(257 days)
The REDAPT Sleeved Monolithic Revision Stems are indicated for:
· Hip components are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or noninflammatory degenerative joint disease (NID) ) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant.
· Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis, atthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; treatments of nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; endoprosthesis, femoral osteotomy, or Girdlestone resection; fracture-dislocation of the hip; and correction of deformity.
The REDAPT™ Revision Hip System (formerly MDF) is intended to be used without cement.
Subject of this Abbreviated premarket notification is the addition of a new stem design to the Smith & Nephew REDAPT Revision Femoral System which are Femoral Components part of Smith & Nephew's Total Hip System. The REDAPT Revision Femoral System currently consists of the Modular Proximally Fluted Hip Stems cleared by K113789, the Modular Sleeved Revision Hip Stems cleared by K121627, and the Monolithic Sleeveless Hip Stems cleared on K151902. The proposed devices are the REDAPT Sleeved Monolithic Revision Stems, new hip stems that will be marketed as part of the REDAPT Revision Femoral System.
The provided text is a 510(k) premarket notification for a medical device (REDAPT Sleeved Monolithic Revision Stems). It describes the device, its intended use, and its technological characteristics. However, it does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of an AI-powered diagnostic device, which your request implies.
The document focuses on the mechanical and material performance of a hip implant device, comparing it to predicate devices to establish substantial equivalence. It explicitly states: "Clinical data was not needed to support the safety and effectiveness of the subject devices." This means there was no multi-reader multi-case (MRMC) study, no standalone algorithm performance, and no ground truth established by expert consensus or pathology data in the way you're asking for an AI/diagnostic device.
Therefore, I cannot fulfill your request as it pertains to acceptance criteria and performance studies for an AI/diagnostic device based solely on the provided text. The information you're asking for (e.g., sample size for test set, number of experts for ground truth, MRMC study, effect size of AI assistance) is characteristic of AI/CAD (Computer-Aided Detection/Diagnosis) device submissions, not mechanical implants like the one described.
If you have a document related to an AI/diagnostic device, please provide that, and I would be happy to analyze it according to your requested criteria.
§ 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.