(86 days)
The plate and screw designs for use in conjunction with the Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery is intended for use in the treatment of fractures and reconstructive procedures of the craniomaxillofacial skeleton and non-load bearing fixation, including: cranial fixation, midface fixation, mandibular fixation, orbital rim fixation, maxillary fixation, graft fixation, bone fixation, brow fixation, zygomatic fixation. The device is intended for single use only and only in conjunction with other titanium and titanium alloy implants.
The Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery is manufactured of commercially pure titanium and a titanium 6A1-4V ELI alloy, materials that have been implanted safely for many years. These materials are recognized as acceptable for implantation purposes through device classification (for example, see 21 Code of Federal Regulations, sections 888.3030.) The plates are substantially equivalent in construction and design to the predicate devices manufactured by Biomedics, Inc., W.L. Lorenz and Synthes (USA.) The screws are manufactured of a titanium alloy that is at least equivalent to commercially pure titanium in strength and they are substantially equivalent in design to the predicate devices.
The provided document is a 510(k) summary for the Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery. It declares substantial equivalence to predicate devices but does not contain acceptance criteria or the results of a study proving the device meets specific performance criteria.
The document focuses on:
- Materials: Commercially pure titanium and titanium 6Al-4V ELI alloy, stating they are recognized as acceptable for implantation.
- Substantial Equivalence: Claiming the plates are substantially equivalent in construction and design to predicate devices by Biomedics, Inc., W.L. Lorenz, and Synthes (USA). The screws are also claimed to be substantially equivalent in design and at least equivalent in strength to commercially pure titanium.
- Indications for Use: Listing various applications in craniomaxillofacial surgery, such as treatment of fractures, reconstructive procedures, and fixation of specific facial bones.
Therefore, I cannot provide the requested information regarding acceptance criteria and study details because this document does not contain that level of detail. The FDA's 510(k) clearance process for this type of device typically relies on demonstrating substantial equivalence to existing devices rather than requiring new, full-scale clinical trials with extensive acceptance criteria and detailed performance studies like those seen for novel, high-risk devices or software algorithms.
In summary, the provided document does not include:
- A table of acceptance criteria and reported device performance.
- Sample sizes for a test set, nor data provenance.
- Information on experts used to establish ground truth or their qualifications.
- Adjudication method for a test set.
- A multi-reader multi-case (MRMC) comparative effectiveness study.
- A standalone performance study.
- The type of ground truth used.
- Sample size for a training set.
- How ground truth for the training set was established.
§ 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.