Search Results

The screws are intended to provide fixed anchorage for attachment of orthodontic appliances intended to facilitate the orthodontic movement of teeth. They are used temporarily and are intended to be removed after orthodontic treatment has been completed. The screws are intended for single use only.

The Syntec Orthodontic Mini Screw Extended System is a modification of our own device Syntec Orthodontic Mini Screw (K090476). The screws are fabricated from stainless steel (SUS316L) per ISO 5832-1:2007/ASTM F138-13 and Titanium-6 Aluminum-4 Vanadium Eli (Extra Low Interstitial) Alloy per ISO 5832-3:1996/ASTM F136-13 as same as previous devices (K090476). The modifications included in the subject submission are a change to the screw hole type, from the previously cleared circular design, to a rectangular shape.

The provided text does not contain information about an AI/ML-based medical device. Instead, it describes a traditional medical device, the "Syntec Orthodontic Mini Screw Extended System," and its 510(k) premarket notification to the FDA.

Therefore, I cannot provide the requested information about acceptance criteria, study details, ground truth establishment, or human-in-the-loop performance studies, as these concepts are typically applied to AI/ML device evaluations and are not present in this document.

The document primarily focuses on demonstrating substantial equivalence of the new orthodontic mini screw system to a previously cleared predicate device, based on material composition, dimensions, and manufacturing processes, with a minor modification in screw hole shape. The performance data section refers to non-clinical tests (dimensional, material mechanical property standards, biocompatibility, fracture load, rotational fracture torque, and axial pull-out strength), stating these tests were leveraged from the predicate device and not repeated for the new submission.

Ask a specific question about this device