(59 days)
The Synthes PFN System is intended to treat stable and unstable proximal fractures including pertrochanteric fractures, intertrochanteric fractures, high subtrochanteric fractures, and combinations of these fractures.
Synthes PFN System is an intramedullary nail which utilizes a weightbearing dynamic femoral neck screw and an anti-rotational parallel hip pin. Distal interlocking is performed with an aiming arm and can be either static or dynamic. The following components makeup the PFN system: proximal femoral nails, hip pins, femoral neck screws, 4.9 mm locking bolts, and 17 mm end caps.
The PFN has a 17 mm proximal diameter, and is 240 mm in length. The PFN features an angle between femoral neck / shaft ranging from 125° - 140°. It has two proximal holes: one is 6.5 mm in diameter and the other is 11 mm in diameter. Two distal holes accept the 4.9 mm locking bolts. The hip pin, femoral neck screws, and 4.9 mm locking bolts are used to lock the PFN into place. The hip pin is 6.5 mm in diameter and is available in lengths ranging from 75 mm to 120 mm. The femoral neck screw is 11 mm in diameter and is available in lengths ranging from 80 mm to 120 mm. The 4.9 mm locking bolts have a 4.9 mm diameter and are available in lengths ranging from 26 mm to 100 mm. The proximal end of the PFN accepts a 17 mm end cap. The end cap is 17 mm in diameter and is available in 0 to 15 mm extensions. Synthes PFN System is manufactured from a titanium alloy and stainless steel.
The provided document is a 510(k) summary for the Synthes Proximal Femoral Nail (PFN) system, comparing it to Howmedica's Gamma Locking Nail (GLN). However, it does not describe an acceptance criteria and study that fits the requested format for device performance based on a test set, ground truth, or an AI/human-in-the-loop scenario.
The document primarily focuses on:
- Intended Use: What the PFN system is designed to treat (proximal femoral fractures).
- Device Description: Detailed specifications of the PFN components (dimensions, materials, locking mechanisms).
- Comparison to a Predicate Device: Stating that the PFN is "at least equivalent to the GLN" based on "mechanical test results."
Therefore, I cannot fulfill the request to provide a table of acceptance criteria, reported device performance, sample sizes, ground truth establishment, or details of efficacy studies as this information is not present in the provided text.
The document is about a medical device (a surgical nail), not a diagnostic or AI-driven device with clearly defined performance metrics like sensitivity, specificity, or reader improvement. It speaks to mechanical equivalence, not a clinical trial design with patient outcomes or expert reads.
§ 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.