(212 days)
The INTRAPLANT Ceramic Head Prostheses is intended for use in total hip arthroplasty. The indications for use of the total hip replacement prosthesis include: degenerative joint disease including osteoarthritis and avascular necrosis; rheumatoid arthritis; correction of functional deformity; revision procedure where previous 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.
The INTRAPLANT Ceramic Head Prostheses are to be used only with SL-PLUS® and SLR-PLUS® hip stems.
The INTRAPLANT Ceramic Head Prostheses are manufactured by METOXIT AG (alumina and zirconia). Both come with the standard taper cone 12/14 in six sizes, 28mm (S, M, L) and 32mm (S, M, L).
The provided text is a 510(k) summary for a medical device called INTRAPLANT Ceramic Head Prostheses. This document describes the device, its intended use, and substantial equivalence to previously marketed devices. It does not contain information about the acceptance criteria for a study, nor does it present a study proving the device meets specific performance criteria in the way typically required for AI/ML or diagnostic devices.
The relevant section, "Performance data," states only: "Biomechanical testing has been provided." This is a very high-level statement and does not include any specifics about:
- Specific acceptance criteria (e.g., minimum force, wear rates, fatigue life)
- The results of biomechanical testing against those criteria
- Sample sizes, data provenance, ground truth establishment, or expert involvement as would be relevant for software or diagnostic device studies.
Therefore, I cannot fulfill the request as it pertains to acceptance criteria and a study proving their fulfillment for the INTRAPLANT Ceramic Head Prostheses based solely on the provided text. The information requested (Table of acceptance criteria, sample sizes, experts, adjudication, MRMC, standalone, ground truth, training set information) is entirely absent from this 510(k) summary.
§ 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.