(247 days)
Biolox ceramic heads and Foundation™ Forged, Textured and Porous Stems are intended for treatment of patients who are candidates for total hip arthroplasty because the natural femoral head and neck have been affected by osteoarthritis, inflammatory arthritis, traumatic arthritis, rheumatoid arthritis, avascular necrosis or femoral neck fracture, and revision arthroplasty where bone loss is minimal.
This document does not describe a medical device that uses AI or machine learning, nor does it provide information about a study involving performance metrics, sample sizes, ground truth establishment, or expert evaluations.
The document is a "Summary of Safety and Effectiveness" for a physical medical device: "Biolox ceramic heads for use with Foundation™ Forged, Textured and Porous Stems." It describes the device, its intended use, and its comparability to predicate devices.
Therefore, I cannot extract the requested information such as acceptance criteria, study details, sample sizes, ground truth, or expert qualifications, as this information is not present in the provided text.
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Summary of Safety and Effectiveness
K9SSS63
Encore Orthopedics™, Inc. 8900 Shoal Creek Bldg. 300 Austin, TX 78757 512-795-8696 Ashley M. Bock
AUG - 9 1996
Trade Name: Biolox ceramic heads for use with Foundation™ Forged, Textured and Porous Stems
Common Name: Ceramic femoral head
Classification Name: Hip joint metal/ceramic/polymer semi-constrained cemented . prosthesis per 21 CFR 888.3353
Description: Biolox ceramic heads for use with Foundation™ Forged, Textured and Porous Stems that were cleared for commercial distribution in K952191, K935263 and K952297, respectively.
Intended Use: Biolox ceramic heads and Foundation™ Forged, Textured and Porous Stems are intended for treatment of patients who are candidates for total hip arthroplasty because the natural femoral head and neck have been affected by osteoarthritis, inflammatory arthritis, traumatic arthritis, rheumatoid arthritis, avascular necrosis or femoral neck fracture, and revision arthroplasty where bone loss is minimal.
Comparable Features to Predicate Device(s):Features comparable to predicate devices include the Biolox heads used with SL-PLUS and SLR-PLUS Stems cleared for commercial distribution in K930963.
§ 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.