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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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The Biomet Headless Compression Screws and Twist-Off Screws are indicated for fixation of a joint (arthrodesis) or bone reconstruction (osteotomy) of the mid-foot bones, metatarsal and phalanges of the foot or the phalanges, metacarpals and carpals of the hand. In the foot, these include procedures to correct Hallux Valgus (bunions), Hallux Varus and Hallux Rigidus, Hammer toe, Claw toe and Mallet toe.

The Biomet Headless Compression and Twist-Off Screws consist of bone screws of various lengths and diameters and dimensionally optimized corresponding instruments which are used to aid in the alignment and stabilization of fractures to the skeletal system. The Biomet Headless Compression Screws are a cannulated headless screw, which is inserted below the bone surface. The Biomet Headless Compression Screw helps minimize soft tissue irritation and provides compression due to a dual thread design. The Biomet Twist-Off Screw is a solid one piece screw that has a direct connection to a drill or large diameter pin driver; this allows the screw to breakoff cleanly upon contact. The Biomet Twist-Off Screw also has compression capabilities with a thread-free segment that achieves automatic compression at the osteotomy site. The purpose of this submission is to introduce two new drivers to be used with the Biomet Headless Compression Screws with a decreased tip-taper length and increased radius of curvature compared to the drivers cleared in K142658.

This is a 510(k) premarket notification for a medical device, specifically bone fixation screws. The document does not describe an AI/ML powered device, nor does it contain information about acceptance criteria or a study related to AI/ML performance.

Therefore, I cannot extract the requested information regarding acceptance criteria and studies that prove an AI/ML device meets them from this document. The document primarily focuses on demonstrating substantial equivalence of the new screw drivers to previously cleared predicate devices through non-clinical performance testing (torque testing, insertion/removal torque tests).

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