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The Dunamis Screws are intended to be used as stand-alone bone screws indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of bone appropriate for the size of the device.

When used in conjunction with Dunamis Force DFX Suture or Suture Tape, the Dunamis Screw and Suture Locking System is intended to be used for fixation of bone-to-bone or soft tissue-to-bone. The components are intended to serve as fixation posts, a distribution bridge, or for distributing suture tension over areas of ligament or tendon repair.

Specifically, Dunamis will be offering these devices for use in orthopedic procedures, such as ACL/PCL repair and reconstruction for the adult and pediatric patient population when the device does not bridge, disrupt, or interfere with the growth plate; MCL, POL, LCL repair and reconstruction; IBT and PRT repair; and MPFL, ALL, Quadriceps Tendon, PLC repair and reconstruction. When used in conjunction with the Dunamis Screws, the Suture Locking System can be used as a cerclage to treat bone fractures, such as patella, greater tuberosity, or olecranon fractures.

The Dunamis Screw and Suture Locking System is to be used for fixation of bone-to-bone or soft tissue-to-bone, and is intended as fixation posts, a distribution bridge, or for distributing suture tension over areas of ligament or tendon repair. The devices are intended to be used in the adult or pediatric patient population, when the device does not bridge, disrupt, or interfere with the growth plate.

The Dunamis Screw and Suture Locking System consists of standalone bone screws, and various components which are compatible with previously cleared Dunamis Fixation Button System, Force DFX sutures and suture tapes, including: screws with suture locking features and suture wheel with various adapter options. The standalone screws are provided in various diameters, lengths, and configurations including headed and headless styles with various overall and threaded lengths. Screws with suture locking features are available in various diameters, lengths, and configurations. The suture wheel is available for standalone use with sutures or for use with compatible orthopedic plates with two adapter options (threaded or non-threaded post). The new components are manufactured from stainless steel and titanium alloy.

This document is an FDA 510(k) clearance letter for a medical device called the "Dunamis Screw and Suture Locking System." It focuses on demonstrating substantial equivalence to existing predicate devices, rather than proving a specific novel clinical performance or effectiveness through a clinical trial with acceptance criteria for an AI or software-based medical device.

Therefore, the requested information about acceptance criteria, AI performance metrics, sample sizes for test/training sets, expert adjudication, MRMC studies, standalone performance, and ground truth establishment for AI/software would not be applicable to this type of traditional medical device clearance.

The clearance letter primarily discusses:

• Intended Use and Indications: For bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation.
• Device Description: Consists of standalone bone screws and components compatible with previously cleared Dunamis systems, manufactured from stainless steel and titanium alloy.
• Predicate Devices: Several predicate devices are listed, including screws and suture systems.
• Performance Testing Summary: "Non-clinical performance data included ASTM F543 screw testing, static and dynamic construct testing, and engineering worst-case rationales." This indicates bench testing to demonstrate mechanical performance comparable to the predicates.
• Substantial Equivalence Conclusion: The device has the same intended use, similar technological characteristics, and similar materials to the predicate devices. Mechanical testing demonstrated substantially equivalent performance.

In summary, this 510(k) clearance is for a physical orthopedic implant system, not a software or AI-based medical device. The "acceptance criteria" here are met through demonstrating mechanical properties and performance that are substantially equivalent to already cleared devices, primarily via non-clinical bench testing.

Thus, a table of acceptance criteria for AI performance, details on test/training sets, expert adjudication, MRMC studies, or specific AI ground truth establishment methods are not present and not relevant to this 510(k) submission as described.

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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, Hallux Valgus Correction, Arthrodesis/Deformity Correction, Fusion resulting from neuropathic osteoarthropathy (Charcot).

