(45 days)
The Accolade™ C Femoral Component is indicated for cemented primary hip surgery in cases of non-inflammatory degenerative ioint disease including osteoarthritis, avascular necrosis, rheumatoid arthritis, and correction of functional deformity. Additionally; this femoral stem can be used in the treatment of nonunion, and femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques. This stem is also indicated for use in revision procedures where other treatments or devices have failed. The Accolade™ C Femoral Component is intended for implantation with bone cement.
The Accolade™ C Femoral Component is a neutral, collared femoral stem and is available in a range of sizes to fit varying anatomical requirements. This device is available in two neck angle options, 127° and 132°, for each corresponding body geometry. A distal spacer is offered for use with this femoral component and is offered in various sizes. This femoral component is intended for the reconstruction of the head and neck of the femoral joint and is intended for implantation with bone cement. The Accolade™ C Femoral Component can be used in conjunction with any currently available Howmedica Osteonics acetabular components, unipolar and bipolar components and Howmedica Osteonics V40™ femoral heads that can be mated with a 5° 40′ BG taper. The Accolade™ C Femoral Component is fabricated from forged cobalt-chromium-molybdenum alloy which complies to ASTM standard F 799. The distal spacer is manufactured from polymethylmethacrylate (PMMA) with BaSO4.
The provided text describes the Accolade™ C Femoral Component, a medical device for hip replacement surgery. The information focuses on its design, materials, intended use, and substantial equivalence to previously marketed devices. However, it does not contain any information about acceptance criteria or a study proving the device meets performance criteria in the way a diagnostic or AI-based device submission would.
The critical missing pieces of information that would be present for such a study are:
- Quantitative Performance Metrics: There are no metrics like sensitivity, specificity, accuracy, AUC, F1-score, etc.
- Test Set Description: No details on the size, source, or characteristics of a test set used to evaluate performance.
- Ground Truth Establishment: No mention of how the "correct" answers were determined for a test set.
- Human Expert Involvement: No mention of radiologists, pathologists, or other experts evaluating the device's output or establishing ground truth.
- AI/Algorithm Performance: This device is a physical prosthetic, not an AI or diagnostic algorithm, so standalone algorithm performance or human-in-the-loop studies are not applicable.
- Training Set Information: As it's not an AI device, there's no concept of a training set for an algorithm.
Based on the provided text, I cannot complete a table of acceptance criteria and reported device performance or answer the specific questions related to an AI/diagnostic device study.
The only performance-related statements are:
- "Finite element analysis of this femoral stem indicates the neck strength equals or exceeds the value proposed by Semlitsch, et. al."
- "Body strength of the smallest size stem meets the performance criteria outlined in ISO 7206-8."
These are engineering performance specifications, not clinical or diagnostic performance metrics.
Therefore, I will state that the requested information is not available in the provided text.
§ 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.