(87 days)
Exactech AcuMatch® A-Series and MCS® Acetabular Shells and Liners are indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, post-traumatic degenerative problems of the hip, and for treatment of proximal femoral fractures where prosthetic replacement is determined by the surgeon as the preferred treatment. Components of Exactech Hip Systems are also potentially indicated for ankylosing spondylitis, congenital hip dysplasia, revision of failed previous reconstructions where sufficient bone stock is present, and to restore mobility resulting from previous fusion.
Exactech AcuMatch A-Series® & MCS® Acetabular Shells and Liners are designed for use with appropriately sized Exactech femoral stems and heads.
The metal shells are made from titanium alloy (Ti-6Al-4V) conforming to ASTM F136. They are porous coated with titanium beads, a blast finish, or with hydroxylapatite.
The liners are machined from compression molded ultra-highmolecular-weight polyethylene (UHMWPE). Polyethylene raw material must meet all aspects of ASTM F648.
The provided document is a 510(k) Premarket Notification for medical devices, specifically for "Exactech AcuMatch® A-Series and MCS® Acetabular Shells and Liners". This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through de novo clinical studies with detailed performance metrics and acceptance criteria as one would find for novel high-risk devices or software algorithms.
Therefore, the information requested in the prompt, which is typically found in studies for new or AI-based devices, is not present in this document. The document explicitly states:
- "Performance Testing: Testing for the Exactech AcuMatch® A-Series and MCS® Acetabular Shells and Liners was performed for, and reviewed, in predicate device submissions. Design Control assessments did not indicate a need for additional testing for the line extensions which are the subject of this Special 510(k)."
- "The new sizes of Exactech AcuMatch® A-Series and MCS® Acetabular Shells and Liners are substantially equivalent to existing previously cleared devices in design, materials of construction, manufacturing, and other characteristics."
This indicates that no new performance studies were conducted for this specific 510(k) submission. Instead, the device's acceptable performance is inferred from its substantial equivalence to previously cleared predicate devices.
Given this, I cannot provide the requested table and study details as they are not available in the provided text. The document does not describe:
- A table of acceptance criteria and reported device performance.
- Sample sizes or data provenance for a new test set.
- Number or qualifications of experts for ground truth establishment.
- Adjudication methods.
- MRMC comparative effectiveness studies.
- Standalone algorithm performance.
- Type of ground truth used for this submission (as no new study was conducted).
- Sample size for a training set (as this is not an AI/software device).
- How ground truth for a training set was established.
§ 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.