degenerative, post-traumatic or rheumatoid arthritis;
avascular necrosis of the femoral condyle;
post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy;
moderate valgus, varus or flexion deformities;
treatment of fractures that are unmanageable using other techniques.
This device may also be indicated in the salvage of previously failed surgical attempts.
This system is to be used for cemented applications.

Device Description

This submission is to request clearance for a line extension to the current patella product line to include a highly cross linked polyethylene patella infused with pharmaceutical grade alphatocopheral.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information based on the provided text, recognizing that this document describes a medical device (a knee implant patella), not an AI algorithm. Therefore, many of the requested fields pertinent to AI algorithm evaluation (like MRMC, ground truth establishment for training data, expert consensus, etc.) will not be applicable.

Device Name: Highly Cross Linked Patella with Vitamin E

Device Type: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied by Predicate Device Comparison & Non-Clinical Testing)	Reported Device Performance
Mechanical Performance: Device must perform under expected conditions, demonstrating adequate strength, durability, and resistance to wear, push-out, lever-out, torsion, and impact.	Demonstrated through non-clinical mechanical characterization testing, push-out, lever-out, torsion, Izod impact, small punch, tensile testing, and wear testing.
Material Characterization: Material properties (highly cross-linked polyethylene with Vitamin E) must be comparable to previously cleared materials and suitable for implantation.	Material characterization testing was not repeated as identical material was cleared in K091956. This implies the material met prior acceptance criteria.
Biocompatibility/Safety: No toxicological response or cytotoxicity.	Demonstrated through animal implant for toxicological response and cytotoxicity testing.
Design Equivalence (absence of certain tests): Absence of need for subluxation and contact stress testing due to design equivalence to predicate devices.	Found not to be required due to design equivalence.
Substantial Equivalence: Features (design, materials, indications, sterilization, packaging, intended use) must be comparable to legally marketed predicate devices.	Stated as meeting the criteria for substantial equivalence to predicate devices (K932246, K905613, K100900, K091956). FDA confirmed substantial equivalence.

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

Test Set Sample Size: Not applicable. This submission relies on non-clinical (bench) testing and comparison to predicate devices, not on a clinical test set with patient data or an algorithm's performance on a dataset.
Data Provenance: Not applicable. The "data" comes from engineering and laboratory tests, not patient data sets.

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

Not applicable. Ground truth, in the context of an AI algorithm, usually refers to labels established by human experts on a dataset. For this medical device, performance is established through physical and material testing, not expert-labeled data.

4. Adjudication Method for the Test Set

Not applicable. There was no "test set" in the context of human interpretation or algorithm output requiring adjudication.

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 is a medical device (implant), not an AI-powered diagnostic or assistive tool. No MRMC study was performed.

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

Not applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

Engineering/Material Science Ground Truth: Performance was judged against established engineering standards, material specifications, and the performance characteristics of previously cleared predicate devices. Examples include:
- Quantifiable mechanical properties (e.g., strength, wear rates, impact resistance).
- Biocompatibility standards (e.g., absence of cytotoxicity).
- Comparability to existing devices as defined by design, materials, and intended use.

8. The Sample Size for the Training Set

Not applicable. This is a medical device, not an AI algorithm. There is no concept of a "training set" for physical bench testing.

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

Not applicable. As above, no training set for an AI algorithm was involved. The "ground truth" for the development of the device itself would stem from engineering specifications, industry standards, and clinical needs for knee joint replacement, guiding the design and material selection.

Summary

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KC 113756

MAR 1 4 2012

Date: January 25, 2012

Manufacturer: Encore Medical, L.P. 9800 Metric Blvd Austin, TX 78758

Contact Person: Teffany Hutto Manager, Regulatory Affairs Phone: (512) 834-6255 Fax: (512) 834-6313 Email: teffany.hutto@djoglobal.com

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------MALLER MELLERS WANNING MINNER MANNE MARK WANTE AND LEASE LEASTof the	LEALERSHIP FOR I SURNAMERS FREEN FORMICAL COLLECT OF C.44.2assification	A Comments of Children Comments of ChildrenTodatot	ProductCode	Regulation and Classification Name
. Patella withHIGHIVVitamin Irossinken '	lass	11/11/1OIV	JWH	Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis per 21 CFR 888.3560
OIY	Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis per 21 CFR 888.3560

510(k) Summary

Description: This submission is to request clearance for a line extension to the current patella product line to include a highly cross linked polyethylene patella infused with pharmaceutical grade alphatocopheral.

Indications for Use:

Joint replacement is indicated for patients suffering from disability due to:

· degenerative, post-traumatic or rheumatoid arthritis;
· avascular necrosis of the femoral condyle;
· post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy;
· moderate valgus, varus or flexion deformities;
· treatment of fractures that are unmanageable using other techniques.

This device may also be indicated in the salvage of previously failed surgical attempts. This system is to be used for cemented applications.

Predicate Devices:

DJO Surgical Metal Backed Patella - K932246 DJO Surgical Tri-Peg Patella - K905613 DJO Surgical Movation Patella - K100900 DJO Surgical 3DKnee Insert - K091956

Comparable Features to Predicate Device(s): Features comparable to predicate devices include the same design features, materials, indications sterilization, packaging and intended use.

Non-Clinical Testing: Previous mechanical testing demonstrated the device's ability to perform under expected conditions. Testing included mechanical characterization testing, push out, lever out, torsion, Izod impact, small punch, tensile, FTIR, wear, animal implant for toxilogical response, and cytotoxicity. Material characterization testing did not need to be repeated as identical material was cleared in K091956. Testing for subluxation, and contact stresses was found not to be required due to design equivalence.

Clinical Testing: None provided.

1 of 1

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

Encore Medical, L.P. % Ms. Teffany Hutto Regulatory Affairs Manager 9800 Metric Boulevard Austin, Texas 78758

MAR 1 4 2012

Re: K113756 Trade/Device Name: Highly Cross Linked Patella with Vitamin E Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: OIY, JWH Dated: January 25, 2012 Received: January 26, 2012

Dear Ms. Hutto:

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 or any i 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. Susanne Smith, MS

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/Resourcesfor You/Industry/default.htm.

Sincerely yours,
Eric Keith

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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510(k) Number (if known):

KN 3756

Device Name: Highly Cross Linked Patella with Vitamin E

Indications for Use:

Highly Cross Linked Patella with Vitamin E Indications for Use

Joint replacement is indicated for patients suffering from disability due to:

degenerative, post-traumatic or rheumatoid arthritis; .
avascular necrosis of the femoral condyle; .
post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, . dysfunction or prior patellectomy;
moderate valgus, varus or flexion deformities; .
treatment of fractures that are unmanageable using other techniques. .

This device may also be indicated in the salvage of previously failed surgical attempts.

This system is to be used for cemented applications

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)

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

510(k) Number K113756

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.