The KneeAlign® 2 System is a computer controlled system intended to assist the surgeon in determining reference alignment axes in relation to anatomical structures during stereotactic orthopedic surgical procedures. The KneeAlign® 2 System facilitates the accurate positioning of implants and instrumentation, relative to these alignment axes. Example orthopedic surgical procedures include but are not limited to: Total Knee Arthroplasty

Device Description

The KneeAlign® 2 System is an innovative non-invasive computer assisted surgical navigation system for use in knee arthroplasty procedures. The KneeAlign® System is configured to detect, measure, and display angular measurement changes in a triaxial format. The KneeAlign® 2 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. The KneeAlign® 2 System comprises a single use computer module and reusable instrumentation.

AI/ML Overview

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state specific numerical acceptance criteria for the KneeAlign® 2 System's performance in terms of accuracy (e.g., within X degrees or Y mm). It instead uses broader statements about the device's ability to be used according to its intended purpose and its substantial equivalence to predicate devices.

However, based on the description of its function, the implicit acceptance criteria would revolve around:

Acceptance Criteria (Implied)	Reported Device Performance
Accuracy in determining mechanical axis of femur: - Varus/valgus angle - Flexion/extension angle of cutting block	"Device performance testing confirms that the KneeAlign® 2 System can be used according to its intended use." "The KneeAlign® 2 System has been verified and validated according to OrthAlign's procedures for product design and development." "System accuracy testing" was performed. "A technological comparison and bench, and cadaver testing demonstrate the substantial equivalence of the KneeAlign® 2 System to the predicate devices."
Accuracy in determining mechanical axis of tibia: - Varus/valgus angle - Posterior slope angle of cutting block	"Device performance testing confirms that the KneeAlign® 2 System can be used according to its intended use." "The KneeAlign® 2 System has been verified and validated according to OrthAlign's procedures for product design and development." "System accuracy testing" was performed. "A technological comparison and bench, and cadaver testing demonstrate the substantial equivalence of the KneeAlign® 2 System to the predicate devices."
Overall ability to facilitate accurate positioning of implants and instrumentation	"Device performance testing confirms that the KneeAlign® 2 System can be used according to its intended use." "The KneeAlign® 2 System has been verified and validated according to OrthAlign's procedures for product design and development." "Simulated use testing" was performed. "A technological comparison and bench, and cadaver testing demonstrate the substantial equivalence of the KneeAlign® 2 System to the predicate devices."

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

Sample Size for Test Set: The document does not specify a numerical sample size for any of the performance tests. It mentions "bench, and cadaver testing" and "simulated use testing."
Data Provenance: The document does not explicitly state the country of origin for the data. Given the applicant's location (Aliso Viejo, CA) and the FDA submission, it's highly probable the testing was conducted in the USA. The data is retrospective in the sense that it describes tests performed as part of the device development and validation process before submission.

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

The document does not provide information regarding the number of experts, their qualifications, or how ground truth was established specifically for the test sets (bench, cadaver, or simulated use).

4. Adjudication Method for the Test Set

The document does not describe any adjudication method (e.g., 2+1, 3+1) for the test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly mentioned or described. The study focuses on the device's accuracy and functionality, not its comparative effectiveness with or without human-in-the-loop performance or its impact on human reader performance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

The testing described (system accuracy, bench, cadaver, simulated use) would inherently involve standalone performance, as it's evaluating the device's ability to measure and display angles. While the device assists a surgeon, the tests would assess the device's output independently of the surgeon's influence on the measurement capabilities themselves. The system "utilizes algorithms to convert sensor outputs into spatial coordinates, providing graphical representation." This implies the core functionality is algorithmic and tested directly.

7. The Type of Ground Truth Used

The document does not explicitly state the specific type of ground truth. However, for "system accuracy testing" and "bench, and cadaver testing" in the context of orthopedic navigation, ground truth would typically be established by:

Highly accurate measurement systems/reference standards: For bench testing, this would involve precise mechanical fixtures and measurement tools.
Anatomical landmarks/pathology: For cadaver testing, ground truth for anatomical axes would be derived from direct anatomical measurements or established radiographic landmarks, potentially verified by experienced surgeons or anatomists.

