Search Results

This device is intended for the orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed. The devices are intended to be single use only

The brackets are bonded to teeth to apply pressure to the tooth, transmitted through a flexible orthodontics wire, to alter the tooth position. The ceramic bracket is produced using Al203, translucent polycrystalline aluminum ox-ide(99.99%). The brackets are bonded to the teeth with commercially available materials and linked together by "arch wire" that applies steady. gentle pressure to produce desired tooth movement.

The provided document is a 510(k) Summary for a medical device called "Orthodontics Bracket" by Speed Dental Co., Ltd. This document is a regulatory submission to the FDA, demonstrating substantial equivalence to a legally marketed predicate device.

However, the information requested about acceptance criteria and a study proving the device meets them, particularly in the context of an AI/algorithm-based device, is not present in this document.

This document describes a traditional medical device (orthodontic brackets) and focuses on demonstrating substantial equivalence based on material, design, and intended use to a predicate device. There is no mention of:

• AI/Algorithm performance: The device is a physical orthodontic bracket.
• Acceptance criteria for an algorithm: No algorithm is involved.
• Studies proving algorithm performance: No such studies are relevant here.
• Sample size for test/training sets: Not applicable for a physical device in this context.
• Ground truth and experts: Not applicable.
• MRMC comparative effectiveness study or standalone performance: Not relevant to this device.

The study mentioned is a Non-Clinical Study performance focusing on:

• Maxillary torque: This is a performance characteristic of the physical bracket.
• Biocompatibility: In compliance with ISO 10993 standards (Part 1, Part 5, Part 10). This assesses the safety of the material in biological contact.

In summary, the provided document does not contain the information requested about acceptance criteria and studies for an AI-based device because the device described is a physical, non-AI medical product.

Ask a specific question about this device