(90 days)
An uni-directional, intra oral device for the distraction of the ascending ramus and mandibular body.
The KLS-Martin distractor device is designed to distract the mandible in cases of deficiency or posttraumatic effects of the mandible. An uni-directional, intra oral device for the distraction of the ascending ramus and mandibular body.
I am sorry, but the provided text primarily consists of a 510(k) summary and FDA clearance letter for a medical device (KLS-Martin Intraoral Zurich Ramus Distractor). This document focuses on the device's intended use, classification, and substantial equivalence to predicate devices, rather than detailed performance studies or acceptance criteria for AI/algorithmic components.
Therefore, I cannot extract information related to:
- A table of acceptance criteria and reported device performance.
- Sample sizes or data provenance for test sets.
- Number or qualifications of experts for ground truth.
- Adjudication methods.
- MRMC comparative effectiveness studies.
- Standalone algorithm performance.
- Type of ground truth used (expert consensus, pathology, etc.).
- Sample size for the training set.
- How ground truth for the training set was established.
These elements are typically found in detailed study reports or clinical trial summaries, which are not present in the provided 510(k) documentation.
§ 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.