(59 days)
The hip joint metal uncemented prosthesis is intended to replace a hip joint. The device is intended for primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intraoperative instability and for whom all other options to constrained acetabular components have been considered.
Joint replacement is indicated for patients suffering from disability due to:
- noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis of the natural femoral head;
- rheumatoid arthritis;
- correction of functional deformity;
- femoral fracture; and
- revision procedures where other treatments or devices have failed.
This stem is to be press-fit. This stem is intended for cementless use.
The EMPOWR™ blade stem represents the latest generation of a press-fit, porous coated, wedge style femoral stem. Building on the design principles of its predicate, Linear® Hip Stem, the EMPOWR™ blade stem system features enhancements such as addition of coxa vara offset, neck angle update, and distal angle reduction for wider application.
The EMPOWR™ blade stem is applicable for use in total hip arthroplasty and the prosthetic replacement of femoral neck fractures in all age groups. It offers a stem design with a reproducible surgical technique carefully developed to enable consistent and accurate implantation. The EMPOWR™ blade stem features streamlined and accurate instrumentation that is highly adaptable to any surgical approach.
I am sorry, but the provided text from the FDA 510(k) Pre-market Notification does not contain the detailed information necessary to fully answer your request. The document describes a medical device, the EMPOWR™ blade stem, and its substantial equivalence to predicate devices based on technological characteristics and performance testing.
However, it explicitly states:
- "No animal data submitted."
- "No clinical data submitted."
This indicates that the submission did not include studies involving human or animal subjects to evaluate the device's performance in a clinical setting, nor did it involve an AI/ML component. Therefore, there is no information in this document regarding:
- Acceptance criteria related to AI/ML performance metrics (e.g., sensitivity, specificity, AUC).
- Any "AI-assisted" studies or "standalone" algorithm performance.
- Sample sizes for test or training sets related to AI models.
- Ground truth establishment by experts, adjudication methods, or MRMC studies.
The performance testing mentioned (CAD Based Range of Motion, Distal Stem Fatigue, Neck Stem Fatigue) refers to mechanical and physical performance of the implant itself, not the performance of a diagnostic or AI-driven system.
In summary, this document is a 510(k) submission for a hip implant, not an AI/ML medical device, and therefore does not contain the information you are seeking regarding AI acceptance criteria and study data.
§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.
(a)
Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis is a device intended to be implanted to replace a hip 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 has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II.