Search Results

The Haymaker® Screw System is intended for fixation of intra-articular and extra-articular fractures and non-unions of small bones and small bone fragments; arthrodesis of small joints; bunionectomies and osteotomies, including scaphoid and other carpal bones, metacarpals, tarsals, metatarsals, patella, ulnar styloid, capitellum, radial head and radial styloid.

The Haymaker® System includes type-II anodized fully threaded titanium (Ti-6Al-4V ELI per ASTM F136) screws which provides a dual thread at the proximal end of the screw, increasing engagement with the head and neck of the metacarpal or other small bones. A tapered design is intended to allow the screw to fit more comfortably through the narrowing of an intramedullary canal. Multiple lengths from 25 mm at 03.6 mm or Ø4.5 mm in diameter are offered for treatment of various shapes and sizes of small bones. Single use supplemental instrumentation is provided sterile packed, consisting of a guide wire, cannulated drill, and T-10 cannulated driver.

The provided text describes a 510(k) premarket notification for a medical device called the Haymaker® Screw System. This specific document type, a 510(k) summary, focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a detailed study design for a new device's acceptance criteria and performance.

Therefore, the information required to answer your questions regarding acceptance criteria, study data, sample sizes, expert involvement, and ground truth establishment is not available in the provided text.

The document mentions "Performance Data" and lists mechanical tests conducted (Static Driving and Removal Torque, Torsional Properties, Axial Pullout per ASTM F543). It then concludes that "The results of this non-clinical testing show that the strength of the Haymaker® Screw System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices."

However, this is not a clinical study proving device effectiveness or safety against specific acceptance criteria in a human population. It's a demonstration of mechanical properties often used to support the claim of substantial equivalence for predicate devices, implying similar performance to already approved devices.

To answer your questions, one would typically need access to a clinical trial report or a more comprehensive performance study report, which is not part of this 510(k) summary.

Ask a specific question about this device