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. Ligament balancing is provided by the OrthAlign Plus® System in primary or revision Total Knee 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
Ligament Balancing

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. The OrthAlign Plus® System comprises a single use computer module and reusable instrumentation.

AI/ML Overview

The OrthAlign Plus® System is a computer-controlled surgical navigation system intended to assist surgeons in determining reference alignment axes during stereotactic orthopedic surgical procedures. It facilitates accurate implant positioning and aids in controlling leg length and offset discrepancies in Total Hip Arthroplasty (THA), and provides ligament balancing in primary or revision Total Knee Arthroplasty (TKA).

Here's an analysis of the provided information regarding acceptance criteria and the study:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria for accuracy. However, it does describe the performance testing conducted and concludes that the device performs "as well as the predicate devices." The key performance metric highlighted is accuracy in gap distance and angle measurement.

Acceptance Criteria (Implied)	Reported Device Performance
Gap distance measurement accuracy	Bench testing with mechanical fixtures verified accuracy.
Angle measurement accuracy	Bench testing with mechanical fixtures verified accuracy.
Software functionality and reliability	Software verification and validation ensured integrity, functionality, and reliability.
Instrument mechanical requirements	System hardware verification/validation confirmed instruments meet mechanical requirements.
Biocompatibility	Assessed per ISO 10993-1 (2009).
Usability and user needs	Validated in simulated use cadaver testing with an advising surgeon.

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

Test Set Sample Size: Not explicitly stated with a numerical value. The document mentions "bench testing with mechanical fixtures" and "simulated use testing in cadaver." The number of mechanical tests or cadavers used is not specified.
Data Provenance: The cadaver testing implies a prospective experimental setting. The location of the test (e.g., country of origin) is not specified.

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

Number of Experts: One "advising surgeon" was involved in the simulated use cadaver testing.
Qualifications: "Advising surgeon" is the only qualification provided. Specific experience or subspecialty is not mentioned.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method for the test set in the traditional sense (e.g., 2+1, 3+1). For the cadaver study, an "advising surgeon" was present, suggesting a direct observation and evaluation of the system's performance in a simulated surgical environment. For bench testing, the ground truth would be objectively measured by the mechanical fixtures themselves.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or described. The study focuses on evaluating the device's standalone performance and its equivalence to predicate devices, not on comparing human reader performance with and without AI assistance.

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

Yes, a standalone performance evaluation was done. "Bench testing with mechanical fixtures to verify gap distance and angle measurement accuracy" specifically evaluates the algorithm's ability to measure accurately without direct human interpretation or intervention affecting the measurement output. The software verification and validation also fall under standalone testing. The "simulated use testing in cadaver" does involve a human surgeon, but the primary focus is on the system's output and meeting user needs, rather than comparing human performance.

7. The Type of Ground Truth Used

Bench Testing: Objective measurements from mechanical fixtures were used as ground truth for gap distance and angle measurement accuracy.
Simulated Use Testing: The "advising surgeon" would have implicitly provided a form of expert consensus/observation regarding the system's ability to meet user needs and usability in a simulated surgical environment. However, this is more for usability and functionality validation rather than a quantitative ground truth for accuracy.

8. The Sample Size for the Training Set

The document does not provide any information about a training set since this is a 510(k) summary for a medical device which is largely a hardware and software system, not an AI/Machine Learning model that undergoes "training" in the traditional sense of data-driven learning. While algorithms are involved, they appear to be rule-based or deterministic rather than machine learning algorithms requiring a distinct "training set."

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

As no training set is mentioned or implied for a machine learning model, the method for establishing ground truth for a training set is not applicable to this submission.

Summary

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November 22, 2017

Image /page/0/Picture/1 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized eagle. To the right is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" and "ADMINISTRATION" in blue text.

OrthAlign, Inc. David Vancelette Sr. Director QA/RA 120 Columbia, Suite 500 Aliso Viejo, California 92656

Re: K172462

Trade/Device Name: OrthAlign Plus® System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: August 11, 2017 Received: August 14, 2017

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. Iisting 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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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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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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Katherine D. Kavlock -S

for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K172462

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
Ligament Balancing

Type of Use (Select one or both, as applicable)
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X Prescription Use (Part 21 CFR 801 Subpart D)

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

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1. 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 (K171780)Brainlab DASH Knee (K102251)OrthoSensor VERASENSE Knee System (K150372)
SUBMISSION TYPE	Traditional 510(k). The subject device is a modificationto the previously cleared OrthAlign Plus® System

SUBSTANTIALLY EQUIVALENT TO:

The OrthAlign Plus® System is substantially equivalent to the previously cleared OrthAlign Plus® System (K171780), Brainlab DASH Knee (K102251) and OrthoSensor VERASENSE Knee System (K150372).

DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:

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SECTION 5. 510(K) SUMMARY

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

Establishing the mechanical axis of the femur, determining the varus/valgus angle and the flexion/extension angle of the cutting block relative to the femur.
. Establishing the mechanical axis of the tibia, determining the varus/valgus and the posterior slope angle of the cutting block relative to the tibia.
. Measuring the angles and gap distances between the femur and proximal tibia, for use in ligament balancing and establishing a reference line to assist in setting the rotation of the femoral implant, in primary or revision procedures.

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 (K171780). Additional functionality has been added to the predicate device to provide ligament balancing and measurements of bone alignment in total knee arthroplasty. Also, Indications for Use are common to the Brainlab DASH Knee (K102251) and OrthoSensor VERASENSE Knee System (K150372). Thus, the Indications for Use are as follows:

OrthAlign Plus® System:

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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. Ligament balancing is provided by the OrthAlign Plus® System in primary or revision Total Knee 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 ●
Ligament Balancing .

