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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 Extremity Medical Screw and Washer System is intended for reduction and internal fixation of arthrodeses, osteotomies, intra- and extrarticular fractures and nonunions of the small bones and joints of the foot, ankle, hand, and wrist. The two-part construct is specifically intended for Talonavicular, Calcaneocuboid, Metatarsocuneiform, Ankle, Capito-Lunate, and Triquetral-Hamate arthrodesis, as well as Metatarsal Osteotomies.

The EXTREMITY MEDICAL Screw and Washer System consists of two pieces, a Screw and a Washer, which couple together to provide stability and compression across an intended area of fusion.

The provided document describes a medical device, specifically the EXTREMITY MEDICAL Screw and Washer System, not an AI/ML-driven medical device. Therefore, many of the requested categories related to algorithms, AI performance, ground truth, and expert evaluation are not applicable.

However, I can extract the information pertinent to the acceptance criteria and the study performed for this device based on the document.

Acceptance Criteria and Device Performance for EXTREMITY MEDICAL Screw and Washer System

Given that this is a 510(k) submission for a traditional medical device (screws and washers), the acceptance criteria are generally based on demonstrating substantial equivalence to a predicate device in terms of design, materials, indications for use, and mechanical performance.

Here's the breakdown:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Test Set Sample Size: Not applicable in the context of an AI/ML algorithm. The "test set" here refers to the samples used in bench testing and cadaver studies.
  • Bench Testing: The document states "pull-out, torque and bending was performed." The specific number of screws/washers tested for each modality is not specified.
  • Cadaver Studies: "Clinical simulations in cadavers were performed." The number of cadavers or specific procedures performed is not specified.
• Data Provenance: Not applicable in the context of AI/ML data provenance (e.g., country of origin, retrospective/prospective). The data originated from in-vitro (bench testing) and ex-vivo (cadaver) studies conducted by the manufacturer.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable as this is a mechanical device, not an AI/ML algorithm requiring expert ground truth for classification or detection. The "ground truth" for mechanical properties is established by engineering standards and measurements, and for surgical technique, by observed performance by qualified personnel (surgeons/engineers) during cadaveric trials. The specific number and qualifications of these personnel are not specified but would typically include bioengineers and orthopedic surgeons.

4. Adjudication method for the test set

• Not applicable. Adjudication methods like 2+1 or 3+1 are used for resolving disagreements among multiple human readers for AI/ML ground truth. For this device, the "adjudication" would involve engineering analysis of the bench test data and expert assessment of the cadaveric simulations.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI/ML diagnostic or prognostic tools, not for a mechanical bone fixation system.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• No, a standalone algorithm performance study was not done. This is a hardware medical device, not an algorithm.

7. The type of ground truth used

• Not applicable in the AI/ML sense. For this device:
  • Mechanical performance: Ground truth is based on established engineering standards and measurements (e.g., specific force required for pull-out, torque values, bending resistance).
  • Surgical technique: Ground truth is based on successful and stable fixation demonstrated in cadaveric models as assessed by trained professionals.

8. The sample size for the training set

• Not applicable. This device does not use a "training set" in the AI/ML context.

9. How the ground truth for the training set was established

• Not applicable. This device does not use a "training set" or require ground truth establishment in the AI/ML context.

Summary of the Study:

The study conducted to demonstrate the safety and effectiveness of the EXTREMITY MEDICAL Screw and Washer System was a non-clinical study. It consisted of:

• Bench testing: This involved mechanical testing such as pull-out, torque, and bending tests. The results of these tests were compared to the predicate devices to demonstrate equivalent mechanical properties.
• Clinical simulations in cadavers: These studies were performed to verify the surgical technique with the additional screw and washer options being introduced.

The conclusion drawn from these studies was that the device is substantially equivalent to its predicate device based on indications for use, materials, design, test data, and principles of operation. No clinical testing in live subjects was performed.

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