Search Results

The DePuy Small Bone Locking Plating System is intended for stabilization and fixation of small bone fragments in fresh fractures, revision procedures, joint fusion and reconstructions of small bones of the hand, foot, wrist, ankle, humerus, scapula, finger, toe, pelvis and craniomaxillofacial skeleton, particularly in osteopenic bone.

The Small Bone Locking Plating System is substantially equivalent to currently marketed devices. The technological characteristics of the Small Bone Locking Plating System are the same as the predicate devices including design and material.

The provided text is a 510(k) summary for the DePuy Small Bone Locking Plating System. This type of regulatory submission focuses on demonstrating substantial equivalence to existing legally marketed devices, rather than establishing acceptance criteria and conducting a detailed study to prove the device meets these criteria through clinical performance metrics.

Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set details for an AI/device.

Here's why the requested information is absent:

• Device Type: This is a physical orthopedic implant (bone plating system), not a software or AI-based diagnostic/interpretive device. Clinical performance for such devices is typically evaluated through pre-clinical testing (e.g., mechanical strength, biocompatibility), and subsequent post-market surveillance.
• Regulatory Pathway (510(k) - Substantial Equivalence): The 510(k) pathway demonstrates that a new device is as safe and effective as a legally marketed predicate device. It usually does not require new clinical studies to establish specific performance metrics against pre-defined acceptance criteria in the same way an AI/software device would. Instead, it relies on demonstrating similar design, materials, and intended use as the predicate.
• Focus of the Document: The document explicitly states, "The Small Bone Locking Plating System is substantially equivalent to currently marketed devices as demonstrated with pre-clinical data. No new issues of safety or efficacy have been raised." This highlights the nature of the submission.

If this were an AI or software device, the 510(k) summary would typically include a detailed section on clinical performance, including the metrics you've asked for. However, for this type of device, that information is not provided in this regulatory document.

Ask a specific question about this device