(68 days)
The KLS-Martin Molina Distractors are intended for use as external distractors for bone elongation. It is used for the correction of asymmetric mandibular deficiencies and mandibular hypoplasia. The devices are external and are anchored to the mandible by external pins.
The KLS-Martin Molina Distractor is a mandibular fixation device consisting of Uni-directional and Bi-directional distractors and pins for anchoring. The product is identical to the predicate device except for material which is a titanium alloy rather than stainless steel.
This document is a 510(k) summary for a medical device called the "MOD Line of Molina Distractors." It describes the device, its intended use, and its comparison to a predicate device. However, it does not contain any information about acceptance criteria or a study proving the device meets those criteria, nor does it discuss AI or algorithm performance.
Therefore, I cannot provide a response that includes the requested information based solely on the provided text. The document is a regulatory submission for a distraction device made of titanium alloy (which is a material change from a previously approved stainless steel device), and its approval is based on substantial equivalence to an existing device, not on specific performance studies against acceptance criteria in the context of an algorithm or AI.
§ 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.