(103 days)
The Ellipse PRECICE Trauma Nail System is indicated for closed fracture fixation, pseudoarthrosis, or mal-unions and non-unions of long bones.
The Ellipse PRECICE Trauma Nail System is composed of a modular implantable intramedullary rod ("Distracting Rod"), locking screws, an external remote controller (ERC), and surgical implantation tools and accessories. The modular implantable in different configurations, lengths, and diameters to accommodate a variety of patient anatomies. Likewise, the locking screws are available in two different diameters and a variety of lengths from 20 mm to 75 mm in 5 mm increments. The distracting rod is a modular system that includes the PRECICE Actuator component and various configurations of PRECICE Extension Rods. The PRECICE Actuator includes an enclosed rare earth magnet, telescoping lead screw/nut assembly and gearing. The PRECICE Actuator is supplied sterile by gamma sterilization while the PRECICE Extension Rods, locking screws, and reusable accessories are supplied non-sterile and must be sterilized prior to use. The External Remote Controller (ERC) is a non-invasive adjustment component of the system. The ERC is electrically powered and is used for non-invasive lengthening of the implanted rod.
I am sorry, but the provided text does not contain information regarding acceptance criteria or details about a study that proves the device meets acceptance criteria.
The document is a 510(k) summary for the Ellipse PRECICE Trauma Nail System, primarily focusing on:
- Product Description: What the device is and its components (intramedullary rod, locking screws, external remote controller).
- Indications for Use: What the device is intended for (closed fracture fixation, pseudoarthrosis, mal-unions, and non-unions of long bones).
- Substantial Equivalence: How the device is similar to previously cleared devices (predicates) and therefore deemed safe and effective. It explicitly states that the purpose of the premarket notification is to provide labeling for fracture fixation and that substantial equivalence is based on similar indications and technological characteristics.
- FDA Clearance Letter: Official communication from the FDA confirming the 510(k) clearance based on substantial equivalence.
There is no mention of specific acceptance criteria, test results, device performance metrics, or study designs to prove that the device meets such criteria. Therefore, I cannot generate the requested table or answer the specific questions about sample sizes, experts, adjudication methods, MRMC studies, standalone performance, or ground truth for either test or training sets.
§ 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.