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1. Non-inflammatory 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 of previously failed total hip arthroplasty.
6. Dislocation risks.

The Active Articulation Hip Bearings and G7 Metal Liners are single-use implants, intended for uncemented applications.

The G7 Dual Mobility System and Active Articulation System are dual articulation systems wherein there are two articulating surfaces in the same joint space. The systems include an Active Articulation polyethylene (UHMWPE) bearing which is assembled over a femoral head. The femoral head articulates on the inner, concave surface of the bearing. The resultant assembly then articulates within a metal liner (G7 Dual Mobility System) or acetabular shell (Active Articulation System). The G7 Dual Mobility and Active Articulation Systems are designed for both primary and revision surgeries, where all device components associated with the wear couple are removed and replaced.

This document is a 510(k) premarket notification from the FDA regarding a hip joint prosthesis (G7 Dual Mobility System, Active Articulation System). It is not about an AI/ML medical device. Therefore, the information requested about acceptance criteria and a study proving an AI/ML device's performance is not available in this document.

The document discusses the substantial equivalence of the hip prosthesis to already marketed predicate devices based on:

• Identical Intended Use and Indications for Use: (e.g., non-inflammatory degenerative joint disease, rheumatoid arthritis, correction of functional deformity, etc.)
• Identical Materials: The materials of the new components are the same as predicates.
• Identical Design Features: No design changes from originally cleared predicate devices.
• Identical Sterilization Methods and Processes.
• Performance Data: This refers to mechanical and physical performance tests for the hip implant itself, not an AI algorithm.

Here's why the requested information cannot be provided from this document:

• No AI/ML Component: The device described is a physical medical implant (hip prosthesis). There is no mention of any artificial intelligence or machine learning component.
• No Diagnostic/Predictive Function: The device's function is mechanical replacement of a hip joint, not diagnostic imaging analysis, risk prediction, or any other function typically associated with AI/ML medical devices.
• Performance Data is for Physical Attributes: The "Summary of Performance Data" explicitly lists engineering analyses and physical tests such as "Wear Justification Reports ISO 7206-2: 2011," "Interference Fit Analyses," "Push-in, Pull-out, Lever-out Analysis - ASTM F1820-13," and "Range of Motion Analyses – ISO 21535:2007." These are all standard tests for a physical implant.

In summary, this document does not contain the information needed to answer your questions about acceptance criteria and a study proving an AI/ML device meets those criteria because the device in question is a mechanical implant, not an AI/ML product.

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