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Damor FT is a polycarbonate bracket system intended to aid in the movement of patient's teeth during orthodontic treatment.

The device is a polycarbonate orthodontic bracket which will encompass maxillary and mandibular brackets from second bicuspid to second bicuspid. The Damon FT appliance has both aesthetic and self-ligating qualities. The Damon FT bracket is designed to 1) increase patient comfort, with its increased corner radius. 2) enhance bracket placement, with its rhomboid design, and 3) improve overall bracket performance without changing treatment mechanics, with its metal archwire slot, rotation control similar to Damon 2 bracket, and compatibility with the Damon 2 bracket.

This submission from Sybron Dental Specialties, Inc. (K032408) is a 510(k) premarket notification for a new medical device, the Damon FT orthodontic bracket. This type of submission relies on demonstrating "substantial equivalence" to a predicate device already legally marketed, rather than extensive clinical studies to prove effectiveness and safety from scratch.

Therefore, the document does not contain the kind of detailed information about acceptance criteria, specific performance metrics, or a study design (sample size, expert ground truth, adjudication, MRMC studies, standalone performance) that would be present in a PMA (Premarket Approval) application or a clinical trial report for a novel, higher-risk device.

Here's an breakdown of the information that can be extracted, and where the requested information is not present:

1. Table of Acceptance Criteria and Reported Device Performance

• Not provided in this document. The concept of "acceptance criteria" for specific performance metrics (like accuracy, sensitivity, specificity, etc.) is typically associated with studies designed to quantify a device's performance against predefined targets. This 510(k) submission focuses on demonstrating substantial equivalence in function and safety to an existing device rather than presenting novel performance data against specific quantitative acceptance criteria.

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

• Not applicable / Not provided. A "test set" in the context of device performance evaluation (e.g., for AI algorithms) is not relevant here. This submission relies on comparing the design and intended use of the Damon FT bracket to a predicate device. No new clinical performance or efficacy study using a "test set" of patients or data is presented.

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

• Not applicable / Not provided. Ground truth establishment is relevant for studies where expert interpretation or diagnosis is being evaluated (e.g., in medical imaging AI). This submission is for an orthodontic bracket, and no such study is described.

4. Adjudication Method for the Test Set

• Not applicable / Not provided. Adjudication methods are used in studies involving multiple readers to resolve discrepancies in interpretation. This is not pertinent to the 510(k) submission for an orthodontic bracket and its demonstration of substantial equivalence.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

• No. An MRMC study is a specific type of clinical trial often used for diagnostic imaging devices to compare the performance of human readers with and without AI assistance across multiple cases. This is not relevant to an orthodontic bracket and its mode of a 510(k) submission.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Not applicable. "Standalone performance" refers to the performance of an algorithm or AI system without human intervention. This device is a physical orthodontic bracket, not an algorithm.

7. The Type of Ground Truth Used

• Not applicable / Not provided. As no performance study with a "test set" is described, the concept of "ground truth" (e.g., pathology, expert consensus) does not apply here. The submission primarily relies on comparing the physical characteristics and intended use of the new bracket to a predicate device.

8. The Sample Size for the Training Set

• Not applicable. A "training set" is used in the development of AI algorithms. This device is a physical orthodontic bracket, not an AI or software device that would require training data.

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

• Not applicable. As there is no training set for an AI algorithm discussed, this question is not relevant.

Summary of What the Document DOES Provide:

• Device Name: Damon FT
• Device Type: Plastic Orthodontic Bracket
• Intended Use: Movement of teeth during orthodontic treatment.
• Predicate Device: Spirit MB bracket marketed by Ormco Corporation.
• Basis for Equivalence: Similar function and intended use; it's a polycarbonate bracket with aesthetic and self-ligating qualities. It's designed to increase patient comfort, enhance bracket placement (rhomboid design), and improve overall bracket performance without changing treatment mechanics (metal archwire slot, rotation control similar to Damon 2, compatibility with Damon 2).
• Regulatory Decision: Substantially equivalent to existing legally marketed devices.

This 510(k) framework specifically bypasses the need for extensive de novo clinical studies demonstrating device performance against specific metrics by showing that the new device is as safe and effective as a device already on the market.

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