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The MotoBAND™ CP Implant System is indication and fixation of fresh fractures, revision procedures, joint fusion and reconstruction of small bones of the hand, feet, wrist, ankles, fingers and toes. When used for these indications, the MotoBAND™ Implant System with the exception of the 2-hole plate may be used with the MotoCLIP™ HiMAX™ Implant System.

The subject MotoBAND CP Implant System is comprised of implant plates and instruments, having various features and sizes to accommodate differing patient anatomy. Plate geometries are 5° valgus and have options of 0°,5°, and 10° dorsiflexion and can be used with 18mm, 20mm or 25mm nitinol clip. Non-locking and poly-axial locking screws are included in the system: 3.0mm diameter and 3.5mm diameters in lengths of 10-50 mm. MotoBAND CP Implant System is compatible with MotoCLIP/HiMAX Clips.

The provided text does not contain information about the acceptance criteria or a study proving that a device meets such criteria. Instead, it is a 510(k) premarket notification letter from the FDA to CrossRoads Extremity Systems, LLC regarding the MotoBAND CP Implant System. This document focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving performance against defined acceptance criteria through a specific study.

The key points from the document regarding the device are:

• Device Name: MotoBAND™ CP Implant System
• Intended Use: Stabilization and fixation of fresh fractures, revision procedures, joint fusion, and reconstruction of small bones of the hand, feet, wrist, ankles, fingers, and toes.
• Comparison to Predicate: The submission compares the MotoBAND CP Implant System to a primary predicate (K173710 MotoBAND CP Implant System) and an additional predicate (K181410 MotoCLIP™/HiMAX™ Implant System).
• Changes from Predicate: The subject device includes:
  • Longer bridge length clips (20mm and 25mm)
  • Longer length screws (32-50mm)
  • Plate geometry modification for clip compatibility (maximum plate length decreased, thickness and width similar).
• Performance Testing (Engineering Analysis): An engineering analysis of the "worst case" MotoBAND™ CP Implant System with MotoCLIP™/HIMAX™ Implant System was performed.
  • Results: This analysis showed that the strength of the plates, staple bending strength and bending stiffness, and staple/screw fixation performance exceeds the strength of the worst-case implants in the predicate system.
  • Conclusion from Analysis: "No additional mechanical testing is required. The results demonstrate the performance of the subject MotoBAND CP Implant System is substantially equivalent to the predicate device."

Therefore, based on the provided text, the specific information requested in the prompt (acceptance criteria, details of a study proving compliance, sample sizes, ground truth establishment, MRMC studies, etc.) is not present. The FDA clearance is based on a demonstration of substantial equivalence through engineering analysis comparing the new device to a predicate, not on a clinical or performance study with defined acceptance criteria for standalone performance.

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The CrossRoads Screw System is indicated for fracture repair and fixation, osteotomy, joint fusion, reconstruction and arthrodesis of bones appropriate for the size of the device.

The CrossRoads Screw System was previously cleared under 510(k)s K143039 & K152072 and is comprised of bone screws having various features in a variety of diameters and lengths to accommodate differing patient anatomy. The screws that are the subject of this submission incorporate design modifications and additional lengths to the 2.0mm, 2.5mm, and 3.0mm screws as well as the addition of new 2.0mm, 4.0mm and 7.0mm Headless Screws. The design modifications include screw thread changes, screw head/driver interface changes, and the addition of reverse cutting threads.

This document describes a 510(k) premarket notification for the CrossRoads Screw System. It indicates that the device has been found substantially equivalent to previously cleared predicate devices.

However, the provided text does not contain the information requested in your prompt regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or clinical effectiveness studies (MRMC or standalone).

The "Performance Testing" section states: "Engineering analysis was performed utilizing the worst-case sizes the subject CrossRoads Screw System. This analysis showed the subject device to be substantially equivalent in terms of performance to the predicate CrossRoads Screw System (K152072 and K143039). Thus, it was determined that no additional mechanical testing is required."

This implies that the device's substantial equivalence was established through an engineering analysis comparing it to existing predicate devices, rather than through new clinical studies demonstrating specific performance metrics against defined acceptance criteria. Therefore, most of your requested information is not present in this document.

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The TriMAX™ Implant System is indicated for hand and foot bone fragment osteotomy fixation and joint arthrodesis.

The TriMAX™ Implant System is a staple system which gives the surgeon a means of bone fixation in the management of bone fractures and reconstructive surgery. Prior to implantation, the legs of the implant are held substantially parallel to facilitate insertion into the prepared bone. Once implanted and released from the insertion device, the implant will move towards each other in a converging fashion. This movement creates compression across the adjoining bone members.

The provided text describes the 510(k) premarket notification for the TriMAX™ Implant System, a metallic bone fixation device. However, this document does not contain information about studies proving the device meets acceptance criteria related to an AI/ML-based medical device.

The document primarily focuses on demonstrating substantial equivalence to predicate devices based on:

• Indications for Use: The TriMAX™ Implant System is indicated for hand and foot bone fragment osteotomy fixation and joint arthrodesis, which is similar to the predicate devices.
• Technological Characteristics: Similarity in basic design, materials of manufacture (implied as metallic), and mechanical properties to the predicate devices.
• Performance Testing (Mechanical): Theoretical analysis and mechanical testing were performed to confirm substantial equivalence in mechanical strength to the predicate CrossRoads MotoCLIP™/HiMAX Implant System (K181410) and the CrossRoads Screw System (K152072).
• Pyrogen Testing: Confirmed the device meets the endotoxin limit of 20 Endotoxin Units (EU)/Device.

Therefore, I cannot provide the requested information about acceptance criteria and a study proving an AI/ML device meets them, as the provided text pertains to a traditional orthopedic implant, not an AI/ML system. The questions regarding sample size, data provenance, expert ground truth establishment, MRMC studies, standalone performance, and training set details are relevant to AI/ML device evaluations, which are not described in this submission.

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