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 consolemounted 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.

AI/ML Overview

Here's a summary of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state numerical acceptance criteria in a table format. Instead, it describes general performance goals and how they were met in comparison to a previous version of the device and other predicates.

Performance Metric	Acceptance Criteria (Not explicitly stated as numerical, inferred from study)	Reported Device Performance (as stated in the document)
Lumbar Measurements	Comparable accuracy and repeatability to previously-cleared KineGraph VMA System (K112109)	"The accuracy and repeatability studies included in the submission of the previously-cleared version of the KineGraph VMA System (K112109) for lumbar measurements were re-run with the modified device." "The modified KINEGRAPH VMA™ software... performed according to specifications and equivalently to the previously-cleared device..."
Cervical Measurements (New)	Met specifications (implied)	"Accuracy and repeatability testing was performed for the new cervical measurements." "The modified KINEGRAPH VMA™ software... performed according to specifications..."
Intervertebral Translation (New)	Met specifications (implied)	"Accuracy and repeatability testing on the new function to produce measurements of intervertebral translation in millimeter units was performed." "The modified KINEGRAPH VMA™ software... performed according to specifications..."
Software Requirements (SWRS)	Each element to be met	"Each element of the Software Requirements Specifications (SWRS) was tested and found to meet the requirements."
Safety and Equivalence	No new issues of safety or effectiveness compared to predicates	"The minor technological differences... 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 devices."

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

The document states:

"The accuracy and repeatability studies included in the submission of the previously-cleared version of the KineGraph VMA System (K112109) for lumbar measurements were re-run with the modified device."
"Accuracy and repeatability testing was performed for the new cervical measurements."
"Accuracy and repeatability testing on the new function to produce measurements of intervertebral translation in millimeter units was performed."

However, the specific sample size (number of patients/cases) used for these accuracy and repeatability tests (which serve as the "test set" for performance evaluation) is not explicitly mentioned in this document.

The data provenance (country of origin, retrospective/prospective) is not specified in the provided text.

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

The document does not specify the number of experts used or their qualifications for establishing ground truth in the performance studies.

4. Adjudication Method for the Test Set

The document does not mention any adjudication method (e.g., 2+1, 3+1, none) used for the test set.

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

The provided text does not indicate that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done comparing human readers with and without AI assistance. The testing focuses on the device's accuracy and repeatability, and its equivalence to predicate devices, rather than human performance improvement.

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

Yes, standalone performance testing was conducted. The document states:

"The accuracy and repeatability studies... for lumbar measurements were re-run with the modified device."
"Accuracy and repeatability testing was performed for the new cervical measurements."
"Accuracy and repeatability testing on the new function to produce measurements of intervertebral translation in millimeter units was performed."

These studies assess the device's inherent measurement capabilities (accuracy and repeatability) independently, without considering a human-in-the-loop scenario. The KINEGRAPH VMA™ software itself processes the digital image files to generate quantitative assessments and reports.

7. The Type of Ground Truth Used

The type of ground truth used for the accuracy and repeatability studies is not explicitly defined in the document. Given the nature of "accuracy and repeatability" for measurement devices, it typically implies comparison against:

Highly precise measurements made by a gold-standard method.
Measurements derived from phantom studies with known values.
Consensus measurements from highly experienced human experts (though not explicitly stated here).

8. The Sample Size for the Training Set

The document does not provide any information regarding the sample size for a training set. This is typical for a 510(k) submission where the focus is on verification and validation of the finished device, and the specifics of model training (if applicable to the type of algorithm) are not usually required in this summary. The device appears to be an image processing and measurement software rather than a deep learning AI model that would typically have a distinct training phase described in this way.

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

Since no information about a training set or its sample size is provided, the method for establishing its ground truth is also not mentioned.

