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The Biolox® delta Ceramic Heads and Biolox® delta Option Ceramic Heads are indicated for use in total hip replacement with cemented or non-cemented femoral and acetabular components in cases of:

1. Non-inflammatory degenerative joint disease including osteoarthritis, avascular necrosis and traumatic arthritis.
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 procedures where other treatment or devices have failed.

Specific indications for compatible components that can be used with the above modular heads include:
Salvage/Oncology Hip and Total Femur System components are also indicated for cases of ligament deficiency, tumor resection, trauma and revision of unsuccessful osteotomy or arthrosis. (K974558. K002757. K0213871)
Interlocking hip stems are indicated for non-cemented application, trauma, fracture, oncology or other situations where severe proximal bone loss may compromise the fixation and stability of a standard-type hip replacement prosthesis. (K990830, K042774)

The Biolox® delta component is a traditional, one-piece, ceramic head for primary hip arthroplasty. The material for the device is Zirconia-Platelet Toughened Alumina (ZPTA) 75% Alumina, 24% Zirconia, and 1% Platelet. The highly polished spherical surface articulates with a polyethylene liner acetabular component. The modular head attaches to a metallic femoral stem with a Type 1 taper. The ceramic heads are available in three sizes, with several offsets. There have been no changes in design or part numbers since their previous clearance in K192683.

The Biolox® delta Option component is a modular ceramic head with a Type I or 12/14 adapter sleeve, indicated for primary or revision hip arthroplasty. The material for the device is Zirconia-Platelet Toughened Alumina (ZPTA) 75% Alumina, 24% Zirconia, and 1% Platelet. The highly polished spherical surface articulates with a polyethylene liner acetabular component. The modular head attaches to any Biomet metallic femoral stem with either a 12/14 or Type 1 taper, using the associated adapter sleeve. There have been no changes in design or part numbers since their previous clearance in K192683.

The provided text is a 510(k) summary for a medical device (Biolox® delta Ceramic Heads), primarily focusing on the addition of MR Conditional labeling. It does not describe a study involving the performance of an AI/algorithm-based device that would have "acceptance criteria" related to diagnostic accuracy, sensitivity, specificity, or similar metrics.

Therefore, I cannot fill out the requested table or answer the questions regarding acceptance criteria and performance studies in the context of an AI device. The document describes physical tests for MR compatibility (RF-induced heating, image artifact, magnetic displacement) for a ceramic hip implant component, and asserts substantial equivalence to a predicate device based on identical intended use, indications, materials, design, and sterilization.

There is no mention of:

• Acceptance criteria for an AI/algorithm's performance.
• A test set with ground truth.
• Experts establishing ground truth.
• Adjudication methods.
• MRMC studies or human-in-the-loop performance.
• Standalone algorithm performance.
• Training sets or their ground truth establishment.

The document's purpose is to demonstrate the MR compatibility of a physical implant and its substantial equivalence to a previously cleared implant, not to evaluate an AI's diagnostic performance.

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