(187 days)
TGM Biolox® delta Ceramic Heads are indicated for use in total hip replacement with cemented or non-cemented femoral and acetabular components of compatible TGM Medical systems in cases of:
A. Significantly impaired joints resulting from rheumatoid, osteo, and post-traumatic arthritis.
B. Revision of failed femoral head replacement, cup arthroplasty or other hip procedures.
C. Proximal femoral fractures.
D. Avascular necrosis of the femoral head.
E. Non-union of proximal femoral neck fractures.
F. Other indications such as congenital dysplasia, arthrodesis conversion, coxa plana, coxa vara, coxa valea, developmental conditions, metabolic and tumorous conditions, osteomalacia, pseudarthrosis conversion, and structural abnormalities.
The Biolox® delta Ceramic Heads are modular femoral components used in hip arthroplasty. The head attaches to a femoral stem via a 12/14 Morse taper and articulates with a polyethylene acetabular component. The ceramic material is Transition-Toughened-Platelet Alumina (TTPA) consisting of 75% Alumina, 24% Zirconia and 1% Platelet. The heads are available in three diameters (28, 32 & 36mm) and a variety of offsets.
I am sorry, but based on the provided document, there is no information available regarding acceptance criteria or a study that proves a device meets such criteria to address your detailed request about performance, sample size, ground truth, or expert involvement in a medical device study.
The document is a 510(k) premarket notification summary for "TGM Biolox® delta Ceramic Heads." It primarily focuses on demonstrating substantial equivalence to predicate devices for marketing authorization, not on providing detailed performance studies against specific acceptance criteria.
Specifically, under "Clinical testing," the document explicitly states: "Clinical testing was not required to demonstrate substantial equivalence in this premarket notification."
Therefore, I cannot extract the information required to populate a table of acceptance criteria, describe a study on device performance, or detail aspects like sample size, ground truth, or expert involvement, as these were not part of the submission described.
§ 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.