(396 days)
Interlocking hip stems are indicated for non-cemented application in cases of revision, trauma, fracture, oncology or other situations where severe proximal bone loss may compromise the fixation and stability of a standard type hip replacement prosthesis.
The Interlocking Hip Stems are metallic femoral stems with transverse screw holes in the distal portion. These devices offer a combination of total hip replacement with the benefits of an intramedullary nail. Each stem has three medial/lateral slots.
Two styles of stems are available. The first geometry is that of a Mallory/Head Calcar device. This device provides head/neck replacement to compensate for bone deficiencies in the proximal/medial portion of the femur. The second style of stem is that of Biomet's Bi-Metric device. This device has a bi-planner taper which promotes increased proximal off-loading and filling of the metaphysis. The device has a collar.
The cross-screws are available in lengths of 25mm to 60mm and 5mm diameters. Only the end of the screw is threaded so that the portion of the screw that resides inside the stem is smooth.
The femoral stems are manufactured from titanium alloy (Ti-6A1-4V) conforming to ASTM F-620. The cross-screws are manufactured from Ti-6Al-4V conforming to ASTM F-136.
The provided text is a summary of safety and effectiveness for a medical device (Interlocking Hip Stems) undergoing a 510(k) premarket notification process for the FDA. It does not contain information about acceptance criteria, device performance results from a study, sample sizes, expert qualifications, or ground truth establishment relevant to an AI/ML powered device.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and reported device performance.
- Sample size used for the test set and data provenance.
- Number of experts used and their qualifications.
- Adjudication method.
- MRMC comparative effectiveness study results.
- Standalone performance information.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
This document describes a traditional medical device submission, focusing on device description, materials, indications for use, potential risks, and substantial equivalence to a predicate device. It is not an evaluation of an AI/ML algorithm's performance.
§ 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.