(81 days)
The Synthes (USA) 2.0mm Titanium T-Plate is intended for use in the reconstruction of the cranium (skull) following surgical decompression procedures of the posterior fossa or transcervical skull based approach, with or without duraplasty, including procedures to treat Chiari Type I Malformation. The plate design is also intended for use in non-load bearing fixation, including cranial bone fixation. The device is intended for single use only.
The Synthes (USA) 2.0mm Titanium T-Plate is a T-shaped plate configuration to be used with the Synthes 2.0mm screws. The plates are manufactured in titanium and are intended for single use only.
This document is a 510(k) summary for the Synthes (USA) 2.0mm Titanium T-Plate. It does not contain acceptance criteria or a study proving the device meets acceptance criteria in the manner you've described.
The 510(k) process is primarily a demonstration of "substantial equivalence" to a legally marketed predicate device, not necessarily a clinical performance study with acceptance criteria. For devices like this cranioplasty plate, substantial equivalence is typically established through:
- Material properties: Demonstrating the new device uses similar materials with comparable strength, biocompatibility, etc., to the predicate.
- Design and dimensions: Showing similar configurations, sizes, and screw compatibility.
- Intended use: Confirming the new device targets the same clinical applications.
Therefore, I cannot provide the requested information as it is not present in the provided text. The document focuses on administrative details, device description, and intended use, concluding with a substantial equivalence determination based on comparison to predicate devices, not a performance study with quantitative acceptance criteria.
If this were a software device or a diagnostic device, the requested information would be expected in a 510(k) submission. However, for a Class II implantable device like a cranioplasty plate, the focus is on materials, mechanical properties, and biocompatibility, often demonstrated through bench testing rather than clinical trials with human readers or ground truth adjudication.
§ 882.5320 Preformed alterable cranioplasty plate.
(a)
Identification. A preformed alterable cranioplasty plate is a device that is implanted into a patient to repair a skull defect. It is constructed of a material, e.g., tantalum, that can be altered or reshaped at the time of surgery without changing the chemical behavior of the material.(b)
Classification. Class II (performance standards).