(29 days)
The M2a-Magnum™ System is indicated for non-cemented 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™ ™ Tri-Spike™ Acetabular Components is a Co-Cr-Mo, full hemisphere shell in outer diameters of 44mm to 66mm designed for metal articulation. The outer surface of the shell features porous plasma spray coating for biological fixation and three dome spikes for rotational stability.
The provided document is a 510(k) summary for a medical device, the M2a-Magnum™ Tri-Spike™ Acetabular Component. This type of submission to the FDA is for demonstrating substantial equivalence to a predicate device, not for proving a device meets specific performance criteria through a study with the details requested.
Therefore, the information you've asked for regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, and MRMC studies is not present in this document.
Here's why and what can be extracted:
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Acceptance Criteria and Reported Device Performance: This document states "Non-Clinical Testing: None provided" and "Clinical Testing: None provided." This indicates that the manufacturer did not submit specific performance metrics from a study to demonstrate the device meets acceptance criteria. Instead, the submission relies on the device's similarity to a previously approved (predicate) device. The "Summary of Technologies: The overall design, materials and processing methods are similar to the predicate device" is the primary argument.
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Sample Size for Test Set, Data Provenance, Number of Experts, Adjudication Method, MRMC Study, Standalone Performance, Type of Ground Truth, Sample Size for Training Set, How Ground Truth for Training Set was Established: All of these points pertain to the details of a study (clinical or non-clinical performance evaluation), which, as stated above, were not provided in this 510(k) summary.
In summary, because no clinical or non-clinical testing was provided, the document does not contain the information required to fill out the table and answer the detailed questions about acceptance criteria and a study proving the device meets them. The 510(k) process in this case relies solely on demonstrating substantial equivalence to a previously marketed device (M2a-Magnum™ System, 510(k) K042037) based on design, materials, and processing methods being similar.
§ 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.