(158 days)
The Rod-5 Distraction device is intended for use in patients with bone loss due to periodontal disease, trauma or post tumor resection, Ankylosed teeth, or Atrophic boney areas inadequate for implant placements or restorative procedures which need to increase in bone mass and height by means of distraction osteogenesis.
The device consists of two bondable attachments and a horizontal rod that spans the distraction site. the rod is supported by these attachments which are bonded to the teeth and has holes for engagement of distraction wire. The spring washers and detents allow for activation of the device during distraction and provide a self-locking mechanism to prevent deactivation of the device. The device is activated by a screwdriver, which is inserted in to the screwdriver slot, pushed against the washer to disengage the detent, and then rotated. The device is predominately - tooth bone, with only a fixation wire attached to the bone; no screws are required. Removal of the device requires only cutting the fixation wire. The wire can then be pulled through the bone and soft tissue without the need for an incision.
The provided document is a 510(k) summary for a medical device (Oral Osteodistraction Distraction Rod Appliance (ROD 5)) and does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria related to a performance study with a test set, expert ground truth, or an AI algorithm.
The document discusses substantial equivalence to a predicate device (KLS-Martin Track Distractor K002152) and uses a comparison chart to highlight similarities in material, distraction rate, distraction mechanism, activation, site of distraction, target use, latency period, distraction period, retention period, intended use, and surgical technique. This type of comparison is standard for 510(k) submissions to demonstrate that a new device is as safe and effective as a legally marketed predicate, rather than proving performance against specific acceptance criteria through a clinical study.
Therefore, I cannot provide the requested information. The document focuses on regulatory approval based on substantial equivalence, not on a detailed performance study with the elements you've listed.
§ 872.4760 Bone plate.
(a)
Identification. A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.(b)
Classification. Class II.