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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 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 MTP plates and 2-hole plate may be used with the MotoCLIPTM Implant System.

The MotoBAND™ CP Implant System is comprised of implant plates and instruments, having various features and sizes to accommodate differing patient anatomy. Plate geometries include valgus options of 0°, 5° and 10°, dorsiflexion options of 0°, 2.5°, 5°, 7.5° and 10° and options to use either a 15mm or 18mm nitinol clip. MotoBAND™ CP Implant System is compatible with MotoCLIP™ Staple.

The provided FDA K173710 document for the MotoBAND™ CP Implant System does not contain the information requested regarding acceptance criteria and study details for a medical device that relies on AI or software for its performance evaluation (e.g., image analysis, diagnostic support devices).

The MotoBAND™ CP Implant System is a physical medical device (metallic bone fixation fastener, plate system) used for orthopedic fixation. Its substantial equivalence determination is based on:

• Theoretical analysis: Predicting torsional, pullout, and plate bending strengths.
• Comparison to predicate devices: Showing that the subject device's predicted performance is substantially equivalent to previously cleared devices (K152306, K160300).
• Materials: Stating the material used (titanium alloy).
• Indications for Use: Matching the scope of the predicate devices.

Therefore, the document does not include:

1. A table of acceptance criteria and reported device performance related to AI/software metrics (e.g., sensitivity, specificity, accuracy).
2. Sample sizes for test sets (as there's no diagnostic test set).
3. Number of experts or their qualifications for ground truth establishment.
4. Adjudication methods.
5. MRMC studies or effect sizes for human readers.
6. Standalone algorithm performance.
7. Types of ground truth (as it relates to diagnostic accuracy).
8. Training set sample sizes or ground truth establishment for training data.

The performance testing mentioned in the document refers to mechanical integrity and strength tests for the physical implant, not data-driven performance of a diagnostic or AI-enabled device.

In summary, this document is irrelevant to the prompt's request for information about a study that proves a device meets acceptance criteria related to AI or data-driven performance.

Ask a specific question about this device