(268 days)
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- Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
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- Rheumatoid arthritis.
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- Correction of functional deformity.
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- Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques.
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- Revision procedures where other treatment or devices have failed.
Porous acetabular shells and femoral stems are indicated for uncemented biological fixation. Non-coated or polyethylene components may be used with mating components that are indicated for either cemented or uncemented use.
Additional indications for Biomet G7 Freedom™ Constrained Liners:
The Biomet G7 Freedom™ Constrained Liner is indicated for use as a component of a total hip prosthesis in primary and revision patients at high risk of dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease, or intraoperative instability, and for whom all other options to constrained acetabular components have been considered.
The G7 OssetoTi™ Acetabular Shells are part of the G7™ Acetabular System, designed to provide numerous options for surgeons and patients in one modular compatible system. The OsseoTi™ Shell utilizes an outer surface porous region produced by additive manufacturing using titanium alloy powder (ASTM F2924). This structure leads to a highly interconnected volume of porosity and promotes biological fixation through tissue ingrowth. The shell is available in either a limited hole or multi-hole design. The inner diameter and locking mechanisms are identical to the previously cleared shells of the G7™ Acetabular System, K121874, and will be compatible with the G7™ Acetabular System's E1™ and ArComXL™ polyethylene acetabular liners, as well as all modular components and instrumentation included in K121874.
The provided document is a 510(k) premarket notification letter from the FDA to Biomet, Incorporated, regarding their G7 OsseoTi™ Acetabular Shells. It describes the device, its indications for use, and a summary of non-clinical testing performed to establish substantial equivalence to predicate devices. However, this document does not contain information about acceptance criteria or a study proving the device meets specific acceptance criteria in the context of an AI-powered medical device.
The information provided pertains to a traditional orthopedic implant (hip replacement component) and focuses on mechanical and material characterization, not AI algorithm performance. Therefore, I cannot extract the requested information regarding AI device performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance.
The non-clinical testing listed covers:
- Mechanical Testing: Deformation, Torsional, Fatigue (anatomic and unsupported), Poly Push Out, Poly Lever Out, Poly Torque Out Testing.
- OsseoTi™ Material Characterization: Chemical Composition, Interconnected Porosity, Average Pore Size, Porosity Volume, Roughness, Tensile Adhesion, Abrasion Resistance, Static Shear Strength, Shear Fatigue, Compressive Strength, Elastic Modulus.
- Other: Animal Data.
The document explicitly states: "Clinical Testing: None provided as a basis for substantial equivalence."
Without information regarding an AI component, I cannot fulfill the request as it is framed for AI device evaluation.
§ 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.