The KneeAlign "M 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™ 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/tibial resection

Device Description

The KneeAlign " 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 " System utilizes a palm-sized computer module and registration instruments 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 tibia, determining the varus/valgus angle and the posterior slope angle of the cutting block relative to tibia. The KneeAlign " System comprises a single use computer module and reusable instrumentation.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information based on the provided text for the K091411 (KneeAlign™ System):

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly state specific quantitative acceptance criteria or detailed numerical device performance metrics. Instead, it makes a general statement about validation.

Acceptance Criteria (Implied)	Reported Device Performance
Device met its intended use.	"Bench and cadaver testing confirm that the KneeAlign™ System can be used according to its intended use."
Device verified and validated.	"The KneeAlign 100 System has been verified and validated according to OrthAlign's procedures for product design and development."
Substantial equivalence to predicates.	"The information provided by OrthAlign in this 510(k) application was found to be substantially equivalent to predicate devices such as the BrainLAB Knee Essential (K073615) and the TOTAL KNEE SURGETICS Navigation System (K060282)."
Technological comparison demonstrates substantial equivalence.	"A technological comparison and bench, and cadaver testing demonstrate the substantial equivalence of the KneeAlign™ System to the predicate devices."

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

Sample Size: Not explicitly stated. The text mentions "bench and cadaver testing." The number of cadavers or specific test cases is not provided.
Data Provenance: Not explicitly stated. "Bench and cadaver testing" generally implies studies conducted by the device manufacturer or a contracted lab. The country of origin is not specified, nor is whether the data was retrospective or prospective.

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

Number of Experts: Not explicitly stated.
Qualifications of Experts: Not explicitly stated.

4. Adjudication Method for the Test Set

Adjudication Method: Not explicitly stated. The document simply mentions "bench and cadaver testing" to confirm the system's intended use and performance. There is no information about expert adjudication for establishing ground truth in a test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

MRMC Study: No, an MRMC comparative effectiveness study is not indicated. The device is a surgical navigation system, not an imaging analysis AI or diagnostic tool that would typically involve human "readers" interpreting output.
Effect Size: Not applicable.

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

Standalone Performance: The core functionality validated is the "algorithm only" in the sense that the device uses "algorithms to convert sensor outputs into spatial coordinates, providing graphical representation of instruments and anatomy." The "bench and cadaver testing" would evaluate the accuracy and reliability of these algorithmic outputs in a controlled environment, which implicitly assesses its standalone performance in providing accurate measurements and guidance. However, it's not described as a "standalone validation" in the typical sense of comparing an AI's output to ground truth without human intervention in a diagnostic context. The system is designed to assist the surgeon, implying a human-in-the-loop during actual surgery.

7. The Type of Ground Truth Used

Type of Ground Truth: Not explicitly stated. For bench testing, ground truth would likely be established using precise measurement tools (e.g., goniometers, CMMs) or highly accurate reference systems. For cadaver testing, ground truth might involve post-procedure measurements using specialized tools or dissection to verify alignment relative to anatomical landmarks. The document does not specify how these ground truths were established.

8. The Sample Size for the Training Set

Training Set Sample Size: Not applicable. This device is a computer-assisted surgical navigation system, and the information provided does not suggest it uses machine learning/AI in a way that would require a separate "training set" for predictive model development as seen in image analysis or diagnostic AI. The algorithms mentioned are likely deterministic (converting sensor outputs to coordinates) rather than machine learning algorithms trained on data.

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

Ground Truth for Training Set: Not applicable, as no training set for machine learning is indicated.

Summary

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K091411

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.6 CromwellSuite 102Irvine, CA 92618Tel: (949) 715-2424Fax: (866) 204-9844
OFFICIALCORRESPONDENT	Amy WaltersAWE, Inc.338 Vista MaderaNewport Beach, CA 92660amy@orth-align.comTel: (949) 923-9400Fax: (949) 718-0402
TRADE NAME	KneeAlign TM System
COMMON NAME	Stereotaxic Instrument
DEVICECLASSIFICATION	Class II, 21 CFR §882.4560
PRODUCT CODES	HAW: Neurological Stereotaxic Instrument
PREDICATEDEVICES	BrainLAB Knee Essential (K073615)TOTAL KNEE SURGETICS Navigation System(K060282)

SUBSTANTIALLY EQUIVALENT TO:

The KneeAlign™ System is substantially equivalent to the BrainLAB Knee Essential(K073615), and TOTAL KNEE SURGETICS Navigation System (K060282).

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 assistance of computer assisted surgery devices. The KneeAlign " System utilizes a palm-sized computer module and

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registration instruments 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 tibia, determining the varus/valgus angle and the posterior slope angle of the cutting block relative to tibia. The KneeAlign " System comprises a single use computer module and reusable instrumentation.

INDICATIONS FOR USE:

The KneeAlign™ System is a computer controlled system intended to assist the surgeon in determining reference alignment axes in relation to anatomical structures during orthopedic surgical procedures. The KneeAlign™ 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/tibial resection .

TECHNICAL CHARACTERISTICS:

The KneeAlign "" System comprises a single use computer module and reusable instrumentation. 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:

Bench and cadaver testing confirm that the KneeAlign™ System can be used according to its intended use. The KneeAlign 100 System has been verified and validated according to OrthAlign's procedures for product design and development.

The validation demonstrates that the device meets its intended use. The information provided by OrthAlign in this 510(k) application was found to be substantially equivalent to predicate devices such as the BrainLAB Knee Essential (K073615) and the TOTAL KNEE SURGETICS Navigation System (K060282).

BASIS FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE:

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

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Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three wavy lines representing the three branches of government. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.

DEPARTMENT OF HEALTH & HUMAN SERVICES

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

SEP 2 5 2009

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

Re: K091411

Trade/Device Name: KneeAlign™ System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: Class II Product Code: OLO Dated: August 28, 2009 Received: August 31, 2009

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.

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 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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.goy/cdrh/industry/support/index.html.

Sincerely yours,

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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4. INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K091411

Device Name: KnecAlign™ System

Indications for Use:

Example orthopedic surgical procedures include but are not limited to:

. Total Knee Arthroplasty/tibial resection
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)
Malike W. for m.Xn

Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K091411

Page I of I

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).