(132 days)
The SBi Foot and Ankle Cannulated Screw System is indicated for fixation of small and long bones, such as femoral neck fractures; slipped capitol femoral epiphysis; tibial plateau fractures; ankle arthrodesis; pediatric femur fractures; intercondylar femur fractures; sacroiliac joint disruptions; and subtalar arthrodesis. The system is not intended for spinal use.
The SBi Foot and Ankle Cannulated Screw System consists of screws and washers that provide fixation of small and long bones. The devices are supplied non-sterile and are available in various sizes and configurations. There are several lengths and diameters of the cannulated screws washers appropriate to the screw diameter. There are fully threaded and partially threaded (16mm and 32mm of thread) configurations. The system also includes guide wires and instruments for use in implanting the screws.
I am sorry, but the provided text does not contain any information about acceptance criteria or a study proving that a device meets those criteria. The document is a 510(k) premarket notification summary for the SBi Foot and Ankle Cannulated Screw System, which focuses on demonstrating substantial equivalence to predicate devices rather than reporting on specific performance studies against acceptance criteria.
Therefore, I cannot provide the requested information, including:
- A table of acceptance criteria and reported device performance.
- Sample sizes or data provenance for a test set.
- Number and qualifications of experts for ground truth establishment.
- Adjudication method for a test set.
- Results of a multi-reader multi-case (MRMC) comparative effectiveness study.
- Results of a standalone performance study.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
§ 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.