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The Delta TT Acetabular System is indicated for use in total hip arthroplasty 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 dysplasia;
• Rheumatoid arthritis; .
• Post-traumatic arthritis, .
• Correction of functional deformity; .
• Fractures, dislocation of the hip and unsuccessful cup arthroplasty. ●
• Revisions in cases of good remaining bone stock. .

The Delta TT cup is intended for cementless use.

The Delta TT Acetabular System consists of a Delta TT cup, a liner and a modular metal femoral head. Bone screws can also be used to give further stability to the cup.

The Delta TT cup is manufactured using an EBM (Electron Beam Melting) process with titanium alloy powder (Ti6Al4V, ASTM F1472 - ISO 5832-3). The Delta TT cup consists of a non porous bulk interior surface and a Trabecular Titanium structure on the external surface.

The Delta TT cup has an external hemi-spherical shape. A polar threaded hole is used for introduction of the cup and mates with the polar peg of the liner when the two components are assembled. Three threaded holes in lateral positions allow additional fixation of the cup using bone screws (polyethylene plugs are used when bone screws are not required). The Delta TT cup is designed to be coupled with ultra high molecular weight polyethylene (UHMWPE) liners by means of a taper coupling.

Delta TT cups are available with external diameters of 44, 46 and 48 mm (for Small liners), 50 and 52 mm (for Medium liners) and 54, 56, 58, 60, 62 and 64 mm (for Large liners).

The liners for Delta TT cups are manufactured from standard UHMWPE (ASTM F648 -ISO 5834-2) or from cross-linked UHMWPE (X-Lima).

Liners are coupled with the Delta TT cup by means of a taper coupling. Two features are intended to give stability to the coupling. A peripheral ring manufactured from Ti6A14V (ASTM F1472 - ISO 5832-3) surrounds the taper of the liner circumferentially, enhancing the rotational stability of the coupling. A polar peg fits into the of the cup, increasing the lever-out stability of the liner. The top of the peg is resurfaced by a Ti6A14V (ASTM F1472 - ISO 5832-3) plug to avoid direct contact between polyethylene and bone.

Liners are available in two versions: neutral and protruded. The protruded design provides greater coverage of the femoral head and is intended to reduce the risk of dislocation. For both the designs, the following sizes are available:

• Cross-linked UHMWPE liners: Small (for femoral heads Ø 28 mm), Medium (for . femoral heads Ø 28 and 32 mm) and Large (for femoral heads Ø 28, 32 and 36 mm).
• Standard UHMWPE liners: Small, Medium and Large liners for femoral heads Ø 28 . mm.

Bone screws are manufactured from Ti6A14V (ASTM F1472 - ISO 5832-3) and can be used to provide additional initial stability to the cup. Bone screws have a diameter of 6.5 mm and are available in lengths of 20, 25, 30, 35, 40, 45, 50, 55 and 60 mm.

The provided text is a Summary of Safety and Effectiveness for the Limacorporate S.p.A. Delta TT Acetabular System. This document describes a medical device (hip implant components) and its comparison to legally marketed predicate devices to establish substantial equivalence for regulatory approval (510(k)).

As such, this document does not contain information about acceptance criteria for an AI/software device, nor does it describe a study to prove an AI/software device meets acceptance criteria. The information requested in your prompt (e.g., sample size for test sets, number of experts for ground truth, MRMC studies, standalone performance, training set details) pertains specifically to the validation of AI/software devices, which is not applicable to the physical medical device described in this text.

The closest relevant information, if we were forced to extrapolate, would be:

• "Acceptance Criteria" (interpreted as performance targets): The device aims to perform comparably to its predicate devices, as demonstrated through non-clinical bench testing. The criteria for success are implicit in "demonstrate the strength of the cup-liner modular connection," "wear tests," "ensure the device design does not overly limit range of motion," and "characterization for tensile, yield, elongation and rotating beam fatigue properties" that "were compared with standard materials used for the manufacturing of predicate acetabular cups."
• "Study that proves the device meets the acceptance criteria": The non-clinical bench testing described, which includes:
  • Deformation testing
  • Fatigue-fretting of the metal shell
  • Push-out, lever-out, and torque-out testing (for cup-liner modular connection strength)
  • Wear tests for the liners
  • Range of Motion simulation
  • Two-point fatigue testing to failure for Delta TT cups (compared with FMP cups using the same protocol)
  • Characterization of EBM Ti6Al4V for tensile, yield, elongation, and rotating beam fatigue properties (compared with standard materials)
  • Biocompatibility testing

However, to reiterate, this is a document for a physical orthopedic implant seeking 510(k) clearance, not an AI/software as a medical device. Therefore, the specific requirements of your prompt are not met by the provided text.

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