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.

Example orthopedic surgical procedures include but are not limited to:

Total Knee Arthroplasty o
Total Hip Arthroplasty: Anterior / Posterior .

The KneeAlign® 3 System is a computer-controlled system intended to assist the surgeon in determining reference alignment axes in relation to anatomical and instrument and structures during stereotactic orthopedic surgical procedures. The KneeAlign® 3 System facilitates the accurate positioning of implants, relative to these alignment axes.

Example orthopedic surgical procedures include but are not limited to:

· Total Knee Arthroplasty

The HipAlign 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 HipAlign® System facilitates the accurate positioning of implants, relative to these alignment axes.

Example orthopedic surgical procedures include but are not limited to:

· Total Hip Arthroplasty: Anterior / Posterior

Device Description

The OrthAlign Plus" System is an innovative 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.

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

The OrthAlign Plus™ System is usable for a total knee arthroplasty or total hip arthroplasty procedure. The System includes two optional configurations: the KneeAlign® 3 System usable for total knee arthroplasty only, and the HipAlign® System usable for total hip arthroplasty only. The OrthAlign Plus" System includes the singleuse OrthAlign Plus™ Unit, a KneeAlign® 3 Instrument Set and a HipAlign® Instrument Set. The optional configurations include a modified version of the OrthAlign Plus" Unit and only one of the Instrument Sets. Indications for Use for each optional configuration are limited to the applicable orthopedic procedure.

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 optional KneeAlign® 3 and HipAlign® system configurations also comprise the single use computer module, reusable reference sensor and applicable reusable jigs. They utilize the same algorithms, sensor conversions, graphical and numerical representations and surgical techniques as the OrthAlign Plus™ System.

AI/ML Overview

The OrthAlign Plus™ System is a computer-assisted surgical navigation system for knee and hip arthroplasty procedures. The submission states that performance testing confirms the system can be used for its intended purpose and demonstrates substantial equivalence to predicate devices.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative "acceptance criteria" or specific metrics for accuracy or precision for the OrthAlign Plus™ System. Instead, it relies on a general statement that "Device performance testing confirms that the OrthAlign Plus™ System can be used according to its intended use."

The performance data describe the types of tests conducted:

Software verification and validation
System hardware verification and validation testing
Electrical safety and electromagnetic compatibility testing
Instrumentation cleaning, sterilization and shipping validations
System components biocompatibility assessment
Customer requirements validation
System accuracy testing: bench testing with mechanical fixtures and foam models
Simulated use testing: cadaver and virtual testing

While the report confirms these tests were done, it does not provide specific numerical results that would typically be found in a section detailing acceptance criteria versus actual performance. The primary claim for regulatory clearance is "substantially equivalent" to predicate devices, which implies that its performance is comparable to already approved devices, rather than needing to meet distinct, pre-defined quantitative acceptance thresholds presented in this document.

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

Test Set Description: Simulated use testing through cadaver and virtual studies.
Knee Arthroplasty (Prospective Cadaver Validation):
- Simulated operating room environment.
- 3 labs.
- 3 surgeons.
- Procedures performed with both anterior and posterior approaches (though specific numbers for knees are not given, the focus then shifts to hips).
Hip Arthroplasty – Anterior Approach (Cadaver Labs):
- 2 cadaver labs.
- 30 specimens (30 hips).
- Data Provenance: Prospective, from cadaver labs. Country of origin not specified, but implied to be within the context of the applying company (OrthAlign, Inc. in Aliso Viejo, CA, USA).
Hip Arthroplasty – Posterior Approach (Cadaver Labs and Virtual Study):
- 2 cadaver labs.
- 12 full body specimens (18 hips).
- Follow-up virtual study (number not specified, but done with software updates).
- Data Provenance: Prospective, from cadaver labs and a subsequent virtual study. Country of origin not specified, but implied USA.

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

Number of Experts: 3 surgeons conducted the procedures in the simulated operating room environment for the initial cadaver validation.
Qualifications of Experts: Referred to simply as "surgeons." No specific experience levels (e.g., years of experience, board certification) are provided in this summary.
Method of Ground Truth Establishment: Radiographic evaluation of cup placements was used to validate the navigation of cup angles in hip arthroplasty cadaver labs. The specific methodology for how these surgeons' actions or radiographic interpretations formed the "ground truth" (e.g., if they were the "truth" or if their results were compared to another gold standard) is not fully detailed. It implies that the surgeons used the device, and the outcome (cup placement) was then evaluated radiographically.

