(30 days)
The Medacta Total Hip Prosthesis System is intended for cementless use in total or partial hip arthroplasty and in primary or revision surgery.
Hip replacement is indicated in the following cases:
- Severely painful and/or disabled joint as a result of arthritis, traumatic 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, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
The modifications to the original Medacta Total Hip Prosthesis system are a line extension to include the AMIStem H femoral stems. As well as, Quadra S short neck and Quadra H short neck femoral stems. The AMIStem H has the same application of a hydroxyapatite (HA) coating as the Quadra H stems cleared in 510(k) K082792. AMIStem H femoral stems are based on the design of the Quadra S femoral stems in the original submission as well as the Quadra H femoral stems cleared in 510(k) K082792. The AMIStem H differs from Quadra H and Quadra S by a decreased length of 15% and a reduced shoulder. The Quadra H short neck femoral stems are the same design femoral stems as the Quadra S femoral stems in the original submission but with the application of a hydroxyapatite coating.
The Quadra S short neck femoral stems are the same as those in the original submission except they are offered in larger sizes. The Quadra H short neck femoral stems are the same as those in submission K082792 except they are offered in larger sizes.
The provided document is a 510(k) summary for a medical device (Medacta Total Hip Prosthesis). It describes modifications to an existing hip prosthesis system and asserts its substantial equivalence to a predicate device.
This document does NOT contain information about acceptance criteria or a study that proves a device meets such criteria. It is a regulatory submission for a modified medical device, focusing on demonstrating substantial equivalence to a previously cleared device, not on presenting performance study results against specific criteria.
Therefore, I cannot fulfill your request for the detailed table and information about acceptance criteria, sample sizes, ground truth, experts, and comparative effectiveness studies, as these details are not present in the provided text. The document states:
- "No performance standards applicable to this device have been adopted under Section 514 of the Food, Drug and Cosmetic Act." This indicates that there are no formally established, externally mandated performance criteria for this specific device.
- "Risk analysis was conducted on the impact of these changes and appropriate design verification and validation was conducted under the company's design controls." This is a general statement about internal company procedures, not a specific performance study with defined acceptance criteria and results.
- The conclusion states: "The results from design controls and the information provided in this submission support the conclusion that the Medacta Total Hip Prosthesis System - AMIStem H femoral stems and Quadra S and H short neck femoral stems are substantially equivalent to their predicate..." This reinforces that the submission is about substantial equivalence, not a standalone performance study.
To answer your request, I would need a document that specifically details performance studies, acceptance criteria, and their results for 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.