The ATEC Alignment App assists healthcare professionals in viewing, and storing images as well as planning orthopedic surgeries. The app allows the healthcare professional to perform generic and specialty measurements of the images, and to plan surgical procedures. The app includes tools for measuring anatomical components for implant selection, and offers the possibility to share data among ATEC Alignment App users. The app is for planning use only and is not intended for primary diagnostic use.

Device Description

The ATEC Alignment App is intended for use by trained healthcare professionals as a standalone software for viewing, measuring, and storing of x-ray images. The app is a medical device software used to measure spinopelvic parameters from patient x-rays images 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 based on published literature. Clinical judgment and experience are required to properly use the software.

AI/ML Overview

The ATEC Alignment App underwent verification and validation testing to ensure it meets its functional requirements.

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Angle measurement accuracy	Verified within ± 2° accuracy
Resultant value display	Displayed properly with correct color-coded range
GUI functionality	Functions as intended
Data system features	Functions as intended

2. Sample Size and Data Provenance for Test Set:
The document does not explicitly state the specific sample size used for the test set or the country of origin of the data. However, it indicates that a direct comparison test was conducted using "the same clinically representative images." It does not specify if the data was retrospective or prospective.

3. Number of Experts and Qualifications for Ground Truth:
The document does not provide information on the number of experts used to establish the ground truth for the test set or their qualifications.

4. Adjudication Method:
The document does not detail the adjudication method used for the test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
The document states that a "direct comparison test between the ATEC Alignment App and the Surgimap device using the same clinically representative images was conducted." However, it does not explicitly describe it as a multi-reader multi-case (MRMC) comparative effectiveness study or provide an effect size for human readers' improvement with AI assistance. The comparison was to evaluate the similarity in performance between the two devices.

6. Standalone Performance:
Yes, a standalone performance assessment was conducted for the ATEC Alignment App. The verification and validation testing confirmed that "the app accurately measures angles from x-ray images, and that resultant values are displayed properly with correct color-coded range."

7. Type of Ground Truth Used:
The type of ground truth used is implied to be based on the "clinically representative images" for which accurate angle measurements and proper display of resultant values were expected. The document mentions that the app's patient parameters and calculations are "based on published literature," which suggests that the ground truth for medical parameters is derived from established medical knowledge.

8. Sample Size for Training Set:
The document does not specify the sample size used for the training set.

9. How Ground Truth for Training Set Was Established:
The document does not explicitly state how the ground truth for the training set was established. However, for the application's core functionality of measuring spiropelvic parameters and calculations, it states that these are "based on published literature." This suggests that the underlying algorithms and expected outcomes are derived from established medical research and clinical guidelines.

Summary

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October 29, 2021

Alphatec Spine, Inc. David Gramse Sr. Director, Regulatory Affairs 1950 Camino Vida Roble CARLSBAD CA 92008

Re: K211987

Trade/Device Name: ATEC Alignment App Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management and Processing System Regulatory Class: Class II Product Code: LLZ Dated: September 30, 2021 Received: October 1, 2021

Dear David Gramse:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K211987

Device Name ATEC Alignment App

Indications for Use (Describe)

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)

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510(k) Summary of Safety and Effectiveness

(21 CFR 807.92)

I.	SUBMITTER:	Alphatec Spine, Inc.1950 Camino Vida RobleCarlsbad, CA 92008Phone: (760) 431-9286Fax: (760) 431-0289
	Contact Person:	David GramseSr. Director, Regulatory AffairsContact Phone: (760) 494-6711

Date Summary Prepared: June 25, 2021

II. DEVICE

Name of Device:	ATEC Alignment App
510(k) Number:	K211987
Common or Usual Name:	Medical Image Management and Processing System
Classification Name:	Medical Image Management and Processing System(21 CFR 892.2050)
Regulatory Class:	Class II
Product Code:	LLZ

LEGALLY MARKETED PREDICATE DEVICES III.

510(k)	Product Code	Trade Name	Manufacturer
Primary Predicate Device
K141669	LLZ	Surgimap 2.0	Nemaris, Inc.
Additional Predicate Device
K162647	LLZ	NuVasive NuvaLine Mobile App	NuVasive, Inc.

IV. DEVICE DESCRIPTION

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V. INDICATIONS FOR USE

The ATEC Alignment App assists healthcare professionals in viewing, measuring, and storing images as well as planning orthopedic surgeries. The app allows the healthcare professional to perform generic and specialty measurements of the images, and to plan surgical procedures. The app includes tools for measuring anatomical components for implant selection, and offers the possibility to share data among ATEC Alignment App users. The app is for planning use only and is not intended for primary diagnostic use.

VI. TECHNOLOGICAL COMPARISON TO PREDICATES

The technological design features of the subject ATEC Alignment App were compared to the predicates in intended use, indications for use, design, function and technology and it was demonstrated that they are substantially equivalent.

