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;

This device may also be indicated in the salvage of previously failed surgical attempts. This device is intended to be used with the 3DKnee System for cemented or uncemented applications.

Device Description

The Highly Cross-Linked Vitamin E UHMWPE (HXL VE) Tibial Inserts are manufactured from ultra high molecular weight polyethylene (UHMWPE) powder that is blended with pure liquid pharmaceutical grade alpha-tocopheral, compression molded and then highly cross-linked. The tibial inserts are available in 9 sizes (2- 12) and 5 thicknesses (9-19) and are provided in right and left orientations. The HXL VE Tibial Insert design is identical to the 3DKnee Tibial Insert cleared via K020114. This insert is intended to more closely match the kinematics of the knee, allowing some rotation along the medial condyle and increased congruency along the lateral condyle. The baseplate attachment mechanism is the same as the previously cleared 3DKnee System inserts.

AI/ML Overview

The provided document is a 510(k) summary for a medical device called "Highly Cross-Linked Vitamin E UHMWPE Tibial Insert." This document focuses on demonstrating substantial equivalence to previously cleared devices rather than presenting a study to prove acceptance criteria for a new, innovative device with unique performance claims.

Therefore, many of the requested elements for a study proving acceptance criteria (like sample size for a test set, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth for training sets) are not applicable to this type of regulatory submission. This document describes a device approval based on non-clinical testing demonstrating similarity to existing devices.

Here's a breakdown of the available information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

This report does not define specific discrete "acceptance criteria" in the way a performance study for an AI algorithm or a novel diagnostic might. Instead, it relies on demonstrating that the new device's material properties, design, and indications for use are substantially equivalent to legally marketed predicate devices. The "reported device performance" is the outcome of various non-clinical tests showing these equivalencies.

Test Category	Acceptance Criteria (Implied)	Reported Device Performance
Mechanical Material Characterization	Comparable to predicate devices (E-Poly Tibial Bearings, K080528)	All testing demonstrated substantial equivalence.
(Tensile, Small Punch, Izod Impact, Crack Prog)
Physical and Chemical Characterization	Comparable to predicate devices (E-Poly Tibial Bearings, K080528)	All testing demonstrated substantial equivalence.
(Oxidation Index, Compressive Modulus, etc.)
Tibial Insert Peel-out Strength	Comparable to predicate devices	All testing demonstrated substantial equivalence.
Wear Testing	Comparable to predicate devices	All testing demonstrated substantial equivalence.
Biocompatibility	Comparable to predicate devices	All testing demonstrated substantial equivalence.
Design (size, thickness, configuration, dim.)	Identical to 3DKnee Tibial Insert (K020114)	Design is identical to the 3DKnee Tibial Insert (K020114).
Indications for Use	Equivalent to 3DKnee Tibial Insert (K020114)	Indications for Use are equivalent.

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

Sample Size: Not applicable. This was non-clinical testing of materials and device components, not a clinical study on patient data. The "sample size" would refer to the number of physical samples tested for each material or mechanical property. This specific number is not provided in the summary but would be detailed in the full test reports.
Data Provenance: Not applicable in the context of clinical data. The data originates from laboratory testing. It is neither retrospective nor prospective clinical data.

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

Not applicable. Ground truth, in the context of this device, would be established by validated engineering and scientific testing standards and methodologies, not by expert medical consensus on clinical cases.

4. Adjudication Method for the Test Set

Not applicable. There's no clinical test set requiring adjudication in this submission.

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

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical Testing: None provided as a basis for substantial equivalence." This is a non-clinical submission.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done

Not applicable. This is a physical medical device (an orthopedic implant), not an algorithm or AI system.

7. The Type of Ground Truth Used

For the non-clinical tests, the "ground truth" is based on:

Established material science properties.
Validated mechanical testing standards (e.g., for wear, strength, fatigue).
Chemical quantification methods.
Biocompatibility standards.
Direct comparison of design specifications to the predicate device.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" as this is not an AI or machine learning device.

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

Not applicable. There is no "training set" for this device.

