(270 days)
The Pantheon Proximal Femur Reconstruction (PFR) System is a modular system intended to be used for the reconstruction of the proximal femur in the case of severe proximal femoral bone loss in hip revision surgery (due to infection, fracture, failed THA) or in the case of a bone tumor.
The FIXA Ti-Por cup is intended for cementless use.
The Pantheon PFR System is manufactured of Ti6A14V (except for femoral heads which are made of CoCrMo or ceramic and acetabular inserts made of cross-linked UHMWPE) and includes various components that can be combined to replace the hip joint and address major bone defects with various options depending upon the size and location of the defects of each patient. The Pantheon PFR System consists of:
- Pantheon Proximal Bodies made of Ti6Al4V Alloy additively manufactured.
- CoCrMo Alloy Femoral Heads Taper 12/14
- Biolox Delta Ceramic Femoral Heads Taper 12/14
- Pantheon Shaft made of Ti6Al4V Alloy
- Pantheon Bridging Collars made of Ti6Al4V Alloy additively manufactured
- Pantheon Cylindrical Bridging Collars made of Ti6A14V Alloy additively manufactured
- Pantheon Salvage Stem (Cemented) made of Ti6Al4V Alloy
- Pantheon Salvage Stem (Uncemented) made of Ti6A14V alloy
- Pantheon Proximal Body Locking Screw made of Ti6A14V Alloy
- Pantheon Salvage Plate Compression Screws made of Ti6Al4V Alloy
- Pantheon Salvage Plate with Spikes made of Ti6A14V Alloy
- Fixa Ti-Por Cup Acetabular Shells made of Ti6Al4V Alloy additively manufactured.
- Titanium Acetabular Screws made of Ti6A14V Alloy.
- Acetabular Inserts Flat made of Cross-Linked PE.
- Acetabular Inserts 15° Lipped made of Cross-Linked PE.
I am sorry, but the provided text describes a medical device called "Pantheon Proximal Femur Reconstruction (PFR) System" and its regulatory approval (510(k) submission) by the FDA. It does not contain any information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the context of an AI/ML device.
The document is a standard FDA 510(k) summary for a physical orthopedic implant. It details:
- The device name and manufacturer.
- Its intended use.
- The materials it's made from.
- Its components and sizes.
- The predicate devices it claims substantial equivalence to.
- The performance testing conducted on the physical device (e.g., fatigue testing, corrosion testing, ceramic head burst testing) against physical device standards, not AI/ML performance metrics.
Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes, experts, adjudication methods, MRMC studies, standalone performance, or ground truth related to an AI/ML device, as this information is not present in the given text.
§ 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.