	Predicate Devices		Subject Device
Characteristic	Nemaris Surgimap	NuVasive NuvaLine	ATEC
	2.0 (K141669)	Mobile App(K162647)	AlignmentApp (K211987)	Discussion
Indications forUse	The Surgimap softwareassists healthcareprofessionals inviewing, storing, andmeasuring images aswell as planningorthopedic surgeries.The device allowsservice providers toperform generic as wellas specialtymeasurements of theimages, and to plansurgical procedures.The device alsoincludes tools formeasuring anatomicalcomponents forplacement of surgicalimplants, and offeronline synchronizationof the database with thepossibility to share dataamong Surgimap users.Clinical judgment andexperience are requiredto properly use thesoftware.	The NuVasiveNuvaLine Mobile Appis a medical devicesoftware mobileapplication intended toassist healthcareprofessionals incapturing, measuring,and storing spinalalignment assessmentimages at various timepoints in patient care.The device allows thehealthcare professionalto conveniently performand review spinalalignment assessmentsof images by featuringmeasurement tools ontheir mobile device.	The ATECAlignment Appassists healthcareprofessionals inviewing,measuring, andstoring images aswell as planningorthopedicsurgeries. Thedevice allows thehealthcareprofessional toperform genericand specialtymeasurements ofthe images, andto plan surgicalprocedures. Thedevice offers thepossibility toshare dataamong ATECAlignment Appusers.	Similar to Surgimap— the only differenceis that the subjectdevice does notinclude tools formeasuringanatomicalcomponents forimplant selection.This difference doesnot affect substantialequivalence to thepredicate.Same as NuvaLine
RegulatoryClass/Code	Class IILLZ(21 CFR 892.2050)	Class IILLZ(21 CFR 892.2050)	Class IILLZ(21 CFR892.2050)	Same
DeviceClassificationName	Medical ImageManagement andProcessing System	Medical ImageManagement andProcessing System	Medical ImageManagement andProcessingSystem	Same
OperatingSystem	PC: Windows + MACMobile: Android + iOS	Mobile: Android + iOS	Mobile: Android+ iOS	Similar to Surgimap— the subject deviceis limited to use onmobile phones (iOSand Android). Thisdifference does notaffect substantialequivalence to thepredicate.
SoftwareFunctionalities /Modalities	Spinal alignmentassessments of images	Spinal alignmentassessments of images	Spinal alignmentassessments ofimages	Same as NuvaLineSimilar
ProvidesNormative Valuesfor MeasurementComparison	Yes	Yes	Yes	Same
Includes user-defined circles foranatomicallocation offemoral head forsagittalmeasurements	Yes	Yes	Yes	Same
Includes user-defined lines foridentification ofendplates forsagittal andcoronalmeasurements	Yes	Yes	Yes	Same
Provides color-codedmeasurementresults to displayvariance from thedefined norm	Yes	Yes	Yes	Same
Algorithms	Patient parameters andcalculations based onpublished literature	Lumbar Algorithm (PT,PI-LL, SVA)Cervical Algorithm(TPA,TS-CL, CSVA)	Patientparameters andcalculationsbased onpublishedliterature	Same
User Interface	PC or mobile device	Mobile device	Mobile device	Similar to Surgimap- the subject deviceis limited to use on
				mobile phones (iOSand Android). Thisdifference does notaffect substantialequivalence to thepredicate.
				Same as NuvaLine
Obtaining animage	Transferred from otherdevices, or mobiledevice camera	Mobile Device Camera	Transferred fromother devices, ormobile devicecamera	Same
Sharing animage	Email	None	Email/QR Code	Same
HumanIntervention forinterpretationandmanipulation ofimages	Required	Required	Required	Same
Control of life-saving devices	None	None	None	Same

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VII. PERFORMANCE DATA

The ATEC Alignment App was subjected to verification and validation testing in accordance with the functional requirements. Performance testing confirmed that the app accurately measures angles from x-ray images, and that resultant values are displayed properly with correct color-coded range. Angle measurements were verified within ± 2° accuracy. Validation testing was performed to confirm that the graphical user interface (GUI) and that data system features function as intended. A direct comparison test between the ATEC Alignment App and the Surgimap device using the same clinically representative images was conducted which concluded that the performance between the two devices was similar.

The results demonstrate that the subject ATEC Alignment App is substantially equivalent to Surgimap 2.0 (K141669) and the NuvaLine Mobile App (K162647) and verifies that the subject device meets design specifications and performance characteristics based upon its intended use.

Clinical Information

Not applicable: determination of substantial equivalence is not based on an assessment of clinical performance data.

VIII. CONCLUSION

Based upon the information provided in this 510(k) submission. it has been determined that the subject device is substantially equivalent to the legally marketed primary predicate

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device (Surgimap 2.0, K141669) based on intended use, design, functionality, performance testing and other key technological characteristics.

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).