The NuVasive® NuvaLine™ Mobile App is a medical device software mobile application intended to assist healthcare professionals in capturing, measuring, and storing spinal alignment assessment images at various time points in patient care. The device allows the healthcare professional to conveniently perform and review spinal alignment assessments of images by featuring measurement tools on their mobile device.

Device Description

The NuVasive NuvaLine Mobile App is a medical device software used to measure spinal pelvic and cervical parameters from an image of patient's x-rays taken with the device's camera. These measured parameters provide a quantifiable way to assess a patient's spinal deformity and correction correlated to health related quality of life (HRQOL) scores.

AI/ML Overview

The NuVasive® NuvaLine™ Mobile App is a medical device software mobile application intended to assist healthcare professionals in capturing, measuring, and storing spinal alignment assessment images. The device allows healthcare professionals to perform and review spinal alignment assessments of images using measurement tools on their mobile device.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criterion (Software Requirements Specifications)	Reported Device Performance (Verification Testing)
Angle measurements accuracy	Within ± 3°
Offset measurement accuracy	Within ± 2 cm
Proper display of values	Verified
Correct color-coded alert indications	Verified
Reproducibility for camera positioning	Verified

2. Sample Size for Test Set and Data Provenance

The document does not explicitly state the sample size used for the test set (number of images or cases). It mentions that "Verification testing was performed to confirm that NuvaLine accurately measures and offsets based off of x-ray images."

The data provenance (e.g., country of origin, retrospective or prospective) is not specified.

3. Number of Experts and their Qualifications for Ground Truth

The document does not mention the number of experts used to establish the ground truth for the test set, nor does it specify their qualifications.

4. Adjudication Method for the Test Set

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

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance is mentioned. The study performed focuses on the device's accuracy against defined criteria, not against human performance or improvement with AI assistance.

6. Standalone Performance

Yes, a standalone performance study was done. The "Verification testing" described focused solely on the accuracy and functionality of the NuvaLine Mobile App without human-in-the-loop performance. Its ability to accurately measure angles and offsets, display values, and provide alerts was tested directly.

7. Type of Ground Truth Used

The type of ground truth used appears to be based on pre-defined "Software Requirements Specifications." The document states, "Verification testing was performed to confirm that NuvaLine accurately measures and offsets based off of x-ray images, and that these values are displayed properly with correct color-coded alert indications. Angle measurements were verified within ± 3° while offset measurement were verified within ± 2 cm accuracy." This implies that the ground truth for measurements was established against these specified accuracy thresholds, likely using known or precisely measured values on test images, rather than expert consensus, pathology, or outcomes data from actual patients.

8. Sample Size for the Training Set

The document does not specify the sample size used for the training set.

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

The document does not provide information on how the ground truth for the training set was established. The focus of the provided text is on nonclinical verification and validation testing of the pre-developed software.

Summary

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

May 1, 2017

NuVasive, Incorporated % Ms. Olga Lewis Senior Manager, Regulatory Affairs 7475 Lusk Blvd. SAN DIEGO CA 92121

Re: K162647

Trade/Device Name: NuVasive® NuvaLine™ Mobile App Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: April 7, 2017 Received: April 10, 2017

Dear Ms. Lewis:

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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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 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. 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 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,

Michael 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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Indications for Use

510(k) Number (if known)

K162647

Device Name NuVasive® NuvaLine™ Mobile App

Indications for Use (Describe)

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

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

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FOR FDA USE ONLY

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

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Image /page/3/Picture/0 description: The image shows the Nuvasive logo. The logo consists of a purple and gray abstract shape on the left, followed by the word "NUVASIVE" in gray. Below the word "NUVASIVE" is the phrase "Speed of Innovation" in a smaller font, with the word "Speed" in gray and the rest of the phrase in purple.

510(k) Summary

In accordance with Title 21 of the Code of Federal Regulations, Part 807, and in particular 21 CFR $807.92, the following summary of information is provided:

A. Submitted by:

Olga Lewis Senior Manager, Regulatory Affairs NuVasive, Incorporated 7475 Lusk Blvd. San Diego, California 92121 Telephone: (858) 909-1800 Date Prepared: April 7, 2017

B. Device Name

Trade or Proprietary Name:	NuVasive® NuvaLine™ Mobile App
Common or Usual Name:	Picture archiving and communications system
Classification Name:	Picture archiving and communications system
Device Class:	Class II
Classification:	§892.2050
Product Code:	LLZ

C. Predicate Devices

The subject NuVasive NuvaLine Mobile App is substantially equivalent to the primary predicate Nemaris Surgimap 2.0 K141669 and the reference predicate NuVasive NVM5 System K152942.

D. Device Description

E. Indications for Use

The NuVasive NuvaLine Mobile App is a medical device software mobile application intended to assist healthcare professionals in capturing, and storing spinal alignment assessment images at various time points in patient care. The device allows the healthcare professional to conveniently perform and review spinal alignment assessments of images by featuring measurement tools on their mobile device.

