The OrthAlign Plus® System is a computer-controlled system intended to assist the surgeon in determining reference alignment axes in relation to anatomical and instrumentation structures during stereotactic orthopedic surgical procedures. The OrthAlign Plus® System facilitates the accurate positioning of implants, relative to these alignment axes. The system aids the surgeon in controlling leg length and offset discrepancies in Total Hip Arthroplasty.

Example orthopedic surgical procedures include but are not limited to:

· Total Knee Arthroplasty
· Total Hip Arthroplasty: Anterior/Posterior
· Unicompartmental Knee Arthroplasty: Tibial transverse resection

Device Description

The OrthAlign Plus® System is a non-invasive computer assisted surgical navigation system for use in knee and hip arthroplasty procedures. The OrthAlign Plus® System is configured to detect, measure, and display angular and positional measurement changes in a triaxial format. The OrthAlign Plus® System utilizes a palm-sized computer module and reference sensor to generate positional information in orthopedic procedures providing a sequence of steps for registration of anatomical landmarks, calculation of mechanical axes, and positioning of instruments relative to the mechanical axes.

AI/ML Overview

Here's an analysis of the provided text to extract information about the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state numerical acceptance criteria in a table format, nor does it provide specific numerical performance metrics for the device. Instead, it describes "performance testing" and states that the "OrthAlign Plus® System can be used according to its intended use" and "performs as well as or better than the predicate devices."

However, we can infer the tested capabilities and the reported validation of those capabilities.

Acceptance Criteria (Implied)	Reported Device Performance
Accuracy of Leg Length and Offset Measurement (THA, Anterior)	- Bench testing with mechanical fixtures and foam models verified leg length and offset measurement accuracy. - Simulated use testing in cadavers validated system accuracy vs. the gold standard of radiographic measurement. - 40 data points (on 5 hips) from cadaver validation showed accurate measurement of intraoperative change in leg length and offset.
Accuracy of Acetabular Shell Insertion Navigation (THA, Anterior, relative to anterior pelvic plane adjusted for pelvic tilt)	- Bench testing with mechanical fixtures and foam models verified updated scale reader measurement accuracy (likely contributing to this). - Simulated use testing in cadavers validated system accuracy vs. the gold standard of radiographic measurement. - 38 data points (on 5 hips) from cadaver validation showed accurate navigation of cup placement angles.
Software Integrity and Functionality	Software verification and validation ensured the integrity of the code and functionality and reliability of the software in various use sequences.
Hardware Mechanical Requirements	System hardware verification/validation testing ensured the electronics hardware meets its mechanical requirements.
Electrical Safety	Electrical safety testing to IEC 60601-1:2005 + Corr. 1 (2006) + Corr. 2 (2007) + AM1 (2012) or IEC 60601-1:2012.
Electromagnetic Compatibility	Electromagnetic compatibility testing to IEC 60601-1-2: 2015.
Laser Product Safety	Laser product safety verification to IEC 60825-1:2014.
Instrumentation Cleaning, Sterilization, and Shipping	Validations for the specified processes.
Navigation Device Sterilization, Packaging, Shelf Life, Environmental, Shipping	Validations for the specified ranges of conditions involved in each process. (Summary data for the identical predicate device is referenced for some validations.)
Biocompatibility	System components biocompatibility assessment per ISO 10993-1 (2009).
User Requirements Validation (Simulated Use)	Customer requirements validation with an advising surgeon validated the system meets design input requirements for its functions in a simulated use environment.

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

Sample Size (for clinical performance aspects):
- Intraoperative change in leg length and offset: 40 data points (on 5 hips)
- Acetabular shell insertion navigation: 38 data points (on 5 hips)
Data Provenance: Prospective cadaver validation in a simulated operating room environment. The country of origin is not specified.

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

Number of Experts: A "surgeon" conducted the procedures in the simulated use cadaver testing. It mentions "an advising surgeon" for customer requirements validation. The exact number of independent experts contributing to ground truth establishment for the cadaver study is not explicitly stated beyond "a surgeon."
Qualifications of Experts: The individual conducting the cadaver procedures is referred to as a "surgeon." No specific years of experience or subspecialty (e.g., orthopedic surgeon) are mentioned, though the context implies an orthopedic surgeon familiar with the procedures.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method for the test set in the sense of multiple reviewers resolving discrepancies. The ground truth (radiographic evaluation) was compared against the device's measurements.

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, an MRMC comparative effectiveness study involving human readers with and without AI assistance was not performed or described. This device is a surgical navigation system, not an AI-assisted diagnostic tool that aids human readers.

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

Yes, the cadaver study described is a standalone performance test of the algorithm and system's accuracy in a simulated surgical environment. The "surgeon" conducts the procedure using the device, and the device's output (measurements and navigation guidance) is then compared to a ground truth (radiographic evaluation). This assesses the system's ability to accurately determine surgical parameters independently, under realistic conditions.

