(108 days)
The hip prosthesis AMIStem-P and AMIStem-P collared are designed for cementless use in total or partial hip arthroplasty, for primary or revision surgery. The hip prosthesis AMIStem-C is designed for cemented 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, 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, arthrodesis, partial hip arthroplasty, hip resurfacing replacement or total hip arthroplasty
The AMIStem-P Short Neck femoral stems are line extensions to the AMIStem-P femoral stems cleared under K173794.
The devices subject to this 510(k) are comprised of the following products:
- AMIStem-P Short Neck STD, Stem sizes 00 to 9, and ●
- AMIStem-P Short Neck LAT, Stem sizes 0 to 8.
The AMIStem-P Short Neck femoral stems are cementless stems manufactured from titaniumniobium alloy (Ti-6A1-7Nb alloy) and are coated with titanium and HA.
This document is a 510(k) summary for the AMIStem-P Short Neck femoral stems, which are a line extension of existing devices. Therefore, the information provided focuses on demonstrating substantial equivalence to a predicate device rather than presenting a de novo study with detailed acceptance criteria and performance data for an AI-powered device.
Based on the provided text, the device is not an AI/ML medical device. It is a hip prosthesis (femoral stem). The "performance data" section describes mechanical testing (range of motion, fatigue, pull-off force) and pyrogenicity testing, which are standard for orthopedic implants, not software.
Therefore, the requested information about acceptance criteria, study details, sample sizes, ground truth, expert involvement, and MRMC studies, which are relevant for AI/ML device studies, cannot be extracted from this document as it does not pertain to such a device.
The document states that "The data and information provided in K173794 support the conclusion that the AMIStem-P Short Neck femoral stems are substantially equivalent and conform to applicable standards and FDA guidance." This implies that the performance of the new device is considered acceptable because it is substantially equivalent to a previously cleared device that met its performance criteria.
Here's what can be extracted regarding performance from the document:
1. Table of Acceptance Criteria and Reported Device Performance:
| Test | Acceptance Criteria (Implied by Predicate Equivalence) | Reported Device Performance |
|---|---|---|
| Mechanical Performance | Conforms to applicable standards for hip-joint replacement implants (e.g., EN ISO 21535, ISO 7206-4, ISO 7206-6, ASTM F2009-00) for range of motion, fatigue, and pull-off force. | Subject devices (AMIStem-P Short Neck) do not represent a new worst case compared to the predicate (AMIStem-P femoral stem, K173794). The data and information in K173794 are considered sufficient to support the substantial equivalence of the mechanical performance. |
| Pyrogenicity (Bacterial Endotoxin Test - LAL Test) | Endotoxin limit of |
§ 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.