(258 days)
The DePuy Synthes Retrograde Femoral Nail Advanced System is intended to stabilize fractures of the distal femur and the femoral shaft, including:
- Supracondylar fractures, including those with intra-articular extension
- Combination of ipsilateral condylar and diaphyseal fractures
- Ipsilateral femur/tibia fractures
- Femoral fractures in multiple trauma patients
- Periprosthetic fractures
- Fractures in the morbidly obese
- Fractures in osteoporotic bone
- Impending pathologic fractures
- Malunions and nonunions
The DePuy Synthes Retrograde Femoral Nail Advanced System was developed to address challenges associated with treating distal femur fractures with intramedullary nails. The modular system incorporates several components to a variety of fracture patterns including those in the presence of previously implanted devices such as the femoral components of a total knee arthroplasty (periprosthetic). The nailing implants are available in two distal bend configurations which enable standard and periprosthetic entry points for the insertion of the femur. The nailing system implants are manufactured from titanium alloys, stainless steel and polyethylene and are provided in a range of dimensions.
The provided document is a 510(k) Premarket Notification from the FDA for a medical device (DePuy Synthes Retrograde Femoral Nail Advanced System). It does not contain any information regarding acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML-driven medical device, as implied by the structure of your request.
This document describes a traditional medical device (an intramedullary nail for fracture stabilization) and its substantial equivalence to a predicate device. The "tests results meet established acceptance criteria" mentioned in the non-clinical and/or clinical tests summary section refers to mechanical and material performance tests for the physical implant, not the performance of an AI/ML system.
Therefore, I cannot fulfill your request for information regarding AI/ML device acceptance criteria and study details based on the provided text. The document does not describe:
- A table of acceptance criteria for an AI/ML device or its reported performance.
- Sample sizes for AI/ML test sets or data provenance.
- Number/qualifications of experts for AI/ML ground truth.
- Adjudication methods for AI/ML test sets.
- MRMC comparative effectiveness studies.
- Standalone AI algorithm performance.
- Types of ground truth for AI/ML.
- Training set sample sizes for AI/ML.
- Ground truth establishment for AI/ML training sets.
The text focuses on the device's indications for use, its mechanical properties, and its substantial equivalence to existing devices based on physical design changes (specifically, the option to remove an "inlay" from the nail).
§ 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.