The VMA software is a quantitative imaging software application intended to be used to process any diagnostic imaging modality except mammography from digital image files in DICOM format. It is designed for physicians and clinical professionals who are interested in the analysis of alignment and motion in medical images, particularly in musculoskeletal images of the spine. VMA software permits users to review static and dynamic digital lumbar, thoracic, and cervical spine images. In the case of fluoroscopic images, these are 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. VMA software also facilitates quantitative assessment of vertebral alignment and motion in digital medical images. Information about the alignment and motion of selected objects, such as bone structures, can be generated and presented in the form of a 'motion analysis' report containing graphics, charts, charts, and text.

Device Description

The subject device consists of the following components and accessories: VMA™ software (for data transfer, post-image processing and analysis), and its accessory device, the MOTION NORMALIZER™ patient handling and data collection device, which is comprised of the MOTION NORMALIZER Upright and Table devices (for patient assistance during image acquisition), and Control Console (for user interface during imaging).

The subject VMA™ software, and its accessory device, the MOTION NORMALIZER patient handling and data collection device, operate as a system ("the VMA™ System") in conjunction with other commercially-available accessory devices to produce quantitative analysis of inter-vertebral motion in adult patients.

None of the software associated with the subject device performs functions that create radiographic images, nor does the software control, operate, or govern the functionality of the imaging device (i.e., C-Arm Fluoroscopy Device).

With respect to the MOTION NORMALIZER™ hardware, this hardware is configured to assist with lumbar and cervical data collection while images are captured with a standard fluoroscope, and this remains unchanged in the modified device relative to the cleared system (K133875). The additional inclusion of the ability to process thoracic images in the modified device pertains to a new ability to process thoracic images that come from a source other than the MOTION NORMALIZER™ hardware.

Image processing operators, who are Ortho Kinematics, Inc. employees, operate the VMA™ software to process images and facilitate template placement for the prescriber. Prescriber users are able to access processed images 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

Here's a breakdown of the acceptance criteria and the study information based on the provided text, using the specified format. It's important to note that the provided text is a 510(k) summary, which often focuses on substantial equivalence rather than detailed clinical study outcomes. Therefore, some requested information might be very general or not explicitly stated.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" with specific numeric thresholds for performance metrics. Instead, it refers to performance data and validation/verification testing. The acceptance criteria can be inferred as the successful completion of these tests and the device functioning "as intended."

Acceptance Criteria (Inferred)	Reported Device Performance
Compliance with Recognized Standards
IEC 60601-1: Medical Electrical Equipment- Part 1 General requirements for Basic Safety and Essential Performance (2012)	The VMA™ system was "designed and developed in accordance with FDA regulations, including validation and verification testing per FDA recognized standards." In all instances, the subject system functioned "as intended."
IEC 60601-1-2: Medical Electrical Equipment Part 1-2: General requirements for safety - Collateral Standard: Electromagnetic Compatibility - requirements and tests (2007)
IEC 60601-1-3: Medical electrical equipment. Part 1: General requirements for safety; Part 1-2: Collateral Standard: Radiation protection in diagnostic X-ray equipment (2013)
IEC 60601-1-6: Medical electrical equipment. Part 1: General requirements for safety; Part 1-4: Collateral Standard: Usability (2013)
IEC 60601-2-54: Medical electrical equipment. Part 2: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy (2009)
NEMA PS 3.1 - 3.20: Digital Imaging and Communications in Medicine (DICOM) Set (2017)
Repeatability and Accuracy	Repeatability and accuracy testing was performed for the integrated system. In all instances, the subject system functioned "as intended."
Software Validation	Software validation testing was performed, and documentation was provided for "moderate level of concern software." The device performs functions "substantially equivalent" to the predicate device, and validation/verification data demonstrates it functions "as intended."
Substantial Equivalence (Overall performance relative to predicate)	The subject system has the "same intended use and similar indications for use, technological characteristics, and principles of operation as the company's own identified predicate device." Minor technological differences "raise no new or different questions of safety or effectiveness."

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

The document does not explicitly state the sample size used for any specific "test set" in the context of clinical performance or diagnostic accuracy. The testing mentioned (repeatability, accuracy, software validation) generally refers to engineering and software validation, not necessarily a clinical study with a defined patient test set size. No information is provided regarding the country of origin of the data or whether it was retrospective or prospective.

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

This information is not provided. The document focuses on technical validation and comparison to a predicate device, not on diagnostic accuracy based on expert ground truth.

