(101 days)
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 3DKNEET™ 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.
The EMPOWR PS Knee System is a line extension to the current EMPOWR system (previously cleared as Rebel 3DKNEE System). It is a total knee system that includes non-porous distal femoral implants made from cast CoCr alloy per ASTM F75 and tibial insert implants made from Highly Cross-Linked with Vitamin E (HXL VE) UHMWPE.
The provided text is an FDA 510(k) summary for a medical device called the EMPOWR PS Knee System. It describes the device, its indications for use, and its substantial equivalence to predicate devices. However, this document does not contain information about acceptance criteria or a study proving that the device meets those criteria, as typically found for AI/ML-driven medical devices. This knee system is a traditional orthopedic implant, and its clearance relies on non-clinical testing for mechanical properties and substantial equivalence to existing devices, not on performance metrics like sensitivity, specificity, or reader studies.
Therefore, most of the requested information cannot be extracted from this document. I can, however, provide what is available.
Here's a breakdown based on the provided text, noting where information is absent:
1. Table of Acceptance Criteria and Reported Device Performance
This document does not specify quantitative acceptance criteria or performance metrics (like accuracy, sensitivity, specificity) because it's for a physical knee implant cleared through the 510(k) pathway, focusing on mechanical properties and substantial equivalence rather than diagnostic or prognostic performance. The "performance" assessment is based on non-clinical testing.
| Acceptance Criteria (Not explicitly stated as numeric) | Reported Device Performance |
|---|---|
| Mechanical strength/durability | "FEA assessments for PS femur condyle closing loads, PS femur flange closing loads, and PS femur wedge loading. CAD analysis was completed for range of motion, and testing was completed for post fatigue, contact area, constraint, and lateral subluxation." |
| Substantial Equivalence to predicate devices | "All testing has determined that the device is substantially equivalent to the predicate devices." (Implies that the non-clinical tests results met engineering standards and were comparable to the predicate devices, though specific thresholds or comparative values are not provided in this summary.) "This device is comparable to the predicate devices in indications, material, dimensions, surgical implantation technique, and intended use. This device has the same implant packaging and sterilization as the EMPOWR Knee are no different technological characteristics from the predicate device." |
2. Sample Size Used for the Test Set and Data Provenance
This information is not applicable and not provided. The testing described is non-clinical (FEA, CAD analysis, fatigue testing of components), not involving human patient data or a "test set" in the context of an AI/ML device.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable and not provided. The "ground truth" for a knee implant's mechanical performance is typically established through engineering standards, material science, and biomechanical principles, not through expert clinical consensus on a dataset.
4. Adjudication Method
This information is not applicable and not provided. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in clinical data for diagnostic/prognostic studies, which is not what this document describes.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. An MRMC study was not done. Such studies are relevant for diagnostic devices that assist human readers (e.g., radiologists interpreting images). This device is a physical knee implant.
6. Standalone Performance Study
Yes, in a sense, a standalone (algorithm-only, or device-only) evaluation was performed regarding its mechanical properties. The "Non-Clinical Testing" section describes evaluations of the device's components and design:
- FEA assessments for PS femur condyle closing loads, PS femur flange closing loads, and PS femur wedge loading.
- CAD analysis for range of motion.
- Testing for post fatigue, contact area, constraint, and lateral subluxation.
These tests evaluate the device itself without human-in-the-loop performance.
7. Type of Ground Truth Used
The ground truth for the non-clinical testing appears to be based on:
- Engineering standards: Implied by the type of mechanical tests (e.g., fatigue, loading) and material specifications (ASTM F75 for CoCr alloy).
- Biomechanics: Underlying principles for range of motion, constraint, and subluxation.
- Comparison to predicate devices: The concept of "substantial equivalence" means the device's performance aligns with that of already-marketed, safe, and effective predicate devices.
8. Sample Size for the Training Set
This information is not applicable and not provided. "Training set" is a term used for AI/ML development. For a physical device, development involves design, prototyping, and iterative engineering, not a training set of data.
9. How Ground Truth for the Training Set Was Established
This information is not applicable and not provided for the reasons stated above.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 19, 2016
Encore Medical, L.P. Ms. Teffany Hutto Manager, Regulatory Affairs 9800 Metric Boulevard Austin, Texas 78758
Re: K160342 Trade/Device Name: EMPOWR PS Knee System Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semiconstrained cemented prosthesis Regulatory Class: Class II Product Code: JWH, OIY Dated: May 2, 2016 Received: May 3, 2016
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 comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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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" (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 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 yours,
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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| Form Approved: OMB No. 0910-0120 | |
|---|---|
| Expiration Date: January 31, 2017 | |
| See PRA Statement below. |
| 510(k) Number (if known) | K160342 |
|---|---|
| Device Name | EMPOWR PS Knee System |
| 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. This device may also be indicated in the salvage of previously failed surgical attempts. All devices are intended for cemented applications except for the 3DKNEET\u2122 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. |
| 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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FORM FDA 3881 (8/14)
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510(k) Summary
Date: May 6, 2016
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: (512) 834-6313 Email: teffany.hutto@djosurgical.com
| Product | Classification | Product Codes | Product Code | Regulation and Classification Name |
|---|---|---|---|---|
| EMPOWR PS Knee System | Class II | JWH, OIY | JWH | Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cementedprosthesis per 888.3560 |
| OIY | Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cementedprosthesis per 888.3560 |
Description:
The EMPOWR PS Knee System is a line extension to the current EMPOWR system (previously cleared as Rebel 3DKNEE System). It is a total knee system that includes non-porous distal femoral implants made from cast CoCr alloy per ASTM F75 and tibial insert implants made from Highly Cross-Linked with Vitamin E (HXL VE) UHMWPE.
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 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.
| Predicate Devices: | EMPOWR Knee System - K143242 |
|---|---|
| Foundation PS Knee System - K933539 | |
| Movation Knee System - K100900 & K121727 |
Comparable Features to Predicate Device(s): This device is comparable to the predicate devices in indications, material, dimensions, surgical implantation technique, and intended use. This device has the same implant packaging and sterilization as the EMPOWR Knee are no different technological characteristics from the predicate device.
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K160342 Page 2 of 2 Key Differences in Subject Device to Predicate: Anterior Cam Position within Intercondylar Housing, Values of Coronal Condylar Radii and Bearing Spacing, Femoral Component PS Housing Profile, Posterior Cam Engagement with Tibial Insert, Post Jump Height, Shape of Tibial Insert Post Section, Tibial Insert Post Coronal Profile, Tibial Insert Articular Geometry Conformity Ratio, and Values of Tibial Post Width.
Non-Clinical Testing: FEA assessments for PS femur condyle closing loads, PS femur flange closing loads, and PS femur wedge loading. CAD analysis was completed for range of motion, and testing was completed for post fatigue, contact area, constraint, and lateral subluxation. All testing has determined that the device is substantially equivalent to the predicate devices.
Clinical Testing: None provided.
§ 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.