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Indicated for use as a mandibular bone lengthener for patients diagnosed with conditions where treatment includes mandibular distraction osteogenesis. These conditions may include diagnoses such as mandibular micrognathia or hemifacial microsomia. The OsteoMed Intraoral Mandibular Distraction System is intended for single patient use only.

The OsteoMed Intraoral Mandibular Distraction System is a subcutaneous bone distractor. It features various curved and straight bars activated with a threaded wire that has screw holes that are fixed to bone via 1.6mm/2.0mm bone screws. The distractor is available in two sizes and in right and left versions. The threaded wire is activated by a hex driver and is capable of distraction lengths of up to 35mm.

I'm sorry, but the provided text does not contain the information required to describe acceptance criteria or a study proving device performance. The document is a 510(k) summary and FDA clearance letter for the OsteoMed Intraoral Mandibular Distraction System. It details the device's intended use, description, and claims of substantial equivalence to predicate devices, but it does not include:

• A table of acceptance criteria and reported device performance.
• Details about a study with sample sizes, data provenance, ground truth establishment, or expert involvement.
• Information on MRMC comparative effectiveness studies or standalone algorithm performance.

The document states that "Due to the similarity of materials and design to both pre-enactment and postenactment devices, OsteoMed believes that the OsteoMed Intraoral Mandibular Distraction System does not raise any new safety or effectiveness issues." This suggests that the clearance was based on equivalence rather than new performance studies demonstrating against specific acceptance criteria.

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