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Insignia Digicast is a computer aided system intended for use as an aid in orthodontic diagnostics for use by dental professionals trained in orthodontic treatment including radiographic analyses and diagnostics.

Insignia Digicast is a software product and service that creates digital models of patients' teeth, which are used primarily to record the status of a patients' dentition prior to treatment. Clinicians may also use the digital model to support their diagnosis. The Insignia Digicast system scans a traditional impression, processes the scan, and electronically delivers a digital study model to the dental professional. The dental professional may view, measure, and analyze the Insignin Digicast three dimensional viewer software. The main analysis tools include TJ Moyers, Bolton analyses, ABO scoring, and Arch and Overbite/Overjet measurements. There are no accessories or patient contacting components of Insignia Digicast.

The provided document describes the Insignia Digicast, a software product and service that creates digital models of patients' teeth for orthodontic diagnostics.

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

1. Table of Acceptance Criteria and Reported Device Performance:

   The document does not explicitly state numerical acceptance criteria (e.g., specific accuracy thresholds for measurements). Instead, it relies on demonstrating substantial equivalence to predicate devices (OrthoCAD iQ and Lava Digital Models) through qualitative comparisons of features and mode of use, and quantitative comparisons of measurement accuracy.

   Feature/Measurement	Acceptance Criteria (Implied by Substantial Equivalence)	Insignia Digicast Performance (Reported)
   Teeth Width	Functionally equivalent to predicates	Bench tested, successfully validated
   Space	Functionally equivalent to predicates	Bench tested, successfully validated
   T-J Moyers Analysis	Functionally equivalent to predicates	Bench tested, successfully validated
   Bolton Analysis	Functionally equivalent to predicates	Bench tested, successfully validated
   Arch Measurements	Functionally equivalent to predicates	Bench tested, successfully validated
   Overbite/Overjet	Functionally equivalent to predicates	Bench tested, successfully validated
   Overall Performance	Substantially equivalent to predicate devices	Deemed substantially equivalent

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

   • Sample Size: Not specified in the provided document. The document states "data from bench testing" was used, but does not quantify the number of cases or models tested.
   • Data Provenance: Not explicitly stated. Given it's bench testing, it's likely synthetic data, cadaver models, or a collection of patient impressions, but the origin (e.g., country) is not mentioned. It is a retrospective evaluation against existing (presumably traditional) measurements.

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

   • Not specified. The document indicates that bench testing was used to "evaluate the performance characteristics... compared to the predicate device." It doesn't mention expert involvement in establishing a separate ground truth for the test set beyond the comparisons made with the predicate device's established performance.

4. Adjudication Method for the Test Set:

   • Not specified. This information is typically relevant for human-reader evaluations, which did not occur for this device.

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. The document explicitly states: "Clinical testing has not been conducted on this product."

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

   • Yes, a standalone evaluation was performed. The "Non-Clinical Performance Data" section describes "bench testing" to evaluate the "performance characteristics of Insignia Digicast," which is an algorithm-only assessment. The software was "successfully validated to confirm the performance of the device."

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • The "ground truth" for the non-clinical performance evaluation was based on comparisons to the predicate device, OrthoCAD iQ, for characteristics such as teeth width, space, and various analyses (T-J Moyers, Bolton, Arch, Overbite/Overjet). This implies the predicate device's measurements served as the reference or accepted standard.

8. The sample size for the training set:

   • Not specified. The document does not provide any details regarding the training data or its size.

9. How the ground truth for the training set was established:

   • Not specified. Since no information on the training set is provided, the method for establishing its ground truth is also unknown.

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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:

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.

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."

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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