The Baby Gorilla® / Gorilla® Bone Plates and Bone Screws of the Baby Gorilla® and Gorilla® Plating System are indicated for use in stabilization and fixation of fractures or osteotomies; intra and extra articular fractures, joint depression, and multi-fragmentary fractures; revision procedures, joint fusion and reconstruction of small bones of the toes, feet and ankles including the distal tibia, talus, and calcaneus, as well as the fingers, hands, and wrists. The system can be used in both adult and pediatric patients. Specific examples include: Forefoot, Mid/Hindfoot, Ankle, First metatarsal osteotomies for hallux valgus correction, Arthrodesis of the first metatarsophalangeal joint (MTP), Flatfoot, Charcot. In addition, the non-locking titanium screws and washers are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair and fracture fixation, appropriate for the size of the device.

The Phantom® Small Bone Intramedullary Nail System is indicated for use in stabilization and fixation of the small bones of the feet and ankle for the treatment of fractures, osteotomies, nonunions, pseudarthroses and malunions by revision, joint fusion or reconstruction procedures.

The Phantom® Hindfoot TTC/TC Nail System is indicated for tibiotalocalcaneal arthrodesis (fusion) and to provide stabilization of the hindfoot and ankle including the transverse tarsal joints coupling the mid-foot to the hindfoot. Examples of specific indications include: Post-traumatic or degenerative arthritis, Previously infected arthrosis, Revision of failed ankle arthrodesis, Revision of failed total ankle arthroplasty, Talar deficiency conditions such as avascular necrosis of the talus (requiring tibiocalcaneal arthrodesis), Neuromuscular deformity or other neuromuscular disease with severe deformity or instability of the ankle, Rheumatoid arthritis, Osteoarthritis, Nonunions or pseudarthrosis of hindfoot and distal tibia, Trauma (severe or malunited tibial pilon fracture), Charcot foot (neuroarthropathy), Severe end-stage degenerative arthritis, Instability and skeletal defects after tumor resection, Pantalar arthrodesis, Severe foot/ankle deformity.

HammerTube™M System is indicated for fixation of The reconstruction and fusion of toes during correction procedures for hammertoe deformity, claw toe deformity, shortening osteotomies of the phalanges and mallet toe deformity as well as revision hammertoe procedures. The cannulated and solid HammerTube™ implants may be used without any other additional device. The cannulated implants may be used with K-Wires for delivery of implants or for the temporary stabilization of nearby joints, such as the metatarsophalangeal joint. The implantable K-Wires are indicated for use in the stabilization and fixation of small bones for use in bone reconstruction, osteotomy, arthrodesis, fracture repair and fixation, appropriate for the size of the joint. Additionally, the implantable K-Wires are indicated as guide pines for insertion of instruments and implants in the HammerTube™ System.

The APEX 3D™ Total Ankle Replacement System is indicated as a total ankle replacement in primary surgery for patients with ankle joints damaged by severe rheumatoid, post-traumatic, or degenerative arthritis. Revision surgery for these patients is also indicated for patients with sufficient bone stock present. Components are intended for cemented use only.

Monster® Screw System: 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. Sized-matched washers are also available.

Baby Gorilla® / Gorilla® Plating System: The Baby Gorilla® / Gorilla® Plating System is comprised of bone plates, threaded bone screws, and washers. Gorilla® Plates are offered in "mini" and "standard" set sizes in a variety of shapes based upon the anatomical fixation required. Screws are also offered in "mini" and "standard" sets and, in addition, in locking and non-locking versions. Size-matched washers are available for use with the non0locking screws when the latter are used for fixation without the plates. Size-matched plate washers are also available for use with plate holes when there is no desire to use a screw. The Baby Gorilla® / Gorilla® Plating System implants are manufactured from medical grade titanium (per ASTM F67), stainless steel (per ASTM F138), and titanium alloy (per ASTM F136).

Phantom® Small Bone Intramedullarv Nail System: The Phantom® Small Bone Intramedullary Nail System is comprised of small bone intramedullary nails, locking screws and threaded pegs. The Phantom® nails are offered in a variety of lengths to accommodate variations in patient anatomy. The Phantom® threaded pegs and locking screws insert through the intramedullary nail to secure the construct. These are offered in varving lengths to accommodate the anatomical fixation required. The system includes instruments for implantation.