Summary

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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 2.0)

SUBMITTED BY	Ortho Kinematics, Inc.7004 Bee Caves Rd.,Bldg. 3, Ste. 315Austin, Texas 78746	AUG 06 2013
CONTACT PERSON	Primary:Adam DeitzChief Technology OfficerOrtho KinematicsPhone: (415) 699-1736Fax: (512) 334-5500	Alternate:Paul GunnoeCEOOrtho KinematicsPhone: (205) 229-9328Fax: (512) 334-5490
DATE PREPARED	July 31, 2013
510(K) NUMBER	K130743
CLASSIFICATION NAME /PRODUCT CODE	System, Image Processing, Radiological / LLZ
DEVICE CLASS	Class II
REGULATION NUMBER	21 C.F.R. 892.2050
PROPRIETARY NAME	The integral system comprised of:- the KINEGRAPH VMA™ (VERTEBRAL MOTIONANALYZER) software (version 2.0), and its accessorydevice,- the MOTION NORMALIZER™ patient handling anddata collection device (version 2.0)

PREDICATE DEVICE

Ortho Kinematics, Inc. is integrated system comprised of the KINEGRAPH VMA™M (VERTEBRAL MOTION ANALYZER) software, and its accessory device, the MOTION NORMALIZER™ patient handling and data collection device (K112109) (version 1.0)

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Medical Metrics, Inc.'s KIMAX OMA Radiological Image Processing System (K022585)

Steris Corporation's Steris 5085 SRT (K090136)

INTENDED USE / INDICATIONS FOR USE

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.

TECHNOLOGICAL CHARACTERISTICS / PRINCIPLES OF OPERATION

PERFORMANCE DATA

The KINEGRAPH VMA™ software and its accessory device, the MOTION NORMALIZERTM, have been designed and developed in accordance with FDA regulations. including validation and verification testing per the following FDA recognized standards:

IEC 60601-1: Medical Electrical Equipment- Part 1: General requirements for safety . (including Amendments 1 and 2) (1995).
IEC 60601-1-2: Medical Electrical Equipment Part 1-2: General requirements for . safety - Collateral Standard: Electromagnetic Compatibility - requirements and rests (2007).

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IEC60601-1-4: Medical Electrical Equipment. Part 1: General requirements for . safety. Part 1-4: Collateral Standard: Programmable electrical medical systems (2000).
IEC60601-2-32: Medical Electrical Equipment. Part 2: Particular requirements for . the safety of associated equipment of X-ray equipment (1994).
NEMA PS 3.1 3.18: Digital Imaging and Communications in Medicine (DICOM) . Set (2009).

In addition, the company performed a complete validation for the modified KineGraph VMA software version 2.0. Each element of the Software Requirements Specifications (SWRS) was tested and found to meet the requirements.

Finally, comparable performance and safety of the subject device to the current standard of care and/or predicate devices were verified via bench and clinical testing. Specifically:

The accuracy and repeatability studies included in the submission of the previously-. cleared version of the KineGraph VMA System (K112109) for lumbar measurements were re-run with the modified device.
Accuracy and repeatability testing was performed for the new cervical measurements. .
. Accuracy and repeatability testing on the new function to produce measurements of intervertebral translation in millimeter units was performed.

The modified KINEGRAPH VMA™ software and its accessory device, the MOTION NORMALIZER™. performed according to specifications. and equivalently to the previously-cleared device, in all bench and clinical tests,

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 devices. The minor technological differences between the KINEGRAPH VMA™ software and its accessory device, the MOTION NORMALIZER™, and the predicate devices 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 devices.

