(36 days)
The PRECICE STRYDE System is indicated for limb lengthening, open and closed fracture fixation, pseudoarthrosis, mal-unions, non-unions, or bone transport of long bones.
The PRECICE STRYDE System includes the PRECICE STRYDE Nail, locking screws, end caps, surgical instruments, and external remote controller (ERC). The PRECICE STRYDE nails and end caps are supplied sterile by gamma radiation while the locking screws and instruments are supplied non-sterile and must be sterilized prior to use. The system is designed to achieve limb correction through gradual lengthening or compression and providing internal fixation for fractures of long bones. The telescopic PRECICE STRYDE Nail is implanted using locking screws, end caps, and reusable surgical instruments. The PRECICE STRYDE Nail contains an enclosed rare earth magnet, telescoping distraction rod, and planetary gearing which allows the length of the nail to be adjusted non-invasively by the External Remote Controller (ERC). The PRECICE STRYDE Nail is available in various diameters, lengths and screw hole configurations to accommodate a variety of patient anatomies and implantation methods. The locking screws are also available in a variety of diameters, lengths, and thread styles. The ERC is available in several compatible models.
The provided text is a 510(k) summary for the PRECICE STRYDE System, an intramedullary fixation rod. It describes the device, its intended use, and its comparison to a predicate device, along with non-clinical performance data.
However, the document does not contain information related to acceptance criteria or a study that uses a test set, expert readers, or AI assistance for performance evaluation. The non-clinical performance data presented is focused on material and mechanical properties of the device itself (e.g., static/dynamic compression, torsion, torque resistance, axial pullout, tensile strength, distraction force) and not on a diagnostics or imaging AI device's performance.
Therefore, I cannot extract the specific information requested in your bullet points because the provided text does not describe a study involving acceptance criteria, human readers, AI performance, ground truth establishment, or sample sizes related to AI or diagnostic image analysis.
The performance data section is titled "Nonclinical performance verification testing was performed to demonstrate that the subject PRECICE STRYDE System is substantially equivalent to the predicate device" and lists physical tests of the device's mechanical properties, not a study evaluating human or AI diagnostic performance.
§ 888.3020 Intramedullary fixation rod.
(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.