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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 also indicated for cases of ligament deficiency, tumor resection, trauma and revision of unsuccessful osteotomy or arthrosis.
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.

The 100 kGy E-Poly™ Acetabular Liners are intended for cemented and uncemented applications with the following indications for use:

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 of previously failed total hip arthroplasty.

Biolox® delta Ceramic Heads are designed to be the bearing surface of a total hip joint replacement. 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 100 kGy E-Poly™ acetabular liners for the Biolox® delta Ceramic Heads are a larger size of the previously cleared 100 kGy E-Poly™ liners, K070364 and K070399.

This document is a 510(k) summary for a medical device (Biolox® delta Ceramic Heads with 100kGy E-Poly™ Acetabular Liners) and does not contain information about acceptance criteria or a study proving that the device meets those criteria, as typically found in clinical studies of AI/software devices.

Instead, this document describes:

• Device Description and Indications for Use: The purpose and intended applications of the hip replacement components.
• Substantial Equivalence Claim: The device's technological similarity to previously cleared predicate devices (K042091, K051411, K061312 for ceramic heads; K070364, K070399 for acetabular liners).
• Non-Clinical Testing Confirmation: It states that all parameters of the "Guidance Document for the Preparation of PreMarket Notifications for Ceramic Ball Hip Systems" were met. This is a crucial point regarding "acceptance criteria" in this context; however, the specific acceptance criteria (e.g., mechanical strength thresholds, wear rates, biocompatibility standards) and the detailed results of the non-clinical tests are not provided in this summary.

Therefore, I cannot provide a response filling in the requested table and study details (sample size, experts, adjudication, MRMC, standalone performance, ground truth, training set) because the provided text does not contain this information.

The 510(k) summary focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and established non-clinical testing guidelines, rather than presenting a clinical study with new performance metrics against specific acceptance criteria for a novel AI/software device.

Ask a specific question about this device

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.

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.

Biolox® delfa Ceramic Heads are designed to be the bearing surface of a total hip joint replacement. 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. This submission covers 28mm diameter heads with neck lengths of -3, 0, +3 and +5 and 32mm diameter heads with neck lengths of -3, 0, +3 and +6.

The Biomet Biolox® delta Ceramic Heads device is a modular ceramic head intended for use in total hip replacement. The provided documentation does not include any clinical or standalone performance studies against a set of acceptance criteria. Instead, the submission relies solely on non-clinical testing to demonstrate substantial equivalence to predicate devices.

Here's a breakdown based on the provided information:

1. A table of acceptance criteria and the reported device performance:

Since no clinical study was performed or reported, a table of acceptance criteria and reported device performance related to diagnostic accuracy, sensitivity, specificity, or similar metrics (which are typical for AI-powered devices) cannot be created from the provided text.

The closest information provided is about meeting non-clinical testing parameters:

This indicates that the device met the established engineering and materials performance standards for ceramic hip systems, likely related to strength, wear, biocompatibility, etc.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Not applicable. No clinical test set or data from human subjects was used for this 510(k) submission. The testing was entirely non-clinical (laboratory/mechanical testing).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

Not applicable. No clinical test set requiring expert ground truth establishment was conducted. The ground truth for the non-clinical testing would be derived from established engineering standards and measurements.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. No clinical test set requiring adjudication was conducted.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. No MRMC study was done, as this is a physical medical device (ceramic hip head), not an AI-powered diagnostic tool. The submission states, "Clinical Testing: None provided."

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This is a physical implantable device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

For the non-clinical testing, the "ground truth" would be the established performance specifications and material properties defined in the "Guidance Document for the Preparation of Pre-Market Notifications for Ceramic Ball Hip Systems." This would involve physical measurements and tests conforming to recognized standards (e.g., ISO standards for implants).

8. The sample size for the training set:

Not applicable. There was no "training set" in the context of machine learning or AI algorithms, as this is a physical device.

9. How the ground truth for the training set was established:

Not applicable, as there was no training set.

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