Phantom® Hindfoot TTC/TC Nail System: The Phantom® Hindfoot TTC/TC Nail System is comprised of intramedullary nails, screws and accessory components. The Phantom® nails are offered in a variety of sizes lengths, and configurations to accommodate variations in patient anatomy. The Phantom® screws insert through the intramedullary nail to secure the construct. These are offered in varying lengths to accommodate the anatomical fixation required.

HammerTube™ System: The HammerTube™ System includes HammerTube™ and K-Wire implants. The HammerTube™ is a commercially pure titanium plasma sprayed PEEK cylinder in varying diameters, lengths, and angles. The K-Wires are stainless steel and double trocar pointed. The implants are sold sterile.

APEX 3D Total Ankle Replacement System: The APEX 3D™ Total Ankle Replacement System is a cemented, fixed bearing device comprised of a tibial component, a talar component and an Ultra-High Molecular Weight Polyethylene (UHMWPE) component used for ankle joint replacement. Components are available in varying sizes and design configurations intended for both primary and revision applications.

This FDA 510(k) summary (K231231) describes the MR Safety and Compatibility Testing and Labeling Updates for several Paragon 28 Orthopedic Fixation Devices. The document states that the purpose of this submission is to obtain clearance for Magnetic Resonance (MR) safety and compatibility testing and Magnetic Resonance Imaging (MRI) Safety Information updates to the labeling of previously cleared devices. It explicitly mentions that there are no other indications for use, design, material, processing, performance, or labeling modifications subject to the submission. This is crucial because it means the study described focuses solely on MR safety, not on clinical effectiveness of the orthopedic fixation devices themselves.

Therefore, the study focuses on ensuring the devices meet MR Conditional labeling requirements based on established standards, rather than evaluating their clinical performance in human patients.

Here's a breakdown of the requested information based on the provided text, with the caveat that the study is not a clinical effectiveness study of the orthopedic devices but rather a safety study for MRI compatibility:

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document does not explicitly state the specific "sample size" of devices tested for MR safety. The testing was performed on the described orthopedic fixation devices (Monster® Screw System, Baby Gorilla® / Gorilla® Plating System, Phantom® Small Bone Intramedullary Nail System, Phantom® Hindfoot TTC/TC Nail System, HammerTube™ System, APEX 3D™ Total Ankle Replacement System).

Data provenance is not directly about country of origin in this context; it's about the nature of the testing. The testing was prospective in relation to the submission, performed specifically to generate the data for the MR safety labeling update. The tests are in vitro (laboratory-based) rather than in vivo (on human subjects).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This question is not applicable to the described study. The "ground truth" here is compliance with established engineering standards for MR safety, not a medical diagnosis or outcome requiring expert medical consensus. The testing involved standardized methods (ASTM standards) and engineering evaluations, not interpretation by medical experts for a test set of patient data.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

This question is not applicable. Adjudication methods like 2+1 or 3+1 typically refer to the process of resolving discrepancies among multiple human readers (e.g., radiologists) in a clinical diagnostic study. This study is an engineering safety performance study of medical devices, not a diagnostic study.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This study is not about AI assistance or human reader performance. It is a safety study evaluating the compatibility of orthopedic implants with MRI environments.

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

No, this question is not applicable. This study involves the physical testing of orthopedic implants in an MRI environment to determine their safety and compatibility characteristics, not the performance of an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this study is compliance with established, recognized engineering standards for MR safety as defined by ASTM (American Society for Testing and Materials) and the FDA's guidance document "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment." These standards provide quantitative metrics and methodologies for evaluating magnetic force, torque, heating, and image artifact.

8. The sample size for the training set

This question is not applicable. The described study is not a machine learning or AI study, so there is no concept of a "training set."

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

This question is not applicable, as there is no training set in this type of device safety study.

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