(118 days)
Cl../..X liner for 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 Cl../..X liner for NOVAE® Dual Mobility Acetabular Cup is made of cross-linked Ultra-High-Molecular-Weight Polyethylene which meet the strength requirements of the ASTM F648 and the testing listed in the ASTM F2565. The liner is mobile (free) in the NOVAE® metallic shell (clearance K111572) and retained on the prosthetic femoral head. Liners can be used with Ø22.2 or 28 mm prosthetic femoral heads.
I am sorry, but the provided text does not contain the detailed information necessary to answer your request about acceptance criteria and the study proving the device meets them.
The document is a 510(k) premarket notification letter from the FDA regarding a medical device called "CI../..X liner for NOVAE® Dual Mobility Acetabular Cup." While it mentions that "Acceptance criteria were met for each test," it does not explicitly state what those acceptance criteria are nor does it provide a detailed description of the study that proves the device meets those criteria.
Specifically, the following information you requested is missing from the provided text:
- A table of acceptance criteria and the reported device performance: The text only generally states that "Acceptance criteria were met."
- Sample size used for the test set and the data provenance: Not mentioned.
- Number of experts used to establish the ground truth and their qualifications: Not applicable for this type of mechanical testing.
- Adjudication method: Not applicable for this type of mechanical testing.
- Multi reader multi case (MRMC) comparative effectiveness study: The document explicitly states "No clinical studies were performed."
- Standalone (algorithm only without human-in-the-loop performance) study: Not applicable as this is a physical medical device, not an AI algorithm.
- Type of ground truth used: For mechanical tests, the ground truth would be the physical measurements themselves against established standards, but details are not provided.
- Sample size for the training set: Not applicable as this is a physical medical device, not an AI algorithm.
- How the ground truth for the training set was established: Not applicable.
The document only lists the types of non-clinical tests performed:
- Dimensional analysis
- Head insertion force
- Head lever out force
- Wear analysis
And states that these tests were conducted to demonstrate substantial equivalence to predicate devices, focusing on design, materials, and mechanical performance according to ASTM standards. It concludes that the device is substantially equivalent based on these non-clinical tests.
§ 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.