Search Results

Insignia with iTero is a treatment planning software and orthodontic appliance system used to correct malocclusions in orthodontic patients, using appliances individualized for the orthodontic patient. The Insignia Orthodontic System is compatible with the iTero scanner.

The Insignia software creates a computer model of the patient's dentition based on a stone model, iTero scan file or impression of the patient's dentition. The iTero scanner produces a digital scan of a patient's tooth data as an alternative to the physical dental impressions. Insignia operators and the orthodontist use this computer model to determine the placement and/or modification of dental brackets to achieve the intended repositioning of the teeth. Ormco then manufactures foam bracket placement jigs to position the brackets on the patient's teeth in specific positions prescribed by the orthodontist. The orthodontist uses the foam jigs to place and secure the brackets with a commercially-available dental adhesive. Insignia with iTero consists of the following components and accessories: 1) Proprietary software that calculates the position of dental brackets based on the dental impressions and treatment plan supplied by the patient's orthodontist. 2) Commercially-available metal, plastic, or ceramic brackets and/or individually modified metal brackets. 3) Patient-specific foam bracket placement jigs to affix the brackets in position. 4) Either commercially-available or patient-specific shaped traditional archwires. The device does not include the adhesive that affixes the brackets to the teeth.

The provided text describes the "Insignia with iTero" device, an orthodontic treatment planning software and appliance system. It claims substantial equivalence to two predicate devices: "Insignia (K121524)" and "Biomet 3i Using Cadent iTero Scanner (K102209)".

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state quantitative acceptance criteria in a typical pass/fail format with specific thresholds. Instead, it relies on the concept of "substantial equivalence" to predicate devices. The primary performance aspect highlighted is the accuracy of the digital impression file generated from the iTero scanner.

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

• Sample Size: Not specified. The document only mentions "Accuracy testing of the digital impression file..." without providing the number of scans or measurements included in this testing.
• Data Provenance: Not specified. It's unclear if the testing was retrospective or prospective, or the country of origin of the data.

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

• Not specified. The document simply mentions "Accuracy testing" without detailing how the ground truth for this testing was established or if experts were involved in its determination.

4. Adjudication Method for the Test Set:

• Not specified. There's no mention of any adjudication method (e.g., 2+1, 3+1, none) for the accuracy testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly mentioned or performed. The device is not presented as an AI-assisted diagnostic tool for human readers but rather as a treatment planning software and appliance system. The evaluation focused on the accuracy of the digital impression and substantial equivalence to existing devices, not on human reader improvement with AI.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

• Yes, implicitly. The "Accuracy testing of the digital impression file generated from the iTero scanner" appears to be a standalone performance evaluation of the scanner component, which produces a digital output (algorithm only) as an alternative to physical impressions. The software then uses this digital model for treatment planning. The "Insignia software" itself also operates in a standalone manner to calculate bracket positions.

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

• Not explicitly defined. For the "accuracy testing of the digital impression file," the ground truth likely involved a comparison against a highly accurate reference measurement of the dentition. This could be a physical impression measured with high-precision instruments or a different, highly accurate 3D scanning method considered the gold standard. However, the document does not specify the exact nature of this ground truth.

8. The Sample Size for the Training Set:

• Not applicable/not specified. The document describes a "proprietary software that calculates the position of dental brackets" and the "iTero scanner" which produces digital scans. While these systems likely have internal algorithms that were developed and potentially "trained," the document does not discuss a training set in the context of machine learning or AI models in the modern sense. The focus is on the output accuracy of the system's components.

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

• Not applicable/not specified. As with the training set itself, the document does not provide details on how ground truth would have been established for any internal training or development of the software or scanner's algorithms.

Ask a specific question about this device