7. The Type of Ground Truth Used

Radiographic measurement: Used for validating the accuracy of leg length and offset changes, and cup placement angles in the hip arthroplasty procedures on cadavers. This is considered a "gold standard" in the context of the study.

8. The Sample Size for the Training Set

The document does not mention a "training set" or "training data" as this device is a rule-based surgical navigation system rather than a machine learning/AI model that requires training data in the conventional sense. The "performance data" section focuses on verification and validation of the system's design and functionality.

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

As no training set is discussed or implied for a machine learning model, this question is not applicable based on the provided text. The system relies on its inherent algorithms and sensor data, validated against known physical principles and clinically accepted measurement techniques (like radiography) rather than being "trained" on a dataset with established ground truth.

Summary

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Image /page/0/Picture/1 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 image of a human figure, represented by three overlapping profiles.

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

January 23, 2017

Orthalign, Inc. David Vancelette Director OA/RA 120 Columbia, Suite 500 Aliso Viejo. California 92656

Re: K162962

Trade/Device Name: Orthalign Plus System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: October 21, 2016 Received: October 24, 2016

Dear David Vancelette:

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 devicerelated 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/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 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,

Mark N. Melkerson -S

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation 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: January 31, 2017 See PRA Statement below.

510(k) Number (if known)	K162962
--------------------------	---------

Device Name OrthAlign Plus System

Indications for Use (Describe)

Example orthopedic surgical procedures include but are not limited to:

· Total Knee Arthroplasty
· Total Hip Arthroplasty: Anterior/Posterior
· Unicompartmental Knee Arthroplasty: Tibial transverse resection

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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5. 510(K) SUMMARY

This 510(k) summary is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92(c).

DATE	October 21, 2016
APPLICANT	OrthAlign, Inc.120 ColumbiaSuite 500Aliso Viejo, CA 92656Tel: (949) 715-2424Fax: (949) 831-9500
OFFICIALCORRESPONDENT	David VanceletteOrthAlign, Inc.120 Columbia,Suite 500Aliso Viejo, CA 92656dvancelette@orthalign.comTel: (858) 692-0335Fax: (949) 831-9500
TRADE NAME	OrthAlign Plus® System
COMMON NAME	Stereotaxic Instrument
DEVICECLASSIFICATION	Class II, 21 CFR §882.4560
PRODUCT CODES	OLO: Orthopedic Stereotaxic Instrument
PREDICATEDEVICES	OrthAlign Plus® System (K153237)Stryker Navigation System - CT Based Hip Module(K050615)
SUBMISSION TYPE	Traditional 510(k). The subject device is a modificationto the previously cleared OrthAlign Plus® System(K153237).

SUBSTANTIALLY EQUIVALENT TO:

The OrthAlign Plus® System is substantially equivalent to the previously cleared OrthAlign Plus® System (K153237) and Stryker Navigation System – CT Based Hip Module (K050615).

DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:

The OrthAlign Plus® System is a non-invasive computer assisted surgical navigation system for use in knee and hip arthroplasty procedures. The OrthAlign Plus® System is configured to

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detect, measure, and display angular and positional measurement changes in a triaxial format. The OrthAlign Plus® System utilizes a palm-sized computer module and reference sensor to generate positional information in orthopedic procedures providing a sequence of steps for registration of anatomical landmarks, calculation of mechanical axes, and positioning of instruments relative to the mechanical axes.

In knee arthroplasty procedures, the device assists the surgeon in:

Establishing the mechanical axis of the femur. determining the varus/valgus and ● the flexion/extension angle of the cutting block relative to the femur.
Establishing the mechanical axis of the tibia, determining the varus/valgus angle and the posterior slope angle of the cutting block relative to the tibia.

In hip arthroplasty procedures, the device assists the surgeon in:

. Establishing the orientation of the anterior pelvic plane and determining the inclination angle and the anteversion angle of the shell impactor relative to the anterior pelvic plane, or to the anterior pelvic plane adjusted for pelvic tilt.
Measuring the intraoperative change in leg length and offset.

In unicompartmental knee arthroplasty procedures, the device assists the surgeon in:

Establishing the mechanical axis of the tibia, determining the varus/valgus angle and ● the posterior slope angle of the cutting block relative to the tibia, for the transverse resection.
The OrthAlign Plus® System comprises a single use computer module and reusable instrumentation.

