(50 days)
The Foundation® Porous Hip Stem is intended for treatment of patients who are candidates for total hip arthroplasty because of degenerative joint disease including osteoarthritis and avascular necrosis: rheumatoid arthritis: correction of functional deformity: revision procedures where other treatments or devices have failed; and treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement, which is unmanageable using other techniques. It is intended to be used in a cementless mode.
The Foundation® Porous Hip Stem is fabricated from wrought/forged Ti-6A1-4V that conforms to ASTM F136. The outside surface of the stem is porous coated with commercially pure titanium (ASTM F67 grade 2) beads.
The Foundation® Porous Hip Stem is available with and without a calcar collar and has a Morse type taper to receive modular heads.
This document is a 510(k) premarket notification for a medical device, the Foundation® Porous Hip Stem - Size 8mm. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the way a diagnostic AI study would.
The provided text describes a submission for a hip stem prosthesis, which is a physical implant, not a diagnostic AI device. Therefore, a study focused on typical AI performance metrics like sensitivity, specificity, or reader improvement is not relevant to this type of medical device submission.
Instead, the "Test Results" section states: "Testing on this device included finite element analysis." This indicates that the evaluations done for this device likely focused on:
- Biocompatibility: Ensuring the materials are safe for implantation in the human body.
- Mechanical Strength and Durability: Assessing how well the implant can withstand the stresses of walking, running, and other activities over time. Finite Element Analysis (FEA) is a common method for this.
- Sterility: Verifying that the device is free from harmful microorganisms.
- Design Validation and Verification: Ensuring the device meets its design specifications and performs as intended.
Without a detailed engineering report or design validation plan, specific acceptance criteria for a hip stem (e.g., minimum fatigue life cycles, maximum stress under load, acceptable wear rates) and the explicit results proving these are met cannot be extracted from this summary.
Therefore, I cannot fulfill the request as it pertains to AI-specific acceptance criteria and studies. The document describes a traditional medical device (hip implant) submission, not an AI/ML device.
§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.
(a)
Identification. A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.(b)
Classification. Class II.