(125 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 Locking Screws for Medullary Nails, 5.0 mm are indicated for the static and dynamic interlocking of femoral, humeral and tibial nails.
The proposed Retrograde Femoral Nail Advanced System is being developed to address challenges associated with treating distal femur fractures with intramedullary nails. The system is modular in nature, incorporating several components to allow for the treatment of a variety of fracture patterns and 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 different bends which enable standard and periprosthetic entry points for the insertion of the nailing implant in the femur. The implants in this submission are manufactured from titanium alloys, stainless steel and polyethylene and are provided in a range of dimensions. The DePuy Synthes Locking Screws for Medullary Nails, 5.0 mm feature a retaining screw head recess, additional shorter, rounded cutting flutes the ability to drive under power. The screws feature either a standard screw head or a low-profile screw head and are available with standard washers and nuts.
The provided text ({0}-{5}) does not contain information about acceptance criteria or a study that uses a test set, ground truth, or human readers for performance evaluation. This document is a 510(k) premarket notification letter for a medical device (DePuy Synthes Retrograde Femoral Nail Advanced System and Locking Screws).
The text explicitly states:
"Clinical testing was not necessary for the determination of substantial equivalence." (Page 4, under "Clinical Performance Data")
Instead, the submission relies on non-clinical performance data to demonstrate substantial equivalence to predicate devices. These non-clinical tests are primarily mechanical and material tests conducted according to ASTM standards.
Therefore, I cannot populate the requested information regarding acceptance criteria, reported device performance, sample sizes for test sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, or ground truth for training/test sets.
The information that is present regarding performance comes from non-clinical engineering tests:
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Non-clinical Performance Data for Retrograde Femoral Nail Advanced System:
- Static Bend according to ASTM F1264
- Static Torsion according to ASTM F1264
- Dynamic Bend according to ASTM F1264
- Mechanical Static Construct
- Poly Inlay Screw Pull Out Test and Debris Evaluation
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Non-clinical Performance Data for DePuy Synthes Locking Screws for Medullary Nails, 5.0:
- Torsional Properties according to ASTM F543
- Driving Torque & Axial Pushout according to ASTM F543
- Driving Torque according to ASTM F543
- Self-tapping Performance according to ASTM F543
- Finite Element Analysis for 3-Point Bending according to ASTM 1264
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Other Additional Analysis:
- Endotoxin Testing according to AAMI ST72
- MRI Conditional analysis performed (though not released with MR Conditional labeling)
These tests are designed to show that the mechanical properties and safety (e.g., in terms of materials and manufacturing) of the new device are comparable to those of existing, legally marketed predicate devices, thereby establishing "substantial equivalence" without requiring human-data-based clinical performance studies.
§ 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.