(85 days)
- Low subtrochanteric fractures
- Pseudarthrosis and corrective osteotomies
- Transverse fractures
- Pathologic fractures, impending pathologic fractures, and tumor resections.
- Oblique and spiral fractures
- Supracondylar fractures, including those with intra-articular extension
- Segmental fractures
- Ipsilateral femoral neck fractures
- Comminuted fractures
- Fractures proximal to total knee arthoplasty
- Fractures distal to a hip implant
- Nonunions and malunions.
- Acute bone lengthening and shortening
- Reamed and unreamed applications
- High Supracondylar fractures, including those with intra-articular extension.
The APEX Intramedullary Nail System consists of intramedullary rods for fixation inside the canal of the tibia or femur. All the rods are cannulated and cylindrical in shape. The rods are available in a variety of diameters and lengths and have holes located the proximal and distal ends for fixation to bone by means of locking screws. An end cap is available. It screws into the threaded end of the nails to prevent bone ingrowth, which may hamper attachment of the extraction instrumentation. All components of the APEX Intramedullary Nail System are manufactured from titanium alloy (Ti-6Al-4V).
This document is a 510(k) premarket notification for a medical device called the "APEX Intramedullary Nail System." This type of submission is for establishing substantial equivalence to a predicate device, not for proving a device meets specific performance criteria through a study with acceptance criteria in the way an AI/ML device would.
Therefore, the requested information points (acceptance criteria, device performance table, sample sizes, expert qualifications, adjudication, MRMC, standalone performance, ground truth, training set size) are not applicable in the context of this specific document, as it describes a traditional orthopedic implant (intramedullary nail) and not a device that would necessitate such a performance study.
The core of a 510(k) for a device like this relies on demonstrating that it is "substantially equivalent" to a legally marketed predicate device (or devices). This is typically achieved by comparing design, materials, intended use, and performance characteristics (often mechanical testing for implants) to established standards or to the predicate device(s).
Summary of what can be extracted from the provided text, related to substantial equivalence:
- Device Type: APEX Intramedullary Nail System (intramedullary rods for fixation inside the canal of the tibia or femur).
- Predicate Devices:
- Stryker Howmedica Osteonics Retrograde/Antegrade Femoral Nail
- ACE AIM Titanium Nails (DePuy/ACE, a Johnson Company)
- Smith & Nephew TriGen Knee Nail
- Basis for Substantial Equivalence: "The APEX Intramedullary Nail System is similar to the listed predicate device in design, function, materials used, and indications for use."
- Materials: Titanium alloy (Ti-6Al-4V) for all components.
- Indications for Use: A comprehensive list of femoral fractures and conditions that the device is intended to treat (e.g., low subtrochanteric fractures, transverse fractures, nonunions, malunions, etc.).
In conclusion, this document does not contain the information required to fill out the table and answer the study-related questions because it describes a different type of regulatory submission (510(k) for a traditional device) than one that would involve performance studies with acceptance criteria for tasks like image interpretation or diagnosis.
§ 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.