F. Technological Characteristics

As was established in this submission, the subject NuvaLine Mobile App is substantially equivalent to other predicate devices cleared by the FDA for commercial distribution in the United States. The subject device was shown to be substantially equivalent and have equivalent technological characteristics to its predicate device through comparison in areas including design, intended use, and functions.

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510(k) Premarket Notification NuVasive® NuvaLine™ Mobile App System

Image /page/4/Picture/1 description: The image shows the Nuvasive logo. The logo consists of a purple and gray abstract shape on the left, followed by the word "NUVASIVE" in gray, and the words "Speed of Innovation" in a smaller font below. The logo is clean and modern, and the colors are eye-catching.

Table 1 – Comparison of Technical Characteristics
Specification/Property	Predicate Device		Subject DeviceNuVasive NuvaLineMobile App	Discussion
	NuVasive NVM5 System (K152942)	Nemaris Surgimap 2.0(K141669)
IntendedUse /Indicationsfor Use	The NVM5® System is a medicaldevice that is intended forintraoperative neurophysiologicmonitoring during spinal surgery. Thedevice provides information directly tothe surgeon, to help assess a patient'sneurophysiologic status. NVM5provides this information byelectrically stimulating nerves viaelectrodes located on surgicalaccessories and monitoringelectromyography (EMG), transcranialor lumbar motor evoked potential(MEP) or somatosensory evokedpotential (SSEP) responses of nerves.The System also integrates Bendini™software used to locate spinal implantinstrumentation for the placement ofspinal rods.	The Surgimap software assistshealthcare professionals inviewing, storing, and measuringimages as well as planningorthopedic surgeries. Thedevice allows service providersto perform generic as well asspecialty measurements of theimages, and to plan surgicalprocedures. The device alsoincludes tools for measuringanatomical components forplacement of surgical implants,and offer onlinesynchronization of the databasewith the possibility to share dataamong Surgimap users. Clinicaljudgment and experience arerequired to properly use thesoftware.	The NuVasive NuvaLineMobile App is a medicaldevice software mobileapplication intended toassist healthcareprofessionals in capturing,measuring, and storingspinal alignmentassessment images atvarious time points inpatient care. The deviceallows the healthcareprofessional toconveniently perform andreview spinal alignmentassessments of images byfeaturing measurementtools on their mobiledevice.	Same
DeviceClassification Name	Surgical nerve stimulatory/locator;Evoked response electrical stimulator;Neurological stereotaxic instrument;Electromyography (EMG)monitor/stimulator	Picture archiving andcommunications system	Picture archiving andcommunications system	Same
SoftwareFunctionalities/Modalities	For NuvaLine - spinal alignmentassessments of images	Spinal alignment assessments ofimages	Spinal alignmentassessments of images	Same
Specification/Property	Predicate Device		Subject Device
	NuVasive NVM5 System (K152942)	Nemaris Surgimap 2.0(K141669)	NuVasive NuvaLineMobile App	Discussion
Algorithms	Lumbar Algorithm (PT, PI-LL, SVA)Cervical Algorithm (TPA, TS-CL,CSVA)	Various	Lumbar Algorithm (PT, PI-LL, SVA)Cervical Algorithm (TPA,TS-CL, CSVA)	Same
UserInterface	NuVasive-supplied computer withoptional touch screen and/orkeyboard/mouseMobile device (for NuvaLine only)	PC or mobile device	Mobile device	Same
Obtainingan image	Mobile Device Camera	Transferred from other devices	Mobile Device Camera	Same
DICOM	N/A	Yes	N/A	Same

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Image /page/5/Picture/0 description: The image shows the Nuvasive logo. The logo consists of a purple and gray abstract shape on the left, followed by the word "NUVASIVE" in gray. Below the word "NUVASIVE" is the phrase "Speed of Innovation" in a smaller font, with the word "Speed" in purple and the rest of the phrase in gray.

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G. Performance Data

Nonclinical testing was performed to demonstrate that the subject NuvaLine Mobile App is substantially equivalent to other predicate devices and to verify that the NuvaLine Mobile App meets design specifications and performance characteristics, based upon the intended use.

The NuvaLine Mobile App was subjected to Verification and Validation Testing according to the Software Requirements Specifications defined for the system. Verification testing was performed to confirm that NuvaLine accurately measures and offsets based off of x-ray images, and that these values are displayed properly with correct color-coded alert indications. Angle measurements were verified within ± 3° while offset measurement were verified within ± 2 cm accuracy. Verification activities also included testing specific to positioning of the camera and reproducibility.

Validation testing was performed to confirm that the graphical user interface (GUI) and device components function as intended.

H. Conclusions

Based on the indications for use, technological characteristics, performance testing, and comparison to predicate devices, the subject NuvaLine App has been shown to be substantially equivalent to legally marketed predicate device.

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).