TECHNICAL CHARACTERISTICS (COMPARED TO PREDICATE):

The OrthAlign Plus System was cleared under K171780. The OrthAlign Plus® System comprises a single use computer module, a reusable reference sensor, a reusable laser module, 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 knee arthroplasty approach to include measurement of bone alignment and ligament balancing, as in the predicate device Brainlab DASH Knee (K102251), and for the application of measurement of bone alignment and ligament balancing in primary or total knee arthroplasty, as in the predicate OrthoSensor VERASENSE Knee System (K150372). 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 instruments meet their mechanical requirements.
. Instrumentation cleaning, sterilization and shipping validations or adoptions for the specified processes.
System components biocompatibility assessment per ISO 10993-1 (2009).
. System accuracy testing: bench testing with mechanical fixtures to verify gap distance and angle measurement accuracy.
Simulated use testing in cadaver with an advising surgeon to validate the system ● meets requirements for user needs and usability in a simulated use environment.

This testing regime demonstrates that the subject device is as safe, as effective, and performs as well as the predicate devices. This testing regime demonstrates that the subject device is

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510(K) SUMMARY

substantially equivalent to the legally marketed predicate devices, for its intended use in the measurement of bone alignment and ligament balancing in TKA.

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 (K171780) and Brainlab DASH Knee (K102251) and OrthoSensor VERASENSE Knee System (K150372).

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 (K171780), with the following exception: the subject device allows for the measurement of bone alignment and ligament balancing in TKA.

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 Comparison to Predicates

Feature orPrinciple	Subject Device: OrthAlign PlusSystem	Predicate OrthAlign PlusSystem (K171780)	Predicate BrainlabDASH Knee (K102251)	Predicate OrthoSensorVERASENSE KneeSystem (K150372)
Materials	• Stainless Steel grades commonto orthopedic surgicalinstruments• Polymer grades common toorthopedic surgical instruments• Internal electronics	Identical	Identical	Similar:• Polymer gradescommon to orthopedicsurgical instruments• Internal electronics
ControlMechanism	Computer generation of positionalinformation, using inertialsensors, microcontroller, digitalsignal processor and physicalpositions of registrationinstruments.	Identical	Similar. Usesstereoscopic camera,reflective trackers andcomputer to generatepositional information,based on physicalpositions of registrationinstruments.	Similar:Computer generation ofpositional informationusing pressure sensorsand physical position ofregistration instrument.
OperatingPrinciplesRegistrationof anatomy	Electronics attached to movableinstruments, placed in specifiedprocedural positions, on or incontact with bony anatomy, forrecording sensor data.	Identical	Similar. Opticalregistration of identicalindicated anatomic pointsand instrumentorientations.	Similar:Electronics attached tomovable instruments,placed in specifiedprocedural positions, incontact with trials orimplants, for recordingsensor data.
Measurementof change indistance	• Computer displayed values.• Optical camera reading ofinstrument position (fordistance).• Accelerometer measurement of	Identical	Similar. Usesstereoscopic camera,reflective trackers andcomputer to generatepositional information,based on physical	N/A
Feature orPrinciple	Subject Device: OrthAlign PlusSystem	Predicate OrthAlign PlusSystem (K171780)	Predicate BrainlabDASH Knee (K102251)	Predicate OrthoSensorVERASENSE KneeSystem (K150372)
	angular change in instrumentpositions.		positions of registrationinstruments.
Measurementof change inangularorientations	Computer displayed valuesbased on internal calculations. Accelerometer measurement ofangular change in instrumentpositions.	Identical	Similar, with:Computer displayedvalues based oninternal calculations. Stereoscopic cameraidentification ofreflective trackerpositions onregistrationinstruments.	Similar, with:Computer displayedvalues based oninternal calculations. Load sensordetermination ofcontact points.
Main SystemComponents	Single-use computer unit Navigation and measurementsoftware Reusable instrument sets	Identical	Similar: reusablecomputer console insteadof single-use unit. Otherelements identical.	Similar:Single-use electronicunit Measurement software Reusable computerconsole
User Interface	Integrated graphical userinterface, on an electronic unitthat attaches to instrumentation.	Identical	Similar, with the additionof a separate computerconsole with a graphicaluser interface	Similar, with the additionof a separate computerconsole with a graphicaluser interface
Energy Type	Navigation unit, referencesensor and laser module: DCbattery power. Instruments: manual	Identical	Similar, with:Electronic userinterface (in thesurgical field):	Identical for:Single-use electronicmodule: DC batterypower.
Feature orPrinciple	Subject Device: OrthAlign PlusSystem	Predicate OrthAlign PlusSystem (K171780)	Predicate BrainlabDASH Knee (K102251)	Predicate OrthoSensorVERASENSE KneeSystem (K150372)
	positioning and manipulation.		Identical.• Instruments: Identical• Computer console: AC power.
Sterilization	• Navigation unit: EOsterilization.• Instruments: autoclavesterilization	Identical	Similar, with:• Electronic userinterface (in thesurgical field): steriledraping.• Instruments: Identical	Identical for:• Single-use electronicmodule: EOsterilization.
Biocompatibility	Per ISO 10993-1, ExternalCommunicating Device,Tissue/Bone/DentinCommunicating, with subsystemsthat have direct and potentialindirect contact for a limitedcontact duration (< 24 hours)	Identical	Identical	Identical
Patient interface	Instrument fixation to bone withpins or screws. Instrumentindications and engagement ofbony anatomy via physicalsurface contact.	Identical	Identical	Similar:Instrument insertion in thejoint, with physicalcontact to trials orimplants
Environmentalspecifications	Specified storage and operatingenvironments for typical transportand surgical environments.	Identical	Identical	Identical

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SECTION 5.

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SECTION 5.

510(K) SUMMARY

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).