The Balanced Knee® System High Flex Vitamin E PS tibial insert and patella are intended for use in cemented total knee arthroplasty procedures with the following.indications:

Loss of knee joint configuration and joint function.
Osteoarthritis of the knee joint.
Rheumatoid arthritis of the knee joint.
Post-traumatic arthritis of the knee joint.
Valgus, varus, or flexion deformities of the knee joint.
Revision procedures where other treatments or devices have failed.

Device Description

The Balanced Knee® System High Flex Vitamin E (High Flex Vit E) PS tibial insert and patella are machined from extensively crosslinked, compression molded, Vitamin E UHMWPE. Both components are single use only. The High Flex Vit E PS tibial insert must be used in conjunction with the High Flex PS femoral component (K123457). Used together, these components are designed to accommodate increased range of motion up to 150° of flexion. The High Flex Vit E patella may be used in conjunction with the Balanced Knee® System (BKS) femoral components (K994370), the BKS modular femoral components (K060569), or the High Flex PS femoral components (K123457). Both the High Flex Vit E PS tibial insert and patella may be used in conjunction with the BKS standard and modular tibial trays, tibial augments, and stems to complete the semi-constrained modular knee prosthesis. The tibial trays, tibial augments, and stems were approved under K994370 and K031201.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Balanced Knee® System High Flex Vitamin E PS Tibial Insert and Patella:

The provided document is a 510(k) summary for a medical device seeking substantial equivalence to existing predicate devices. It focuses on the technological characteristics and performance data to demonstrate this equivalence, rather than a clinical study with human patients. This is common for devices that are modifications of already approved devices.

1. Table of Acceptance Criteria and Reported Device Performance

The "Performance Data" section (page 2) lists various properties tested. Since this is a 510(k) summary demonstrating substantial equivalence, the "acceptance criteria" are implicitly that the device's performance is "Substantially Equivalent" or "Substantially equivalent or better than" the predicate device(s).

Property	Acceptance Criteria (Implied)	Reported Device Performance
Range of Motion	Substantially Equivalent to predicate device, BKS High Flex	Up to 150° flexion; Substantially Equivalent to predicate device, BKS High Flex
Femorotibial Constraint	Substantially Equivalent to predicate device, BKS High Flex	Substantially Equivalent to predicate device, BKS High Flex
Femorotibial Contact Area	Substantially Equivalent to predicate device, BKS High Flex	Substantially Equivalent to predicate device, BKS High Flex
Patellofemoral Constraint	Substantially Equivalent to predicate device, BKS High Flex	Substantially Equivalent to predicate device, BKS High Flex
Patellofemoral Contact Area	Substantially Equivalent to predicate device, BKS High Flex	Substantially Equivalent to predicate device, BKS High Flex
PS Spine Fatigue	Substantially Equivalent to predicate device, BKS High Flex	Substantially Equivalent
Insert Assembly/Disassembly	Substantially Equivalent to predicate device, BKS High Flex	Substantially Equivalent
Crosslinking Characterization of High Flex Vit E	Substantially equivalent or better than BKS	Substantially equivalent or better than BKS
Vitamin E Characterization of High Flex Vit E	Substantially equivalent or better than BKS	Substantially equivalent or better than BKS
High Flex Knee Wear	Not explicitly stated as "equivalent," but improvement is implicit	Decrease in wear over BKS

Note: The last item, "High Flex Knee Wear," is reported as a "Decrease in wear over BKS," which suggests an improvement rather than just equivalence. This would still be considered meeting an implicit acceptance criterion of being at least as good as the predicate (or better).

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

The document does not specify sample sizes in terms of number of patients or clinical cases because the studies described are non-clinical (benchtop) tests. The "test set" here refers to the physical samples of the device and predicate devices used in the mechanical and material characterization tests. The provenance of this data is from the manufacturer's internal testing. There is no information about country of origin for data or whether it's retrospective/prospective, as these terms apply to clinical studies.

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

This document describes non-clinical (benchtop) testing rather than studies that require expert-established ground truth from medical imaging or clinical observations. Therefore, there were no medical experts (e.g., radiologists) involved in establishing ground truth for the test set in the way this question implies. Ground truth for these types of tests is established by engineering and material science standards and measurements.

4. Adjudication Method for the Test Set

Not applicable. As this is non-clinical benchtop testing, there is no "adjudication method" involving human experts in the context of clinical studies (e.g., 2+1, 3+1). The results are based on objective physical measurements and comparisons to predicate devices.

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

No. There is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study, as this device is not an AI-assisted diagnostic tool. No effect size of human readers improving with AI vs. without AI assistance is reported.

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

No. This is a medical implant (total knee replacement components), not a software algorithm or AI device. Therefore, a standalone algorithm performance study is not applicable.

7. The Type of Ground Truth Used

The "ground truth" for this submission is based on:

Objective mechanical and material property measurements: Standards for flexion, constraint, contact area, fatigue, crosslinking, and Vitamin E content.
Comparison to predicate devices: The "ground truth" for substantial equivalence is the established performance characteristics and safety profile of the legally marketed predicate devices. The new device must meet or exceed these established benchmarks.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm that requires a "training set."

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

Not applicable. As there is no training set, there is no ground truth established for it.