Summary

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DJOsurgical

SEP 2 8 2010

Summary of Safety and Effectiveness

Preparation Date:	September 22, 2010
Applicant/Sponsor:	Encore Medical (d.b.a. DJO Surgical)9800 Metric BlvdAustin, TX 78758
Contact Person:	Elizabeth PughRegulatory Affairs Specialist
Device Name:	Highly Cross-Linked Vitamin E UHMWPE Tibial Insert
Classification Name:	Knee joint patellofemorotibial polymer/metal/polymersemi-constrained cemented prosthesis (888.3560), OIY,JWH, MBH

Legally Marketed Devices to Which Substantial Equivalence is Claimed
3DKnee	K020114	Encore Medical
E-Poly Tibial Bearings	K080528	Biomet

Device Description:

Compatible Systems	Clearance	Cemented/Cementless
3DKnee System	K020114	Cemented
3DKnee Porous Coated Femoral	K032905	Cementless
Component

Indications for Use:

Total joint replacement is indicated for patients suffering from disability due to:

degenerative, post-traumatic or rheumatoid arthritis; ●
. avascular necrosis of the femoral condyle;

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K091956 *みよ

post-traumatic loss of joint configuration, particularly when ● there is patellofemoral erosion, dysfunction or prior patellectomy;
. moderate valgus, varus or flexion deformities;

This device may also be indicated in the salvage of previously failed surgical attempts. This device is intended to be used with the 3DKnee System for cemented or uncemented applications.

Intended Use:

DJO Surgical knee devices are intended for treatment of patients who are candidates for knee arthroplasty per the indications for use. While total knee replacements are not intended to withstand activity levels and loads of normal healthy bone, they are a means of restoring mobility and reducing pain for many patients.

Summary of Technologies:

Design Feature	Equivalent Device
Highly Cross-Linked Vitamin EPolyethylene MaterialUHMWPe (α-tocopherol)	E-Poly Tibial Bearings – Biomet(K080528)
Indications for Use	3DKnee Tibial Insert – EncoreMedical (K020114)
Design (size, thickness, configuration,dimensions)	3DKnee Tibial Insert – EncoreMedical (K020114)

Substantial Equivalence Table

Non-Clinical Testing:

The following non-clinical laboratory testing was performed to determine substantial equivalence: mechanical material characterization (Tensile, Small Punch, Izod Impact, and crack propagation), physical and chemical characterization ( Oxidation Index, Compressive Modulus, Poisson's Ratio, Surface Roughness, Density, Onset Melting Temperature, Peak Melting Temperature, Delta H, Degree of Crystallinity, Crosslink Density, Swell Ratio, Molecular Weight, Polydispersity Index, Lamallae Thickness, Free Radical Concentration, Vitamin E Concentration, Vitamin E Consolidation, Vitamin E Elution/Extraction, Trans-vinylene Index), tibial insert peel-out strength, wear testing, and biocompatibility. All testing has demonstrated the device is substantially equivalent to the predicate devices.

Clinical Testing:

None provided as a basis for substantial equivalence.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circle around the eagle. The logo is black and white.

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

Encore Medical, L.P. % Mrs. Beth Pugh Regulatory Affairs Specialist 9800 Metric Boulevard Austin, Texas 78758

SEP 2 8 2010

Re: K091956

Trade/Device Name: Highly Cross-linked Vitamin E UHMWPE Tibial Inserts Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer semi-constrained cemented prothesis Regulatory Class: Class II Product Code: OIY, JWH, MBH Dated: July 29, 2010 Received: July 30, 2010

Dear Mrs. Pugh:

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

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Page 2 - Mrs. Beth Pugh

CFR Part 807); laheling (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 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.

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

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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SEP 2 8 2010

510(k) Number (if known): K091956

Device Name: Highly Cross-Linked Vitamin E UHMWPE Tibial Insert

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;

This device may also be indicated in the salvage of previously failed surgical attempts. This device is intended to be used with the 3DKnee System for cemented or uncemented applications.

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

Over-The-Counter Use (21 CFR 801 Subpart C) '

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Omitir for mxm

Dission Sign-OH) Division of Surgical, Orthepedic, and Restorative Devices

510(k) Number K091956

Page 1 of 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.