(64 days)
Total hip components are indicated for Uncemented use in individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma, inflammatory joint disease such as rheumatoid arthritis, or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses such as osteoarthritis; avascular necrosis; traumatic arthritis; slipped capital epiphysis; fused hip; fracture of the pelvis; diastrophic variant; old, remote osteomyelitits with an extended drainage-free period; nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; femoral osteotomy; or Girdlestone resection; fracture dislocation of the hip; and correction of deformity. Smith & Nephew MIS Hip Stem components are intended for single use only and are to be implanted without bone cement.
The Smith & Nephew MIS Stem is a straight, tapered, proximally loading stem designed to match the geometry of the femur. The stems are proportionally sized and shaped in sizes 1 through 9 and have modular neck options to address patient anatomy. The stems are manufactured from titanium alloy (Ti-6Al-4VI and the necks are manufactured from Cobalt Chrome. Each femoral stem is proximally coated with Smith & Nephew's Stiktite porous coating.
I am sorry, but the provided text does not contain information about the acceptance criteria or a study that proves a device meets such criteria. The document is a 510(k) premarket notification for a medical device (Smith & Nephew MIS Hip Stem with Stiktite), primarily focusing on:
- Device description and classification
- Indications for Use
- Substantial equivalence information
- FDA's letter acknowledging the 510(k) submission and substantial equivalence determination.
There is no mention of specific acceptance criteria (e.g., performance metrics, thresholds) for the device's function, nor is there a description of a study conducted to evaluate the device against any such criteria. The text does not discuss:
- Device performance data or metrics.
- Sample sizes for test or training sets.
- Data provenance (country of origin, retrospective/prospective).
- Number or qualifications of experts.
- Adjudication methods.
- Multi-reader multi-case (MRMC) comparative effectiveness studies or effect sizes.
- Standalone algorithm performance.
- Types or establishment of ground truth.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided document.
§ 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.