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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 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 joint 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 resulting from neuropathic osteoarthropathy (Charcot) such as:

• Medial and lateral column
• · Subtalar, talonavicular, and calcaneocuboid

The Monster Screw System is comprised of threaded bone screws (Ti Alloy or Stainless Steel) offered in 2.0mm to 9.5mm diameters (in 0.5mm increments). In addition, a 2.7mm diameter is also part of the system. The overall screw length ranges from 8mm (for smaller diameters) thru 200mm (for larger diameters). The screws are available in a variety of designs including: fully or partially threaded, self-drilling or blunt, cannulated or solid, and headed or headless. Sizedmatched washers are also available.

The provided document is a 510(k) summary for the Paragon 28 Monster® Screw System. This document DOES NOT contain information regarding acceptance criteria or a study that proves a device meets acceptance criteria related to AI/ML device performance.

Instead, it's a regulatory submission for a medical device (bone fixation screws) demonstrating substantial equivalence to previously marketed predicate devices. The "studies" mentioned are preclinical tests (engineering analysis, torsional, pullout, insertion/removal evaluations, sterilization validations) to show that modifications to the screws do not adversely affect performance compared to the predicate devices.

Therefore, I cannot fulfill your request as the information requested is not present in the provided text.

Here's a breakdown of why this document doesn't fit your request:

• Acceptance Criteria for AI/ML Performance: Not applicable. This is a traditional medical device (hardware).
• Study Proving Device Meets Acceptance Criteria (AI/ML): Not applicable. The "studies" are mechanical and material tests for screws, not AI/ML performance evaluations.
• Table of Acceptance Criteria and Reported Device Performance: Not applicable for AI/ML.
• Sample Size for Test Set and Data Provenance: Not applicable for AI/ML.
• Number of Experts for Ground Truth and Qualifications: Not applicable for AI/ML.
• Adjudication Method: Not applicable for AI/ML.
• Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable. There are no human readers or AI assistance.
• Standalone (algorithm only) Performance: Not applicable.
• Type of Ground Truth Used: Not applicable for AI/ML. (For the screws, the "ground truth" would be the established mechanical properties and safety profiles of predicate devices).
• Sample Size for Training Set & How Ground Truth Established for Training Set: Not applicable. This device does not use a training set in the AI/ML sense.

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