(111 days)
Prosthetic replacement of the femoral head associated with a hip prosthesis having a taper compatible with the head taper, and with a prosthetic acetabulum having an inside diameter compatible with that of the head. The alumina head can only be used with polyethylene inserts. This prosthesis may be used for degenerative joint 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 hip, diastrophic variant, slipped capital epiphysis, non-union.
Alumina heads are made of Biolox forte alumina (trademark of CERAMTEC) according to ASTM F 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.
Here's an analysis of the provided text, focusing on the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Test Performed) | Reported Device Performance |
|---|---|
| Fatigue test (to rupture) | In compliance with FDA requirements / selected standard |
| Static compression test (to rupture) | In compliance with FDA requirements / selected standard |
| Static compression test (at 2000 N) | In compliance with FDA requirements / selected standard |
| Head extraction force measurement | In compliance with FDA requirements / selected standard |
| Material characteristics (adherence to FDA guidance "Guidance document for the preparation of prematerial notifications for ceramic ball hip systems" dated Jan 10, 1995) | All requirements set forth in the guidance document were met. |
| Compliance with ASTM F 6474 (for Biolox forte alumina) | Alumina heads are made of Biolox forte alumina according to ASTM F 6474 standard. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the numerical sample size used for the test set for the performance tests (fatigue, static compression, head extraction). It only mentions "two series of tests."
The data provenance is not specified beyond the tests being performed by the manufacturer seeking clearance in France ("Fournitures Hospitalières Industrie"). It is retrospective, as the tests were conducted prior to the 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable as the studies are performance tests on a physical device, not an AI/software device that requires human expert ground truth for labeling data. The "ground truth" for these tests is the physical behavior of the device under stress, measured against engineering standards.
4. Adjudication Method for the Test Set
This information is not applicable for the same reason as point 3.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic tools or systems where human readers interpret medical images or data. The device in question is a physical orthopedic implant (alumina femoral head), which does not involve human readers for its primary function.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This information is not applicable as the device is a physical medical implant, not an algorithm or AI system. The "performance" being evaluated is the mechanical integrity and material properties of the implant itself.
7. Type of Ground Truth Used
The ground truth for the device's performance is based on:
- Engineering Standards: Specifically ASTM F 6474 for the material (Biolox forte alumina).
- Regulatory Requirements: "Requirements set forth by the FDA" for the performance tests, and "FDA's guideline: 'Guidance document for the preparation of prematerial notifications for ceramic ball hip systems' dated January 10, 1995" for material characteristics.
8. Sample Size for the Training Set
This information is not applicable. The device is a physical implant, not an AI/ML algorithm that requires a "training set." The manufacturing process would involve process controls and quality assurance, but not in the sense of a data training set for an AI model.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as point 8.
§ 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.