(49 days)
The Revelation™ Porous Hip Stem is intended for treatment of patients who are candidates for total hip arthroplasty because of degenerative joint disease including osteoarthritis and avascular necrosis; rheumatoid arthritis; correction of functional deformity; revision procedures where other treatments or devices have failed; and treatment of nomunion, femoral neck and trochanteric fractures of the proximal femur with head involvement, which is unmanageable using other techniques.
The Revelation™ Porous Hip Stem is fabricated from wrought/forged or cast Ti-6A1-4V that conforms to ASTM F136 or F1108. respectively. The outside surface of the stem is porous coated with commercially pure titanium (ASTM F67 grade 2) beads to provide a porous surface for enhanced fixation. The Revelation™ Porous Hip Stem is collarless and has a Morse type taper to receive modular heads.
This document is a 510(k) premarket notification for a medical device (Revelation™ Porous Hip Stem). It indicates that the device has been found substantially equivalent to a predicate device already on the market.
Crucially, this document does not describe acceptance criteria or a study that proves the device meets those criteria, in the way one would typically expect for an AI/software device submission.
Instead, it's a notification about a physical orthopedic implant. For such devices, "acceptance criteria" and "studies" usually refer to mechanical testing (fatigue strength, torsional strength, etc.), biocompatibility testing, and potentially limited clinical follow-up for specific features if new. However, the provided text does not contain any of this information.
Therefore, I cannot fulfill your request as the information regarding acceptance criteria and performance studies for the Revelation™ Porous Hip Stem is not present in the provided text. The document is primarily an FDA clearance letter and a summary of the device's characteristics and intended use, asserting substantial equivalence to existing devices rather than detailing specific performance studies against acceptance criteria.
§ 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.