(144 days)
The hip prosthesis MasterLoc® is designed for cementless use in total or partial hip arthroplasty in primary or revision surgery.
Hip replacement is indicated in the following cases:
· Severely painful and/or disabled joint as a result of arthritis, traumatoid polyarthritis, or congenital hip dysplasia:
· Avascular necrosis of the femoral head;
· Acute traumatic fracture of the femoral head or neck;
· Failure of previous hip surgery: joint reconstruction, internal fixation, arthrodesis, surface replacement
arthroplasty, or total hip replacement.
A hip prosthesis consists of a femoral stem made of metal, a modular femoral head made of metal or ceramic, and acetabular components. The acetabular components consists of a metal cup, and a liner that is made of ultra-high molecular weight polyethylene (UHMWPE), or Highcross highly crosslinked ultra-high molecular weight polyethylene (HXUHMWPE). Acetabular components can be: Versafitcup, Versafitcup CC Trio, Mpact, Medacta Bipolar Head.
All the auxiliary components of the prosthesis are supplied in single-use individual packages.
The MasterLoc® stems can be combined with the CoCr ball heads, Endo Head or with the MectaCer BIOLOX® forte or MectaCer BIOLOX® delta femoral heads. Refer to the MectaCer BIOLOX® forte or MectaCer BIOLOX® delta femoral heads package insert and to CoCr heads package insert for more information about ball heads.
The provided text describes a 510(k) premarket notification for a hip prosthesis called the "MasterLoc Stem." This document focuses on demonstrating substantial equivalence to predicate devices rather than proving device performance against specific acceptance criteria for a novel AI/software medical device.
Therefore, the information required to answer your prompt, which is tailored for an AI/software medical device (e.g., acceptance criteria for model performance, training/test set details, expert ground truth establishment, MRMC studies), is not present in the provided document.
The document details:
- Device Name: MasterLoc Stem
- Regulation Number/Name: 21 CFR 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis
- Regulatory Class: Class II
- Product Codes: LZO, LPH, MEH, KWY, LZY
- Indications for Use: Cementless use in total or partial hip arthroplasty in primary or revision surgery for conditions like arthritis, avascular necrosis, femoral head/neck fracture, or failure of previous hip surgery.
- Predicate Devices: K052792 ANTHOLOGY Hip Stem (Smith & Nephew, Inc.) and K072857 Medacta Total Hip Prosthesis (Medacta International).
- Performance Testing: Mechanical testing (e.g., ISO 7206-4, ISO 7206-6, EN ISO 21535, ASTM F2009-00) for risks like breakage, limited range of motion, coating adhesion, and modular connection instability. These are physical product performance tests against engineering standards, not AI/software performance criteria.
In summary, this document does not contain the information needed to fill out your requested table and details for an AI/software medical device.
If you have a document describing the validation of an AI/software medical device, please provide that, and I would be happy to help.
§ 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.