	KineGraph VMASystem v2.0(subject device)	KineGraph VMASystem v1.1(K112109)	KIMAX QMA(K022585)	Steris 5085 SRT(K090136)
ClassificationName	System, ImageProcessing,Radiological	System, ImageProcessing,Radiological	System, ImageProcessing,Radiological	Operating Room,Powered Table
Product Code	LLZ	LLZ	LLZ	FQO
Indications for	The KINEGRAPH	The KINEGRAPH	KIMAX QMA is a	The STERIS 5085
	KineGraph VMASystem v2.0(subject device)	KineGraph VMASystem v1.1(K112109)	KIMAX QMA(K022585)	Steris 5085 SRT(K090136)
Use	VMATM software isa quantitativeimaging softwareapplication intendedto be used toprocess digitalimage files. It isdesigned forphysicians andclinicalprofessionals whoare interested in theanalysis of motionin medical images,particularly inmusculoskeletalimages of the spine.KINEGRAPHVMATM softwarepermits users toreview static anddynamic digitallumbar and cervicalspine imagesacquired with theassistance of theMOTIONNORMALIZERTMpatient handling anddata collectiondevice, which isdesigned for use byimaging techniciansand intended toassist with patientlumbar and cervicalbending and datacollection duringimaging.KINEGRAPHVMATM softwarealso facilitatesquantitativeassessment ofvertebral motion indigital medicalimages.Information aboutthe motion ofselected objects,such as bone	VMATM software is aquantitative imagingsoftware applicationintended to be used toprocess digital imagefiles. It is designed forphysicians and clinicalprofessionals who areinterested in theanalysis of motion inmedical images,particularly inmusculoskeletalimages of the spine.KINEGRAPHVMATM softwarepermits users to reviewstatic and dynamicdigital lumbar spineimages acquired withthe assistance of theMOTIONNORMALIZERTMpatient handling anddata collection device,which is designed foruse by imagingtechnicians andintended to assist withpatient lumbar bendingand data collectionduring imaging.KINEGRAPHVMATM software alsofacilitates quantitativeassessment ofvertebral motion indigital medical images.Information about themotion of selectedobjects, such as bonestructures, can begenerated andpresented in the formof a 'motion analysis'report containinggraphics, charts, andtext.	quantitative imagingsoftware application.It is designed forphysicians andclinical professionalswho are interested inthe analysis ofmotion in medicalimages, particularlyin musculoskeletalimages. KIMAXQMA permits usersto review static anddynamic digitalimages acquiredfrom a variety ofradiographic sources.It also facilitatesquantitativeassessment ofmotion inradiographic images.Information aboutthe motion ofselected objects,such as bonestructures, can begenerated andpresented in the formof a 'motionanalysis' reportcontaining graphics,charts, texts.	SRT is a generalsurgical table withhigh patient weightcapacity, extendedwidth capability,and lower minimaltable top elevation.The STERIS 5085SRT accommodatesall general surgicalproceduresincluding but notlimited to, cardiacand vascular,endoscopic,gynecology,urology,nephrectomy,neurology,ophthalmologic,orthopedics andother proceduresrequiringintraoperativefluoroscopic C-armimaging and alsosupportslaparoscopicsurgical techniquefor the largestsurgical patients.The STERIS 5085SRT enables patienttransport on hardlevel surfaceswithin the surgicalsuite (from pre-operative areas tothe operating roomand again from theoperating room topost operativerecovery).
	KineGraph VMASystem v2.0(subject device)	KineGraph VMASystem v1.1(K112109)	KIMAX QMA(K022585)	Steris 5085 SRT(K090136)
	generated andpresented in theform of a 'motionanalysis' reportcontaining graphics,charts, and text.
TechnologicalCharacteristics /Functionality	• Lumbar, cervicalintervertebralmotionmeasurements• Lumbar, cervicaldevice assistedbending	• Lumbarintervertebralmotionmeasurements• Lumbar deviceassisted bending	• Cervical inter-vertebral motionmeasurements• Calibration ofimages to createmeasurements ofintervertebraltranslation inmillimeter units	• Cervical deviceassisted bending
Principles ofOperation		• Samemeasurements withsimilar level ofmeasurementaccuracy andrepeatability• Assists patientsthrough a similarrange of lumbarbending	• Samemeasurementswith similar levelof measurementaccuracy andrepeatability	• Assists patientsthrough a similarrange of cervicalbending

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Image /page/5/Picture/0 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 a stylized symbol that resembles a bird or a human figure with outstretched arms.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

August 6, 2013

ORTHO KINEMATICS, INC. C/O JOHN J SMITH PARTNER 555 13TH STREET NW WASHINGTON DC 20005-3096

Re: K130743

Trade/Device Name: Kinegraph VMA (Vertebral Motion Analyzer) Software Version 2.0: Motion Normalizer Patient Handling and Data Collection Version 2.0 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: July 08, 2013 Received: July 08, 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

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/ResourcesforYou/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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Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

KINEGRAPH VMA™ (VERTEBRAL MOTION ANALYZER) Device Name: software and its accessory, the MOTION NORMALIZER™ patient handling and data collection device (version 2.0)

Indications for Use:

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 in the form of a 'motion analysis' report containing graphics, charts, and text.

Prescription Use × (Part 21 CFR 801 Subpart D)

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of Center for Devices and Radiological Health (CDRH)

Smh.7)

510(k) K130743

Page I of

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).