(210 days)
The BiCONTACT Hip System (prosthesis, hip, semi-constrained, metal/polymer, porous uncemented) is intended to replace a hip joint. The device is intended for: - patients suffering from severe hip pain and disability due to rheumatoid . arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head and nonunion of previous fractures of the femur. - Patients with congenital hip dysplasia, protrusion acetabuli, or slipped capital . femoral epiphysis - Patients suffering from disability due to previous fusion ◆ - Patients with acute femoral neck fractures ◆
The BICONTACT Hip Stem and Femoral Head are available in one design. The femoral stem is manufactured from Ti with a Ti plasma spray coating (Plasmapore). This component is intended for uncemented use. A CoCrMo femoral head is available. The acetabular cup is manufactured solely of UHMWPE.
This document is a 510(k) summary for the BiCONTACT Hip System, a medical device for hip replacement. It outlines the device description, indications for use, and a claim of substantial equivalence to previously marketed devices. The document references performance data but does not provide specific acceptance criteria or study results in the common format for evaluating AI/machine learning medical devices.
Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, sample sizes, ground truth establishment, or clinical study details as none of this is contained within the provided text.
Specifically, the document states:
- "All required testing per 'Draft Guidance for the Preparation of Premarket Notifications (510(k)s) Applications for Orthopedic Devices-The Basic Elements' were done where applicable."
- It also lists additional guidance documents for testing orthopedic implants.
However, it does not provide:
- A table of acceptance criteria or reported device performance metrics (e.g., sensitivity, specificity, accuracy).
- Details on sample sizes for test sets, training sets, or data provenance.
- Information on experts, adjudication methods, or ground truth types.
- Any mention of a multi-reader, multi-case comparative effectiveness study or standalone algorithm performance, as these typically apply to AI/ML device evaluations.
The document focuses on demonstrating substantial equivalence to predicate devices based on design and general testing guidance for orthopedic implants, not on specific performance metrics against defined acceptance criteria that would be relevant for an AI/ML device.
§ 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.