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The Dual Top Screw System is intended for use as a temporary anchor treatment for use in patients aged 12 and older.

The Dual Top Screw System is a temporary fixation and screws in various configurations, shapes and sizes. The Dual Top Screw System is made of Titanium Alloy (Ti-6AL-4V), which meets ASTM F136, Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications, which are widely used for surgical implants with well-known biocompatibility. The head of the screw is dual head of the Dual Top Anchor System screw is designed to apply various orthodontic tools. There is a hole in the screw head through which a wire can be passed to fix the mandible and maxilla in orthodontic treatment. Also, dual head design of screw accommodates the use of the screw with the orthodontic appliances (bracket, wire, and elastic band etc.) The sizes of the Dual Top System are diverse enough to satisfy various clinical cases. The Dual Top System screws are provided either non-sterilized or gamma-sterilized.

The provided text describes a 510(k) premarket notification for the "Dual Top Screw System," an endosseous dental implant (temporary anchor for orthodontic treatment). This document focuses on demonstrating substantial equivalence to existing predicate devices, rather than proving the device meets specific performance acceptance criteria through the kind of study typically performed for AI/ML devices.

Therefore, the information requested regarding acceptance criteria, performance studies and ground truth establishment, which are typical for AI/ML device submissions, is not present in this document. This submission is for a physical medical device (an orthodontic screw) and relies on bench testing and material conformity to established standards to demonstrate equivalence to a predicate device.

Here's why the requested information cannot be found based on the provided text:

• Acceptance Criteria/Reported Device Performance (Table): The document doesn't provide specific numerical performance metrics (e.g., accuracy, precision) for the device. Instead, it states that "The results of this testing indicate that the Dual Top Screw System is equivalent to predicate devices." This is satisfied through demonstrating similar mechanical properties and biocompatibility.
• Sample Size for Test Set and Data Provenance: No clinical test set data is provided, as "No clinical studies were necessary for the demonstration of substantial equivalence." The bench tests mentioned (Axial Pullout, Torsional Property, Driving Torque) would have sample sizes for the devices tested, but these aren't specified in the summary.
• Number of Experts/Qualifications/Adjudication Method: These points are relevant for studies that establish ground truth, typically in the context of diagnostic or AI-powered devices where human expert consensus is used. Since no clinical studies or AI components are mentioned, these are not applicable.
• MRMC Comparative Effectiveness Study: This is a type of study specifically for evaluating the impact of AI on human reader performance. As this is not an AI/ML device, such a study was not conducted.
• Standalone Performance: This refers to the algorithm-only performance of an AI/ML device. Not applicable here.
• Type of Ground Truth: Ground truth for AI/ML is typically established by expert consensus, pathology, or outcomes data. For this physical device, "ground truth" is defined by material standards (ASTM F136) and established mechanical testing protocols (ASTM 543).
• Sample Size for Training Set and How Ground Truth was Established for Training Set: These are concepts entirely related to AI/ML model development. They are not relevant for this traditional medical device submission.

In summary, the provided document outlines the substantial equivalence approach for a physical medical device, which differs significantly from the performance study requirements for AI/ML devices or novel diagnostic tools. The "acceptance criteria" here are largely met by conformity to material standards and comparable mechanical performance to predicate devices through bench testing, not clinical performance metrics or expert-adjudicated ground truth.

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