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Indicated for acquisition, storage, display, and manipulation of Dental Images
Acquiring and handling of radiographs and color images
Viewing and manipulation for insurance claims adjudication
Viewing and manipulation for diagnostic purposes
Viewing for patient education and consultation including cosmetic imaging.

Intended uses in the dental industry include the following:
Acquiring and handling of radiographs and color images:
Viewing and manipulation for insurance claims adjudication
Viewing and manipulation for diagnostic purposes
Viewing for patient education and consultation including cosmetic imaging.

This document, K012439, describes the "DentalEye 2, Dental Image Management System," which is a dental image management system. This device is indicated for acquisition, storage, display, and manipulation of dental images for various purposes including diagnostic purposes. However, the provided text does not contain a study or data proving the device meets specific acceptance criteria in the way a clinical study would typically demonstrate. Instead, it relies on substantial equivalence to a predicate device and internal software testing.

Here's an analysis of the provided information, addressing your points where possible:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria or a "reported device performance" in terms of clinical accuracy (e.g., sensitivity, specificity, AUC) for diagnostic purposes. The acceptance criteria implied here are related to software functionality and conformity with internal protocols, not clinical performance metrics.

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

This information is not provided in the document. The text mentions "software testing and validation were done according to internal company protocols," but does not specify the type of data (dental images), the number of cases, or the origin (country, retrospective/prospective) of any test data used.

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

This information is not provided. Since the testing described is primarily software validation and not a clinical performance study, there's no mention of experts or ground truth establishment in this context.

4. Adjudication Method

This information is not provided.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A MRMC comparative effectiveness study was not done or is not reported in this document. The submission focuses on substantial equivalence and software validation, not a comparison of human reader performance with and without AI assistance.

6. Standalone Performance

A standalone performance study (i.e., algorithm only without human-in-the-loop performance evaluation in a clinical context) was not done or is not reported. The device is an "Image Management System," implying human interaction is central to its intended use for diagnostic purposes. The testing described is software validation.

7. Type of Ground Truth Used

The type of ground truth is not mentioned. Given the nature of the device (image management) and the described testing (software validation), the "ground truth" for the software testing would likely be adherence to functional requirements and expected software behavior, not clinical diagnostic truth.

8. Sample Size for the Training Set

This information is not provided. The device seems to be a software system without an explicit "training set" in the machine learning sense. The "training" for the software would be its development and coding based on established specifications.

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

This information is not provided. Again, the concept of a "training set" with established ground truth as in AI/ML is not applicable to the description of this device and its validation in the provided text. The "ground truth" for the software development would be its design specifications and functional requirements.

In summary, the provided document K012439 describes the "DentalEye 2" Dental Image Management System as substantially equivalent to a predicate device (TAU TigerView, K955237). The "study" proving the device meets acceptance criteria primarily refers to internal software testing and validation protocols. It does not contain information on clinical performance metrics, sample sizes of images (beyond general software testing), expert involvement in ground truth establishment, or any comparative effectiveness studies typically associated with AI-driven diagnostic devices.

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