Summary

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510(k) Summary

				NAME OF SPONSOR:
--	--	--	--	------------------	--

510(k) CONTACT:

Ortho Development Corporation 12187 South Business Park Drive Draper, Utah 84020

Total Knee Replacement Prosthesis

Tom Haueter Regulatory Affairs Manager Telephone: (801) 553-9991 Facsimile: (801) 553-9993 Email: thaueter@orthodevelopment.com

OCT 11 2013

DATE PREPARED:

PROPRIETARY NAME:

Balanced Knee® System High Flex Vitamin E PS Tibial Insert and Patella

COMMON NAME:

CLASSIFICATION:

21 CFR 888.3560, Knee joint, patellofemorotibial, polymer/metal/polymer semi-constrained cemented prosthesis, Class II device

DEVICE PRODUCT CODE:

PREDICATE DEVICES:

OIY, JWH

April 24, 2013

Balanced Knee® System (K994370), Ortho Development Corp.

Balanced Knee® System High Flex PS (K123457), Ortho Development Corp.

Highly Cross-Linked Vitamin E UHMWPE Tibial Insert (K091956), DJO Surgical/Encore Medical

High Flex Vit E 510(k)

Section 5, 510(k) Summary

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K131337 (2/3)

- Device Description

Intended Use

The Balanced Knee® System High Flex Vitamin E PS tibial insert and patella are intended for use in cemented total knee arthroplasty procedures with the following indications:

1. Loss of knee joint configuration and joint function.
Osteoarthritis of the knee joint. 2.
1. Rheumatoid arthritis of the knee joint.
1. Post-traumatic arthritis of the knee joint.
ഗ് Valgus, varus, or flexion deformities of the knee joint.
1. Revision procedures where other treatments or devices have failed.

Technological Characteristics

Feature	Equivalent Device
Indications for Use and Design	Ortho Development: Balanced Knee® System (K994370)Ortho Development: Balanced Knee® System High Flex PS (K123457)
Material: Extensively Crosslinked Vitamin EPolyethylene UHMWPE (α-tocopherol)	DJO Surgical/Encore Medical: Vit E UHMWPE Tibial Insert (K091956)

There is only one difference between the High Flex Vit E PS insert when compared to the BKS High Flex PS insert: the implementation of a different material, crosslinked Vitamin E UHMWPE. Likewise, the High Flex Vit E patella is identical to the BKS patella except for the crosslinked Vitamin E UHMWPE material. The indications for use for the High Flex Vit E PS tibial insert and patella are identical to the indications for use for the BKS High Flex. The crosslinked Vitamin E UHMWPE for the High Flex Vit E PS insert and patella undergoes substantially equivalent fabrication and final processing as its predicate, DJO/Encore's Vitamin E UHMWPE tibial insert.

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Performance Data

The following non-clinical testing was performed to determined substantial equivalence to the predicate devices:

Property	Result
Range of Motion	Up to 150° flexion; Substantially Equivalent to predicate device, BKS High,Flex
FemorotibialConstraint	Substantially Equivalent to predicate device, BKS High Flex
FemorotibialContact Area	Substantially Equivalent to predicate device, BKS High Flex
PatellofemoralConstraint	Substantially Equivalent to predicate device, BKS High Flex
PatellofemoralContact Area	Substantially Equivalent to predicate device, BKS High Flex
PS Spine Fatigue	Substantially Equivalent
Insert Assembly/Disassembly	Substantially Equivalent
CrosslinkingCharacterization ofHigh Flex Vit E	Substantially equivalent or better than BKS
Vitamin ECharacterization ofHigh Flex Vit E	Substantially equivalent or better than BKS
High Flex Knee Wear	Decrease in wear over BKS

Basis for Substantial Equivalence

Ortho Development believes that the High Flex Vit E PS tibial insert and patella are substantially equivalent to the previously cleared predicate devices based on similarities in intended use, design, materials, manufacturing methods, packaging, and mechanical performance.

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Image /page/3/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized caduceus, a symbol often associated with healthcare, with a single snake winding around a staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the caduceus.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-Gho9 Silver Spring, MIJ 20993-0002

October 11, 2013

Ortho Development Corporation Mr. Tom Haueter Regulatory Affairs Manager 12187 South Business Park Drive Draper, Utah 84020

Re: K131337

Trade/Device Name: Balanced Knee* System High Flex Vitamin E PS Tibial Insert and Patella Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patcllofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: JWH, OIY Dated: September 6, 2013 Received: September 9, 2013

Dear Mr. Haucter:

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. Ilisting 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

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Page 2 - Mr. Tom Haueter

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 (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/ReportalProblem/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.

Sincercly yours,

Image /page/4/Picture/7 description: The image shows the name "Erin I. Keith" in a bold, sans-serif font. The name is presented in a single line, with the first name "Erin" clearly visible. The middle initial "I." is followed by the last name "Keith", completing the full name displayed in the image.

for

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

Enclosure

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Indication for Use Form Ortho Development Balanced Knee® System High Flex Vitamin E PS Tibial Insert and Patella 510(k)

510(k) Number (if known): _K131337

Device Name: Balanced Knee® System High Flex Vitamin E PS Tibial Insert and Patella

Indications for Use:

The Balanced Knee® System High Flex Vitamin E PS tibial insert and patella are intended for use in cemented total knee arthroplasty procedures with the following.indications:

1. Loss of knee joint configuration and joint function.
1. Osteoarthritis of the knee joint.
Rheumatoid arthritis of the knee joint. 3.
1. Post-traumatic arthritis of the knee joint.
1. Valgus, varus, or flexion deformities of the knee joint.
Revision procedures where other treatments or devices have failed. 6.

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)

Casey L. Hanley, Ph.D.
Division of Orthopedic Devices

Regulation Number and Section

§ 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.

(a)
Identification. A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented 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 includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.