(341 days)
The MaxFace Maxillofacial Ostheosynthesis System is indicated for trauma fixation of the superior, middle and inferior segments of the facial skeleton, for ostheosynthesis of corrective osteotomies in congenital deformities treatment (acquired or in development) and for the fixation of grafts in reconstructive surgeries.
The MaxFace Maxillofacial Ostheosynthesis System is composed of plates and screws, which are available in four different kit sizes: Cranio, Micro, Standard, and Macro systems.
The provided 510(k) summary for the MaxFace Maxillofacial Osteosynthesis System does not contain any information about acceptance criteria or a study proving that the device meets such criteria.
This document describes a medical device, its intended use, and its substantial equivalence to predicate devices, but it does not detail performance metrics, clinical studies, or AI/algorithm-based testing. Therefore, I cannot provide the requested table or details regarding acceptance criteria, sample sizes, ground truth establishment, or multi-reader studies.
Based on the provided text, the device's substantial equivalence was demonstrated through "Bench performance testing." However, the details of this testing, including specific acceptance criteria, results, or the methodology that would align with the requested AI/algorithm-focused questions, are not present.
Here's an explanation of why the requested information cannot be extracted from the provided text:
- Type of Device: The MaxFace Maxillofacial Osteosynthesis System is a physical medical device (plates and screws) used for surgical fixation, not a software algorithm or AI-driven diagnostic tool.
- Regulatory Pathway: The document is a 510(k) premarket notification. For devices like this, substantial equivalence is often demonstrated primarily through comparison to predicate devices and bench testing, rather than extensive clinical efficacy studies or performance metrics as would be seen for AI/software as a medical device (SaMD).
- Lack of Performance Data: The 510(k) summary explicitly states that equivalence is shown through "Bench performance testing," but it does not provide any data, metrics, or specific acceptance criteria from this testing. There are no reported device performance values, sensitivities, specificities, or other statistical measures.
- No AI/Algorithm Component: The device described is a physical implant. The concepts of "test set," "training set," "ground truth experts," "adjudication," "MRMC studies," or "standalone algorithm performance" are not applicable to the description of this particular device.
Therefore, I cannot fulfill the request for a table of acceptance criteria and reported device performance or other details related to AI/algorithm performance.
§ 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.