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The MINIMA S System stems are indicated for use in partial or total hip arthroplasty and are intended for press-fit (uncemented) use. When used in total hip arthroplasty, the MINIMA S Stems are intended for use with compatible femoral heads and acetabular components. When used in partial hip arthroplasty, the MINIMA S stems are intended for use with Lock Bipolar Heads. Hip arthroplasty is intended for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:
· non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis and hip dvsplasia:
· rheumatoid arthritis;
· treatment of femoral head and neck fracture;
· revisions in cases of good remaining femoral bone stock.

The MINIMA S System is intended for partial or total hip arthroplasty in cementless use. It is a monolithic collarless stem currently available in 9 sizes (sizes from 4 to 12) in standard and lateralized versions. This Special 510(k) is to introduce Size 3 of the stem. Also this size comes in a standard and a lateralized version.
The Minima S stem is made of Ti6Al4V, and it has a plasma sprayed titanium coating in the proximal area (ASTM F1472, ISO 5832-3). The stem is characterized by a 12/14 conical taper to be coupled to LimaCorporate Femoral Heads, Biolox Delta femoral heads or Lock Bipolar Heads.

The provided text does not contain information about acceptance criteria or a study proving that a device meets those criteria, as it relates to AI/ML or diagnostic performance.

The document is a 510(k) premarket notification for a hip joint prosthesis (MINIMA S System) and primarily focuses on establishing substantial equivalence to previously cleared predicate devices. It states that:

• No clinical testing was necessary to support equivalence.
• No additional preclinical testing was required for the new Size 3 of the stem because it does not represent a "worst-case" for mechanical testing, and results from previously cleared sizes (K141327) are applicable.

Therefore, none of the requested information (acceptance criteria table, sample size for test set, data provenance, expert qualifications, adjudication method, MRMC study, standalone performance, ground truth type, training set size, or training set ground truth establishment) is available in the provided text.

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