(55 days)
The DJO EMPOWR POROUS FEMUR WITH HAnano Surface™ is indicated for use in total knee arthroplasty patients, receiving total joint replacement because of disability or suffering 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. The device is intended for uncemented 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 Porous Femur with HA"™ Surface is a line extension to the EMPOWR Knee Platform and EMPOWR Porous Knee Platform (cleared via K143242 and K171991), to include a hydroxyapatite-coated porous femoral component in the system.
The EMPOWR Porous Femur with HA"" Surface™ has an adjunct hydroxyapatite (HA) coating on the 3D Matrix® porous coating inside the cement pocket. Since the device is porous coated, it is indicated for cementless use.
This document, K210308, is a 510(k) Premarket Notification for a medical device. It describes a new iteration of a total knee implant, the EMPOWR POROUS FEMUR with HAnano Surface™. The document focuses on demonstrating substantial equivalence to a predicate device, as clinical testing was not required for this submission. Therefore, the information provided primarily concerns non-clinical testing and comparisons, rather than a detailed study proving the device meets an extensive set of acceptance criteria through clinical trials.
Based on the provided text, here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
As this is a 510(k) submission, the "acceptance criteria" are primarily related to demonstrating substantial equivalence through non-clinical testing, rather than explicit performance metrics derived from a clinical trial with pre-defined success/failure thresholds. The reported performance is framed in terms of meeting these comparison points.
| Acceptance Criteria Category | Reported Device Performance/Conclusion |
|---|---|
| Material Composition | Substrate material is identical to the EMPOWR Porous Femur predicate. |
| Articulating Geometry | Identical to the EMPOWR Porous Femur predicate. |
| Articulating Surface Roughness | Identical to the EMPOWR Porous Femur predicate. |
| Porous Coating | Identical to the EMPOWR Porous Femur predicate (3D Matrix® porous coating). |
| Bone-Facing Geometry | Identical to the EMPOWR Porous Femur predicate. |
| Hydroxyapatite (HA) Coating | Added HA™ Coating (HAnano Surface™) to the 3D Matrix® porous coating on the bone-facing side. This specific HA™ coating has been utilized in previously cleared dental and spinal applications (K101225, K170392, K190025, K201614). The application process is analogous to previously cleared products. |
| Abrasion Resistance | Testing performed, demonstrating its ability to perform under expected conditions. (Specific quantitative acceptance criteria or results are not provided). |
| Pin-on-Disk Wear | Testing performed, demonstrating its ability to perform under expected conditions. (Specific quantitative acceptance criteria or results are not provided). |
| Cleanability | Testing performed, demonstrating its ability to perform under expected conditions. (Specific quantitative acceptance criteria or results are not provided). |
| Femur Fatigue | Prior mechanical testing (for the predicate device with identical geometry) demonstrated the device's ability to perform under anticipated clinical conditions. |
| Contact Area | Prior mechanical testing (for the predicate device with identical geometry) demonstrated the device's ability to perform under anticipated clinical conditions. |
| Bacterial Endotoxin | Acceptance criterion: 20 EU/device. Testing performed per USP and ANSI/AAMI ST72. (Results are not explicitly stated, but implied to have met the criterion for substantial equivalence). |
| Overall Substantial Equivalence Determination | All testing and evaluations demonstrate that the device is substantially equivalent to the predicates identified. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable in the context of human clinical data for this 510(k) submission. The "test set" here refers to non-clinical laboratory tests on device components or full devices. The document does not specify the number of samples used for each non-clinical test (e.g., how many devices were subjected to abrasion testing).
- Data Provenance: The data comes from non-clinical laboratory testing performed by the manufacturer, DJO Surgical (Legal Name: Encore Medical, L.P.). The document does not specify the country of origin for these lab tests, but it is implied to be internal testing or contracted testing performed under the manufacturer's oversight. The testing is not retrospective or prospective clinical data, but rather bench and material testing.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
- This question is not applicable as there was no "ground truth" derived from human experts for a clinical test set. The
ground truthin this context would be the results of the non-clinical tests (e.g., passing or failing a fatigue test, measured wear rates). These results are obtained through standardized testing protocols, not expert consensus on medical images or patient outcomes.
4. Adjudication Method for the Test Set
- This question is not applicable. There was no human "test set" in need of adjudication. The non-clinical tests have objective outcomes based on established methods and criteria.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Improvement with AI vs. Without AI Assistance
- Not applicable. This device is a medical implant (total knee prosthesis), not an AI-assisted diagnostic or therapeutic tool for which an MRMC study would be relevant. No AI component is described in the provided text.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Not applicable. This is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
- As discussed, "ground truth" here refers to the outcomes of the non-clinical tests. The types of "ground truth" used are:
- Engineering Test Results: Measurements from abrasion testing, pin-on-disk wear testing, fatigue testing, contact area testing.
- Biocompatibility/Safety Testing: Bacterial endotoxin assessment results compared against pre-defined specifications (20 EU/device).
- Material and Geometric Specifications: Confirmation that the new device's substrate material, geometry, and porous coating are identical to the predicate.
- Predicate Device Performance: Reliance on the previously cleared predicate's mechanical testing results for identical geometries.
8. The Sample Size for the Training Set
- Not applicable. There is no "training set" in the context of this 510(k) submission as it does not involve machine learning or AI.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. See point 8.
§ 888.3565 Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial metal/polymer porous-coated uncemented 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 is designed to achieve biological fixation to bone without the use of bone cement. This identification includes fixed-bearing knee prostheses where the ultra high molecular weight polyethylene tibial bearing is rigidly secured to the metal tibial base plate.(b)
Classification. Class II (special controls). The special control is FDA's guidance: “Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA.” See § 888.1 for the availability of this guidance.