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Generation CTM Aesthetic Self-Ligating Bracket System indication for use is to correct malocclusions of the teeth as determined by a licensed Orthodontist/Dentist. The brackets are intended to only be bonded to natural teeth. The brackets are used with orthodonic wire to control the direction of the tooth movement of the individual teeth by providing a slow and continuous force to the teeth.

Generation CTM Aesthetic Self-Ligating Bracket System

This document is a 510(k) clearance letter from the FDA for an orthodontic bracket system. It is not a study report and therefore does not contain the detailed information requested regarding acceptance criteria, device performance results, sample sizes, expert qualifications, or ground truth establishment.

A 510(k) clearance letter primarily assesses substantial equivalence to a predicate device and does not typically include a detailed performance study with specific acceptance criteria and results in the manner a clinical trial report or a comprehensive validation study would.

Therefore, I cannot provide the requested information from the given document as it does not contain details about:

1. A table of acceptance criteria and the reported device performance
2. Sample sized used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and their qualifications
4. Adjudication method for the test set
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of human readers improving with AI vs without AI assistance
6. If a standalone (algorithm only) performance study was done
7. The type of ground truth used
8. The sample size for the training set
9. How the ground truth for the training set was established

This document only confirms that the FDA reviewed the premarket notification and determined the device is substantially equivalent to legally marketed predicate devices.

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Equa Pull Constant Force Headgear is a safety release module used during the wear of Orthodontic Head Gear products, connected to Orthodontic Face Bows. The module is designed to provide pull force for treatment at light (12 ounce) or heavy (24 ounce) levels, and a release point force (60-90 ounces) for patient safety. The devices are for Orthodontic Use Only, on the order of an Orthodontist.

Equa Pull Constant Force Headgear is a safety release module used during the wear of Orthodontic Head Gear products, connected to Orthodontic Face Bows. The module is designed to provide pull force for treatment at light (12 ounce) or heavy (24 ounce) levels, and a release point force (60-90 ounces) for patient safety.

This document is a 510(k) clearance letter from the FDA for the "Equa Pull Constant Force Headgear." It states that the device is substantially equivalent to legally marketed predicate devices. However, this type of document does not contain the information requested in your prompt regarding acceptance criteria, study details, sample sizes, ground truth establishment, or expert qualifications.

The 510(k) clearance process primarily focuses on demonstrating substantial equivalence to a predicate device, rather than requiring extensive clinical trials or detailed performance study reports with the level of detail you've asked for. While a manufacturer might conduct performance testing to support their substantial equivalence claim, the FDA's clearance letter itself typically summarizes the regulatory decision and does not provide these detailed technical specifications of the studies.

Therefore,Based on the provided text, I cannot extract the acceptance criteria or the details of a study proving the device meets those criteria. The document is an FDA 510(k) clearance letter, which confirms substantial equivalence to a predicate device but does not contain the detailed performance study information you've requested.

Ask a specific question about this device

Ask a specific question about this device