(86 days)
Synthes Resorbable Fixation System devices (Plates, Meshes, Screws and Tacks), are intended for use in fracture repair and reconstructive procedures of the craniofacial skeleton.
In addition, Resorbable Meshes, Sheets, Screws and Tacks may be used in non-load bearing applications for :
- Maintaining the relative position of and/or containing bony fragments, bone grafts (autograft or allograft) or bone graft substitutes in reconstruction of the craniofacial or mandibular areas
- Preventing soft tissue prolapse at bone graft donor sites, e.g., the iliac crest
Synthes Resorbable Fixation System consists of resorbable plates, meshes, screws, tacks and accessory devices. Synthes Resorbable devices are manufactured from 70:30 poly (L/DL-lactide) and are available in various sizes. Resorbable meshes and sheets may be used as indicated, either alone or in conjunction with internal fixation devices (e.g., metallic plates and screws) that serve to further stabilize the treatment area.
Resorbable Fixation System devices are provided pre-sterilized by gamma radiation. They are not intended to be resterilized by the user.
The provided document is a 510(k) Pre-market Notification from the FDA for the Synthes Resorbable Fixation System. It describes the device, its indications for use, and a correction to a previous clearance. Crucially, this document is a regulatory approval letter and does NOT contain information about acceptance criteria or a study proving the device meets those criteria.
The letter from the FDA (pages 0-2) and the accompanying 510(k) Summary and Indications for Use (pages 3-4) focus on:
- Clarifying the appropriate indications for use of the device.
- Correcting a previous erroneous clearance regarding an indication for soft tissue prolapse in the iliac crest because it was considered a load-bearing application and outside the scope previously cleared for maxillofacial devices.
- Stating that the FDA has determined the device is substantially equivalent to legally marketed predicate devices for the indications specified.
- Outlining the regulatory requirements and general controls for the device.
Therefore, I cannot extract the requested information (acceptance criteria, study details, sample sizes, ground truth, expert qualifications, etc.) from this document because it is not present. This document does not describe a clinical study or performance evaluation with specific acceptance criteria.
§ 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.