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The TriMed Distal Xtremities System is indicated for use in stabilization of fractures, malunions and non-unions of the small bones of the foot.

The TriMed Distal Xtremities System includes 2.0mm and 2.3mm locking screws and six new plate configurations designed for distal extremity fixation. The titanium plates vary in hole count and geometric profile (straight and T-shaped) to accommodate a range of anatomical and clinical needs. The Distal Xtremities plates represent variations in design to TriMed's current Xtremities plate, with additional sizes and removal of the PEEK inserts.

The provided FDA 510(k) Clearance Letter for the TriMed Distal Xtremities System does not contain any information about an acceptance criteria table, a study proving the device meets acceptance criteria, or any details related to AI/algorithm performance.

The document describes a medical device (bone fixation appliances) and its regulatory clearance process, which relies on demonstrating substantial equivalence to a predicate device based on material properties, design comparisons, and non-clinical engineering analyses (FEA analysis, theoretical calculations, and retrospective review of physical testing data for screws).

Therefore, I cannot provide the requested information for acceptance criteria and study proving meeting those criteria from the given text.

The following points are what the document does include regarding performance evaluation:

• Non-Clinical and/or Clinical Tests Summary & Conclusions (21 CFR 807.92(b)):
  • Subject device screws were evaluated against TriMed predicate screws for performance and found to be substantially equivalent. Analysis included theoretical calculations along with retrospective review of physical testing data to show that the new 2.0 and 2.3mm screws did not create a new worst case within the TriMed screw families. Therefore physical testing of the new screws was not necessary.
  • FEA analysis was completed comparing material performance between the new Distal Xtremities plates and the current Easy Lock and Xtremities plates. The analysis showed that the dimensional differences and the change in plate materials does not impact performance.
  • Engineering analysis and physical test data show that the Distal Xtremities Screws are substantially equivalent to other TriMed screws used in the fixation of small bones of the foot. FEA analysis comparing the Distal Xtremities Plates to the predicates, showed that the dimensional and material changes did not impact mechanical performance.

This content indicates that the "study" proving the device meets the criteria was primarily non-clinical engineering analysis (FEA, theoretical calculations, and retrospective review of existing physical test data), not a clinical study involving human or AI performance. The criteria for acceptance were likely based on demonstrating comparable mechanical performance and material properties to the predicate devices.

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