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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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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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Partial replacement of the articulating surfaces of the knee when only one side of the knee joint is affected due to the compartmental primary degenerative or post-traumatic degenerative disease, previous tibial condyle or plateau fractures, deformity or revision of previous partial arthroplasty in the affected compartment.

The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implanted with bone cement.

The Oxford Femoral components are indicated for use in the lateral compartment for a fixed bearing application. They are intended to be implanted with bone cement.

The Oxford Fixed Lateral Bearing Partial Knee Replacement is a partial knee replacement option that consists of a femoral component (single and twin peg versions) manufactured from CoCrMo (ASTM F-75), a tibial tray/plate manufactured from CoCrMo (ASTM F-75), and a fixed tibial bearing of direct compression molded (DCM) polyethylene (UHMWPE) conforming to ASTM F-648 which is molded onto the tibial tray.

The document is a 510(k) Summary for the Oxford® Fixed Lateral Bearing Partial Knee Replacement, seeking substantial equivalence to a previously cleared device (K122277). The modification is a design change to add a chamfer to the anterior corner of the tibial bearing, resulting in asymmetric left and right configurations.

Here's an analysis of the provided information regarding acceptance criteria and the study:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria for performance measures. Instead, the "performance data" section focuses on demonstrating substantial equivalence through non-clinical testing. The conclusion reached is that the subject construct is "substantially equivalent to legally marketed devices offering a reasonable assurance of safety and effectiveness."

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

The document states "Non-clinical performance testing included cadaver evaluation and MRI justification."

• Sample Size for Test Set: Not explicitly stated as a number of samples or subjects. It only mentions "cadaver evaluation," implying a limited set of cadaver knees were used.
• Data Provenance: The cadaver evaluation would be considered prospective data collection for the specific purpose of this evaluation. The country of origin for the cadavers is not specified. MRI justification likely refers to engineering analysis or imaging studies to demonstrate the design change.

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.

4. Adjudication Method for the Test Set

• Adjudication Method: Not specified. Given it's a cadaver evaluation for a mechanical device modification, formal clinical adjudication methods like 2+1 or 3+1 are unlikely to have been employed in the same way they would for diagnostic imaging studies. The evaluation would likely have been conducted by biomechanical engineers or orthopedic surgeons.

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

• MRMC Study Done? No. The product is a knee implant, not a diagnostic imaging AI algorithm that would typically undergo MRMC studies.

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

• Standalone Study Done? Not applicable. This is a physical medical device (knee implant), not an AI algorithm. The performance evaluation focuses on the mechanical and functional aspects of the implant itself, primarily through non-clinical testing.

7. Type of Ground Truth Used

• Type of Ground Truth: The "ground truth" for this device modification is established through physical and mechanical evaluation (cadaver evaluation), engineering justification, and comparison to the safety and effectiveness profile of the legally marketed predicate device. The goal is to show the modified device functions as intended without introducing new safety or effectiveness concerns, akin to demonstrating physical equivalence.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This is a physical medical device, not an AI algorithm that requires a training set in the conventional sense. The "training" for the design comes from extensive biomechanical and materials science knowledge, as well as experience with the predicate device.

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

• How Ground Truth for Training Was Established: Not applicable. See point 8. The design process for a physical device relies on established engineering principles, material properties, biomechanical considerations, and clinical experience with similar devices, rather than a "ground truth" derived from a specific "training set" of data.

In summary: This document pertains to a 510(k) submission for a physical medical device (a knee implant modification), not a software or AI-driven diagnostic device. Therefore, many of the typical acceptance criteria and study components relevant to AI/software performance (like human reader studies, training/test sets, expert adjudication for image interpretation) are not applicable or described in this type of submission. The focus is on demonstrating "substantial equivalence" through non-clinical (cadaver and engineering) testing to a predicate device.

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