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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)*
*Note - for the USA only

The Biolox® delta component is a traditional, one piece ceramic head indicated 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 Biomet Type I taper. The ceramic heads are available in three sizes, with several offsets.

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 a Type 1 taper or a 12/14 taper. using the associated adapter sleeve.

This document is a 510(k) premarket notification for a medical device called "Biolox® delta Ceramic Heads and Biolox® delta Option Ceramic Heads." This is a regulatory submission to the FDA (Food and Drug Administration) for medical device clearance, not a study report detailing acceptance criteria for an AI/software device.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert adjudication, MRMC studies, and standalone performance for an AI/software device cannot be extracted from this document.

Here's why and what kind of information is present instead:

• Device Type: This document pertains to physical orthopedic implants (ceramic hip components), not a software or AI device. The regulatory pathway (510(k)) is for demonstrating "substantial equivalence" to a legally marketed predicate device, primarily focusing on materials, design, manufacturing processes, and indications for use.
• Focus of the Submission: The submission highlights cumulative changes to already cleared devices, specifically:
  • Manufacturing site transfer
  • Change of sterilization sub-contractor
  • Labeling changes (including Instructions For Use and labels)
  • Packaging changes
  • Inclusion of additional compatible products
• Performance Data: The document explicitly states:
  • Non-Clinical Testing: Includes "Product Compatibility Testing" and "Pyrogenicity Testing."
  • Clinical Testing: "None provided as a basis for substantial equivalence."
• Acceptance Criteria for THIS device: For this type of physical device and submission (510(k) for changes), acceptance criteria would relate to engineering specifications, material properties, biocompatibility, sterilization efficacy, and functional performance (e.g., mechanical strength, wear resistance) as demonstrated by bench testing against established standards or predicate device performance. These specific criteria are not detailed in this summary, but rather the types of testing performed are mentioned.

In summary, this document does not contain the information requested about acceptance criteria and a study proving an AI/software device meets those criteria.

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