(27 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® 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. This submission covers 36mm diameter heads with neck lengths of -3, 0, +3 and +6.
The provided text describes a 510(k) submission for a medical device (36mm Biolox® delta Ceramic Heads), not a study evaluating an AI device or a device that meets acceptance criteria through a performance study. Therefore, most of the requested information cannot be extracted from this document.
However, I can extract information related to non-clinical testing and the absence of clinical testing.
Here's what can be extracted:
- Acceptance Criteria and Reported Device Performance: This document states that "All parameters of the 'Guidance Document for the Preparation of PreMarket Notifications for Ceramic Ball Hip Systems' were met for the devices contained in this 510(k)." This indicates that the device met the non-clinical acceptance criteria outlined in the relevant guidance document. However, the specific parameters and reported performance values are not detailed in this summary.
Table of Acceptance Criteria and Reported Device Performance (Based only on the provided text):
| Acceptance Criteria Category | Specific Criteria (from document) | Reported Device Performance (from document) |
|---|---|---|
| Non-Clinical Testing | Parameters in "Guidance Document for the Preparation of PreMarket Notifications for Ceramic Ball Hip Systems" | "All parameters of the 'Guidance Document for the Preparation of PreMarket Notifications for Ceramic Ball Hip Systems' were met." |
Information that CANNOT be extracted from the provided text:
- Sample sizes used for the test set and the data provenance: Not applicable, as no clinical or AI-based performance study is mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- 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. This is a hip implant, not an AI-assisted diagnostic device.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable for a traditional medical device submission without AI or clinical outcome studies detailed.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
Summary of what was found about the "study" (non-clinical testing):
- Clinical Testing: "None provided" - explicitly stated that no clinical testing was performed for this 510(k) submission.
- Non-Clinical Testing: "All parameters of the 'Guidance Document for the Preparation of PreMarket Notifications for Ceramic Ball Hip Systems' were meet for the devices contained in this 510(k)." This indicates regulatory compliance through in-vitro or bench testing as per guidance documents, not an AI or clinical performance study. The specific "study" is therefore the non-clinical testing performed to satisfy the guidance document, but details of this testing are not provided in the summary.
§ 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.