Rheumatoid arthritis.
Post-traumatic arthritis, osteoarthritis, or degenerative arthritis.
Failed osteotomies, unicompartmental replacement, or total knee replacement.
Posterior stabilized knee systems are designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact.

The ANTHEM PS Total Knee System is indicated for use only with cement and is a single use device.

Device Description

The subject ANTHEM PS Total Knee System is a posterior stabilized implant design that includes cobalt chromium (ASTM F75) femoral components and titanium (ASTM F1472) tibia baseplate components that are intended to be used with existing GENESIS II components to complete the total knee construct. The femoral components are based on the LEGION Narrow PS (K112941) and GENESIS II PS (K951987) designs, and are available in two categories: ANTHEM Standard (Sizes: 3-8; left and right options) and ANTHEM Narrow (Sizes 1-6; left and right options). The ANTHEM Tibia Baseplates are leveraged from the GENESIS II Tibia Baseplate (K951987) design, with a modification to the stem, and provided in sizes 1-8 with left and right options. All of the implants are gamma sterilized single-use prescription devices intended to be used under the guidance of a physician at a healthcare facility.

AI/ML Overview

This document is a 510(k) Premarket Notification for a medical device (ANTHEM PS Total Knee System) and focuses on demonstrating substantial equivalence to previously cleared predicate devices. It does not contain information about acceptance criteria or a study proving the device meets specific performance criteria in the way a clinical study would for an AI/software device.

Therefore, the requested information elements related to AI device performance evaluation, such as sample size, ground truth, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance, are not present in this document.

However, I can provide the available information regarding the "study" that proves the device meets requirements, which in this context refers to preclinical bench testing to establish substantial equivalence.

Here's a breakdown of the available information:

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

This document does not provide a table of acceptance criteria with specific quantitative performance metrics. Instead, it relies on demonstrating substantial equivalence to predicate devices through biomechanical testing. The "acceptance criteria" here is implicitly that the device performs comparably to the predicate devices in the described tests.

Acceptance Criteria (Implicit)	Reported Device Performance (Summary)
Mechanical performance comparable to predicate devices consistent with orthopedic standards.	Test results demonstrated that the proposed devices are substantially equivalent to one or more of the previously cleared predicate devices (LEGION Narrow PS Knee System K112941, Genesis II PS Total Knee System K951987) for Contact area testing (ASTM F2083) and Constraint testing (ASTM F2083 and ASTM F1223).

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Sample Size: Not explicitly stated in terms of number of devices tested, but the testing was "non-clinical bench (mechanical) testing" done on "the proposed femoral and tibial components." This typically involves a set number of test samples for each device variant and test type, as per ASTM standards, but specific numbers are not detailed here.
Data Provenance: The testing was conducted as part of the regulatory submission process for Smith & Nephew, Inc., located in Memphis, TN, USA. This is preclinical (bench) data, not clinical data from patients.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

Not applicable. This is a mechanical device, and "ground truth" for mechanical testing is established by the test setup, calibration, and adherence to ASTM standards by engineers and technicians, not clinical experts for diagnostic accuracy.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. This is a mechanical device; there's no "adjudication" in the clinical sense for determining ground truth.

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:

Not applicable. This document pertains to a total knee system, not an AI or software device.

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

Not applicable. This document pertains to a total knee system, not an AI or software device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

For this mechanical device, the "ground truth" used for testing aligns with established ASTM (American Society for Testing and Materials) standards for orthopaedic implants. These standards define the methodology and expected performance characteristics for evaluating factors like contact area and constraint. The "truth" is whether the device's mechanical performance conforms to these scientific/engineering benchmarks and is comparable to predicate devices.

8. The sample size for the training set:

Not applicable. This document pertains to a mechanical device, not an AI/ML algorithm that requires a training set.

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

Not applicable. No training set is involved for this type of device submission.

