(60 days)
Joint replacement is indicated for patients suffering from disability due to:
- . noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis of the natural femoral head;
- rheumatoid arthritis; .
- correction of functional deformity;
- . femoral fracture
This device may also be indicated in the salvage of previously failed surgical attempts.
The modification consists of a new material used in the manufacture of the Biolox® Ceramic Femoral Heads. The femoral heads, manufactured from Biolox® delta* material, are fabricated from an alumina matrix composite. The standard femoral head with a femoral stem through a taper fit. The Option femoral head includes a sleeve that is inserted into the head and attached to the femoral stem through a taper fit. The heads will be available in sizes 22, 28, 32, 36, 40 and 44mm.
The provided document is a 510(k) summary for a medical device, the Biolox® Ceramic Femoral Head. It describes the device, its intended use, and its comparability to predicate devices. However, this document does not contain information about:
- Acceptance criteria in terms of performance metrics
- A study proving the device meets acceptance criteria
- Sample sizes for test sets or training sets
- Data provenance
- Ground truth establishment or number/qualifications of experts
- Adjudication methods
- Multi-reader multi-case (MRMC) studies or standalone algorithm performance.
The document states: "Non-Clinical Testing: Mechanical testing has demonstrated the device's ability to perform under expected clinical conditions. Clinical Testing: None provided."
Therefore, I cannot provide the requested information from the given text. The information below is based solely on the explicit statements in the provided K082844 submission:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Performance Metric) | Reported Device Performance |
|---|---|
| No specific performance acceptance criteria are mentioned for the device in the provided text. | The document states: "Mechanical testing has demonstrated the device's ability to perform under expected clinical conditions." No specific quantitative performance metrics or results from this mechanical testing are reported. |
2. Sample size used for the test set and the data provenance
No test set for performance evaluation (e.g., related to AI or diagnostic accuracy) is mentioned as no clinical testing was provided. The "Non-Clinical Testing" refers to mechanical testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable, as no test set requiring ground truth establishment by experts is described for AI or diagnostic performance.
4. Adjudication method for the test set
Not applicable, as no test set requiring adjudication is described.
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
No MRMC study was reported. This submission does not involve an AI device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable, as this submission does not involve an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable, as no ground truth for AI or diagnostic performance was established.
8. The sample size for the training set
Not applicable, as this submission does not involve a machine learning model with a training set.
9. How the ground truth for the training set was established
Not applicable, as this submission does not involve a machine learning model with a 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.