Search Results

The Ortholock Anchorage Devices are intended to provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth in adolescents greater than 12 years of age and adults. The devices are used temporarily and are removed after orthodontic treatment has been completed. Screws are intended for single use only.

The Ortholock anchorage device is an implantable self-drilling orthodontic microimplant intended to provide a temporary fixed anchorage point to facilitate orthodontic treatment. The device interacts with an appliance accessory, which includes two insertion locations for Ortholock and a tube for the attachment of general orthodontic appliances. The devices are made from Ti6Al4V and their surfaces are anodized so the different lengths can easily be visually identified.

The provided text describes the regulatory clearance of a medical device called "Ortholock Anchorage Devices" and details its equivalence to predicate devices, primarily through bench testing. It does not include information about acceptance criteria for typical AI/ML medical devices, nor does it describe a study with performance metrics in the way these are typically presented for AI/ML device evaluations.

Therefore, I cannot fulfill the request to describe the acceptance criteria and a study proving the device meets those criteria, as the document does not contain this type of information for an AI/ML device.

The document focuses on the substantial equivalence of the Ortholock Anchorage Devices to existing predicate devices based on:

• Indications for Use: Both the subject device and predicate devices are intended to provide fixed anchorage for orthodontic appliances to facilitate tooth movement in adolescents and adults, for temporary use.
• Material: All devices are made from Titanium Alloy.
• Surface Treatment: All are anodized.
• Principle of Operation: All are orthodontic implants used for anchorage of orthodontic appliances.
• Sterilization: All are provided non-sterilized and user-sterilized, with sterilization validated.
• Bench Testing: Comparative bench testing was performed for torsional properties, driving torque, axial pullout strength, and self-tapping performance, demonstrating similar mechanical performance values to the primary predicate device (The C-Type and Special Type Orthodontic Anchor Screws, K063495) and having similar characteristics to the reference device (PSM Medical BENEFIT Screw, K110392).

The information provided is for a traditional medical device (orthodontic microimplant), not an AI/ML device, and thus does not include data like sample sizes for test sets, data provenance, expert ground truth, MRMC studies, standalone performance for an algorithm, or training set details.

Ask a specific question about this device

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.

Ask a specific question about this device