8. The Sample Size for the Training Set

The document does not provide any information about a specific "training set" or its sample size. This device appears to be a direct measurement and navigation system, rather than a machine learning model that requires a distinct training phase. Its algorithms convert sensor outputs, implying a rule-based or model-based approach rather than a learned one from a large dataset.

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

Since no training set is mentioned (see point 8), there is no information on how ground truth for a training set was established.

Summary

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SECTION 5.

510(K) SUMMARY

510(K) SUMMARY

APR - 4 2011

This 510(k) summary is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92(c).
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APPLICANT	OrthAlign, Inc.120 ColumbiaSuite 500Aliso Viejo, CA 92656Tel: (949) 715-2424Fax: (949) 831-9500
OFFICIALCORRESPONDENT	Amy WaltersAWE, Inc.338 Vista MaderaNewport Beach, CA 92660amy@orthalign.comTel: (949) 923-9400Fax: (949) 831-9500
TRADE NAME	KneeAlign® 2 System
COMMON NAME	Stereotaxic Instrument
DEVICECLASSIFICATION	Class II, 21 CFR §882.4560
PRODUCT CODES	OLO: Orthopedic Stereotaxic Instrument
PREDICATEDEVICES	KneeAlign System with Reference Sensor (K093998)Navitrack System- S&N Image Free Knee (K043536)

12103899

SUBSTANTIALLY EQUIVALENT TO:

The KneeAlign® 2 System is substantially equivalent to the previously cleared KneeAlign System with Reference Sensor (K093998) and Navitrack System-S&N Image Free Knee (K043536).

DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:

The current standard of care for knee arthroplasty procedures has the physician estimating these changes either by visual observation and tactile feedback or with

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assistance of computer assisted surgery devices. The KneeAlign® 2 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.

The KneeAlign® 2 System comprises a single use computer module and reusable instrumentation.

INDICATIONS FOR USE:

The KneeAlign®2 System has the same indications for use as the previously cleared KneeAlign™ System with Reference Sensor (K093998). Additional functionality has been added to the predicate device to enable femoral navigation. Also, Indications for Use are common to the Navitrack System-S&N Image Free Knee (K043536). Thus, the Indications for Use are as follows:

The KneeAlign® 2 System is a computer-controlled system intended to assist the surgeon in determining reference alignment axes in relation to anatomical structures during stereotactic orthopedic surgical procedures. The KneeAlign® 2 System facilitates the accurate positioning of implants and instrumentation, relative to these alignment axes. Example orthopedic surgical procedures include but are not limited to:

. Total Knee Arthroplasty

TECHNICAL CHARACTERISTICS:

The KneeAlign® 2 System comprises a single use computer module, a reusable reference sensor, a reusable femoral jig and a reusable tibial iig. The device utilizes algorithms to convert sensor outputs into spatial coordinates, providing graphical representation of instruments and anatomy on the user display screen.

PERFORMANCE DATA:

Device performance testing confirms that the KneeAlign® 2 System can be used according to its intended use. The KneeAlign® 2 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/validation testing .

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Electrical safety and electromagnetic compatibility testing .
. System accuracy testing
. Simulated use testing

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 was found to be substantially equivalent to predicate devices such as the KneeAlign® System with Reference Sensor (K093998), and Navitrack System- S&N Image Free Knee (K043536).

BASIS FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE:

A technological comparison and bench, and cadaver testing demonstrate the substantial equivalence of the KneeAlign® 2 System to the predicate devices.

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the seal is an abstract symbol that resembles a stylized caduceus or a series of flowing lines. The symbol is black, and the text is also black.

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

OrthAlign, Inc. % AWE, Inc. Ms. Amy Walters 338 Vista Madera Newport Beach, California 92660

APR - 4 2011

Re: K103829

Trade/Device Name: KneeAlign® 2 System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: Class II Product Code: OLO Dated: March 23, 2011 Received: March 24, 2011

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

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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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/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 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,

Kc. Robert Thomas

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

Enclosure

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SECTION 4.

INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K103829

Device Name: KneeAlign® 2 System

Indications for Use:

. Total Knee Arthroplasty

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)

Neil RP Ogler farman

(Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K103829

Page of

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).