(90 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 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.
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.
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.
§ 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.