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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).

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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:

• 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

• 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

• 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.

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