(76 days)
The Synthes Midface Distractor is intended for use in adult and pediatric populations for the treatment of cranial or midface conditions for which reconstructive osteotomy and segment advancement are indicated. This includes conditions such as syndromic craniosynostosis and midfacial retrusion. The device is intended to provide temporary stabilization and gradual lengthening of the cranial or midfacial bones.
The Synthes Midface Distractor is a craniofacial distraction device consisting of two telescoping components with attached footplates. The device is intended to be placed subcutaneously, with an anterior footplate fastened to the lateral orbital rim, extending down to the maxilla and spanning the zygomaticomaxillary suture; and a posterior footplate fastened to the temporal region of the cranium. The plates are fixed to the bone through unthreaded screw holes using 1.5 mm or 2.0 mm Cortex screws.
The provided text describes the "Synthes Midface Distractor," a medical device. However, it does not include information about acceptance criteria or a study proving its performance against such criteria.
The document is a 510(k) premarket notification summary from the FDA for a Class II medical device (Bone Plate, product code JEY). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing detailed performance studies against specific acceptance criteria.
Therefore, I cannot fulfill your request for the tables and study details because the necessary information is not present in the provided text.
Here is a summary of what the document does provide:
- Device Name: Synthes Midface Distractor
- Sponsor: Synthes (USA)
- Device Classification: Class II, §872.4760 - Bone Plate
- Indications for Use: For use in adult and pediatric populations for the treatment of cranial or midface conditions for which reconstructive osteotomy and segment advancement are indicated (e.g., syndromic craniosynostosis and midfacial retrusion). Intended to provide temporary stabilization and gradual lengthening of cranial or midfacial bones.
- Materials: Titanium Alloy, Titanium, Chromium Cobalt, Silicone
- Regulatory Action: The FDA determined the device is substantially equivalent to other legally marketed devices.
To answer your specific questions, information regarding acceptance criteria, performance studies, sample sizes, expert qualifications, ground truth establishment, MRMC studies, or standalone algorithm performance would need to come from other sources, such as detailed clinical trial reports or engineering validation studies, which are not included in this 510(k) summary.
§ 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.