Painful, disabling joint disease of the knee resulting from degenerative arthritis, rheumatoid arthritis or post-traumatic arthritis:
Post-traumatic loss of knee joint configuration and function;
Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability:
Revisions of previous unsuccessful knee replacement or other procedure.

Additional indications for posteriorly stabilization components:

Ligamentous instability requiring implant bearing surfaces with increased constraint;
Absent or non-functioning posterior cruciate ligament.

These devices are single use only and are intended for implantation with the exception of porous coated femoral components which can be used cemented (biological fixation).

Device Description

The Arthrex iBalance® TKA System consists of femoral components, tibial tray, tibial bearing components and patellar components. All components are available in a range of sizes to fit varying anatomical requirements. Femoral components and tibial bearing components are available in both posteriorly stabilized (PS) and cruciate retaining (CR) configurations. Femoral components are available in left and right versions, as well as cemented and uncemented (biological fixation) versions and are designed to work with the Arthrex dome patella components. Tibial bearing components are offered in PS, CR and CR Plus configurations.

The proposed Arthrex iBalance® TKA System line extension of this submission adds Vitamin E blended tibial bearing components and Vitamin E blended patella components to the product offering.

AI/ML Overview

This is a 510(k) premarket notification for a medical device (Arthrex iBalance® TKA System - Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis), not an AI/ML device. Therefore, the requested information about acceptance criteria, study data, sample sizes, ground truth, expert adjudication, MRMC studies, and training/test sets is not applicable in the context of an AI/ML device.

Here's why:

Device Type: The document describes a traditional medical device (a knee replacement system), not a software or AI/ML-driven diagnostic or therapeutic tool.
Regulatory Pathway: A 510(k) submission demonstrates substantial equivalence to a legally marketed predicate device, primarily through performance testing (e.g., mechanical tests) and material characterization, rather than clinical efficacy studies often found in AI/ML device submissions.
Content of the Document: The summary focuses on material properties, design changes (addition of Vitamin E blended components), and mechanical testing to demonstrate that the new components perform similarly to the predicate devices and meet industry standards. There is no mention of algorithms, data sets for training or testing, or human reader performance.

However, I can extract the general acceptance criteria and the study type conducted from the document, tailored to the context of this traditional medical device:

1. A table of acceptance criteria and the reported device performance:

Acceptance Criteria (Implied)	Reported Device Performance
Compliance with FDA Guidance and industry standards (e.g., for wear, fatigue, and shear)	The wear, fatigue, and shear testing demonstrates the Arthrex iBalance® TKA System remains in compliance with FDA Guidance and industry standards.
Substantial equivalence to predicate devices based on dimensions, general design, intended use, indications for use, technological characteristics, packaging, storage, and sterilization.	The Arthrex iBalance® TKA System is substantially equivalent to the predicate device as the dimensions, general design, intended use, indications for use, technological characteristics, packaging, storage and sterilization remain the same. Any differences... (are assessed through testing).

2. Sample size used for the test set and the data provenance:

Sample Size: Not explicitly stated in the provided text. The testing would involve a certain number of physical device components for mechanical testing.
Data Provenance: Not applicable in the context of patient data. The provenance relates to laboratory testing of manufactured components.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. "Ground truth" in the AI/ML sense (e.g., expert consensus on clinical findings) is not relevant for the mechanical testing of a knee implant. The "ground truth" here would be the physical properties and performance characteristics determined by validated testing methods.

4. Adjudication method for the test set:

Not applicable. Adjudication is typically associated with human interpretation of data. For mechanical testing, the results are quantitative and compared against established engineering standards.

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. This is not an AI-assisted device, so MRMC studies are not relevant.

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

No. This is not an AI algorithm.

7. The type of ground truth used:

Material and mechanical performance standards. The "ground truth" for this device's performance would be established engineering specifications, material properties, and outputs from standardized mechanical tests (wear, fatigue, shear).

8. The sample size for the training set:

Not applicable. This device does not involve a "training set" in the AI/ML sense.

9. How the ground truth for the training set was established:

Not applicable. No training set for an AI/ML algorithm is involved.

Summary of the Study that Proves the Device Meets Acceptance Criteria (as described in the document):

The study referenced is a series of mechanical performance tests. The document states:

"The wear, fatigue and shear testing demonstrates the Arthrex iBalance® TKA System remains in compliance with FDA Guidance and industry standards."
"Based on the indication for use, technological characteristics, and the summary of mechanical testing data submitted, Arthrex, Inc. has determined that the Arthrex iBalance® TKA System is substantially equivalent to currently marketed predicate devices."

This indicates that specific laboratory tests for wear, fatigue, and shear properties were conducted on the device components (including the new Vitamin E blended components). The results of these tests were then compared against predetermined acceptance criteria derived from FDA guidance and established industry standards for knee prostheses. The successful outcome of these tests led to the conclusion that the device performs equivalently to previously cleared predicate devices and is suitable for its intended use.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name encircling a stylized image of a caduceus, a symbol often associated with medicine and healthcare. The caduceus is depicted with a staff entwined by two snakes and topped with wings. The seal is in black and white.

