Search Results

The TriMAX™ Implant System is indicated for hand and foot bone fragment osteotomy fixation and joint arthrodesis.

The TriMAX™ Implant System is a staple system which gives the surgeon a means of bone fixation in the management of bone fractures and reconstructive surgery. Prior to implantation, the legs of the implant are held substantially parallel to facilitate insertion into the prepared bone. Once implanted and released from the insertion device, the implant will move towards each other in a converging fashion. This movement creates compression across the adjoining bone members.

The provided text describes the 510(k) premarket notification for the TriMAX™ Implant System, a metallic bone fixation device. However, this document does not contain information about studies proving the device meets acceptance criteria related to an AI/ML-based medical device.

The document primarily focuses on demonstrating substantial equivalence to predicate devices based on:

• Indications for Use: The TriMAX™ Implant System is indicated for hand and foot bone fragment osteotomy fixation and joint arthrodesis, which is similar to the predicate devices.
• Technological Characteristics: Similarity in basic design, materials of manufacture (implied as metallic), and mechanical properties to the predicate devices.
• Performance Testing (Mechanical): Theoretical analysis and mechanical testing were performed to confirm substantial equivalence in mechanical strength to the predicate CrossRoads MotoCLIP™/HiMAX Implant System (K181410) and the CrossRoads Screw System (K152072).
• Pyrogen Testing: Confirmed the device meets the endotoxin limit of 20 Endotoxin Units (EU)/Device.

Therefore, I cannot provide the requested information about acceptance criteria and a study proving an AI/ML device meets them, as the provided text pertains to a traditional orthopedic implant, not an AI/ML system. The questions regarding sample size, data provenance, expert ground truth establishment, MRMC studies, standalone performance, and training set details are relevant to AI/ML device evaluations, which are not described in this submission.

Ask a specific question about this device