INDICATIONS FOR USE:

The OrthAlign Plus® System has the same indications for use as the previously cleared OrthAlign Plus System (K153237). Additional functionality has been added to the predicate device to enable the measurement of intraoperative change in leg length and offset and navigation of the shell impactor to an alternate reference plane in total hip arthroplasty: anterior approach. Also, Indications for Use are common to the Stryker Navigation System - CT Based Hip Module (K050615). Thus, the Indications for Use are as follows:

OrthAlign Plus® System:

Example orthopedic surgical procedures include but are not limited to:

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Total Knee Arthroplasty
. Total Hip Arthroplasty: Anterior/Posterior
Unicompartmental Knee Arthroplasty: Tibial transverse resection ●

TECHNICAL CHARACTERISTICS (COMPARED TO PREDICATE):

The OrthAlign Plus® System was cleared under K153237. The OrthAlign Plus® System comprises a single use computer module, a reusable reference sensor, a reusable femoral jig, a reusable tibial jig, a reusable posterior hip jig and a reusable anterior hip jig. The device utilizes algorithms to convert sensor outputs into spatial coordinates, providing graphical and numerical representation of instruments and anatomy on the user display screen. The OrthAlign Plus System is being updated for total hip arthroplasty: anterior approach to include navigation of the shell impactor to an alternate reference plane, as in the predicate device Stryker Navigation System - CT Based Hip Module (K050615), and enable the measurement of intraoperative change in leg length and offset using a laser to guide repositioning of the leg, as in the predicate device OrthAlign Plus® System (K153237). All other features and principles of operation remain unchanged.

PERFORMANCE DATA:

Device performance testing confirms that the OrthAlign Plus® System can be used according to its intended use. The OrthAlign Plus® System has been verified and validated according to OrthAlign's procedures for product design and development. Performance testing addressed the new functionality and surgical procedure steps. Performance testing included:

. Software verification and validation to ensure the integrity of the code and functionality and reliability of the software in various use sequences.
System hardware verification/validation testing to ensure the electronics hardware meets its mechanical requirements.
Electrical safety testing to IEC 60601-1:2005 + Corr. 1 (2006) + Corr. 2 (2007) + AM1 (2012) or IEC 60601-1:2012.
Electromagnetic compatibility testing to IEC 60601-1-2: 2015.
Laser product safety verification to IEC 60825-1:2014.
Instrumentation cleaning, sterilization and shipping validations for the specified processes.
Navigation device sterilization, packaging, shelf life, environmental conditions and shipping validations for the specified ranges of conditions involved in each process. (Summary data for the identical predicate device is referenced for some validations.)
System components biocompatibility assessment per ISO 10993-1 (2009). ●
Customer requirements validation with an advising surgeon to validate the system . meets design input requirements for its functions in a simulated use environment.
System accuracy testing: bench testing with mechanical fixtures and foam models to

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verify leg length and offset and updated scale reader measurement accuracy.

. Simulated use testing in cadaver to validate system accuracy vs. the gold standard of radiographic measurement in a simulated use environment (see discussion below).
For simulated use testing, a prospective cadaver validation was done in a simulated operating room environment with a surgeon conducting the procedures.

Measurement of the intraoperative change in leg length and offset was validated for the anterior approach with 40 data points (on 5 hips), using radiographic evaluation of the leg length and offset changes.

Navigation of the acetabular shell insertion relative to the anterior pelvic plane adjusted for pelvic tilt was validated for the anterior approach with 38 data points (on 5 hips), using radiographic evaluation of the cup placement angles.

This testing regime demonstrates that the subject device is as safe, as effective, and performs as well as or better than the predicate devices. This testing regime demonstrates that the subject device is substantially equivalent to the legally marketed predicate devices, for its intended use in facilitating the accurate measurement of intraoperative change in leg length and offset and navigation of the acetabular shell impactor relative to the anterior pelvic plane adjusted for pelvic tilt, in THA, anterior approach.

The information provided by OrthAlign in this 510(k) application confirms that the OrthAlign Plus® System is substantially equivalent to predicate devices such as the OrthAlign Plus® System (K153237) and Stryker Navigation System - CT Based Hip Module (K050615).

BASIS FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE:

A technological comparison and bench and cadaver testing demonstrate the substantial equivalence of the OrthAlign Plus® System to the predicate devices.

The subject device is identical to the predicate OrthAlign Plus® System (K153237), with the following exceptions:

The subject device allows for the measurement of intraoperative changes in leg length and joint offset in THA, anterior approach.
The subject device uses a laser to facilitate repositioning of the leg for the ● measurement of intraoperative changes in leg length and joint offset in THA, anterior approach.
. The subject device allows for the navigation of the acetabular shell impactor relative to the anterior pelvic plane adjusted for pelvic tilt, in THA, anterior approach.

The table below summarizes the features of the subject device as compared to the predicate devices.

