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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:

• 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.

• 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.

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