(23 days)
The Restoration® ADM system X3® Acetabular Insert is a sterile, single-use device intended for use in primary and revision total hip arthroplasty to alleviate pain and restore function. This device is intended to be used only with any currently available Howmedica Osteonics 28 mm diameter femoral heads.
The indications for use for total hip arthroplasty include:
- Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis; 1)
-
- Rheumatoid arthritis:
-
- Correction of functional deformity;
-
- Revision procedures where other treatments or devices have failed;
- : 2) Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
- () Dislocation risks
This acetabular cup is intended for cementless use only.
The Restoration® Anatomic Dual Mobility (ADM) System X3® Acetabular Insert is a component of the Restoration® ADM System. The Restoration® ADM X3® Acetabular Insert retains a femoral head. The outer diameter of the insert articulates on the inner surface of the polished metal acetabular cup. The polyethylene insert therefore functions as a bipolar head as there are two articulating surfaces.
The device includes the acetabular inserts of a total hip system. These components are used for the replacement of the bearing surface of the acetabulum to relieve pain, instability, and the restriction of motion due to degenerative bone disease, including osteoarthritis, failure of other levices, or trauma.
Here's a breakdown of the acceptance criteria and study information for the Restoration® ADM System X3® Acetabular Insert, based on the provided text:
Summary of Device Acceptance Criteria and Performance
| Acceptance Criteria Category | Specific Test/Measure | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|---|
| Mechanical/Material | Material Properties Characterization | Equivalence to predicate devices | Performed and demonstrated "equivalence of the subject products to the predicate devices." |
| Mechanical/Wear | Hip Simulated Wear Testing | Equivalence to predicate devices | Performed and demonstrated "equivalence of the subject products to the predicate devices." |
| Mechanical/Assembly | Disassembly Force Evaluation | Equivalence to predicate devices | Performed and demonstrated "equivalence of the subject products to the predicate devices." |
| Risk Management | Risk Analysis | Acceptable risk profile compared to predicate | Performed and demonstrated "equivalence of the subject products to the predicate devices." |
Study Information
-
Sample size used for the test set and the data provenance: Not explicitly stated in the provided text. The study involved in-vitro testing (material properties, wear, disassembly force), not human clinical data. Therefore, "data provenance" in terms of country of origin or retrospective/prospective does not apply to this type of testing.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The ground truth for this device is based on engineering and material science standards and measurements, not expert human interpretation of medical images or conditions. The "ground truth" is derived from the physical testing results and comparison to predicate device performance.
-
Adjudication method for the test set: Not applicable. As the "ground truth" is derived from physical and mechanical testing, there is no human adjudication process involved.
-
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 physical orthopedic implant, not an AI/software device that involves human reader interpretation. No MRMC study was performed.
-
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is a physical orthopedic implant, not an algorithm or AI.
-
The type of ground truth used: The ground truth for this device's performance is based on engineering test standards and the performance of legally marketed predicate devices. The text states, "A risk analysis and research and development testing have been performed to demonstrate equivalence of the subject products to the predicate devices."
-
The sample size for the training set: Not applicable. This is a physical orthopedic implant, not a machine learning algorithm.
-
How the ground truth for the training set was established: Not applicable. As this is not an AI/machine learning device, there is no "training set" or corresponding ground truth establishment in that context.
§ 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.