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 which is 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 CR Knee™ Tibial Insert is a line extension to the EMPOWR platform, to include Cruciate Retaining Knee implants and instruments, which provides surgeons with comprehensive surgical solutions to address a variety of patient demographics and surgeon preferences. The Empowr CR Knee™ Tibial Insert utilizes a PCL (posterior cruciate ligament) retaining TKA (total knee arthroplasty) procedure.

The tibial insert implants made from Highly Cross-Linked with Vitamin E (HXL VE) UHMWPE. The tibial inserts are intended to mate with tibial base implants made from cast CoCr alloy per ASTM F75. The Empowr CR Knee™ Tibial Insert implants provide a kinematically relevant bearing geometry for the knee's primary articulating surfaces, replacing the medial and lateral tibial compartments. The articular geometry features a less conforming asymmetric condylar surfaces to match the highly polished Empowr 3D distal femoral implant's asymmetric condylar surfaces. The distal side of the implant includes a precisely machined coupling designed to interface and lock with the EMPOWR tibial base implant. The tibial insert implant also offers soft tissue relief sections in the anterior region for the patellar tendon and the posterior region for the PCL in PCL retaining procedures.

AI/ML Overview

This response describes the acceptance criteria and study that proves the device meets the acceptance criteria based on the provided document.

It's important to note that the provided document is a 510(k) Premarket Notification for a medical device (Empowr CR Knee Tibial Insert), and as such, the "acceptance criteria" discussed are primarily related to demonstrating substantial equivalence to a predicate device through non-clinical testing, rather than performance criteria for an AI/CADe device. The document explicitly states that clinical testing was not required.

Therefore, the answers below will reflect the information available for a mechanical orthopaedic implant, not AI software. Many of the requested fields pertinent to AI/CADe studies will be marked as "Not Applicable" or "Not Provided" due to the nature of the device and the submission type.

Acceptance Criteria and Device Performance for Empowr CR Knee™ Tibial Insert

The acceptance criteria for the Empowr CR Knee™ Tibial Insert are based on demonstrating substantial equivalence to predicate devices through non-clinical mechanical testing, rather than a clinical performance study typical for AI/CADe software.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category (Basis for Substantial Equivalence)	Specific Test Conducted	Acceptance Limit/Benchmark (Implicitly, Comparable to Predicate)	Reported Device Performance
Mechanical Performance	Constraint testing	(Implicit: Performance comparable to predicate devices)	Device's ability to perform under expected conditions demonstrated.
	Contact area testing	(Implicit: Performance comparable to predicate devices)	Device's ability to perform under expected conditions demonstrated.
	Locking mechanism testing	(Implicit: Performance comparable to predicate devices)	Device's ability to perform under expected conditions demonstrated.
Material/Manufacture Equivalence	Comparison of implant material	(Implicit: Identical or bio-equivalent to predicate)	Identical to predicate (HXL VE UHMWPE, CoCr alloy).
	Comparison of manufacturing process	(Implicit: Identical or equivalent to predicate)	Similar to predicate.
Biocompatibility	Endotoxin assessment	Pyrogen limit specifications met.	Pyrogen limit specifications met via Kinetic Chromogenic method.

Summary Conclusion: All testing and evaluations demonstrated that the device is substantially equivalent to the identified predicate devices.

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

For mechanical testing of physical implants:

Sample Size: Not explicitly stated as a numerical value (e.g., number of inserts tested). Mechanical tests typically involve multiple samples to ensure statistical validity, but the specific quantity is not reported in this summary.
Data Provenance: Not applicable in the context of human data. The testing is performed on physical device samples in a laboratory setting. It is not retrospective or prospective human data.

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

Not Applicable. This is a hardware device (knee implant), not an AI/CADe system requiring expert adjudication of images or clinical outcomes for performance evaluation. Ground truth for mechanical performance is established by engineering standards and test methods.

4. Adjudication Method for the Test Set

Not Applicable. No human adjudication of results in the sense of consensus reading for AI algorithm evaluation. Mechanical testing results are objective measurements against established engineering principles and benchmarks.

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

No. An MRMC study is relevant for medical image analysis AI/CADe systems to assess human reader performance with and without AI assistance. This device is a knee implant, and as such, this type of study was not performed or necessary for its submission.

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

No. This question is also focused on AI algorithm performance. For this physical device, mechanical testing evaluates the device's inherent properties and performance in a controlled lab environment, which is analogous to "standalone" performance but in a mechanical context. It's not an algorithm.

7. The Type of Ground Truth Used

Engineering Standards and Benchmarks: The "ground truth" for this device's performance evaluation comes from established mechanical testing standards (e.g., ASTM standards, though not explicitly cited in the summary, they are typically used for such tests) and comparative data from the legally marketed predicate devices. The performance of the new device is compared against the known safe and effective performance of the predicate.

8. The Sample Size for the Training Set

Not Applicable. This is a hardware device, not an AI model requiring a training set of data.

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

Not Applicable. As no training set was used for an AI model, this question is not relevant.

Summary

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

Encore Medical, L.P. Desiree Wells Regulatory Affairs Specialist 9800 Metric Blvd. Austin, Texas 78758

May 31, 2017

Re: K170573

Trade/Device Name: Empowr CR Knee 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: JWH, OIY Dated: February 24, 2017 Received: February 27, 2017

Dear Desiree Wells:

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

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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 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 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.

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) K170573

Device Name Empowr CR Knee™ 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)
× 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: May 24, 2017

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

Contact Person: Desireé Wells Regulatory Affairs Specialist Phone: (512) 834-6302 Fax: (760) 597-3466 Email: desiree.wells@djoglobal.com

Product	Common Name	Classification	Product Code
Empowr CR Knee™ Tibial Insert	Cruciate-retaining tibialinsert	Class II	JWH

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 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.

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:

Primary Predicate Device: Empowr Knee System - K143242

Reference Devices:

Foundation PS Knee - K933539
Movation Knee System - K100900
Foundation Ultra Congruent - K963028
3DKnee System K020114 ●

Comparable Features to Predicate Device(s): This device is comparable to the predicate devices in implant material, manufacturing process, snap lock interface, design of the tibial insert, indications, intended use, packaging and sterilization.

Key Differences in Subject Device to Predicate: Offers an additional intermediate thickness, a higher anterior lip geometry and lower posterior lip geometry, asymmetric condyle geometries and a different coronal conformity ratio.

Non-Clinical Testing: Mechanical testing (Constraint testing, contact area testing, and locking mechanism testing) has demonstrated the device's ability to perform under expected conditions. 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.