(69 days)
Prosthetic replacement of the femoral head associated with a hip prosthesis having a taper compatible with the head taper, and with a prosthetic UHMWPE acetabulum having an inside diameter compatible with that of the head.
The alumina head can only be used with polyethylene inserts.
This prothesis may be used for degenerative ioint disease such as osteoarthritis and avascular necrosis, correction of functional deformity, rheumatoid arthritis, revision procedure where other devices or treatments have failed, congenital dislocation, femoral neck and trochanteric fractures, traumatic arthritis, fused diastrophic variant, slipped capital hip, epiphysis, non-union.
Alumina heads are made of Biolox forte alumina (trademark of CERAMTEC) according to ISO 6474 standard.
Alumina heads have a 12/14 cone and are available in two diameters: 28mm and 32mm, with three offsets: -3.5; 0; +3.5.
This special 510 (k) is being submitted to propose an extension at the 10/12 cone in diameter : 32 mm with three offsets: -3.5; 0; +3.5. This heads are made in HIP Vitox® alumina (trademark of Morgan Advanced Ceramics Ltd according to ISO 6474 standard.
The provided text describes a 510(k) premarket notification for "ALUMINA HEADS," which are ceramic femoral heads for hip prostheses. The submission is an extension for additional cone sizes. The document outlines material characteristics and performance tests, but it does not describe an AI/device acceptance criteria study.
Therefore, many of the requested categories cannot be answered from the provided text.
Here's a breakdown of what can be answered based on the input:
1. Table of Acceptance Criteria and Reported Device Performance
The document references compliance with established standards and FDA guidelines rather than defining specific numerical acceptance criteria.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Material Characteristics | - Compliant with FDA's "Guidance document for the preparation of premarket notifications for ceramic ball hip systems" dated January 10, 1995. |
- 10/12 cone alumina heads reach all requirements set up in this guidance document. |
| Performance - Fatigue Test | - Results in compliance with selected standard (implied, as part of overall performance claim). - All results were in compliance with the requirements set forth by the FDA. |
| Performance - Static Compression Test to Rupture | - Results in compliance with selected standard (implied, as part of overall performance claim). - All results were in compliance with the requirements set forth by the FDA. |
| Performance - Pre-loading of femoral head and extraction force measurement | - Results in compliance with selected standard (implied, as part of overall performance claim). - All results were in compliance with the requirements set forth by the FDA. |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. This is a medical device for orthopedic surgery, not an AI/software device. The tests performed are mechanical in nature, on the device itself, not on data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. (See #2)
4. Adjudication Method for the Test Set
Not applicable. (See #2)
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
Not applicable. This document describes a physical medical device (ceramic femoral head), not an AI algorithm or diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. (See #5)
7. The Type of Ground Truth Used
Not applicable. The "ground truth" for this device's performance is established by its compliance with predefined mechanical performance standards (e.g., ISO 6474) and FDA guidance documents for ceramic hip systems.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This is not an AI/machine learning device.
§ 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.