(65 days)
The M2a Magnum™ 12/14 Taper Inserts and One-Piece Modular Heads are indicated for use in patients requiring total hip replacement due to the following:
- Non-inflammatory degenerative joint disease including avascular necrosis, diastrophic variant, fracture of the pelvis, fused hip, Legg Perthes, osteoarthritis, slipped capital epiphysis, subcapital fractures and traumatic arthritis.
- Rheumatoid arthritis.
- Correction of functional deformity.
- Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques.
- Revision of previously failed total hip arthroplasty.
The M2a Magnum™ 12/14 Taper Inserts and One-Piece Modular Heads are designed for use with the Taper oc 12/14 taper femoral components and the articulating heads and shells of the M2a Maqnum™ Sytem (K043537) for uncemented applications.
There are two sets of taper inserts, each providing neck offsets from to +9mm. The first set has a smaller diameter and mates with modular head sizes 42mm. The second set of taper inserts has a larger outer diameter and mates with modular head sizes 52mm through 60mm. The one-piece 12/14 modular head sizes will include 38mm and 40mm outer diameters. Available neck offsets will range from -6mm to +9mm.
The provided document does not contain information about the acceptance criteria or a study proving the device meets those criteria, as it is a 510(k) summary for a hip joint prosthesis (M2a Magnum™ 12/14 Taper Inserts and One-Piece Modular Heads) and an FDA clearance letter.
Instead, the document states:
- Non-Clinical Testing: "Non-clinical laboratory testing had been previously performed to determine substantial equivalence. The results indicated that the device was functional within its intended use." However, specific acceptance criteria or details of these tests are not provided.
- Clinical Testing: "None provided as a basis for substantial equivalence." This indicates that no clinical studies were performed to prove the device meets acceptance criteria.
The 510(k) summary focuses on demonstrating substantial equivalence to predicate devices, primarily based on similar technological characteristics (materials, design, sizing, articulating surface, and indications).
Therefore, I cannot provide the requested information for the following points:
- A table of acceptance criteria and the reported device performance.
- Sample sized used for the test set and the data provenance.
- Number of experts used to establish the ground truth for the test set and their qualifications.
- Adjudication method for the test set.
- If a multi reader multi case (MRMC) comparative effectiveness study was done.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done.
- The type of ground truth used.
- The sample size for the training set.
- How the ground truth for the training set was established.
§ 888.3330 Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis.
(a)
Identification. A hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis is a two-part device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that consist of a femoral and an acetabular component, both made of alloys, such as cobalt-chromium-molybdenum. The femoral component is intended to be fixed with bone cement. The acetabular component is intended for use without bone cement (§ 888.3027).(b)
Classification. Class III.(c)
Date PMA or notice of completion of PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before May 18, 2016, for any hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component that was in commercial distribution before May 28, 1976, or that has, on or before May 18, 2016, been found to be substantially equivalent to a hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component that was in commercial distribution before May 28, 1976. Any other hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.