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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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Biolox® delta 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 and avascular necrosis
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, K021380, K033871)

Interlocking hip stems are indicated for non-cemented application in cases of revision, 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)

Biolox® delta Option Ceramic Heads are designed to be the bearing surface of a total hip joint replacement. A highly polished spherical head in a variety of diameters articulates with a polyethylene liner acetabular component. The modular head attaches to a metallic femoral stem via a taper adapter. Adapters are available for either Biomet's Type I taper or Biomet's 12/14 taper in a variety of neck lengths.

This 510(k) premarket notification describes a medical device, the Biolox® delta Option Ceramic Heads, which is a component of a total hip joint replacement. The document focuses on demonstrating substantial equivalence to previously marketed devices rather than presenting de novo clinical study data to meet specific acceptance criteria for a novel device.

Therefore, many of the requested categories (2-9) regarding specific study details, sample sizes, expert involvement, and ground truthing are not applicable or provided in this 510(k) submission. The core of this submission is non-clinical testing and comparison to predicates.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation of the "Acceptance Criteria" for this type of submission: In a 510(k) submission for substantial equivalence, the "acceptance criteria" are typically defined by regulatory guidance documents and the demonstration that the new device is as safe and effective as a legally marketed predicate device. For the Biolox® delta Option Ceramic Heads, fulfilling all parameters outlined in the "Guidance Document for the Preparation of Pre-Market Notifications for Ceramic Ball Hip Systems" serves as the primary acceptance criterion related to device performance and safety.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not applicable. No clinical test set data from human subjects is presented or required for this type of 510(k). The evaluation relies on non-clinical testing and comparison to predicates.
• Data Provenance: Not applicable. The "testing" mentioned is non-clinical, likely mechanical and material testing, rather than data from human subjects.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

• Not applicable. No expert ground truth establishment for a test set of human data is described as clinical testing was not provided.

4. Adjudication Method for the Test Set

• Not applicable. No clinical test set requiring adjudication is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No. This type of study was not conducted or presented. The submission explicitly states "Clinical Testing: None provided."

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Not applicable. This medical device is a physical implant (ceramic hip head), not an algorithm or AI system.

7. Type of Ground Truth Used

• Not applicable. For this 510(k), the "ground truth" for the device's acceptability is established through conformity to regulatory guidance documents for ceramic hip systems (non-clinical testing) and demonstration of substantial equivalence to predicate devices with established safety and effectiveness records. There isn't a "ground truth" in the clinical sense (e.g., pathology, outcomes data) derived directly from a study for this submission.

8. Sample Size for the Training Set

• Not applicable. This is not an AI/ML device that requires a training set.

9. How the Ground Truth for the Training Set Was Established

• Not applicable.

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