4. Adjudication Method for the Test Set

The document does not describe an explicit "adjudication method" (like 2+1 or 3+1 consensus) for establishing ground truth, especially concerning expert agreement on image interpretation or surgical outcomes. It mentions "radiographic evaluation of the cup placements," which implies a measurement-based assessment rather than an adjudication of expert opinions on a diagnostic interpretation. The surgeons were performing the procedures, not adjudicating ground truth.

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

No MRMC comparative effectiveness study was mentioned. The studies described are performance evaluations of the device itself and its assistance to surgeons, not a comparison of human readers with and without AI assistance to quantify an improvement effect size. The device is a navigation system, assisting in real-time surgical guidance, rather than a diagnostic tool interpreted by multiple readers.

6. Standalone Performance

Yes, standalone (algorithm only) performance seems to be implicitly covered as part of the overall system testing. The description includes "System accuracy testing: bench testing with mechanical fixtures and foam models" and "virtual testing." These types of tests specifically evaluate the algorithms and hardware in isolation or in a controlled simulated environment before human interaction is introduced in cadaver studies. However, a distinct numerical "standalone performance" metric (e.g., x% accuracy without human intervention) is not explicitly stated.

7. Type of Ground Truth Used

Measurement-based outcomes:
- For hip arthroplasty cadaver labs, radiographic evaluation of the cup placements was used. This indicates that the "ground truth" was a measurement derived from imaging after the procedure, which was then compared to the intended or desired outcomes guided by the device. This is often considered an objective measurement or an outcome-based ground truth for surgical accuracy.

8. Sample Size for the Training Set

The document does not specify a separate "training set" sample size or methodology for establishing ground truth for a training set. This is a medical device, specifically a surgical navigation system, rather than a machine learning algorithm that typically requires a large, annotated training dataset in the conventional sense. The "algorithms" mentioned convert sensor outputs into spatial coordinates, suggesting a more deterministic or model-based approach rather than a learning-based approach where a distinct training set (for a neural network, for example) would be used. The "performance data" section focuses on verification and validation of the system rather than training of an AI model.

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

As a conventional "training set" (for machine learning) is not described, the concept of establishing ground truth for it is also not applicable here based on the provided text. The device’s "algorithms" are likely based on established biomechanical and geometric principles, and their accuracy is verified through the various testing described (bench, virtual, cadaver), not through training on data with pre-established ground truth labels.

Summary

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K130387

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).

APPLICANT	OrthAlign, Inc.120 ColumbiaSuite 500Aliso Viejo, CA 92656Tel: (949) 715-2424Fax: (949) 831-9500
OFFICIALCORRESPONDENT	Amy WaltersAWE, Inc.338 Vista MaderaNewport Beach, CA 92660amylynnwalters@gmail.comTel: (949) 923-9400Fax: (949) 831-9500
	NOV 0 8 2013
TRADE NAME	OrthAlign Plus™ System
COMMON NAME	Stereotaxic Instrument
DEVICECLASSIFICATION	Class II, 21 CFR §882.4560
PRODUCT CODES	OLO: Orthopedic Stereotaxic Instrument
PREDICATEDEVICES	KneeAlign® 2 System (K103829)Navitrack System - S&N Image Free Knee (K043536)Navitrack System - S&N Image Free Hip (K041369)
SUBMISSION TYPE	Traditional 510(k). The subject device is a modificationto the previously cleared KneeAlign® 2 System(K103829).

SUBSTANTIALLY EQUIVALENT TO:

The OrthAlign Plus" System is substantially equivalent to the previously cleared KneeAlign® 2 System (K103829), Navitrack System - S&N Image Free Hip (K041369) and Navitrack System- S&N Image Free Knee (K043536).

DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:

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The current standard of care for knee arthroplasty procedures has the physician estimating these changes either by visual observation and mechanical guides with tactile feedback or with assistance of computer assisted surgery devices.

The current standard of care for hip arthroplasty procedures has the physician estimating angular orientation of the acetabular shell either by visual observation and mechanical guides or with assistance of computer assisted surgery devices.

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 femur.
Establishing the mechanical axis of the tibia, determining the varus/valgus angle . and the posterior slope angle of the cutting block relative to 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.
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 KneeAlign® 2 System (K 103829). Additional functionality has been added to the predicate device to enable navigation for Total Hip Arthroplasty. Also, Indications for Use are common to the Navitrack System- S&N Image Free Hip (K041369) and Navitrack System- S&N Image Free Knee (K043536). Thus, the Indications for Use are as follows:

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OrthAlign Plus™ System:

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.

Example orthopedic surgical procedures include but are not limited to:

Total Knee Arthroplasty o
Total Hip Arthroplasty: Anterior / Posterior .

KneeAlign® 3 System:

The KneeAlign® 3 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 KneeAlign® System facilitates the accurate positioning of implants, relative to these alignment axes.