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

February 19, 2016

Arthrex, Incorporated Leon Brown, Ph.D. Regulatory Project Manager 1370 Creekside Boulevard Naples, Florida 34108-1945

Re: K153586 Trade/Device Name: Arthrex iBalance® TKA System Regulation Number: 21 CFR 888.3565 Regulation Name: Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis Regulatory Class: Class II Product Code: MBH, JWH, OIY Dated: December 27, 2015 Received: December 29, 2015

Dear Dr. Brown:

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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

{1}------------------------------------------------

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 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" (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 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 yours,

Mark N. Melkerson -S

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

Enclosure

{2}------------------------------------------------

Expiration Date: January 31, 2017

See PRA Statement below

Indications for Use

K153586

Device Name

Arthrex iBalance® TKA System

Indications for Use (Describe)

The Arthrex iBalance® TKA System is indicated for use in individuals undergoing surgery for:
- · Painful, disabling joint disease of the knee resulting from degenerative arthritis, rheumatoid arthritis or post-traumatic arthritis:
- · Post-traumatic loss of knee joint configuration and function;
- · Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability:
- · Revisions of previous unsuccessful knee replacement or other procedure.

Additional indications for posteriorly stabilization components:

· Ligamentous instability requiring implant bearing surfaces with increased constraint;
· Absent or non-functioning posterior cruciate ligament.

These devices are single use only and are intended for implantation with the exception of porous coated femoral components which can be used cemented (biological fixation).

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

2.5 510(K) SUMMARY

Date Summary Prepared	February 3, 2016
Manufacturer/Distributor/Sponsor	Arthrex, Inc.1370 Creekside BoulevardNaples, FL 34108-1945 USA
510(k) Contact	Leon Brown II, Ph.D.Regulatory Project ManagerArthrex, Inc.1370 Creekside BoulevardNaples, FL 34108-1945 USATelephone: 239/643.5553, ext. 72028Fax: 239/598.5508Email: Leon.Brown@Arthrex.com
Trade Name	Arthrex iBalance® TKA System
Common Name	Knee Prosthesis
Primary Product Code -	MBH
Classification Name	888.3565: Knee joint patellofemorotibial metal/polymer
CFR	porous-coated uncemented prosthesis.
Secondary Product Code -	JWH
Classification Name	888.3560: Prosthesis, Knee, Patellofemorotibial, Semi-
CFR	Constrained, Cemented, Polymer/Metal/Polymer
Tertiary Product Code -	OIY
Classification Name	888.3560: Prosthesis, Knee, Patellofemorotibial, Semi-
CFR	Constrained, Cemented, Polymer/Metal/Polymer
Predicate Device	K081127: Arthrex iBalance® TKA SystemK133854: Arthrex iBalance® TKA SystemK143047: Arthrex iBalance® Patella Implant, DomeK152252: Arthrex iBalance® TKA SystemK152382: Arthrex iBalance® TKA System
Purpose of Submission	This traditional 510(k) premarket notification issubmitted to obtain clearance for a line extension to theArthrex iBalance® TKA System which would addVitamin E blended tibial bearing components and VitaminE blended patella components to the system.
Device Description	The Arthrex iBalance® TKA System consists of femoralcomponents, tibial tray, tibial bearing components andpatellar components. All components are available in arange of sizes to fit varying anatomical requirements.Femoral components and tibial bearing components areavailable in both posteriorly stabilized (PS) and cruciateretaining (CR) configurations. Femoral components areavailable in left and right versions, as well as cemented

and uncemented (biological fixation) versions and aredesigned to work with the Arthrex dome patellacomponents. Tibial bearing components are offered inPS, CR and CR Plus configurations.
The proposed Arthrex iBalance® TKA System lineextension of this submission adds Vitamin E blendedtibial bearing components and Vitamin E blended patellacomponents to the product offering.
The Arthrex iBalance® TKA System is indicated for useIntended Usein individuals undergoing surgery for:Painful, disabling joint disease of the knee resulting●from degenerative arthritis, rheumatoid arthritis orpost-traumatic arthritis;Post-traumatic loss of knee joint configuration and●functionModerate varus, valgus, or flexion deformity in which●the ligamentous structures can be returned to adequatefunction and stability;Revisions of previous unsuccessful knee replacement●or other procedure.
forAdditional indicationsstabilizedcomponents:Ligamentous instability requiring implant bearingsurfaces with increased constraint;Absent or non-functioning posterior cruciate ligament.●
These devices are single use only and are intended forimplantation with bone cement, with the exception ofporous coated femoral components which can be usedcemented or uncemented (biological fixation).
The proposed Arthrex iBalance® TKA System adds
Vitamin E blended tibial bearing components and Vitamin
E blended patella components to the existing system. TheArthrex iBalance® TKA System is substantiallyequivalent to the predicate device as the dimensions,general design, intended use, indications for use,technological characteristics, packaging, storage andsterilization remain the same. Any differences between

The wear, fatigue and shear testing demonstrates theArthrex iBalance® TKA System remains in compliancewith FDA Guidance and industry standards.
Based on the indication for use, technologicalcharacteristics, and the summary of mechanical testingdata submitted, Arthrex, Inc. has determined that theArthrex iBalance® TKA System is substantiallyequivalent to currently marketed predicate devices.

{4}------------------------------------------------

{5}------------------------------------------------

Regulation Number and Section

§ 888.3565 Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis.

(a)
Identification. A knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis is a device intended to be implanted to replace a knee joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device is designed to achieve biological fixation to bone without the use of bone cement. This identification includes fixed-bearing knee prostheses where the ultra high molecular weight polyethylene tibial bearing is rigidly secured to the metal tibial base plate.(b)
Classification. Class II (special controls). The special control is FDA's guidance: “Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA.” See § 888.1 for the availability of this guidance.