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The iDENT-A100 Intraoral video camera of the Confident Technology Inc. is used to provide a view of the mouth in order to assist the dentist in describing dental procedures and to show a patient before and after views of his/her mouth showing the patient results of the dental procedures which the dentist has performed on him/her. These are not intended to aid in dental surgical procedures.

The iDENT-A100 Intraoral Video Camera provides clear, high resolution images of the oral cavity, which can be stored and manipulated in the built digital memory and used for visual communication directly to the patient. The System can capture one full image or can capture four images into one frame and the captured images can be display on a video monitor. The operation of the capturing image can be done by a foot switch or a push button and is very user-friendly. The typical dentist and assistant can use the system with a few minutes training.

A high resolution, true color image is produced on the screen by a rod lens scope design which is the standard in the industry for endoscopic procedures. There is no peripheral distortion of the image. Manual focusing is not required and a single tooth or full arch view can be captured without changing the scope. The unit is easily detached for autoclaving cleaning.

This prompt describes a 510(k) submission for the iDENT-A100 Intraoral Video Camera. Unfortunately, the provided document does not contain information related to specific acceptance criteria, comprehensive device performance data, or a detailed study proving the device meets acceptance criteria.

The document is a 510(k) summary, which focuses on establishing substantial equivalence to predicate devices rather than providing a detailed clinical or performance study report. It states that the device is substantially equivalent because its design, technology, and specifications are comparable to those of already cleared devices.

Therefore, I cannot provide the requested information for the following points as they are not present in the provided text:

1. A table of acceptance criteria and the reported device performance
2. Sample size used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
4. Adjudication method for the test set
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size
6. If a standalone performance (algorithm only) was done
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
8. The sample size for the training set
9. How the ground truth for the training set was established

Summary of available information:

The document primarily focuses on demonstrating substantial equivalence to predicate devices for the purpose of 510(k) clearance. It states:

• Rationale for Substantial Equivalence: "The iDENT-A100 Intraoral Video Camera shares the same indications for use as the predicate devices. Since the design is comparable, technology virtually identical, the specifications very similar."
• Conclusion: "Based on the supportive documentation and descriptions outlined in this premarket notifications-510 (k), we believe that the iDENT-A100 Intraoral video camera is substantially equivalent to those of similar types of products, used for parallel purposes, currently on the market. The iDENT-A100 Intraoral Video Camera was found to be substantially equivalent to the predicate devices."

This indicates that the device was deemed acceptable based on its similarity to existing, legally marketed devices, rather than through a new, independent performance study against specific acceptance criteria.

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