The Movation Knee System is Indicated For: 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.

Device Description

The Movation Highly Cross Linked Vitamin E Tibial Inserts are manufactured from HXL VE (75KgY) ultra high molecular weight polyethylene (UHMWPE). The tibial inserts are available in 11 sizes (1,2,3,4,5,6,7,8,10,12, and 14) and 6 thicknesses (9mm -21mm) and are provided neutral in orientation. The tibial insert is identical in design to the compression molded UHMWPE Movation tibial insert cleared via K100900. The tibial insert is identical in materials to the Highly Cross-Linked Vitamin E UHMWPE Tibial Insert cleared via K091956.

AI/ML Overview

The provided document describes a medical device, the "Movation Highly Cross Linked Vitamin E Tibial Insert," and its substantial equivalence to predicate devices, not a study evaluating a device's performance based on specific acceptance criteria as you'd typically find for AI/software-as-a-medical-device (SaMD).

This document is a 510(k) Premarket Notification summary for an orthopedic implant. It focuses on demonstrating that the new device is as safe and effective as existing legally marketed devices, primarily through non-clinical testing (mechanical, physical, chemical, and wear testing) and comparisons of design and materials. It explicitly states "Clinical Testing: None provided."

Therefore, I cannot fulfill your request to describe acceptance criteria and a study proving device performance in the context of an AI/SaMD, as this document does not contain that type of information.

Here's what I can extract from the provided text, highlighting why the requested information for acceptance criteria and a "study" (in the AI/SaMD sense) isn't present:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria: Not explicitly stated as pass/fail thresholds for clinical performance metrics (e.g., sensitivity, specificity, accuracy). The acceptance criteria for this type of device are generally related to demonstrating substantial equivalence to predicate devices through various non-clinical engineering and material tests. For example, ensuring mechanical properties (tensile strength, impact resistance, crack propagation) fall within acceptable ranges and are comparable to predicate devices.
Reported Device Performance: The document reports results for various non-clinical tests (Tensile, Small Punch, Izod Impact, crack propagation, Oxidation Index, Compressive Modulus, Poisson's Ratio, Surface Roughness, Density, Melting Temperatures, 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). The document states, "All testing has demonstrated the device is substantially equivalent to the predicate devices." This is the ultimate "performance" reported in this context – equivalence to existing devices, not a standalone clinical performance against a ground truth.

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

Not applicable. This document describes non-clinical laboratory testing (material characteristics, mechanical properties, wear, biocompatibility). These tests typically use material specimens or prototypes, not clinical "test sets" of patient data. There is no concept of country of origin for "data" in this context.

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

Not applicable. This relates to clinical performance evaluation, which was not performed or submitted.

4. Adjudication Method for the Test Set:

Not applicable. This relates to clinical performance evaluation, which was not performed or submitted.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No. This is a premarket notification for an implantable medical device, not an AI or diagnostic software. Clinical studies, especially MRMC studies, are not mentioned and are often not required for 510(k) clearances if substantial equivalence can be demonstrated through other means (like non-clinical testing for implants). The document explicitly states: "Clinical Testing: None provided."

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

No. This is for a physical medical device (tibial insert), not an algorithm or software.

7. The Type of Ground Truth Used:

For the non-clinical tests, the "ground truth" implicitly refers to established engineering standards, material specifications, and performance characteristics of the predicate devices. The testing confirmed the new device met these criteria and was comparable. There's no biological or clinical "ground truth" (e.g., pathology, outcomes data) used in this submission.

8. The Sample Size for the Training Set:

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

9. How the Ground Truth for the Training Set was Established:

Not applicable. As above, no training set or associated ground truth.

In summary, the provided document details a 510(k) submission for a physical orthopedic implant. Its "acceptance criteria" revolve around demonstrating substantial equivalence to predicate devices through extensive non-clinical (laboratory and materials) testing, not through clinical studies of performance against ground truth, which would typically be included for an AI/SaMD product.

Summary

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Summary of Safety and Effectiveness

K12172741

Date: August 13, 2012

Manufacturer: Encore Medical, L.P. Trade Name: DJO Surgical 9800 Metric Blvd Austin, TX 78758

AUG 1 5 2012 Contact Person: William Garzon Regulatory Affairs Specialist Phone: (512) 834-6391 Fax: (512) 834-6313 Email: william.garzon@djoglobal.con

Product	Product Code	Regulation and Classfication Name
Movation Highly Cross LinkedVitamin E Tibial Insert	JWH,OIY	Knee Joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis per 21 CFR 888.3560

Legally Marketed Devices to which Substantial Equivalence is Claimed:

and and the control of the country of the country of the first and of the first and of the first and of the first and of the first and of the first and of the first and of thMovation Knee	K100900	DJO Surgical
HXL Vitamin E Tibial Insert K091956		DJO Surgical

Description: The Movation Highly Cross Linked Vitamin E Tibial Inserts are manufactured from HXL VE (75KgY) ultra high molecular weight polyethylene (UHMWPE). The tibial inserts are available in 11 sizes (1,2,3,4,5,6,7,8,10,12, and 14) and 6 thicknesses (9mm -21mm) and are provided neutral in orientation. The tibial insert is identical in design to the compression molded UHMWPE Movation tibial insert cleared via K100900. The tibial insert is identical in materials to the Highly Cross-Linked Vitamin E UHMWPE Tibial Insert cleared via K091956.

The Movation Knee System is Indicated for:

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.

Comparable features to Predicate Device: Features comparable to predicate devices include same design, intended use and sterilization method.

Summary of Technologies: The Movation HXL VE Tibial Inserts are infused with a vitamin E to stabilize free-radicals and prevent oxidative degredation and then highly cross-linked to improve wear resistance. The design feature Highly Cross-Linked Vitamin Polyethylene Material UHMWPe (α-tocopherol) is equivalent to the Highly Cross-Linked Vitamin E UHMWPE Tibial Insert . cleared via K091956. The Movation HXL VE Tibial Inserts are attached to the baseplate via a super locking snap feature, equivalent to the Movation Knee cleared via K100900.

Page 1 of 2

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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

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle faces to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the left side of the eagle.

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

AUG 15 2012

Encore Medical, L.P. % Mr. William Garzon Regulatory Affairs Specialist 9800 Metric Boulevard Austin, Texas 78758

Re: K121727

Trade/Device Name: Movation Highly Crossed Linked Vitamin E Tibial Insert 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: July 13, 2012 Received: July 16, 2012

Dear Mr. Garzon:

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 - Mr. William Garzon

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 forth in 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ycm115809.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,

fir

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): K121727

Device Name: Movation Highly Cross Linked Vitamin E Tibial Insert

Indications for Use:

The Movation Knee System is Indicated For:

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)

Ander

(Division Sign-Oft) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K121727

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.