(210 days)
The Osteomedics® Resorbable Small Fixation System is intended for use in selective trauma or for reconstructive procedures in the midface and craniofacial skeleton; craniofacial surgery; reconstructive procedures, and selective orthognathic surgery of the maxilla and chin. The Osteomedics® Resorbable Small Fixation System is intended to provide temporary stabilization and fixation of bone during the healing in conjunction with appropriate postoperative immobilization. The use is in both adult and pediatric patients' cases involving trauma or reconstruction.
The Osteomedics® Resorbable Small Fixation System, OsteoSorb® consists of a series of plates, screws, bone fasteners and meshes, which are made from poly (L-lactide-co-D, Llactide) 70: 30. The plates are designed in varying configurations and lengths, which are attached to the bone using screw or bone fastener fixation.
The provided text is a 510(k) summary for a medical device (Osteomedics® Resorbable Small Fixation System, OsteoSorb®) submitted to the FDA. It does not include information about acceptance criteria or a study proving the device meets said criteria.
510(k) submissions typically demonstrate substantial equivalence to a predicate device rather than presenting detailed efficacy studies with acceptance criteria in the way a PMA (Premarket Approval) submission would. The document mainly focuses on:
- Device Description: What the device is made of and what it's used for.
- Intended Use: The specific medical conditions and patient populations for which the device is designed.
- Predicate Device: Identifying existing, legally marketed devices that the new device is substantially equivalent to.
- Substantial Equivalence Justification: Highlighting similarities in intended use, design, operational principles, and materials to the predicate devices.
Therefore, I cannot provide the requested information from this document. The sections you asked for (acceptance criteria table, sample sizes, expert ground truth, adjudication, MRMC, standalone performance, ground truth types, training set size, and training set ground truth establishment) are not present 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.