(211 days)
The PediFlex™ Flexible Nail System is intended for fixation of diaphyseal fractures of long bones where the medullary canal is narrow or flexibility of the implant is required. This includes upper extremity fractures and lower extremity fractures in pediatric or small stature patients, the flexibility of the nail allows it to be inserted at a point that does not disturb or disrupt the growth plate.
The PediFlex™Flexible Nail System includes stainless steel and titanium flexible nails, interlocking clamps, and clamp screws for the application of aiding bone fracture repair and healing. The PediFlex™Flex™Flexible Nail System was evaluated for use in an MR Environment and were determined to be MR Conditional. The system is implanted using Class I exempt instruments.
The PediFlex™ flexible nails are provided in 316L stainless steel and titanium alloy (Ti-6A1-4V). The 316L stainless steel flexible nails are available in diameters ranging from 1.5 mm to 4.0 mm in increments of 0.5 mm. The titanium allov (Ti-6Al-4V) flexible nails are available in diameters ranging from 1.5 mm to 4.5 mm in increments of 0.5 mm. The tip of the flexible nails is available in two designs, the round tip and the advanced round tip. Both tip designs are provided in 316L stainless steel and titanium alloy (Ti-6Al-4V) in various diameters and lengths. The PediFlex™ interlocking clamps are designed to hold flexible nails in place after insertion by clamping the nail and being fixed to the bone. Using the interlocking Clamps is optional in the surgery. The interlocking clamps are manufactured from both 316L stainless steel and titanium allov (Ti-6Al-4V) materials. The 316L stainless steel interlocking Clamps are available in right and left configurations, in diameters of 3.0 mm, 3.5 mm and 4.0 mm which are to be used with 316L stainless steel flexible nails in diameters of 3.0 mm. 3.5 mm and 4.0 mm. The 316L stainless steel clamp screws are available in 15 mm, and 35 mm in length. The titanium alloy (Ti-6A1-4V) interlocking Clamps are available in right and left configurations, in diameters of 3.0 mm, 3.5 mm, 4.0 mm and 4.5 mm which are to be used with titanium alloy (Ti-6AI-4V) flexible nails in diameters of 3.0 mm, 3.5 mm, 4.0 mm and 4.5 mm. The titanium alloy (Ti-6Al-4V) clamp screws are available in 15 mm, 25 mm, and 35 mm in length. The material of the clamp must match the material of the nail and screw in the surgery.
The system is implanted using Class I exempt instruments. The Class II instruments in the system include hex drivers which are for installing the clamp screws and the hex easy out which is to remove the clamp screws if the hex strips. The instruments in the system are Class I exempt.
The implants in the PediFlex™ Flexible Nail System are for single use only and will be provided non-sterile. The instruments in the PediFlex™ Flexible Nail System are reusable, except for the Hex Easy Out instrument which is single use. Instruments are also provided non-sterile. The devices must be sterilized by the end user before use.
The prompt provides a 510(k) summary for the PediFlex Flexible Nail System. However, this is a medical device for orthopedic fixation and does not involve AI or algorithms that would have a "test set," "training set," "ground truth," or "human readers." The document focuses on performance data related to mechanical testing, MR compatibility, and biocompatibility, as per regulatory standards for such devices.
Therefore, I cannot provide the requested information because the context of the device and the provided document do not align with the questions about AI performance, sample sizes for AI training/testing, or expert-established ground truth for AI algorithms.
§ 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.