Summary

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

December 22, 2014

Smith and Nephew, Incorporated % Mr. Samir Ibrahim Senior Regulatory Affairs Specialist 1450 Brooks Road Memphis. Tennessee 38116

Re: K142807 Trade/Device Name: ANTHEM PS Total Knee System Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semiconstrained cemented prosthesis Regulatory Class: Class II Product Code: JWH Dated: September 26, 2014 Received: September 29, 2014

Dear Mr. Ibrahim:

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) 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" (21 CFR 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,

Lori A. Wiggins -S

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

Enclosure

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Premarket Notification Indications for Use Statement

510(k) Number (if known): K142807

Device Name: ANTHEM® PS Total Knee System

Indications for Use:

1. Rheumatoid arthritis.
1. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis.
1. Failed osteotomies, unicompartmental replacement, or total knee replacement.
1. Posterior stabilized knee systems are designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact.

The ANTHEM PS Total Knee System is indicated for use only with cement and is a single use device.

Prescription Use ______________ (Part 21 CFR 801 Subpart D) AND/OR

Over-the-Counter Use _ (Part 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)

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510(k) Summary Smith & Nephew, Inc. ANTHEM® PS Total Knee System

Submitted by:	Smith & Nephew, Inc.1450 East Brooks RoadMemphis, TN 38116
Date of Summary:	September 26, 2014
Contact Person and Address:	Samir Ibrahim, PhD, MBA, RACSenior Regulatory Affairs SpecialistT (901) 399-6139F (901) 721-2421
Name of Device:	Smith & Nephew, Inc. ANTHEM® PS Total Knee System
Common Name:	Knee Prosthesis
Device Classification Nameand Reference:	21 CFR 888.3560 Knee Joint Patellofemorotibiapolymer/metal/polymer semi-constrained cemented prosthesis
Device Class:	Class II
Panel Code:	Orthopedics/87
Product Code:	JWH

Device Description

Intended Use

The Smith & Nephew ANTHEM PS Total Knee System is intended for total knee arthroplasty.

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Indications for Use

1. Rheumatoid arthritis.
1. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis.
1. Failed osteotomies, unicompartmental replacement, or total knee replacement.
1. Posterior stabilized knee systems are designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact.

The ANTHEM PS Total Knee System is indicated for use only with cement and is a single use device.

Technological Characteristics

Device comparisons described in this premarket notification demonstrate that the proposed femoral and tibial components of the ANTHEM PS Total Knee System are substantially equivalent to the legally marketed predicate devices (listed below in Table 1) with regard to intended use, indications for use, and performance characteristics. The primary technological differences that exist between the subject and predicate devices are the following:

Narrower ML width of the femoral component
Narrower anterior flange shape of the femoral component
Shorter, non-tapered stem of the tibial component ●

.
Manufacturer	Description	Submission Number	Clearance Date
Smith & Nephew, Inc.	Legion Narrow PS Knee System	K112941	12/20/2011
Smith & Nephew, Inc.	Genesis II PS Total Knee System	K951987	08/22/1995

Table 1: Substantially Equivalent Predicates to the ANTHEM Total Knee System

Summary of Preclinical Testing

To further support a determination of substantial equivalence, non-clinical bench (mechanical) testing was conducted on the proposed femoral and tibial components of the ANTHEM Total Knee System. Test results demonstrated that the proposed devices are substantially equivalent to one or more of the previously cleared predicate devices listed in Table 1. The specific types of non-clinical testing conducted are listed below and conform to the requirements of FDA Guidance for the Preparation of Premarket Notifications (510(k)s) for Cemented, Semi-constrained Total Knee Prostheses, dated April 1993:

Contact area testing according to ASTM F2083
Constraint testing according to ASTM F2083 and ASTM F1223

Conclusion

Based on the similarities to the predicate components and a review of the mechanical testing performed, the subject devices are substantially equivalent to the predicate devices listed in Table 1.

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.