(234 days)
Biolox® delta Ceramic Heads are indicated for use in total hip replacement with cemented or non-cemented femoral and acetabular components in cases of:
- Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
- Rheumatoid arthritis
- Correction of functional deformity
- Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques.
- 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:
| Acceptance Criterion (Non-Clinical) | Reported Device Performance |
|---|---|
| All parameters of the "Guidance Document for the Preparation of PreMarket Notifications for Ceramic Ball Hip Systems" were met | All parameters were met. |
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.
§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.
(a)
Identification. A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.(b)
Classification. Class II.