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

General Indications LINK Endo-Model EVO Knee System: The LINK Endo-Model EVO Knee System is intended for mobility limiting diseases, fractures or defects of the knee joint, distal femur or proximal tibia which cannot be treated by conservative or os- teosynthetic procedures. This device is intended for cemented use only unless a cementless modular stem is indicated for use. Indications: All LINK Endo-Model EVO components: - · Primary and secondary osteoarthritis. - Rheumatoid arthritis. - · Revision after primary or revision total knee replacement. - · Bone necroses which won't compromise the successful implantation of a hinged total knee endoprosthesis. - · Varus and valgus deformity with contracture or laxity of the medial or lateral stabilizers. The LINK Endo-Model EVO Pure Hinge is additionally indicated for: · Extreme cases of varus/valgus deformities (20-30°), theumatoid arthritis, muscular deficiency and any kind of genu laxum. · Oncological and revision surgery in lower limb (in conjunction with the Endo- Model EVO -W and the Megasystem-C) The LINK Endo-Model EVO Rotating Hinge is additionally indicated for: · Oncological and revision surgery in lower limb (in conjunction with the Endo- Model EVO - W and the Megasystem-C) General Indications Link OptiStems: The Link OptiStems are for use with the following LINK knee femoral components, both intracondylar and distal femoral replacement versions: LINK Endo-Model SL. LINK Endo-Model EVO-M. and LINK Endo-Model EVO-W and are indicated for mobility limiting diseases, fractures or defects of the knee joint, distal femur or proximal tibia which cannot be treated by conservative or osteosynthetic procedures. The Link OptiStems cemented are intended for cemented use only. The Link OptiStems cementless are intended for cementless use only. Indications: · Revision arthroplasty due to juxta-articular bone defects. - · Revision of loosened femoral prosthesis components by peri-/subprosthetic fracture. - · Bone deficiencies, e.g. due to tumors, as well as in large post-revision and posttrauma segmental bone defects. · Oncological and revision surgery in the area of the distal femur (in conjunction with Endo-Model SL Rotational and Hinge Knee Prostheses or LINK Endo-Model EVO - M/ - W).

The LINK Endo-Model EVO Knee System is available in multiple versions with different applications, characteristics, and materials. The LINK Endo-Model EVO is a constrained total knee prosthesis, which is based on the previously cleared LINK Endo-Model Knee System (K143179, K152431, K212742), and is considered an evolution ('EVO') of the previous designs. The Knee System is available in two different hinge designs - Rotating Hinge and Non- rotating (Pure) Hinge. Also like the previously cleared system, the subject LINK Endo- Model EVO is available in two versions - LINK Endo-Model EVO Standard and LINK Endo-Model EVO - Modular. The femoral and tibial components of the standard version have fixed stems while the femoral and tibial components of the modular system are available with stems having a taper connection. The modular system includes femoral components with either a male taper or a female taper, and are designated as LINK Endo-Model EVO-M (male taper) and Endo-Model EVO-W ("weiblich" = female taper). The LINK Endo-Model EVO - Standard consists of a cemented monoblock femoral component made from CoCrMo and cPE and a cemented monoblock tibial component made from CoCrMo and an articulating surface made from cPE. The Standard System is available in Rotating Hinge or Pure Hinge. The LINK Endo-Model EVO – M consists of a cemented modular femoral component made from CoCrMo, Ti6A14V (Tilastan) and cPE and a cemented modular tibial component made from CoCrMo, Ti6Al4V (Tilastan) and an articulating surface made from cPE and with modular stems, cemented made from CoCrMo or cementless made from Ti6Al4V (Tilastan). The Modular System is available in Rotating Hinge or Pure Hinge. The LINK Endo-Model EVO – W intracondylar and condylar replacements consists of a cemented modular femoral component made from CoCrMo, Ti6Al4V (Tilastan) and cPE and a cemented modular tibial component made from CoCrMo, Ti6Al4V (Tilastan) and an articulating surface made from cPE and with modular stems, cemented made from CoCrMo or cementless made from Ti6Al4V (Tilastan). The Modular System is available in Rotating Hinge or Pure Hinge. The femoral components can be used with distal and femoral (straight and L-shaped) segments made from Ti6A14V (Tilastan). The modular tibial components can be used with tibial spacers made from Ti6Al4V (Tilastan). The femoral and tibial components Rotating Hinge versions are also available in LINK PorEx (TiNbN) coated version. Additionally a 3-peg patella can be used with the LINK Endo-Model EVO Knee System. It is made from cPE. The LINK Endo-Model EVO Knee System femoral and tibial components are compatible with the previously cleared LINK Endo-Model Knee System (K143179, K152431 and K212742). The femoral components of the LINK Endo-Model EVO – W are compatible with the previously cleared LINK MEGASYSTEM-C (K151008). The LINK Endo-Model EVO Knee System is compatible with previously cleared Tibial and Femoral Cones of Waldemar Link GmbH & Co. KG (K200113 and K201364). The Link OptiStems are an expansion of the modular stem portfolio. The Link OptiStems consist of a modular stem, adapter and fixation screw. The Link OptiStems come in cemented and cementless version. The Link OptiStems have to be joined and implanted in combination with the Femoral Components of LINK Endo-Model SL (K151008) or LINK Endo-Model EVO – M / -W.

The provided text is a 510(k) summary for the LINK Endo-Model EVO Knee System. It details the device description, indications for use, and a comparison to predicate devices, along with performance testing.

However, this document does not describe the acceptance criteria or a study that proves a device meets acceptance criteria in the context of an AI/ML-enabled medical device.

The document states:

• "Clinical performance testing was not required to demonstrate the substantial equivalence of this device." This explicitly indicates that a clinical study, which would typically involve human subjects and the type of performance evaluation (e.g., accuracy, sensitivity, specificity) relevant to AI/ML devices, was not performed.
• The "Performance Testing" section lists non-clinical tests such as "Range of Motion analysis," "Wear analysis," "Particle analysis," "Tibial baseplate component fatigue testing," "Contact area/stress analysis," and "Fretting / Corrosion." These are mechanical and material performance tests typically done for orthopedic implants, not software or AI algorithm performance.

Therefore, I cannot provide the requested information based on the given text. The details about acceptance criteria, test set size, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance, training set, and ground truth establishment are not present in this regulatory submission for a knee implant.

Ask a specific question about this device