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Indicated for small bone fusion, fractures and inter-digital fusion of the fingers, toes and small bones.

The ToeMATE® Hammertoe Correction System consists of two intramedullary bone screws, a taper lock pin and a set of instruments used for implant site preparation and delivery. The implants are offered in three size options, x-small, small and large. The taper lock pin provides a press fit connection between the two screws with light contact pressure and is available in straight and angled configurations. The implant components are manufactured using implant grade titanium alloy and cobalt-chrome alloy.

I am sorry, but the provided text is a 510(k) premarket notification letter from the FDA regarding the "ToeMATE® Hammertoe Correction System". This document focuses on the regulatory clearance process and establishing substantial equivalence to previously cleared predicate devices.

It does not contain information about acceptance criteria, device performance, or any specific study details such as sample sizes, data provenance, expert qualifications, ground truth establishment, or specific study types like MRMC or standalone performance. The document primarily discusses:

• Device Name and Regulation Information: ToeMATE® Hammertoe Correction System.
• Indications for Use: Small bone fusion, fractures, and inter-digital fusion of the fingers, toes, and small bones.
• Device Description: Two intramedullary bone screws, a taper lock pin, and instruments, made from implant grade titanium alloy and cobalt-chrome alloy.
• Substantial Equivalence: Claiming substantial equivalence to predicate devices (K130859, K101165, K120645) based on similar indications for use, operating principles, materials, instrumentation, packaging, and sterilization.
• Non-Clinical Tests: Lists "Device Comparative Analysis," "Mechanical Testing" (static and dynamic cantilever bending, torque to failure, insertion/removal torque, axial pullout, and disassembly), and a "Kinetic Chromogenic LAL Test" for bacterial endotoxins.

Therefore, I cannot provide the requested table or answer the specific questions about acceptance criteria, study details, sample sizes, ground truth, or expert involvement, as this information is not present in the provided document. The document states that the results demonstrated substantial equivalence but does not provide those results or the detailed methodology of how performance was assessed against any specified acceptance criteria.

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