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1. Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis
2. Rheumatoid arthritis
3. Correction of functional deformity
4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques
5. Revision procedures where other treatment or devices have failed

Porous acetabular shells and femoral stems are indicated for uncemented biological fixation. Non-coated or polyethylene components may be used with mating components that are indicated for either cemented use.

Indications for G7® Vivacit-E® Freedom® Constrained Liner:

The G7® Vivacit-E® Freedom® Constrained Liner is indicated for use as a component of a total hip prosthesis in primary and revision patients at high risk of distory of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease, or intraoperative instability, and for whom all other options to constrained acetabular components have been considered.

The G7 Acetabular System currently offers a constrained Vitamin E infused highly crosslinked ultra high molecular weight polyethylene (UHMWPE) liner, branded E1 polyethylene, with a preassembled titanium alloy constraining ring. The constrained liner is designed for use in primary or revision total hip arthroplasty (THA) patients that are at a greater risk of dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease, or intraoperative instability.

Zimmer Biomet has designed and developed a new constrained liner for use within the G7 Acetabular System, the G7® Vivacit-E® Freedom® Constrained Liner. The purpose of this submission is to obtain clearance for this new constrained liner.

The provided text describes the 510(k) submission for the G7® Vivacit-E® Freedom® Constrained Liner, a medical device for total hip arthroplasty. The document does not contain information about acceptance criteria or a study that proves the device meets those criteria in the context of a diagnostic AI/ML device.

Instead, the document focuses on demonstrating substantial equivalence to a predicate device, which is a common pathway for medical device approval in the United States. This involves comparing the new device's characteristics and performance to a legally marketed predicate device.

Therefore, I cannot extract the requested information from the provided text for the following reasons:

• No acceptance criteria for an AI/ML device are described. The document pertains to a physical orthopedic implant, not a diagnostic AI/ML software. Acceptance criteria for mechanical implant devices typically involve benchmarks for physical properties, wear, and mechanical strength, which are mentioned in the "Summary of Performance Data," but these are not the type of diagnostic performance metrics expected for an AI/ML device.
• No study proving diagnostic performance is detailed. The studies listed are engineering performance tests for a physical implant (e.g., insertion energy, torque out, wear testing, fatigue testing, range of motion), not studies to assess diagnostic accuracy, sensitivity, or specificity of an AI/ML algorithm.
• No information on ground truth, expert consensus, or training/test sets for an AI/ML model is present. These concepts are not applicable to the type of device described in the document.

In summary, the provided document does not align with the request to describe acceptance criteria and a study for an AI/ML diagnostic device. It describes a traditional medical device (a hip implant component) and its substantial equivalence submission to the FDA.

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