(28 days)
The DePuy Ceramic Femoral Head is indicated for use as the femoral head component in total hip arthroplasty procedures. Total hip arthroplasty is intended to provide increased patient mobility and to reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. Total hip replacement is indicated in the following conditions:
- A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, theumatoid arthritis, or congenital hip dysplasia.
- Avascular necrosis of the femoral head.
- Acute traumatic fracture of the femoral head or neck.
- Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
- Certain cases of ankylosis.
The DePuy Ceramic Femoral Head is composed of an alumina composite material and is available in a 36mm head diameter with a +12-offset option. The internal bore of the ceramic femoral head, which is designed to interlock with the external taper on the femoral hip stem, is available in a 12/14 Articul/eze taper option. The ceramic head is designed to mate with a corresponding DePuy femoral hip stem and provide the femoral articular surface of a total hip replacement.
The DePuy Ceramic Femoral Head is a ceramic femoral ball prosthesis, intended for use as the femoral head component in total hip arthroplasty procedures.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from predicate) | Reported Device Performance (DePuy Ceramic Femoral Head) |
|---|---|
| Design | Similar to predicate device (K031803) |
| Material Composition | Same as predicate device (K031803) |
| Sterilization Methods | Same as predicate device (K031803) |
| Packaging Methods | Same as predicate device (K031803) |
| Intended Use/Indications for Use | Same as predicate device (K031803) |
| Labels | Similar to predicate device (K031803) |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not describe a specific clinical test set or study for the DePuy Ceramic Femoral Head. Instead, the basis for substantial equivalence is primarily a comparison to a previously cleared predicate device (DePuy Ceramic Femoral Heads, K031803).
Therefore, there is no information on:
- Sample size used for a test set.
- Data provenance (e.g., country of origin, retrospective or prospective nature).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Since no specific test set or clinical study for this particular device is described as part of the 510(k) submission, there is no information regarding experts used to establish a "ground truth." The acceptance is based on substantial equivalence to a predicate device.
4. Adjudication Method for the Test Set
As there is no described test set or clinical study for the DePuy Ceramic Femoral Head in this submission, there is no information on an adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or described in the provided document. The submission relies on substantial equivalence to a predicate device, not on demonstrating improved human reader performance with AI assistance (which is not applicable here as this is a physical medical device, not an AI-based diagnostic tool).
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This is a physical medical device (ceramic femoral head), not an algorithm or AI system. Therefore, a "standalone algorithm performance" study is not applicable and was not conducted or described.
7. Type of Ground Truth Used
The "ground truth" for this device's acceptance is the established safety and effectiveness of the legally marketed predicate device (K031803). The manufacturer asserts that the new device is substantially equivalent to this predicate based on core characteristics.
8. Sample Size for the Training Set
The concept of a "training set" is typically associated with machine learning models. Since this is a physical medical device and its clearance is based on substantial equivalence to a predicate, there is no training set in the context of an algorithm.
9. How the Ground Truth for the Training Set Was Established
As explained above, the concept of a "training set" with associated ground truth in the context of an algorithm is not applicable to this device's submission. The "ground truth" for acceptance is the predicate device's clearance.
§ 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.