(164 days)
The hip prosthesis QUADRA-P is designed for cementless use in total or partial hip arthroplasty; for primary or revision surgery. Hip replacement is indicated in the following cases:
• Severely painful and/or disabled joint as a result of arthritis, rheumatoid 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, arthroplasty, hip resurfacing replacement or total hip arthroplasty.
The Quadra-P implants are line extensions to Medacta's Total Hip Prosthesis – AMIStem-H, Quadra-S, and Quadra-H Femoral Stems (K093944); AMIStem and Quadra - Line Extension (K121011); AMIStem-P, AMIStem-P Collared, and AMIStem-H Proximal Coating Femoral Stems (K173794); Quadra-H and Quadra-R Femoral Stems (K082792); and AMIStem-H Proximal Coating (K161635).
The Quadra-P implants subject of this submission are comprised of the following products:
- . Quadra-P STD. Stem sizes 0 - 10;
- Quadra-P LAT, Stem sizes 0 - 10.
The Quadra-P implants are part of the Medacta Total Hip Prosthesis system. The Medacta Total Hip Prosthesis system consists of femoral stems, modular femoral heads, and acetabular components. The acetabular components consist of metal cups and liners made of ultra-high molecular weight polyethylene (UHMWPE) or Highcross highly crosslinked ultra-high molecular weight polyethylene (HXUHMWPE). Acetabular components include the Mpact DM (K143453), VersafitCup (K083116 and K092265), VersafitCup CC Trio (K103352), Mpact (K103721 and K132879), Mpact 3D Metal (K171966), and Medacta Bipolar Head (K091967).
The Quadra-P implants can be combined with the CoCr Ball Heads (K072857 and K080885), Endo Head (K111145), MectaCer Biolox Option Heads (K131518), or with the MectaCer BIOLOX® Forte (K073337) or MectaCer BIOLOX® Delta Femoral Heads (K112115).
This document is a 510(k) premarket notification for the "Quadra-P" hip prosthesis, specifically describing the physical and mechanical testing performed to demonstrate substantial equivalence to previously cleared predicate devices. It does not contain information about the performance or acceptance criteria of an AI/Software device, nor does it describe a study involving humans or the establishment of ground truth for such a device.
Therefore, I cannot extract the information required to answer your questions about acceptance criteria and studies proving the device meets those criteria, as the provided document pertains to a physical medical device (hip prosthesis) and its mechanical engineering performance tests, not an AI or software-based medical device.
The document discusses:
- Device Name: Quadra-P (hip prosthesis)
- Regulation Number: 21 CFR 888.3353 (Hip Joint Metal/Ceramic/Polymer Semi-Constrained Cemented Or Nonporous Uncemented Prosthesis)
- Performance Data (Non-Clinical Studies):
- Range of Motion (ROM) testing (EN ISO 21535:2009)
- Fatigue testing (ISO 7206-4 and ISO 7206-6)
- Pull off force testing (ASTM F2009-00)
- Pyrogenicity testing (European Pharmacopoeia §2.6.14/USP and USP )
- Clinical Studies: "No clinical studies were conducted."
Since the request is specifically about a device proving it meets acceptance criteria through a study involving a test set, expert ground truth, adjudication methods, and potentially human readers (which implies an AI/Software device or diagnostic device), the provided text is entirely irrelevant to those questions.
§ 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.