(59 days)
The DePuy Synthes MatrixMANDIBLE Plate and Screw System is intended for oral, maxillofacial surgery; trauma; reconstructive surgery; and orthognathic surgery (surgical correction of dentofacial deformities).
The Synthes MatrixMANDIBLE Plate and Screw System consists of a variety of plates offered in multiple shapes and sizes and a variety of screws offered in multiple diameters and lengths to meet the anatomical needs of the patient. System implants are manufactured in either titanium or titanium alloy and are intended for single use only.
The Synthes MatrixMANDIBLE screws that are the subject of this submission are made from titanium alloy (Ti-6Al-7Nb) and are available in a diameter of 2.4 mm and lengths ranging from 26-40mm, and have a thread pitch of 1.0 mm. These screws work with all plates within the MatrixMANDIBLE Plate and Screw system.
These devices are offered non-sterile and must be sterilized before use. MatrixMANDIBLE screws are intended for single use only.
The provided text is a 510(k) premarket notification for a medical device, specifically the DePuy Synthes 2.4mm Ti Self-Tapping MatrixMANDIBLE Screws. This document details the device description, indications for use, comparison to predicate devices, and non-clinical performance testing for substantial equivalence.
However, the request asks for specific information regarding acceptance criteria and a study proving a device meets those criteria, particularly in the context of an AI/algorithm-based diagnostic or assistive device.
The document does not contain information about acceptance criteria or studies related to AI performance, sensitivity, specificity, MRMC studies, ground truth establishment for AI, or training/test set sizes for an algorithm.
Instead, it focuses on demonstrating substantial equivalence for a physical implantable device.
Therefore, I cannot extract the requested information from the provided text as it pertains to a different type of device evaluation. The document describes:
- Device: DePuy Synthes 2.4mm Ti Self-Tapping MatrixMANDIBLE Screws (26-40mm)
- Purpose of Submission: To introduce a non-sterile packaged version of the screws with additional lengths (26mm - 40mm).
- Performance Testing: Non-clinical performance testing was conducted per ASTM F543 to compare the proposed screws to a reference device, demonstrating non-inferior mechanical performance. Sterilization adoption, packaging validation, and biocompatibility evaluations were also performed.
- Clinical Data: "Clinical data was not necessary for the determination of substantial equivalence."
In summary, the provided document does not contain the information required to answer your specific questions regarding acceptance criteria and studies for an AI-driven device.
§ 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.