(756 days)
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:
- Where bone loss is present in the acetabular region
- Pelvic discontinuities
Porous-coated TriFlange Hip Prostheses are indicated for cementless applications.
The 3D Additive TriFlange Acetabular Cup is a patient-specific cup system designed and manufactured to match the individual patient's anatomy. The system consists of a porous coated acetabular cup with three patient-specific ilial, ischial and pubic flanges. The cup is manufactured via additive manufacturing technology using Ti6Al4V ELI powder, followed by traditional finishing operations. The cups may have hydroxyapatite (HA) coating. The cups are intended for cementless use only.
This document is a 510(k) Premarket Notification from the FDA for a medical device called the "DePuy 3D Additive TriFlange Acetabular Cup." It details the device's characteristics, intended use, and substantial equivalence to a predicate device.
Key takeaway: This document does not pertain to an AI/ML powered medical device. It's about a physical implant (acetabular cup for hip replacement) manufactured using an additive process. Therefore, the requested information regarding AI/ML device acceptance criteria and study details (like sample sizes for test/training sets, expert ground truth, MRMC studies, etc.) is not applicable to this submission.
The "PERFORMANCE DATA" section (Page 5) explicitly states:
- SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE: This lists various engineering and material tests (e.g., drawing comparison, surface finish, tensile testing, corrosion testing, hardness testing, functional fatigue testing, pyrogenicity testing). These are standard tests for physical implants to ensure material properties and mechanical performance.
- SUMMARY OF CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE AND/OR OF CLINICAL INFORMATION: It explicitly states, "No clinical tests were conducted to demonstrate substantial equivalence."
In summary, none of the requested information about acceptance criteria and studies for an AI/ML device is present in this document because the device in question is a physical orthopedic implant, not an AI/ML diagnostic or therapeutic tool.
§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.
(a)
Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across the joint. This generic type of device has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II.