(70 days)
The OsteoMed External Mandibular Distraction System, which is a family of external distraction osteogenesis devices for bone elongation for the correction of congenital deficiencies, mandibular hypoplasia or post traumatic defects of the mandible that require gradual distraction.
The OsteoMed External Mandibular Distraction System is intended for use in either adults or pediatric patients.
The OsteoMed External Mandibular Distraction System is intended for single patient use only.
This submission describes the OsteoMed External Mandibular Distraction System, which is a family of external distraction osteogenesis devices for bone elongation for the correction of congenital deficiencies, mandibular hypoplasia or post traumatic defects of the mandible that require gradual distraction. This system is intended for use in either adults or pediatric patients. The OsteoMed External Mandibular Distraction System is intended for single patient use only.
The OsteoMed External Mandibular Distraction System is comprised of interchangeable distraction rods that connect to a posterior and anterior pin clamp, and/or the middle link. The anterior pin clamp can accommodate variations in pin placement. The pin clamps will accept 1.6 mm to 3.2 mm pins and lock to the pins via screws. The interchangeable distraction rods are available in various lengths for distraction up to 70 mm. The distraction rods are activated by a hex driver.
I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves the device meets those criteria.
The document is a 510(k) summary for the OsteoMed External Mandibular Distraction System. It describes the device, its intended use, and claims substantial equivalence to several legally marketed predicate devices. The FDA's letter confirms this substantial equivalence determination.
However, the provided text does not contain:
- A table of acceptance criteria or reported device performance.
- Details about sample sizes, data provenance, or expert qualifications for a test set.
- Information on adjudication methods or MRMC studies.
- A standalone algorithm performance study.
- The type of ground truth used.
- Sample size or ground truth establishment for a training set.
The basis for market clearance in this document is a determination of substantial equivalence to existing devices, meaning its materials, design, and operational principle are similar and it does not raise new safety or effectiveness issues, rather than performance against specific acceptance criteria in a dedicated study.
§ 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.