(130 days)
The Aequalis Humeral Nail System is intended to provide temporary stabilization of various types of proximal and/or diaphyseal fractures of the humerus. Types of fractures include, but are not limited to, non-unions, malalignments, pathological fractures, and impending pathological fractures. Examples of specific indications according to AO classification include Type A-Fractures, dislocated, Type B Fractures, dislocated, Type C-Fractures, with intact calotte, or Humeral Fractures according to Neer-Classification (2, 3 and 4 part fractures).
The Aequalis Humeral Nail System includes intramedullary nails and screws. The Aequalis Humeral Nail is a straight, cannulated intramedullary nail with a 9mm proximal diameter and a distal diameter that tapers from 8mm to 5mm. It is 130mm long and is available in right and left configurations. The proximal end of the nail contains screw holes in four axes for proximal locking using 5mm cannulated screws. The proximal end of the nail also contains a cannulated polyethylene insert with screw holes aligned with those of the nail. This insert is intended to help prevent the proximal screws from backing out. The distal end of the nail incorporates one slot and one screw hole for distal locking using 4.5mm screws. The nail and screws are manufactured from anodized Ti-6Al-4V alloy.
This document is a 510(k) summary for a medical device (Aequalis Humeral Nail System) seeking market clearance, not a study report detailing performance against acceptance criteria. Therefore, the information requested regarding acceptance criteria, study design, and performance metrics is not present in the provided text.
Specifically, the document:
- Describes the device (Aequalis Humeral Nail System) and its intended use.
- Compares it to predicate devices to demonstrate substantial equivalence, based on similarities in indications for use, design, materials, and "results of stress calculations."
- Contains the FDA's clearance letter stating that the device is substantially equivalent to legally marketed predicate devices.
There is no experimental study described in this document that would establish acceptance criteria or provide device performance data in the manner requested. The clearance is based on substantial equivalence to existing devices that have already been cleared and are deemed safe and effective.
Therefore, I cannot provide the requested table or answer the specific questions about sample sizes, ground truth, expert qualifications, adjudication methods, or MRMC studies for this device based on the provided text. The "stress calculations" mentioned as a basis for comparison are not further detailed or presented with specific results and acceptance criteria.
§ 888.3020 Intramedullary fixation rod.
(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.