(76 days)
The Stryker® Leibinger Universal CMF and Universal 2.0 Mini Plating Systems are Craniomaxillofacial (CMF) plate and screw systems intended for osteotomy, stabilization of CMF fractures and reconstruction.
The MP LeFort I Plates as part of the predicate subgroup Universal 2.0 Mini Plating System are implants indicated for osteotomy stabilization and rigid fixation of LeFort I fractures of the maxillofacial skeleton.
The LeFort I Plates, which were cleared as part of the overall plate system in K022185, have been modified for use with 2.0 mm screws, more flexible applications, and in-between advancements for stabilizing osteotomies. The proposed modifications to the LeFort I Plates comprise a dimensional design modification for maxillofacial use only. There have been no modifications to the screws, meshes/plates, screwdriver blades, or other accessory devices.
The provided text describes a 510(k) premarket notification for a medical device called "MP LeFort I Plates." This submission aims to demonstrate substantial equivalence to a predicate device, as opposed to providing detailed performance data against specific acceptance criteria for a novel device.
Therefore, the document does not contain the information needed to fill out the table regarding acceptance criteria and reported device performance, nor does it describe a study proving the device meets those criteria in the way one might expect for a new, AI/software-driven medical device.
Specifically, the document states:
- "Biocompatibility and sterility testing was not required as a basis for substantial equivalence."
- "The results of the performance bench tests support the proposed substantial equivalence of the subject device."
- "It is concluded that the information included in this submission supports substantial equivalence."
This indicates that the focus of this submission is on demonstrating that the modified device is as safe and effective as a legally marketed predicate device, rather than proving performance against novel acceptance criteria for a device like an AI algorithm.
Based on the provided text, I cannot describe acceptance criteria or a study that proves the device meets them because the document focuses on demonstrating substantial equivalence through bench testing and material comparisons, not on establishing and meeting new performance thresholds for a device like an AI algorithm.
If this were a submission for an AI/software device, the "Performance Bench Testing" section (VIII) would contain details like the acceptance criteria, metrics, sample sizes, and ground truth establishment methods. However, for this physical bone plate device, it simply lists "Analysis of functional interfaces" and "Fatigue Test" to support substantial equivalence, without detailing specific thresholds or the type of study typically associated with AI performance validation.
§ 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.