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The KeYi Total Hip System is designed for total hip arthroplasty. The indications for use are:
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 valga, developmental conditions, metabolic and tumorous conditions, osteoporosis, pseudarthrosis conversion, and structural abnormalities.
The Ke Yi femoral stems are indicated for cementless use. The KeYi acetabular shells are indicated for cemented or cementless use.

The KeYi Total Hip System is a porous-coated, semi-constrained, hip prosthesis designed for either primary or revision hip arthroplasty. The system is comprised of femoral stems and mating metal femoral heads; acetabular shells and mating acetabular liners; optional acetabular cancellous bone screws; and optional acetabular dome hole plug.
The KeYi Femoral Stems are forged titanium alloy, feature a proximal CP Titanium plasma porous coating, and are offered in a range of sizes. The KeYi Femoral Heads are polished cobalt chromium alloy and designed to mate with 12/14 taper of the femoral stem through taperlocking arrangement and to articulate with the acetabular liner. The heads are available in different sizes with various offsets.
The KeYi Acetabular Shells are manufactured from titanium alloy and feature a porous CP Titanium plasma porous coating. The shells feature a dome hole, are available with a two or three-hole pattern for supplemental bone screw fixation, and come in a range of outer diameter sizes. The KeYi Acetabular Liners are manufactured from ultrahigh molecular weight polyethylene (standard/non-crosslinked UHMWPE).
Optional components include threaded acetabular dome hole plugs and acetabular cancellous bone screws, all manufactured from titanium alloy.

The provided text is a 510(k) summary for the KeYi Total Hip System, a medical device. It describes the device's components, intended use, and a summary of non-clinical tests performed to demonstrate substantial equivalence to predicate devices.

However, the document does not contain any information regarding acceptance criteria, study methodologies, or performance data related to AI/algorithm-driven components, human reader performance, or comparative effectiveness studies involving AI assistance.

Therefore, based solely on the provided text, I cannot describe the acceptance criteria and the study that proves the device meets the acceptance criteria in the manner requested. The questions asked, such as those about sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone algorithm performance, and training set details, are relevant to the evaluation of AI/ML-driven medical devices, which is not what this document addresses.

This document focuses on the mechanical and material performance of a physical orthopedic implant (hip replacement system) and its substantial equivalence to established predicate devices, a typical pathway for traditional medical devices.

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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.

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