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The TriMed Threaded IM Nail System is intented for the treatment of select fractures and corrective of short tubular bones.

Specific indications for TriMed Small Threaded IM Nails include:

1. Phalangeal fractures of the hand, non-unions, malunions and corrective osteotomies

2. Metacarpal fractures, non-unions, malunions and corrective osteotomies

TriMed Threaded Intramedullary (IM) Nail System implants are non-sterile, non-bioabsorbable implantable devices used as aids to the treatment of certain types of fractures and osteotomies that lend themselves to the principle of nail/rod/screw fixation. TriMed Threaded IM Nail System implants are cannulated, partially threaded, intramedullary fixation nails used to align and stabilize fractures and osteotomies of short tubular bones. TriMed threaded IM Nails are either made from Ti-6AL-4V ELI per ASTM F136 or 316L Stainless steel per ASTM F138. TriMed Threaded IM Nails are offered in diameters ranging from 1.8mm - 3.0mm in diameter and lengths between 20mm and 70mm.

The provided document is an FDA 510(k) clearance letter and associated summary for the "TriMed Threaded Intramedullary Nail System." This document pertains to a medical device (a physical object), specifically an orthopedic implant, and not a software-as-a-medical-device (SaMD) or an AI/ML-based device.

Therefore, the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/ML-based device evaluation (which would involve test sets, expert ground truth, MRMC studies, etc.) is not applicable to this submission.

The document discusses the following types of performance data for this physical medical device:

• Non-Clinical Evidence Performance Data:

  • Torsional Strength
  • Driving Torque
  • Axial Pullout Strength Calculation
  • These tests were conducted according to FDA Guidance Document "Orthopedic Non-Spinal Metallic Bone Screws and Washers - Performance Criteria for Safety and Performance Based Pathway" and ASTM F543-17.

• Clinical Evidence: "Clinical testing was not necessary for the determination of substantial equivalence." This is common for 510(k) submissions of devices demonstrated to be substantially equivalent to existing predicate devices.

In summary, none of the questions related to AI/ML device validation can be answered from this document because it describes a traditional hardware medical device.

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