(35 days)
Synthes Distal Femur Plate (DFP) System is intended for buttressing multifragmentary distal femur fractures. Distal femur fractures include supra-condylar; condylar; articular and extra-articular fractures; fractures in osteopenic bone; and acute fractures, non- unions and malunions.
Synthes DFP System is a plate and screw system. The primary feature of the plate and screw system is that the 7.3 mm locking screws engage with the head of the plate to form a locked, fixed angle construct. The DFP shaft features dynamic compression unit (DCU) screw holes and a limited- contact profile. The plate is available with an anatomically curved head in the longitudinal plane of the plate. The overall length of the plate ranges from 178 mm to 322 mm. The head of the plate has six screw holes: four of the six holes are threaded to accept the 7.3 mm locking screws; the two posterior holes are non-threaded and will accept 6.5 mm cancellous screws or 7.0 / 7.3 mm cannulated screws for additional fixation. The shaft will accept 4.5 mm cortex screws. The 7.3 mm locking screws feature self-drilling and self-tapping tips, are cannulated, and are available in lengths ranging from 50 mm to 110 mm. The threads just below the head of the screw engage with the threaded holes of the DFP. This engagement of the screw to the plate creates a locked, fixed angle construct. Synthes 4.5 mm cortex screws, 6.5 mm cancellous screws, and the 7.0 mm / 7.3 mm cannulated screws can be utilized with this system as well.
The provided text is a 510(k) summary for the Synthes Distal Femur Plate (DFP) System, which is a medical device for fracture fixation. It does not describe a study involving an algorithm or AI, nor does it present acceptance criteria or performance data in the way a study for such a device would. The document focuses on the regulatory clearance process for a traditional medical implant, establishing its substantial equivalence to a predicate device.
Therefore, I cannot extract the requested information regarding acceptance criteria and study details for an AI-powered device from this text. The questions below pertain to AI/algorithm performance studies, which are not present in this document.
However, based on the context of the prompt, I can infer that the general acceptance criteria for a physical medical device like the Synthes DFP System would typically involve:
- Substantial Equivalence: The primary "acceptance criterion" for this 510(k) submission is that the device is substantially equivalent to a legally marketed predicate device. This means it has the same intended use and the same technological characteristics, or if there are differences, those differences do not raise different questions of safety and effectiveness.
- Performance Testing (Benchtop/Mechanical): For a device like a bone plate and screw system, the "study" demonstrating it meets acceptance criteria would involve extensive mechanical and materials testing (e.g., fatigue strength, torsional strength, pull-out strength, corrosion resistance, biocompatibility) to ensure it meets established standards and performs comparably or better than the predicate device. These tests would be conducted according to relevant ASTM or ISO standards.
- Material Compatibility: Confirmation that the stainless steel material meets specified biocompatibility standards.
- Labeling and Instructions for Use: Ensuring the labeling accurately reflects the device's intended use and provides adequate instructions for safe and effective use.
Without an actual study description for an AI device, I cannot fill out the requested table or answer the specific questions related to AI studies. The document only describes a physical medical device and its regulatory clearance based on substantial equivalence.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.