(154 days)
Intended for use in the treatment of cranial or midface conditions for which reconstructive osteotomy and segment advancement are indicated. This includes conditions such as, syndromic craniosynostosis, midfacial retrusion, hemifacial microsomia, and micrognathia. The OsteoMed Maxillary / LeFort III Distraction device is intended to provide temporary stabilization and gradual lengthening of the cranial or midfacial bones. The OsteoMed Maxillary / LeFort III Distraction System is intended for single patient use only.
The OsteoMed Maxillary / LeFort III Distraction System is a distraction osteogenesis system consisting of distractor frame, bone plates, threaded rods, and an activation instrument. The plates attach to bone using bone screws and then gradually distract the osteotomized segment via activation of the threaded rod with the activation instrument.
This document is a 510(k) summary for the OsteoMed Maxillary / LeFort III Distraction System. This type of device is cleared through substantial equivalence to predicate devices, not through studies demonstrating a specific level of performance against acceptance criteria as might be expected for an AI/ML device.
Therefore, the requested information about acceptance criteria, specific performance metrics, sample sizes, ground truth establishment, expert involvement, and MRMC studies is not available and not applicable in the context of this 510(k) submission.
The 510(k) summary focuses on demonstrating that the new device is "substantially equivalent" to existing predicate devices already on the market. This typically involves showing similarities in:
- Intended Use: The purpose and conditions for which the device is used.
- Materials: The components the device is made from.
- Design: The physical construction and mechanism of the device.
- Operational Principle: How the device functions.
The document explicitly states: "Equivalence for this device is based on similarities in intended use, material, design and operational principle to the Howmedica Leibinger Cohen Distractor (K972154) and the Lorenz Maxilla Distraction System (K982604)." It further notes: "Due to the similarity of materials and design to predicate devices, OsteoMed believes that the OsteoMed Maxillary / LeFort III Distraction System does not raise any new safety or effectiveness issues."
In summary, there are no acceptance criteria or a study demonstrating device performance in the way described for AI/ML devices in this 510(k) submission. The "study" here is a comparison to predicate devices to establish substantial equivalence.
§ 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.