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The Monster® Screw System is indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, ligament fixation, fracture repair and fracture fixation, appropriate for the size of the device. Specific examples include: Fractures and Osteotomies - Fractures of the tarsals, metatarsals and other fractures of the foot (i.e. LisFranc) . - Avulsion fractures and fractures of the 5th metatarsal (i.e. Jones Fracture) ● - . Talar fractures - Ankle fractures - Navicular fractures - Fractures of the fibula, malleolus, and calcaneus - Metatarsal and phalangeal osteotomies ● - Weil osteotomy - Calcaneal osteotomy ● Hallux Valgus Correction - Fixation of osteotomies (i.e. Akin, Scarf, Chevron) ● - Interphalangeal (IP) arthrodesis . - Proximal, midshaft, or distal osteotomy - Lapidus arthrodesis ● Arthrodesis/Deformity Correction - 1st MTP arthrodesis - Metatarsal deformity correction ● - Tarsometatarsal joint arthrodesis ● - Naviculocuneiform ioint arthrodesis ● - Talonavicular arthrodesis - Subtalar joint arthrodesis - Triple arthrodesis - Medial column arthrodesis - Subtalar joint distraction arthrodesis - . Ankle arthrodesis - Lateralizing calcaneal osteotomy - Lateral column lengthening - Hammertoe Fusion results from neuropathic osteoarthropathy (Charcot) such as: - Medial and lateral column ● - Subtalar, talonavicular, and calcaneocuboid

The Monster Screw System contains bone screws of various diameters, lengths, and configurations. One configuration is a snap-off style bone screw offered in two diameters having various overall and threaded lengths.

This document describes the regulatory clearance of a medical device, the "Monster Screw System," not an AI/ML powered device. Therefore, the information typically requested regarding acceptance criteria and performance studies for an AI/ML device (e.g., sample sizes for test/training sets, expert ground truth, MRMC studies, standalone performance, etc.) is not applicable and not present in the provided text.

The document states: "Clinical testing was not necessary to support equivalence." This indicates that no clinical performance study, as would be required for AI/ML device validation, was conducted or submitted for this device's 510(k) clearance.

The clearance is based on substantial equivalence to a predicate device, meaning the new device has the same intended use and technological characteristics as the previously cleared predicate, and does not raise new questions of safety or effectiveness. The non-clinical testing performed focuses on material, manufacturing, and sterilization properties, not a performance evaluation in a clinical setting against a specific diagnostic or clinical outcome acceptance criteria.

Therefore, I cannot provide the requested information about acceptance criteria or a study proving the device meets those criteria in the context of AI/ML performance, as such a study was not performed for this device's clearance.

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