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Inspire ICE, a ceramic orthodontic bracket, is intended for use during orthodontic treatment of malocclusions. A malocclusion is imperfect positioning of the teeth when the jaws are closed.

Inspire ICE, is a single-use orthodontic bracket made from monocrystalline alumina. The brackets are intended for use during orthodontic treatment of malocclusions. A malocclusion is imperfect positioning of the teeth when the jaws are closed. After following standard office protocols for tooth preparation, the brackets are bonded to the teeth with an orthodontic adhesive or cement. An archwire is then threaded through the bracket's archwire slot and is held in place with a ligature tie. These ligatures are tightened, or ligated, around the 'wings' of the bracket and over the archwire. To aid in optimal teeth movement, the individual brackets can also be ligated to other brackets or other orthodontic devices. After the teeth have moved into their proper positions, the orthodontic / dental professional will remove the brackets with the Inspire ICE Debonding Pliers. This step is also known as debonding.

This document is a 510(k) premarket notification for the Inspire ICE™ aka Inspire ICE™ Clear Brackets, an orthodontic plastic bracket. The document details the device's characteristics and its substantial equivalence to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the non-clinical performance data and the comparison to predicate devices, demonstrating the device performs "as safe, as effective, and performs as well as the predicate devices". Specific quantitative acceptance criteria or pass/fail thresholds for each test are not explicitly stated in this summary. The table below summarizes the reported non-clinical performance data categories.

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

The document does not explicitly state the sample sizes used for the non-clinical performance testing (Bond Strength, Tie Wing Strength, Torque Strength, Biocompatibility, Stability testing). It mentions that "internal test methods" were utilized alongside applicable ISO standards.

The data provenance is from non-clinical performance data (laboratory testing) conducted by the manufacturer, Ormco Corporation, or accredited research service companies. The country of origin of the data is not explicitly stated, but the submitter (Ormco Corporation) is based in Orange, California, USA, suggesting the testing was likely conducted in the USA or by labs adhering to international standards (ISO). The testing is prospective for the Inspire ICE device, comparing its performance to already marketed predicate devices.

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

This document describes non-clinical performance testing and a comparison to predicate devices for substantial equivalence. It does not involve a "test set" in the context of human interpretation or diagnostic accuracy where expert ground truth would be established by panels of human experts. Instead, the "ground truth" for material properties and mechanical performance would be derived from:

• Established international standards (e.g., ISO 27020, ISO 10993 series).
• Validated laboratory testing methodologies.

Therefore, the concept of "number of experts" or their qualifications for establishing ground truth as typically understood in studies involving diagnostic accuracy is not directly applicable here. The experts involved would be engineers, material scientists, and toxicologists familiar with the respective ISO standards and testing procedures.

4. Adjudication Method for the Test Set

As this study focuses on non-clinical performance data and comparison to predicate devices, there is no "adjudication method" in the context of resolving discrepancies in expert interpretations (e.g., 2+1, 3+1). The performance is assessed against established technical specifications and international standards.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No MRMC comparative effectiveness study was done. This device is an orthodontic bracket, a physical medical device, not a software algorithm that assists human readers.

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

Not applicable. This device is a physical orthodontic bracket, not an algorithm.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The "ground truth" for this submission is based on:

• Established performance specifications and standards: Primarily ISO 27020 for orthodontics brackets and tubes, and the ISO 10993 series for biological evaluation of medical devices.
• Validated laboratory testing methodologies: Used to measure Bond Strength, Tie Wing Strength, Torque Strength, Biocompatibility, and Stability.
• Comparison to legally marketed predicate devices: The "ground truth" for demonstrating safety and effectiveness relies on showing that the new device performs equivalently to previously cleared devices which have an established history of safe and effective use.

8. The Sample Size for the Training Set

Not applicable. This device is a physical orthodontic bracket and does not involve AI or machine learning models requiring a "training set."

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

Not applicable, as no training set is involved.

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