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510(k) Data Aggregation
(78 days)
The Insignia Orthodontic System 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 software creates a computer model of the patient's dentition based on either a stone model or impression of the patient's dentition. 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 consists of the following components and accessories:
- Proprietary software that calculates the position of dental brackets based on the dental impressions and treatment plan supplied by the patient's orthodontist.
- Commercially-available metal, plastic, or ceramic brackets and/or individually modified metal brackets.
- Patient-specific foam bracket placement jigs to affix the brackets in position.
- Either commercially-available or patient-specific shaped traditional archwires.
The device does not include the adhesive that affixes the brackets to the teeth.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Insignia device:
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary does not explicitly state specific acceptance criteria (e.g., minimum accuracy percentages, error tolerances) for the Insignia software. Instead, it relies on a comparison to a predicate device and a statement of "successful validation."
| Acceptance Criteria (Not Explicitly Stated as Numerical Targets) | Reported Device Performance (Summary Statements) |
|---|---|
| Software Performance (General) | "the Insignia software has been successfully validated to confirm the performance of the device." |
| Substantial Equivalence to Predicate Device (OrthoCAD iQ) | "Insignia functions in a manner similar to and is intended for the same use as OrthoCAD iQ... Based upon... successful validation of the Insignia software, the performance of Insignia is deemed to be substantially equivalent to OrthoCAD iQ." The detailed comparison table outlines similar technological characteristics, intended use, treatment plan sequence, bracket materials, archwire materials, positioning device materials, mode of use, description of appliance placement, and manufacturing method between Insignia and OrthoCAD iQ. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a sample size for any test set used to validate the software. It merely states "the Insignia software has been successfully validated." There is no information provided regarding data provenance (e.g., country of origin, retrospective or prospective nature).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
The document does not mention the use of experts to establish a ground truth for a test set. The validation information is extremely high-level and lacks details about specific methodologies.
4. Adjudication Method for the Test Set
Since no test set with expert-established ground truth is described, there is no information provided regarding an adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or reported. The document explicitly states: "Clinical testing has not been conducted on this product." The focus is on software validation and biocompatibility, not on human-in-the-loop performance or comparison to human readers.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study
A standalone study of the algorithm's performance, separate from human interaction, was done, but with very limited detail. The statement "the Insignia software has been successfully validated to confirm the performance of the device" indicates a standalone evaluation of the software. However, the specifics of this validation (e.g., metrics, methodology, dataset) are not provided in the summary.
7. Type of Ground Truth Used
The document does not explicitly state the type of ground truth used for the software validation. Given the nature of the device (treatment planning and bracket positioning), the ground truth for an ideal outcome would likely be established through engineering design specifications, simulated clinical scenarios, or potentially comparisons to historical treatment outcomes, but this is not detailed.
8. Sample Size for the Training Set
The document does not provide any information regarding a training set sample size. As a software for treatment planning, it's possible that the "training" refers more to the development and refinement of algorithms based on orthodontic principles and mechanical models rather than traditional machine learning training data.
9. How the Ground Truth for the Training Set Was Established
The document does not describe how ground truth for a training set was established. This lack of detail is consistent with the generally high-level overview of software validation provided in the summary.
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