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The TriFlange Hip Prosthesis is intended to be used with modular liners to resurface the acetabular socket in cementless application during total hip arthroplasty.

The TriFlange Hip Prosthesis is indicated in the following conditions:

1. Where bones loss is present in the acetabular region
2. Pelvic discontinuities
   Porous-coated TriFlange Hip Prostheses are indicated for cementless applications.

The system is intended to be used with modular liners to resurface the acetabular socket in cementless application during total hip arthroplasty.

Total hip arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components.

Total hip replacement is indicated in the following conditions:

1. A severely painful and/or disabled joint from osteoarthritis, traumatoid arthritis, or congenital hip dysplasia.
2. Avascular necrosis of the femoral head.
3. Acute traumatic fracture of the femoral head or neck.
4. Failed previous hip surgery including joint reconstruction, arthrodesis, hemi-arthroplasty, surface replacement arthroplasty, or total hip replacement.
5. Certain cases of ankylosis.
   Porous-coated TriFlange Hip Prostheses are indicated for cement-less applications.

The 3D Additive TriFlange Acetabular Cup and TriFlange II Acetabular Cup System is an acetabular cup system designed and manufactured to match the individual patient's anatomy. The system consists of a porous coated acetabular cup (Pinnacle cup) with three patients specific illial, ischial and pubic flanges added to reinforce weak acetabula. The device may be fixed in place with titanium bone screws of various lengths through a variety of screw holes in the flanges. The 3D Additive TriFlange Acetabular Cup is manufactured via additive manufacturing technology using Ti6Al4V ELI powder, followed by traditional finishing operations. TriFlange II Acetabular Cup System is following traditional CNC machining manufacturing process. The cups are intended for cementless use only. The proposed changes apply to product codes with hydroxyapatite (HA) coating.

The provided FDA 510(k) summary (K232556) does not contain information about an AI/ML-driven medical device and therefore does not include acceptance criteria or a study proving the device meets those criteria in the context of AI/ML performance.

The submission is for a hip joint prosthesis (DePuy 3D Additive TriFlange Acetabular Cup and TriFlange II Acetabular Cup System), and the only change for this submission is that the Hydroxyapatite (HA) coating process will be conducted at an alternate facility. The substantial equivalence is based on non-clinical tests demonstrating that the material and coating properties remain consistent with the predicate devices, despite the change in manufacturing location for the HA coating.

Therefore, the information requested in your prompt regarding acceptance criteria and studies for AI/ML device performance (such as sample size, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance, training set details) is not applicable to this specific 510(k) submission.

The document mentions "SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE" and lists several engineering/material tests (e.g., HA Powder characterization, HA Coating thickness, Tensile Adhesion testing, Shear Adhesion testing, Rotating Beam Fatigue, Solubility, Dissolution, FTIR analysis). It explicitly states: "No clinical tests were conducted to demonstrate substantial equivalence."

In summary, this document does not describe the kind of device or study you are asking about.

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