(84 days)
NOVAE® Dual mobility Acetabular Cup is indicated for total hip replacement, which includes:
- . Osteoarthritis
- . Femoral neck fracture
- . Dislocation risk
- . Osteonecrosis of the femoral head
- Revision procedures where other treatments or devices have failed and if bone . reconstruction so permits
SUNFIT TH, NOVAE E TH and COPTOS TH are intended for press-fit use and NOVAE STICK is indicated for cemented use.
The NOVAE® Dual Mobility Acetabular Cup is composed of a metallic shell fixed in the acetabulum and a polyethylene liner.
Cemented metallic shell:
- NOVAE STICK: the cemented metallic shell is made of stainless steel according to ISO 5832-1:2007. The outer surface is sandblasted and presents macro-volumes to augment contact between the implant and the cement. The inner surface is highly polished.
Cementless metallic shell:
The cementless metallic shell is made of stainless steel according to ISO 5832-1:2007 and is coated with a CP titanium and hydroxyapatite plasma spray (double layer coating) on the outer surface and is highly polished on the inner surface.
Three cementless metal-backs are available: - SUNFIT TH: the SUNFIT TH version is available without the pegs and screw, and is a press fit onlv.
- NOVAE E TH: the NOVAE E TH has 3 fixation points (2 divergent pegs towards the pubis and ischium and 1 cortical screw through a flange towards the ilium).
- COPTOS TH: the COPTOS TH has 5 fixation points (2 divergent pegs towards the pubis and ischium, cortical screws through 2 flanges towards the ilium and 1 foramen hook).
Liner:
The liner is made of Ultra-High-Molecular-Weight Polyethylene according to ISO 5834-2:2006. The liner is mobile (free) in the metallic shell and retained on the prosthetic femoral head. Liners can be used with Ø22,2 or 28 mm prosthetic femoral heads.
Pegs and cortical screws:
When applicable, primary fixation can be reinforced by impacted pegs and self tapping cortical screws made of stainless steel according to ISO 5832-1:2007.
This summary describes the validation of the NOVAE® Dual Mobility Acetabular Cup.
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Dimensional analysis | Met specified dimensional requirements (details not provided in the document) | "acceptance criteria was met" |
| Uncemented metal-back push-out force | Met specified push-out force requirements (details not provided in the document) | "acceptance criteria was met" |
| Head insertion force and Head Pull-Out testing | Met specified insertion and pull-out force requirements (details not provided in the document) | "acceptance criteria was met" |
| Head lever out force | Met specified lever-out force requirements (details not provided in the document) | "acceptance criteria was met" |
| Number of bending cycles to flange fracture | Met specified bending cycle requirements (details not provided in the document) | "acceptance criteria was met" |
| Characterization of CP titanium and HA plasma spray | Met specified coating characteristics and integrity (details not provided in the document) | "acceptance criteria was met" |
| Range Of Motion Analysis | Met specified range of motion requirements (details not provided in the document) | "acceptance criteria was met" |
| Wear Analysis | Met specified wear performance requirements (details not provided in the document) | "acceptance criteria was met" |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for each non-clinical test. The tests were non-clinical, meaning they were likely conducted in a laboratory setting. Therefore, there is no data provenance in terms of country of origin or retrospective/prospective data for human subjects.
3. Number of Experts Used to Establish Ground Truth and Their Qualifications
Not applicable. The tests are non-clinical (mechanical and material characterization), and ground truth is established by engineering specifications and standards, not expert clinical interpretation.
4. Adjudication Method for the Test Set
Not applicable. As the tests are non-clinical, there is no human interpretation or adjudication required in the same way as, for example, a clinical image review. The results are a direct measurement against predefined engineering criteria.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. The document explicitly states: "No clinical studies were performed." Therefore, no MRMC study was conducted.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. This device is a physical medical implant (an acetabular cup for total hip replacement), not an algorithm or AI system. Therefore, the concept of standalone algorithmic performance is not relevant. The "performance" being evaluated is the mechanical and material integrity of the device itself.
7. Type of Ground Truth Used
The ground truth used for these non-clinical tests is based on engineering specifications, material standards (e.g., ISO 5832-1:2007, ISO 5834-2:2006), and predefined acceptance thresholds for mechanical and material properties.
8. Sample Size for the Training Set
Not applicable. This device is a physical medical implant, not a machine learning model, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for a physical medical 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.