(279 days)
The indications for the Corin MetaFix™ Hip Stem as a total hip arthroplasty, and when used in combination with a Corin hemi-arthroplasty head, as a hip hemi-arthroplasty, include:
- Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
- Rheumatoid arthritis
- Correction of functional deformity
- Treatment of non-union and femoral neck fractures
- Developmental dysplasia of the hip (DDH) and congenital dysplasia of the hip (CDH)
The Corin MetaFix™ Hip Stem is indicated for cementless use only.
The MetaFix™ Hip is a tapered stem manufactured from titanium alloy (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 (collared and 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.
The MetaFix™ hip is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components.
I apologize, but the provided text does not contain information about the acceptance criteria and the study that proves a device meets those criteria. Instead, the document is a 510(k) premarket notification for a medical device called the "Corin MetaFix™ Hip Stem."
This document focuses on demonstrating substantial equivalence to existing legally marketed predicate devices, rather than proving the device meets specific performance acceptance criteria through a clinical or non-clinical study in the way you've outlined.
The key points from the provided text are:
- Substantial Equivalence: The document asserts that the Corin MetaFix™ Hip Stem is substantially equivalent to predicate devices (other MetaFix Hip Stems). This is a regulatory pathway for medical devices in the U.S. that does not always require new clinical trials to prove efficacy or safety from scratch, but rather demonstrates it's as safe and effective as a device already on the market.
- Non-Clinical Testing: It mentions "mechanical fatigue testing of the neck and stem" and a "range of motion assessment." These are non-clinical (laboratory) tests used to support the claim of substantial equivalence, likely ensuring the new variations perform comparably to the predicates under simulated conditions.
- Clinical Testing: The document explicitly states: "Clinical testing was not necessary to determine substantial equivalence between the Corin MetaFix™ Lateralized Collared Hip Stem, Corin MetaFix™ Collared Short Neck Hip Stem and the predicate devices."
Therefore, I cannot provide the information requested in your numbered points (acceptance criteria table, sample size, expert ground truth, MRMC study, standalone performance, etc.) because the scope of this FDA document is to establish substantial equivalence for a hip stem, not to validate an AI/algorithm-based device and its performance against detailed acceptance criteria that your questions imply for such a device.
§ 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.