· 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. All devices are intended for cemented applications except for the 3DKNEE™ Porous Coated Femur, EMPOWR Porous™ Knee Femur and EMPOWR Porous™ Knee Tibia which are intended for cementless applications.

While 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.

Device Description

The EMPOWR Varus / Valgus Constrained (VVC) Tibial Insert and accessory is a line extension to the EMPOWR Knee platform (cleared via K143242), to include a more constrained tibial insert component that provides additional internal / external and varus / valgus rotational stability, which provide surgeons with comprehensive surgical solutions to address a variety of patient demographics and surgeon preferences.

AI/ML Overview

The provided text is a 510(k) summary for the EMPOWR VVC Tibial Insert, a medical device. This document focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing. It explicitly states that clinical testing was not required. As such, the information typically found in a study proving the device meets acceptance criteria, an MRMC study, or a standalone algorithm performance study is not present. The document focuses on mechanical testing.

Here's the breakdown of what can and cannot be extracted from the provided text regarding acceptance criteria and studies:

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

The document lists "Non-Clinical Testing" that was performed, implying that the results of these tests met certain acceptance criteria, but the specific numerical acceptance criteria and the detailed reported performance values are not provided. The conclusion states, "All testing has determined that the device is substantially equivalent to the predicate devices," which implies that the device did meet the acceptance criteria, whatever they were.

Acceptance Criteria Category	Reported Device Performance
Femoral Tibial Contact Area	Met criteria for substantial equivalence to predicate devices.
Femoral – Tibial Intrinsic Stability	Met criteria for substantial equivalence to predicate devices.
VVC Post Fatigue	Met criteria for substantial equivalence to predicate devices.
Locking mechanism Static Stability and Fatigue	Met criteria for substantial equivalence to predicate devices.
Reinforcement Pin Taper Characterization	Met criteria for substantial equivalence to predicate devices.
Varus / Valgus Constraint Characterization	Met criteria for substantial equivalence to predicate devices.
Endotoxin Assessment	Pyrogen limit specifications were met via the Kinetic Chromogenic method.

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

This information is not provided in the document. The Non-Clinical Testing section describes types of mechanical tests but does not specify sample sizes for these tests or data provenance beyond "All testing has determined that the device is substantially equivalent to the predicate devices."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable as the document describes mechanical, non-clinical testing, not a study involving human experts or ground truth establishment in a clinical sense.

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

This information is not applicable as the document describes mechanical, non-clinical testing.

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

This information is not applicable. The device is a medical implant (Tibial Insert), not an AI-powered diagnostic or assistive tool for human readers. Additionally, the document explicitly states: "Clinical Testing: Clinical testing was not required."

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

This information is not applicable. The device is a physical medical implant, not a standalone algorithm.

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

For the non-clinical tests, the "ground truth" would be established by engineering standards, manufacturing specifications, and the performance characteristics of the predicate devices. The document implies that the device's performance met these engineering and substantial equivalence criteria. No clinical "ground truth" (like pathology or outcomes data) was used or required.

8. The sample size for the training set

This information is not applicable. There is no "training set" as this is a physical medical device undergoing mechanical testing, not a machine learning model.

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

This information is not applicable for the same reason as point 8.

Summary

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

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

Re: K180930

Trade/Device Name: EMPOWR VVC Tibial Insert Regulation Number: 21 CFR 888.3560 Regulation Name: Knee Joint Patellofemorotibial Polymer Semi-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: JWH, OIY Dated: April 9, 2018 Received: April 10, 2018

Dear Teffany 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 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 of medical device-related adverse events) (21 CFR 803); good

July 9, 2018

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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.

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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Mark N. Melkerson -S

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

Enclosure

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Indications for Use

510(k) Number (if known) K180930

Device Name EMPOWR VVC Tibial Insert

Indications for Use (Describe)

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.

While 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.

Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

Date: July 9, 2018

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

Contact Person: Teffany Hutto Manager, Regulatory Affairs Phone: (512) 834-6255 Fax: (760) 597-3466 Email: teffany.hutto@djoglobal.com

Product	Common Name	Classification	Product Code
EMPOWR VVC Tibial Insert	Total Knee Implant	Class II	JWH, OIY

Product Code	Regulation and Classification Name
JWH	Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesisper 21 CFR 888.3560
OIY	Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesisper 21 CFR 888.3560

Description:

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. All devices are intended for cemented applications except for the 3DKNEE™ Porous Coated Femur. EMPOWR Porous™ Knee Femur and EMPOWR Porous™ Knee Tibia which are intended for cementless applications.

While 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.

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Predicate Devices:

EMPOWR PS Knee System (K160342)
Exprt Knee System (K140830)
Foundation Constrained Posterior Stabilized Tibial Insert (K933539) ●

Reference Devices:

Encore Medical Acetabular System (K072154)
Highly Cross-Linked Vitamin E UHMWPE Tibial Insert (K091956) ●

Comparable Features to Predicate Device(s):

The EMPOWR VVC Tibial Insert Implant is a line extension also includes a modified version of the EMPOWR PS Tibial Insert Implants (cleared via K160342). The sizing architecture, material (highly crosslinked UHMWPe with vitamin E per ASTM F648), minimum thickness offering (10mm), and distal locking mechanism geometry with the mating tibial baseplate remains identical to EMPOWR PS Tibial Insert Implants.

Key Differences in Subject Device to Predicate:

A primary difference between the EMPOWR VVC Tibial Insert compared to the EMPOWR PS Tibial Insert Implants is the proximal side of the tibial insert and post geometry was modified to configure an additional amount of internal / external and varus / valgus constraint when compared to the EMPOWR PS Tibial Insert Implants.

Non-Clinical Testing: Mechanical testing has demonstrated the device's ability to perform under expected conditions. This testing includes:

Femoral Tibial Contact Area ●
Femoral – Tibial Intrinsic Stability
VVC Post Fatigue
Locking mechanism Static Stability and Fatige ●
Reinforcement Pin Taper Characterization
Varus / Valgus Constraint Characterization ●

All testing has determined that the device is substantially equivalent to the predicate devices.

Endotoxin Assessment: DJO Surgical conducts device testing to assure that pyrogen limit specifications are met via the Kinetic Chromogenic method for bacterial endotoxin testing.

Clinical Testing: Clinical testing was not required

Conclusions: All testing and evaluations demonstrate that the device is substantially equivalent to the predicates identified.

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.