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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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