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Indications for use of the ConsensusTM Hip System or UNISYN™ Hip System

• A) Significantly impaired joints resulting from rheumatoid, osteo, and post-traumatic arthritis.
• B) Revision of failed femoral head replacement, cup arthroplasty or other hip procedures.
• C) Proximal femoral fractures.
• D) Avascular necrosis of the femoral head.
• E) Non-union of proximal femoral neck fractures.
• F) Other indications such as congenital dysplasia, arthrodesis conversion, coxa magna, coxa vara, coxa vara, coxa valga, developmental conditions, metabolic and tumorous conditions, osteomalacia, osteoporosis, pseudarthrosis conversion, and structural abnormalities

Acetabular components are indicated for cemented and cementless use. Consensus femoral stems are indicated for cemented and cementless use. UniSyn femoral stems are indicated for cementless use only. HA coated implants are indicated for cementless use only.

The Consensus Hip 36mm CoCrMo (ASTM F799 or ASTM F1537) femoral head is offered with four different offsets, -5mm, neutral, +5mm and +10mm. Other than size, it incorporates no new design features. Female head taper is identical to the head taper design for the cleared devices.

The 36mm acetabular insert is offered in sizes 54 - 68 (2 mm increments), in neutral, 10 and 20 degree hooded configurations. Material for all 36mm insert sizes is crosslink UHMWPE (ASTM F648). Hooded configurations incorporate a titanium alloy x-ray marker (Ti 6Al-4V ELJ ASTM F136). Insert locking detail of the subject device is identical to the locking detail of the cleared devices.

The provided text is a 510(k) summary for a medical device: a 36mm CoCrMo Femoral Head and Acetabular Insert for the Consensus Hip System. This document focuses on demonstrating substantial equivalence to previously cleared devices, rather than presenting a study with acceptance criteria and a detailed performance evaluation of a new AI/software device.

Therefore, the information requested in your prompt (acceptance criteria, study details, sample sizes, ground truth, expert qualifications, adjudication, MRMC studies, standalone performance, training set details) is not applicable to this type of regulatory submission.

This 510(k) relies on the following for demonstrating safety and effectiveness:

• Comparison to Cleared Device: The primary argument is that the new 36mm femoral head and acetabular insert are substantially equivalent to existing, legally marketed devices. The only change is the addition of a new size (36mm).
• Intended Use, Material, Design Features, and Type of Interface: These aspects of the new components are stated to be identical or highly similar to predicate devices.
• Materials Data: The submission mentions "materials data" was provided to support safety and effectiveness, implying biocompatibility and mechanical properties testing relevant to the materials used (CoCrMo and UHMWPE) rather than clinical performance data.

In summary, this document does not contain the kind of study design and performance data typically associated with evaluating a novel AI/software medical device against specific acceptance criteria.

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