTS hardware accessories. The subject system is able to capture and record radiographic image data, as well as data from the patient handling devices, and to output this data into DICOM compatible digital image files for analysis using the KINEGRAPH VMA™ software. Once images have been created, they can be uploaded to online servers using running KINEGRAPH VMA™ software using an internet connected computer. All software operation and data storage that occurs subsequent to uploading occurs via online servers running KINEGARPH VMA software. Image processing operators, who are Ortho Kinematics, Inc. employees, operate the KINEGRAPH VMA™ software to process images and facilitate template placement for the prescriber. Prescriber users are able to access processed image and measurement results via an online account administered by Ortho Kinematics, Inc. Prescriber users are able to configure account settings that enable the prescriber to be alerted any time specific user-defined measurement thresholds are exceeded.

PERFORMANCE DATA

The KINEGRAPH VMA™ software and its accessory device, the MOTION NORMALIZER™ , have been designed and developed in accordance with FDA regulations, including validation and verification testing per FDA recognized standards. In addition, repeatability and accuracy testing was performed for the integrated system. In all instances, the KINEGRAPH VMA ™ software and its accessory device, the MOTION NORMALIZER ™, functioned as intended.

7004 Bee Caves Road Building Three, Suite 315 Austin, Texas 78746 Fax: (512) 334-5500 Ortho Kinematics

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SUBSTANTIAL EQUIVALENCE

The KINEGRAPH VMA™ software and its accessory device, the MOTION NORMALIZER™, has the same intended use and indications for use, technological characteristics, and principles of operation as the identified predicate device. The minor technological differences between the KINEGRAPH VMA™ software and its accessory device, the MOTION NORMALIZER™ , and the predicate device raise no new issues of safety or effectiveness. Validation and verification data (including software validation) demonstrate that the subject device functions as intended, and performs functions substantially equivalent to the predicate device.

	KineGraph VMA™ System v2.2(subject device)	KineGraph VMA™ System v2.0(K130743, the cleared device)
Classification Name	System, Image Processing, Radiological	System, Image Processing, Radiological
Product Code	LLZ	LLZ
	KineGraph VMA™ System v2.2(subject device)	KineGraph VMA™ System v2.0(K130743, the cleared device)
Indications forUse	The KINEGRAPH VMA™ software is aquantitative imaging softwareapplication intended to be used toprocess digital image files. It isdesigned for physicians and clinicalprofessionals who are interested in theanalysis of motion in medical images,particularly in musculoskeletal imagesof the spine. KINEGRAPH VMA™software permits users to review staticand dynamic digital lumbar and cervicalspine images acquired with theassistance of the MOTIONNORMALIZER™ patient handling anddata collection device, which isdesigned for use by imagingtechnicians and intended to assist withpatient lumbar and cervical bendingand data collection during imaging.KINEGRAPH VMA™ software alsofacilitates quantitative assessment ofvertebral motion in digital medicalimages. Information about the motionof selected objects, such as bonestructures, can be generated andpresented in the form of a 'motionanalysis' report containing graphics,charts, and text.	The KINEGRAPH VMA™ software is aquantitative imaging softwareapplication intended to be used toprocess digital image files. It isdesigned for physicians and clinicalprofessionals who are interested in theanalysis of motion in medical images,particularly in musculoskeletal imagesof the spine. KINEGRAPH VMA ™software permits users to review staticand dynamic digital lumbar and cervicalspine images acquired with theassistance of the MOTIONNORMALIZER™ patient handling anddata collection device, which isdesigned for use by imaging techniciansand intended to assist with patientlumbar and cervical bending and datacollection during imaging. KINEGRAPHVMA™ software also facilitatesquantitative assessment of vertebralmotion in digital medical images.Information about the motion ofselected objects, such as bonestructures, can be generated andpresented in the form of a 'motionanalysis' report containing graphics,charts, and text.
TechnologicalCharacteristics/ Functionality	• Lumbar, cervical intervertebral motionmeasurements• Lumbar, cervical device assistedbending	• Lumbar, cervical intervertebral motionmeasurements• Lumbar, cervical device assistedbending
Principles ofOperation	• Produce digital imaging output fileswith the use of the MOTIONNORMALIZER device incombination with a standard,commercially available fluoroscopeand standard radiological proceduretable.• KineGraph VMA™ ImageProcessing software is operated byOrtho Kinematics, Inc. staff as aservice to facilitate templateplacement for prescriber users.• Transfer output files from theMOTION NORMALIZER device to	• Produce digital imaging output fileswith the use of the MOTIONNORMALIZER device in combinationwith a standard, commerciallyavailable fluoroscope and standardradiological procedure table.• KineGraph VMA™ Image Processingsoftware is operated by OrthoKinematics, Inc. staff as a service tofacilitate template placement forprescriber users.• Transfer output files from theMOTION NORMALIZER device to
KineGraph VMA™ System v2.2(subject device)	KineGraph VMA™ System v2.0(K130743, the cleared device)
the company by uploading to aserver using the KineGraph VMA™DataLink Software.	the Company using removablemedia that is shipped to theCompany.
• KineGraph VMA™ Imageprocessing and Image Reviewsoftware, as well as patient resultswhich have been processed byOrtho Kinematics, Inc., are availablevia any internet connected computerterminal running installed withinternet browsing software.	• KineGraph VMA™ Image processingsoftware runs on standard off-the-shelf image review workstationsinstalled with certain specific off theshelf software (Matlab runtimecompiler, Microsoft Excel, others)
• Prescribers can use online useraccounts to store alert preferences,such that they can be alerted uponlogin whenever patient resultsexceed the user-defined thresholds.	• Patient results transferred from thecompany to the prescriber viaremovable media.
	• KineGraph VMA™ Image Reviewsoftware runs on standard off-the-shelf image review workstationsinstalled with certain specific off theshelf software (Adobe Flash,ghostscript, others)
	• No alerting features.

