The OKI Surgical Planning Software assists healthcare professionals in planning lumbar spinal fusion surgeries. The device allows service providers to plan surgical procedures, including tools for assessing anatomical components for placement of surgical implants. Clinical judgment and experience are required to properly use the software.

Device Description

The Ortho Kinematics OKI Surgical Planning Software is a software only accessory to a picture archiving and communications system. It is designed to be used to assess measurements from DICOM compliant images in a cleared PACS device and plan surgical spinal procedures. It offers the ability to plan certain surgical procedures, such as lumbar spine fusion. It offers tools for viewing data, and the ability to facilitate the estimation of a potential post-operative alignment and correction, based on pre-operative measurements, as well as the geometric parameters associated with specific lumbar interbody implant devices.

AI/ML Overview

The provided document (K171617) is a 510(k) premarket notification for the "OKI Surgical Planning Software." It assesses the device's substantial equivalence to a predicate device, "Nemaris, Inc.'s Surgimap 2.0 (K141669)." However, the document does not contain the detailed performance study information typically required to describe the acceptance criteria and the study that proves the device meets those criteria, specifically concerning advanced AI/machine learning model validation.

This document focuses on:

Device Description: A software accessory for PACS to assist in lumbar spinal fusion planning.
Comparison to Predicate Device: Table outlining similar technological characteristics.
Performance Data: A very high-level statement that "Software verification and validation testing was completed for the subject device. The software functioned as intended and all results observed were as expected."

It does not provide any of the following information pertinent to a detailed performance study proving acceptance criteria:

A table of acceptance criteria and the reported device performance: No specific metrics (e.g., accuracy, sensitivity, specificity, AUC) or defined thresholds are mentioned.
Sample sizes used for the test set and the data provenance: No information on the number of cases or their origin.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No mention of expert involvement for ground truth.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: No information on how discrepancies were resolved.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance: No such study is mentioned or implied. The software "assists healthcare professionals" but no improvement metrics are provided.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable for this device as "Human Intervention for interpretation and manipulation of images is Required."
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not specified.
The sample size for the training set: Not applicable/not mentioned, as this is not an AI/ML training report.
How the ground truth for the training set was established: Not applicable/not mentioned.

Conclusion based on the provided text:

The document states, "Software verification and validation testing was completed for the subject device. The software functioned as intended and all results observed were as expected." This is a general statement indicating that the software was tested for functionality, likely against its design specifications and requirements, as opposed to a clinical or AI/ML performance study with specific acceptance criteria and detailed results.

This type of submission (510(k) for a PACS accessory) often relies on demonstrating substantial equivalence to a predicate device primarily through similar functional capabilities and safety principles, rather than extensive clinical performance studies that would be required for a novel diagnostic AI algorithm. The device is a "planning software" that provides "tools for assessing anatomical components" and "facilitate the estimation," requiring "Clinical judgment and experience." It is not an automated diagnostic system. Therefore, the detailed performance study information requested is not present in this regulatory filing.

Summary

{0}------------------------------------------------

Public Health Service

Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes entwined around it, and three human profiles. The logo is surrounded by a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it.

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

August 22, 2017

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

Re: K171617

Trade/Device Name: OKI Surgical Planning Software Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: August 11, 2017 Received: August 11, 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

{1}------------------------------------------------

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

{2}------------------------------------------------

510(k) Number (if known) K171617

Device Name

OKI Surgical Planning Software

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

510(k) SUMMARY (K171617)

Ortho Kinematics, Inc.'s OKI Surgical Planning Software

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 11, 2017

Name of Device: OKI Surgical Planning Software

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

Regulatory Class: Class II

Product Code: LLZ

Predicate Device: Nemaris, Inc.'s Surgimap 2.0 (K141669)

Device Description

Intended Use / Indications for Use

Comparison of Technological Characteristics

The following table provides a comparison of technological characteristics to the predicate device:

{4}------------------------------------------------

Feature	OKI Surgical PanningSoftware	Surgimap 2.0
Computer	PC Compatible	PC Compatible
Operating System	Windows + MAC	Windows + MAC
Image Input	No image input; measurementsfrom DICOM compliant imagesinputted from cleared PACS	Local + PACS connectivity
Runs on Server	Optional	Yes
Generic measurements	Yes	Yes
Spine measurements	Yes	Yes
Pre-operative planning	Yes	Yes
Custom implants	No	Yes
Database of implants	Yes	Yes
Case sharing	No	Yes
Human Intervention forinterpretation andmanipulation of images	Required	Required

Performance Data

Software verification and validation testing was completed for the subject device. The software functioned as intended and all results observed were as expected.

Conclusions

The OKI Surgical Planning Software is as safe and effective as the predicate device. The subject device has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate device. The minor differences in indications do not alter the intended therapeutic use of the device and do not affect its safety and effectiveness when used as labeled. In addition, the minor technological differences between the subject device and its predicate device raise no different questions of safety or effectiveness. Software verification and validation testing demonstrates that the device performs as intended. Thus, the Surgical Planning Software 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).