(136 days)
Smith & Nephew Image Guided Surgical Instruments for Trauma Applications are intended to be used with the Universal Accessories to assist the surgeon in precisely locating anatomical structures in either open or percutaneous procedures. Image Guided Surgical Instruments for Trauma Applications are indicated for use in surgical trauma procedures, in which the use of stereotactic surgery may be appropriate, and where a reference to a rigid anatomical structure such as a long bone (femur, tibia, humerus, radius, ulna, fibula), pelvic bone (including acetabular), calcaneus, and talus bone can be identified relative to a CT or MR based model or fluoroscopy images of the anatomy.
Example procedures include but are not limited to:
Spinal procedures and spinal implant procedures such as pedicle screw placement Pelvis and acetabular fracture treatment such as screw placement or ilio-sacral screw fixation Fracture treatment procedures, such as intramedullary nailing or plating or screwing or external fixation procedures in the tubular bones Fracture reduction procedures High Tibia Osteotomy
The Smith & Nephew Image Guided Instruments for Trauma Applications are instruments that have been modified to allow image-guided arrays (Fighters) to be fixed onto the instruments. The image-guided arrays can use either infrared LEDs (light emitting diodes) or universal accessories (passive spheres) to transmit or reflect the infrared LEDs (light emitting diodes) that are emitted by an IGS Platform System. Along with commercially available software, this will allow the instruments to be recognized and tracked in real time in the surgical field. The universal accessories (passive spheres) will be available as either sterile or non-sterile and are for single use only. Each package will contain a multiple number of spheres. The infrared LEDs (light emitting diodes) or universal accessories (passive spheres) do not come in contact with the open wound during surgical procedures. The image-guided arrays that are affixed to the instruments work in conjunction with reference frames that are rigidly attached to the anatomy. Each reference frame is also fitted with either infrared LEDs (light emitting diodes) or universal accessories (passive spheres) to transmit or reflect the infrared LEDs (light emitting diodes) that are emitted by the IGS Platform System. The reference frames will allow the IGS Platform System to continuously track the position of the anatomy during navigation. If any movement of the IGS Platform System or anatomy is detected, the system can compensate for it, thereby maintaining accurate navigation.
I am sorry, but the provided text does not contain information regarding acceptance criteria, reported device performance, or any study details that would allow me to populate the requested table and answer the study-related questions. The document is a 510(k) summary for Image Guided Surgical Instruments for Trauma Applications, primarily focusing on its description, intended use, and substantial equivalence to predicate devices, rather than detailed performance study results.
§ 882.4560 Stereotaxic instrument.
(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).