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The Progressive Technology Inc. Chi Lites Orthodontic Sapphire Bracket is a line of single-use devices intended for orthodontic movement of teeth. The bracket is used temporarily and is removed upon completion of orthodontic treatment.

Progressive Technology Inc. is submitting this Premarket Notification for its Class II product, an orthodontic sapphire bracket. The device is intended for use in conjunction with comprehensive orthodontics to control the movement of individual teeth. The brackets are comprised of several geometries that vary from bracket to bracket, corresponding to the intended tooth. These geometries contribute to the fit of the bracket to the tooth and also impart the axial control of the energy from the archwire.

The provided text describes the 510(k) premarket notification for the "Chi Lites Orthodontic Sapphire Bracket." This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study for a new, AI-powered medical device. Therefore, much of the requested information regarding acceptance criteria, AI performance metrics, and human reader studies is not applicable to this specific document.

However, I can extract information related to the device performance testing done to support the substantial equivalence claim.

Here's the breakdown based on the provided text, adapted to fit the requested format where possible, and noting where information is not available or outside the scope of this document:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Fracture Testing: 20 brackets were tested (10 Chi Lites Orthodontic Sapphire bracket, 10 predicate bracket).
• Bond/Shear Strength: 40 brackets were tested (20 Chi Lites Orthodontic Sapphire bracket, 20 predicate bracket).
• Data Provenance: The document does not specify the country of origin of the data or whether the tests were retrospective or prospective. Given the nature of a 510(k) submission for a physical device, these tests would typically be prospective, controlled laboratory tests performed by the manufacturer.

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

• Not applicable. This is a physical device where ground truth is established through direct measurements of mechanical properties (force, shear strength) rather than expert interpretation of images or patient data.

4. Adjudication Method for the Test Set

• Not applicable. As above, ground truth is based on direct measurements, not subjective expert judgment requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No. This type of study is relevant for AI-powered diagnostics or image interpretation systems, not for a physical orthodontic bracket.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done

• Not applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

• The ground truth for the performance testing was established through direct physical measurement of mechanical properties (fracture force and bond/shear strength) in controlled laboratory settings. These are objective, quantitative measurements.

8. The Sample Size for the Training Set

• Not applicable. This is a physical device, not an AI model requiring a training set.

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

• Not applicable.

Summary from the Document regarding Substantial Equivalence:

The document concludes that the "function and performance of Chi Lites Orthodontic Sapphire bracket is similar to the predicates. There are no changes in the intended use and fundamental scientific technology. All of the materials used in the device have been used in cleared orthodontics devices. Since the subject and predicate are similar in design, function and performance, they are substantially equivalent to the predicate device."

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