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The Vectors Temporary Anchorage System is a threaded titanium dental implant screw intended to provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. The device is used temporarily and is removed after orthodontic treatment. The screw is sterile and is intended for single use only.

The Vectors Temporary Anchorage System consists of sterile, single-use titanium screws that are available in 6, 8, 10, and 12mm lengths which are designed to aid in dental movement by providing a rigid skeletal fixation point. They are inserted into the bone and serve as a temporary anchor for various orthodontic tooth movements. The selfdrilling thread design allows for easy insertion and removal with the use of the system's driver. The product is sterilized using gamma radiation.

The provided text is a 510(k) summary for the Sybron Dental Specialties Vectors Temporary Anchorage System. This document focuses on establishing substantial equivalence to existing legally marketed devices, rather than presenting a study with specific acceptance criteria and performance data for the device itself.

Therefore, many of the requested items (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable (N/A) because the regulatory pathway chosen (510(k)) does not require such studies for this type of device.

The core of this submission is to demonstrate that the new device is as safe and effective as pre-existing, legally marketed devices. This is typically done by comparing materials, design, intended use, and general performance characteristics, not through new clinical trials with detailed performance metrics.

Here's a breakdown based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size (Test Set): Not Applicable (N/A) - No specific test set for performance evaluation is described.
• Data Provenance: Not Applicable (N/A) - The submission is based on comparison to existing predicate devices, not on new data from a test set.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts:

• Number of Experts: Not Applicable (N/A)
• Qualifications of Experts: Not Applicable (N/A)

4. Adjudication Method for the Test Set:

• Adjudication Method: Not Applicable (N/A)

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• Was an MRMC study done? No.
• Effect size of human readers with AI vs. without AI assistance: Not Applicable (N/A) - This device is a physical implant, not an AI-assisted diagnostic or therapeutic tool.

6. Standalone (Algorithm Only) Performance Study:

• Was a standalone study done? No. This device is a physical implant, not an algorithm.

7. Type of Ground Truth Used:

• Type of Ground Truth: Not Applicable (N/A) - The "ground truth" in a 510(k) for this type of device is the safety and effectiveness of the predicate devices to which equivalence is claimed.

8. Sample Size for the Training Set:

• Sample Size (Training Set): Not Applicable (N/A) - No training set is relevant for this type of device submission.

9. How the Ground Truth for the Training Set Was Established:

• Ground Truth Establishment: Not Applicable (N/A) - No training set is relevant for this type of device submission.

Summary of Relevant Information from the Document:

While the document doesn't provide the requested study details, it does contain the following pertinent information:

• Device Name: Vectors Temporary Anchorage System
• Intended Use: To serve as a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. The device is used temporarily and is removed after orthodontic treatment. The screw is sterile and is intended for single use only.
• Predicate Devices:
  • Medicon eG. Aarhus Anchorage System
  • Dentaurum, Tomas Pin
  • Imtec Corporation, Ortho Implant
  • Mondeal Medical Systems, Lomas Quattro
• Substantial Equivalence Claim: The Vectors Temporary Anchorage System is composed of the same material (titanium) and is substantially equivalent in application and function to the listed predicate devices.

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