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Table 1. OrthAlign Plus® System Components, Classes & Clearances – Summary

Property	SUBJECT DEVICEORTHALIGN PLUS® SYSTEM	PREDICATE 1ORTHALIGN PLUS® SYSTEM (K153237)	PREDICATE 2Stryker Navigation System – CTBased Hip Module (K050615)
Indications for Use	Total Knee Arthroplasty / Total HipArthroplasty:The OrthAlign Plus® System is acomputer-controlled system intended toassist the surgeon in determiningreference alignment axes in relation toanatomical and instrumentation structuresduring stereotactic orthopedic surgicalprocedures. The OrthAlign Plus®System facilitates the accurate positioningof implants, relative to these alignmentaxes. The system aids the surgeon incontrolling leg length and offsetdiscrepancies in Total Hip Arthroplasty.Example orthopedic surgical proceduresinclude but are not limited to:Total Knee Arthroplasty Total Hip Arthroplasty:Anterior/Posterior Unicompartmental KneeArthroplasty: Tibial transverseresection	Total Knee Arthroplasty /Total HipArthroplasty:The OrthAlign Plus® System is acomputer-controlled system intended toassist the surgeon in determiningreference alignment axes in relation toanatomical and instrumentation structuresduring stereotactic orthopedic surgicalprocedures. The OrthAlign Plus®System facilitates the accurate positioningof implants, relative to these alignmentaxes. The system aids the surgeon incontrolling leg length and offsetdiscrepancies in Total Hip Arthroplasty:Posterior.Example orthopedic surgical proceduresinclude but are not limited to:Total Knee Arthroplasty Total Hip Arthroplasty:Anterior/Posterior Unicompartmental KneeArthroplasty: Tibial transverseresection	Total Hip Arthroplasty:The Navitrack Stryker NavigationSystem - CT Based Hip Module isintended as a planning andintraoperative guidance system toenable open or percutaneous computerassisted surgery. The system isindicated for any medical condition inwhich the use of computer assistedsurgery may be appropriate, and where areference to a rigid anatomical structuresuch as but not limited to the pelvis, orfemur, can be identified.The system shall be operated only bytrained personnel such as orthopedicsurgeons and clinical staff.The Stryker Navigation System - HipModule supports, but is not limited tothe following surgical procedures Any form of Total HipArthroplasty (THA), e.g. open orminimally invasive Precisely position instruments,implants and bony tissue duringorthopedic surgery, such asoperations performed with Hipand bones in the upper extremities Revisions
Property	SUBJECT DEVICEORTHALIGN PLUS® SYSTEM	PREDICATE 1ORTHALIGN PLUS® SYSTEM (K153237)	PREDICATE 2Stryker Navigation System – CTBased Hip Module (K050615)
Technological Principles
Computer generation ofpositional information	Uses inertial sensors, microcontroller anddigital signal processor to generatepositional information, based on physicalpositions of registration instruments.	Identical	Similar. Uses stereoscopic camera,reflective trackers and computer togenerate positional information, basedon physical positions of registrationinstruments.
Registration of anatomy	Ipsilateral ASIS, contralateral ASIS andpubic symphysis are registered toestablish a pelvic reference frame, whichcan be rotated normal to the gravityvector, to adjust for pelvic tilt.	Similar. Identical registrations andanterior pelvic reference frame.	Similar. Optical registration of identicalindicated anatomic points. Computergeneration of identical anterior pelvicreference frame. Similar adjustment forpelvic tilt.
Navigation of acetabularshell impactor	With anteversion and abduction angles	Identical	Identical
Measurement ofintraoperative changes inleg length and offset	For total hip arthroplasty: posterior andanterior approaches	Similar: for total hip arthroplasty:posterior approach	Identical
Surgical work flow	● Patient preparation● Instrument setup● Instrument attachment to patient● Anatomic registrations● Joint preparation● Implant navigation● Measurement of changes in legposition	Identical	Identical
Design Elements
Property	SUBJECT DEVICEORTHALIGN PLUS® SYSTEM	PREDICATE 1ORTHALIGN PLUS® SYSTEM (K153237)	PREDICATE 2Stryker Navigation System – CTBased Hip Module (K050615)
Main SystemComponents	Single-use computer unitNavigation softwareReusable instrument setRegistration instrumentsAcetabular Shell Impactor	Identical	Similar: reusable computer consoleinstead of single-use unit. Otherelements identical.
ser Interface	Integrated graphical user interface, onsingle-use unit that attached toinstrumentation.	Identical.	Similar: graphical user interface onreusable console screen outside thesterile field.
Femur registration	Physically registers a fiduciary point:instrument attaches to the femur.	Similar: physically registers a fiduciaryplate: instrument temporarily attaches tothe femur.	Similar: optically registers a fiduciaryelement: instrument attaches to thefemur.
Leg positioning	Laser crosshair pattern used to locate leg.	Similar: visual positioning andregistration of a reference plane used tolocate leg.	Similar: visual positioning andregistration of a reference plane used tolocate leg.

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Regulation Number and Section

§ 882.4560 Stereotaxic instrument.

(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).