4. Adjudication Method for the Test Set

This information is not provided. Adjudication methods are typically associated with clinical studies involving human interpretation or labeling, which are not detailed here.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No MRMC comparative effectiveness study is mentioned. The device is a "quantitative imaging software application" designed to facilitate assessment for "physicians and clinical professionals," but there's no study presented here that evaluates human reader improvement with or without AI assistance.

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

The document describes the VMA software, which performs "quantitative assessment of vertebral alignment and motion" and generates "motion analysis reports." This implies a standalone algorithmic function for measurement generation. The "Image processing operators, who are Ortho Kinematics, Inc. employees, operate the VMA™ software to process images and facilitate template placement for the prescriber" indicates a human-in-the-loop for template placement. However, the subsequent "Quantitative graphical output report generation" suggests the measurements themselves are algorithmically derived from the placed templates. The "repeatability and accuracy testing" performed on the "integrated system" would likely encompass the standalone performance of the measurement algorithms once templates are placed.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For the repeatability and accuracy testing mentioned, the type of ground truth is not explicitly stated. Given it's a quantitative measurement device for alignment and motion, the ground truth would likely be a highly precise, perhaps manually derived or phantombased, measurement of the actual alignment and motion against which the device's measurements are compared. It's not explicitly stated to be expert consensus, pathology, or outcomes data in the context of diagnostic performance.

8. The Sample Size for the Training Set

No information regarding a training set or its sample size is provided. This 510(k) summary focuses on the modified device and its substantial equivalence to a predicate, not on a new AI model development cycle.

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

Since no training set is mentioned in the document, there is no information on how its ground truth would have been established.

Summary

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Public Health Service

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

August 25, 2017

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

Re: K172327

Trade/Device Name: VMA System™ version 3.0 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: August 1, 2017 Received: August 1, 2017

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

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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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) 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. 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 Industry and Consumer Education (DICE) 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,

Michael D. O'Hara For

Robert Ochs, Ph.D. 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

Form Approved: OMB No. 0910-0120 Expiration Date: 6/30/2020 See PRA Statement below.

510(k) Number (if known)

K172327

Device Name

VMA™ System version 3.0

Indications for Use (Describe)

The VMA software is a quantitative imaging software application intended to be used to process any diagnostic imaging modality except mammography from digital image files in DICOM format. It is designed for physicians and clinical professionals who are interested in the analysis of alignment and motion in medical images, particularly in musculoskeletal images of the spine. VMA software permits users to review static and dynamic digital lumbar, thoracic, and cervical spine images. In the case of fluoroscopic images, these are 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. VMA software also facilitates quantitative assessment of vertebral alignment and motion in digital medical images. Information about the alignment and 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.

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

� Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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510(k) SUMMARY

Ortho Kinematics, Inc. VMA™ System

Submitter

Ortho Kinematics, Inc. 110 Wild Basin Road, Suite #250 Austin, Texas 78746 Phone: (512) 334-5490 Facsimile: (512) 334-5500 Contact Person: Adam Deitz, Chief Technology Officer

Date Prepared: August 18, 2017

Name of Device: VMA™ System version 3.0

Classification Name: Picture archiving and communications system (21 C.F.R. 892.2050)

Regulatory Class: Class II

Product Code: LLZ

Predicate Device

Ortho Kinematics, Inc.'s VMA System, version 2.2 (K133875)

Device Description

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modified device pertains to a new ability to process thoracic images that come from a source other than the MOTION NORMALIZER™ hardware.

Intended Use / Indications for Use

Summary of Technological Characteristics

The cleared and modified VMA Systems are substantially equivalent with the similarities and minor differences noted in the comparison table below:

	Ortho Kinematics, Inc.'s VMA™Software and MOTIONNORMALIZER System, Version 2.2(K133875)	Ortho Kinematics, Inc.'s VMA™ Softwareand MOTION NORMALIZER System,Version 3.0(additions are underlined)
ClassificationNameProduct Code	System, Image Processing,RadiologicalLLZ	System, Image Processing, RadiologicalLLZ
Required OTSComponents forImageAcquisition	Fluoroscope Radiological Table Fixed Media Access to an internet connectedcomputer terminal installed withinternet browsing software	If MOTION NORMALIZER is being usedFluoroscope Radiological Table Fixed Media Access to an internet connectedcomputer terminal installed with internetbrowsing software If MOTION NORMALIZER is NOT beingused, then there are no required accessoriesfor image acquisition.
	Ortho Kinematics, Inc.'s VMAT™Software and MOTIONNORMALIZER System, Version 2.2(K133875)	Ortho Kinematics, Inc.'s VMAT™ Softwareand MOTION NORMALIZER System,Version 3.0(additions are underlined)
Digital ImageProcessingFunction	Digitizes analog fluoroscopy videofeeds to enable digital imageprocessingUtilizes a manual vertebral bodytemplating process, plus a semi-automated tracking process	Digitizes analog fluoroscopy video feeds toenable digital image processingUtilizes a semi-automated vertebral bodytemplating process, plus a manual trackingprocess
Assists w/ Lyingvs. StandingPostures	Standing and Lying	Standing and Lying
Range ofAssisted LumbarArticulation	Maximum achievable lumbar ANDcervical bendingrange = $-40° to +60°$	Maximum achievable lumbar AND cervicalbendingrange = $-40° to +60°$
User/OperatorDuring Imaging	Credential radiation technologists(AART) or other clinical professionalscredentialed to operate a fluoroscope	Credential radiation technologists (AART) orother clinical professionals credentialed tooperate a fluoroscope
Materials ofPatient HandlingDevice	Welded tube and sheet stainless steel; Standard powder coating; Standard ABS plastic; 4-way nylon stretch fabric; Vinyl covered synthetic leather.	Welded tube and sheet stainless steel; Standard powder coating; Standard ABS plastic; 4-way nylon stretch fabric; Vinyl covered synthetic leather.
Dimensions ofComponentOccupying thePlanePerpendicular toImaging Beam	Table: 87" x 52"Upright: 80" x 45"	Table: 87" x 52"Upright: 80" x 45"
Required OTScomponents	Image review workstation (PC): Process: Pentium 4 equivalent or better Ram Memory: 4 GB Monitor: Resolution of 1280x800 pixels or greater suitable for medical diagnostic image review Required installed software Internet Browser i.e. Internet Explorer, Firefox, etc. that supports HTML5	Image review workstation (PC): Process: Pentium 4 equivalent or better Ram Memory: 4 GB Monitor: Resolution of 1280x800 pixels or greater suitable for medical diagnostic image review Required installed software Internet Browser i.e. Internet Explorer, Firefox, etc. that supports HTML5
User/Operator	Physicians and clinical professionals	Physicians and clinical professionals

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	Ortho Kinematics, Inc.'s VMA™Software and MOTIONNORMALIZER System, Version 2.2(K133875)	Ortho Kinematics, Inc.'s VMA™ Softwareand MOTION NORMALIZER System,Version 3.0(additions are underlined)
Input Data Files	DICOM files created using theMOTION NORMALIZER System	DICOM files created using theMOTION NORMALIZER System DICOM files generated using anymodality.
KeyFunctionality	Load image data Display & Playback Enhance Contrast Put templates on anatomy Auto and manual templatingfeatures Forced manual review Quantitative graphical outputreport generation	Load image data Display & Playback Edit DICOM header data Enhance Contrast Put templates on anatomy Auto and manual templating features Forced manual review Quantitative graphical output reportgeneration
QuantitativeAnalysis &Measurement	IVR & IVT measurements forlumbar and cervical motion Image registration & tracking Clinical Reporting Calibration of translation data	IVR & IVT measurements for lumbarand cervical motion Alignment measurements, includingmillimeter based "Sagittal VerticalAxis" measurements plus a range ofangular measurements Image registration & tracking Clinical Reporting Calibration of translation data Grid correction for fluoroscopic images

Performance Data

The 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, such as the following:

. IEC 60601-1: Medical Electrical Equipment- Part 1: General requirements for Basic Safety and Essential Performance (2012).
IEC 60601-1-2: Medical Electrical Equipment Part 1-2: General requirements for . safety - Collateral Standard: Electromagnetic Compatibility - requirements and tests (2007).
IEC 60601-1-3: Medical electrical equipment. Part 1: General requirements for . safety; Part 1-2: Collateral Standard: Radiation protection in diagnostic X-ray equipment (2013).
. IEC 60601-1-6: Medical electrical equipment. Part 1: General requirements for safety; Part 1-4: Collateral Standard: Usability (2013).
IEC 60601-2-54: Medical electrical equipment. Part 2: Particular requirements for . the basic safety and essential performance of X-ray equipment for radiography and radioscopy (2009).
. NEMA PS 3.1 - 3.20: Digital Imaging and Communications in Medicine (DICOM) Set (2017).

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In addition, repeatability and accuracy testing was performed for the integrated system. In all instances, the subject system functioned as intended. Lastly, software validation testing was performed and documentation was provided for moderate level of concern software.

Substantial Equivalence Conclusion

The VMA™ software and its accessory device, the MOTION NORMALIZER, have the same intended use and similar indications for use, technological characteristics, and principles of operation as the company's own identified predicate device. The minor technological differences between the subject system and the predicate system raise no new or different questions 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. Thus, the subject device is substantially equivalent.

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).