Example orthopedic surgical procedures include but are not limited to:

· Total Knee Arthroplasty

HipAlign® System:

Example orthopedic surgical procedures include but are not limited to:

· Total Hip Arthroplasty: Anterior / Posterior

TECHNICAL CHARACTERISTICS:

The terms "OrthAlign Plus" System" and "OrthAlign Plus™ Unit" are used henceforth in this submission to refer to all three system configurations and all three single-use computer modules, except where all three configurations are cited and differentiated.

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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 included:

Software verification and validation ●
System hardware verification and validation testing ●
Electrical safety and electromagnetic compatibility testing .
Instrumentation cleaning, sterilization and shipping validations ●
System components biocompatibility assessment �
Customer requirements validation ●
System accuracy testing: bench testing with mechanical fixtures and foam models .
. Simulated use testing: cadaver and virtual testing

For simulated use testing, a prospective cadaver validation was done with a series of 3 labs in a simulated operating room environment with 3 surgeons conducting the procedures, both anterior and posterior approaches. A follow-up virtual study was conducted on the system's navigation in the posterior approach with software updates applied to the earlier testing.

Navigation of cup angles in the anterior approach was validated in a series of 2 cadaver labs with 30 specimens (30 hips), using radiographic evaluation of the cup placements.

Navigation of cup angles in the posterior approach was validated in a series of 2 cadaver labs with 12 full body specimens (18 hips), using radiographic evaluation of cup placements and a follow-up virtual study of navigation with software updates applied.

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 positioning of implants and instrumentation, relative to reference alignment axes.

The information provided by OrthAlign in this 510(k) application confirms that the OrthAlign Plus™ System is substantially equivalent to predicate devices: KneeAlign® 2 System (K103829), Navitrack System- S&N Image Free Knee (K043536) and Navitrack System- S&N Image Free Hip (K041369).

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.

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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" around the perimeter. Inside the circle is a stylized symbol that resembles a person with outstretched arms.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

November 8, 2013

OrthAlign, Incorporated % Ms. Amy Walters A WE, Incorporated 338 Vista Madera Newport Beach, California 92660

Re: K130387

Trade/Device Name: OrthAlign Plus" System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: Class II Product Code: OLO Dated: September 25, 2013 Received: October 1, 2013

Dear Ms. Walters:

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

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Page 2 - Ms. Amy Walters

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 Small Manufacturers, International and Consumer Assistance at its tollfree 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" (21CFR 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/defay.lt,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 Small Manufacturers, International and Consumer Assistance 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,

Mark N. Melkerson -S

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

Enclosure

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2. INDICATIONS FOR USE STATEMENT

2.1. ORTHALIGN PLUS™ SYSTEM

510(k) Number (if known): K130387

Device Name: OrthAlign Plus™ System

Indications for Use:

Example orthopedic surgical procedures include but are not limited to:

Total Knee Arthroplasty .
Total Hip Arthroplasty: Anterior / Posterior .

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Long H. Chen -A

9 2342,19200300 100,1.1 = 13003690

Page 1 of 3

for MXM

(Division Sign-Off) Division of Surgical Devices 510(k) Number: K130387

Response to Questions K130387

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2.2. KNEEALIGN® 3 SYSTEM

510(k) Number (if known): K130387

Device Name: KneeAlign® 3 System

Indications for Use:

Example orthopedic surgical procedures include but are not limited to:

Total Knee Arthroplasty ●
Prescription Use x (Part 21 CFR 801 Subpart D)

AND/OR

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

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(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 2 of _ 3

Lona H. Chen -A

igitally signed by Lang H. Chen-A
c=US, o=U.S. Government, ou=HHS,
OU=FDA, ou=People, cn=Long H. Chen-A,
1.2.342.19200300 100 1.1-1300369056
Date 2013.11.08 11:12:55 -05:00

for MXM

(Division Sign-Off) Division of Surgical Devices 510(k) Number: K130387

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2.3. HIPALIGN® SYSTEM

510(k) Number (if known): K130387

Device Name: HipAlign® System

Indications for Use:

The HipAlign® 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 HipAlign® System facilitates the accurate positioning of implants, relative to these alignment axes.

Example orthopedic surgical procedures include but are not limited to:

Total Hip Arthroplasty: Anterior / Posterior .
Prescription Use x (Part 21 CFR 801 Subpart D)

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 3 of 3

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gitally signed by Long H. Chen-A
*CUS. DUS. Govemment, ouOHMS
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0.2342.19200300.100.1.1-1300369056
te: 2013.11.08 11:13:15-0500

for

for MXM

(Division Sign-Off) Division of Surgical Devices S10(k) Number: K130387

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).