Search Results

Total 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;

This device may also be indicated in the salvage of previously failed surgical attempts where bone loss may require the use of augments, sleeves cones or extensions.

The EMPOWR Revision Knee™ Symmetric Cones are indicated for the following conditions:

EMPOWR™ Revision Knee™ Symmetric Cones are indicated for use in skeletally mature patients with bone defect or poor bone quality (osteoporotic bone) or in case of sclerotic bone that requires supplemental fixation in the clinical judgment of the surgeon.

EMPOWR™ Revision Knee™ Symmetric Cones are indicated for uncemented fixation to the bone and are fixed to the femoral and tibial implants using bone cement.

Envois is adding a non-mating modular component accessory to the EMPOWR™ Knee product line and is compatible with the EMPOWR Revision Knee™ Femur (K213793), the EMPOWR PS Knee® Femur (K160342), the EMPOWR ™ Universal Tibial Baseplate (K173723), and the EMPOWR™ Knee Cemented Stems and Extender Accessories (K173723, K213793, and K230441).

The EMPOWR Revision Knee™ Symmetric Cone implants (also known as Cones) are an optional accessory in primary or revision Total Knee Arthroplasty. The Cones are sterile, single-use device that are compatible for use with the EMPOWR Revision Knee™ components. The EMPOWR™ Cones are composed of Ti6Al4V alloy per ASTM F1472 and contain a modified surface composed of commercially pure titanium per ASTM F67. This modified surface (i.e. porous coating) is exactly the same as applied to existing FMP™ Porous Coated Acetabular Shells (K072888).

The EMPOWR Revision Knee™ Symmetric Cones are intended to the mating femoral and/or tibial component using bone cement. The cones are intended for fixation as an assembled construct in the distal femur and/or proximal tibia, without bone cement.

The provided text describes a 510(k) premarket notification for a medical device, EMPOWR Revision Symmetric Knee Cones. It details the device's indications for use, comparison to predicate devices, and the types of testing performed to demonstrate substantial equivalence.

However, the document does not contain information about the acceptance criteria and the study that proves the device meets the acceptance criteria in the context of an AI/ML medical device. The product is a physical knee implant accessory, not an AI/ML software device. Therefore, the questions related to AI/ML device performance (such as sample sizes for test sets, expert ground truth establishment, MRMC studies, standalone algorithm performance, training set details, etc.) are not applicable to this submission.

The document states:

• "No animal data submitted."
• "No clinical data submitted."

Instead, substantial equivalence is demonstrated through:

• Biocompatibility testing: In accordance with FDA guidance and ISO 10993 standards.
• Performance Testing:
  • Dynamic Fatigue Testing: ASTM F1800-19e1 (modified)
  • MR Conditional Labeling: ASTM F2052 -21, ASTM F2213-17, ASTM F2119-07(2013), ASTM F2182-10e2, ASTM F2503-20

Therefore, I cannot provide the requested information regarding acceptance criteria and study details relevant to an AI/ML medical device based on the provided text.

Ask a specific question about this device