(642 days)
Noninflammatory degenerative (oint disease (NID), e.g., avascular necrosis, osteoarthritis, and inflammatory (out disease (IJD), e.g., rheumatoid arthritis.
Failed previous surgery where pain, deformity, or dysfunction persists.
Revision of previously failed hip arthroplasty.
The Subject CoCr Heads are intended to be used as a modular head component for articulation in total hip arthroplasty. A system consisting of a femoral stem, a ball head and a cup or a shell with an insert is used for replacement of the proximal femur in total hip arthroplasty. The articulation is comprised of a modular femoral head and a corresponding cup or acetabular insert. CoCr Heads are to be used in combination with polyethylene cups or inserts. It is also possible to use CoCr Heads in revision cases (unless subsequent to a broken ceramic component) where the stem remains in place.
The Subject CoCr Heads have a head diameter of 38 mm and are provided with 5 different neck lengths (from -8 to +8) to allow an individual adaptation of leg length and offset. A 12/14 taper, incorporated in the design of the head, interlocks with the femoral stem. The CoCr Heads are made from Protasul®-20 (CoCrMo alloy).
This is a good question! However, the provided document is a 510(k) summary for a medical device (CoCr Head) that is a hip prosthesis, not an AI/ML-enabled medical device.
Therefore, the requested information about acceptance criteria and studies demonstrating AI performance (such as sample sizes for test and training sets, number of experts, adjudication methods, MRMC studies, standalone performance, and ground truth establishment) is not present in this document.
The document primarily focuses on demonstrating substantial equivalence to a predicate device through:
- Non-Clinical Performance Data: Engineering analyses, wear justification, material equivalence testing (ISO and ASTM standards), and Range of Motion testing (ISO 21535).
- MR Conditional Labeling: Evaluation in accordance with ASTM F2503-13 for RF-induced heating, static magnetic field interactions, and image artifact generation in MRI environments.
It explicitly states: "Clinical data and conclusions were not needed for this device."
In summary, as this document is not for an AI/ML medical device, none of the requested information regarding AI acceptance criteria and performance studies can be extracted.
§ 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.