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Intended for the treatment of fracture fixation, osteotomies (ex. Akin, Chevron, Scarf, Weil), reconstruction, revision surgery and arthrodesis of small bones in the upper and lower extremities.

The AlignMATE™ Lapidus Arthrodesis System consists of bone plates and bone screws (locking, non-locking and interfragmentary), which are intended to be used for surgical fusion or arthrodesis between two bone segments (ex. 1st metatarsalcuneiform fusion as in a Lapidus procedure). All implant components are manufactured from implant grade titanium alloy.

This document is a 510(k) premarket notification for a medical device (AlignMATE™ Lapidus Arthrodesis System), not an AI/ML medical device. Therefore, the information requested in your prompt regarding acceptance criteria, study details for AI/ML performance, sample sizes, expert involvement, and ground truth establishment, is not applicable to this document.

This document describes a traditional medical device (bone plates and screws) and proves its substantial equivalence to previously cleared predicate devices based on:

1. Indications for Use: The new device has the same intended uses as the predicate devices.
2. Operating Principle: It functions in the same way.
3. Materials: It is made from the same implant-grade titanium alloy.
4. Instrumentation: It uses similar tools for placement.
5. Packaging and Sterilization: These processes are consistent with the predicate devices.
6. Non-clinical Testing: Mechanical testing (bending, torsional, insertion/removal, pullout) per ASTM standards and a bacterial endotoxins test were performed to demonstrate performance comparable to predicate devices.

There is no mention of any AI/ML component in the AlignMATE™ Lapidus Arthrodesis System, nor any AI/ML performance study conducted or referenced in this FDA submission.

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