(22 days)
Total hip components are indicated for uncemented use only 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 (NDJD) or any of its composite diagnoses such as osteoarthritis; avascular necrosis; traumatic arthritis; slipped capital epiphysis; fused hip; fracture of the pelvis and diastrophic variant; old, remote osteomyelitis with an extended drainage-free persod; non-union; 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.
Echelon Porous Plus HA Hip Stem components are intended uncemented use and for single use only.
Echelon Porous Plus HA Hip Stems are fully porous coated HA stems. These stems are designed for use with existing modular Smith & Nephew, Inc. femoral heads.
The provided text describes a 510(k) premarket notification for the "Echelon Porous Plus HA Hip Stems." This type of submission focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than on providing detailed clinical study data with specific acceptance criteria and performance metrics typically found in efficacy studies for novel devices.
Therefore, the information requested regarding acceptance criteria, specific measured device performance against those criteria, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, and ground truth for training/testing sets is not available in the provided document.
The document states:
- "Design Verification Test results indicate that the subject devices meet the requirements of the applicable FDA guidance documents." This is a general statement that implies testing was done, but it does not provide the specifics of the acceptance criteria or the actual performance results.
- The entire submission is focused on demonstrating substantial equivalence to existing predicate devices (Smith & Nephew Synergy HA on Porous Hip Stems (K002996), Howmedica Meridian ST/PA Femoral Stems (K971206), and Osteomplant Technology, Inc. LSF HA Coated Triad Total Hip System).
Because this is a 510(k) summary, the focus is on comparing the new device to existing devices on the market that have similar technological characteristics and intended use. The FDA determines substantial equivalence based on this comparison, often relying on material properties, design specifications, and non-clinical performance testing (e.g., mechanical strength, fatigue testing, biocompatibility) rather than extensive clinical efficacy studies with the detailed metrics you've requested.
In summary, the provided document does not contain the specific information needed to fill out your requested table and answer the questions.
§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.
(a)
Identification. A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.(b)
Classification. Class II.