7004 Bee Caves Road Building Three, Suite 315 Austin, Texas 78746 Fax: (512) 334-5500 Ortho Kinematics

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Ortho Kinematics

7004 Bee Caves Road
Building Three, Suite 315
Austin, Texas 78746 Fax: (512) 334-5500

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K133875
Page 5 of 5

7004 Bee Caves Road
Building Three, Suite 315
Austin, Texas 78746 Fux: (512) 334-5500

Ortho Kinematics

・

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Public Health Service

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

January 17, 2014

Ortho Kinematics, Inc. % John Smith, M.D., J.D. Hogan Lovells US LLP 555 13th Street, NW WASHINGTON DC 20004

Re: K133875

Trade/Device Name: KineGraph VMA™ (Vertebral Motion Analyzer) Software, and the Motion Normalizer™ Patient Handling and Data Collection Device (Version 2.2) Regulation Number: 21 CFR 892,2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: December 20, 2013 Received: December 20, 2013

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

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Page 2-Dr. Smith Section of the Research and Career of the Ca

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Smh.7)

for

Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K133875

Device Name

KINEGRAPH VMA™ (VERTEBRAL MOTION ANALYZER) and MOTION NORMALIZER (version 2.2)

Indications for Use (Describe)

The KineGraph VMA™ sollware is a quantitative imaging software application intended to be used to process digital image files. It is designed for physicians and clinical professionals who are interested in the analysis of motion in in musculoskeletal images of the spine. KineGraph VMA™ software permits users to review static and dynamic digital lumbar and cervical spine images acquired with the assistance of the Motion Normalizer patient handling and data collection device, which is designed for use by imaging technicians and intented to assist with patient lumbar and cara collection during imaging. KineGraph VMA™ software also facilitates quantitative assessment of vertebral motion in digital images. Information about the motion of selected objects, such as bone structures, can be generated in the form of a `motion analysis' report containing graphics, charts. and text.

Type of Use (Select one or both, as applicable)

[X] Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Sm.h.f)

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

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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).