(59 days)
The indications for the Corin Metalix Hip Stem as a total hip arthroplasty and, when used in combination with Corin hemi-arthroplasty femoral heads, as a hemi-arthroplasty, include:
- · Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
- · Rheumatoid arthritis
- · Correction of functional deformity
- · Treatment of non-union, femoral neck and trochanteric fractures of the proximal femur
- · Developmental dysplasia of the hip (DDH) or congenital dysplasia of the hip (CDH)
The Corin Metafix Hip Stem is intended for cementless, single use only.
The Metafix Hip is a tapered stem manufactured from titanium (Ti6Al4V) with a layer of hydroxyapatite (HA) Coating applied. The Metafix™ Hip is available in a 135° standard offset (collared and collarless), 135° lateralized high offset (collarless), a 125° standard offset (collared and collarless), a 125° short neck (collared) and a 135° short neck (collared). The device is intended to be used with 12/14 modular taper heads.
This document is a 510(k) premarket notification for a medical device called the Corin Metafix Hip Stem. It's an FDA submission, not a study report. Therefore, it does not contain the information requested in your prompt regarding acceptance criteria and a study proving device performance.
The document discusses the device's intended use, indications, and claims of substantial equivalence to previously marketed predicate devices. It mentions that non-clinical mechanical fatigue testing and range of motion analysis were performed, but no clinical testing was deemed necessary to establish substantial equivalence.
Here's a breakdown of why this document cannot provide the requested information:
- Acceptance Criteria & Reported Performance: These are typically quantitative metrics set for a medical device's performance, often established in clinical trials or specific engineering tests. This document doesn't provide such a table.
- Sample Size (Test Set) & Data Provenance: This refers to the number of patients or samples used in a study to evaluate the device's performance. Since no clinical study was conducted for this submission, this information is not present.
- Number of Experts & Qualifications: This is relevant for studies where expert opinion is used to establish ground truth or evaluate outcomes. Not applicable here.
- Adjudication Method: Also relevant for studies involving human interpretation of data. Not applicable here.
- MRMC Comparative Effectiveness Study: This is a specific type of clinical study comparing human reader performance with and without AI. The device described, a hip stem, is a physical implant, not an AI or imaging device, so this type of study is irrelevant.
- Standalone Performance (Algorithm only): This refers to the performance of an AI algorithm without human involvement. Not applicable to a physical hip stem.
- Type of Ground Truth: This refers to the definitive determination of a condition or outcome in a study. Since no clinical study is presented, no ground truth is established in this document.
- Sample Size (Training Set) & Ground Truth for Training Set: This is relevant for AI/machine learning models where data is used to 'train' the algorithm. Not applicable to a physical hip stem.
In summary, this document is a regulatory submission for a hip implant, not a clinical or AI performance study. It does not contain the detailed information you requested about acceptance criteria and study data.
§ 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.