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EzDent-i is dental imaging software that is intended to provide diagnostic tools for maxillofacial radiographic imaging. These tools are available to view and interpret a series of DICOM compliant dental radiology images and are meant to be used by trained medical professionals such as radiologist and dentist.

EzDent-i is intended for use as software to acquire, view, save 2D image files, and load DICOM project files from panorama, cephalometric, and intra-oral imaging equipment.

EzDent-i is a device that provides various features to acquire, transfer, edit, display, store, and perform digital processing of medical images. EzDent-i is a patient & image management software specifically for digital dental radiography. It also provides server/client model so that the users upload and download clinical diagnostic images and patient information from any workstations in the network environment.

EzDent-i supports general image formats such as JPG and BMP for 2D image viewing as well as DICOM format. For 3D image management, it provides uploading and downloading support for dental CT Images in DICOM format. It interfaces with a 3D imaging software made by our company, the Ez3D-i (K131616, K150761, K161246) but the EzDent-i itself does not view, transfer or process 3D radiographs.

EzDent-i supports the acquisition of dental images by interfacing with OpenCV library to import the intra-oral camera images. It also supports the acquisition of CT/Panoramic/Cephalo/Intra-Oral Sensor images by interfacing with X-ray capture software.

EzDent-i makes it easier to diagnose and analyze 2D dental images with simple and convenient user interface. EzDent-i's main functions are;

• Easy and convenient data search function for patient information and clinical images
• Various image viewing format for 2D dental images
• Various image processing functions including adjustment of brightness and contrast for images
• Measurement function of length and angle for 2D images
• Dental implant simulation for treatment planning and effective patient consultation
• Crown simulation for more effective patient consultation
• Print function supporting various viewing output format

The provided text describes a 510(k) premarket notification for a dental imaging software called EzDent-i (also referred to as E2 and ProraView). The primary purpose of this submission is to demonstrate substantial equivalence to a legally marketed predicate device. As such, the document focuses on comparing the new device to the predicate device rather than detailing specific performance studies with acceptance criteria for diagnostic accuracy.

Therefore, based on the provided text, I cannot provide a table of acceptance criteria and reported device performance related to diagnostic accuracy because such information is not present. The document focuses on performance related to functionality and reliability of the software.

Here's an analysis addressing the other points based only on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

As noted above, the provided text does not contain specific acceptance criteria or reported device performance metrics related to diagnostic accuracy (e.g., sensitivity, specificity, AUC) for the EzDent-i software. The document states:

"Verification, validation and testing activities were conducted to establish the performance, functionality and reliability characteristics of the modified devices. The device passed all of the tests based on pre-determined Pass/Fail criteria."

This indicates that internal performance tests were conducted for functionality and reliability, and the device met its own pre-determined pass/fail criteria for these aspects. However, further details on these criteria or the results are not provided.

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

The document does not specify any sample size used for a test set (in the context of evaluating diagnostic performance) or the data provenance (e.g., country of origin, retrospective/prospective). The testing mentioned refers to "performance, functionality and reliability characteristics" of the software itself.

3. Number of Experts Used to Establish Ground Truth and Qualifications

The document does not mention the use of experts to establish a ground truth for any diagnostic performance test set. The software is described as providing "diagnostic tools," but its own diagnostic accuracy is not explicitly evaluated in the provided text.

4. Adjudication Method

No adjudication method is mentioned, as there is no described diagnostic performance study involving human readers or expert panels.

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

A multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned. The document focuses on the software's features and its substantial equivalence to a predicate device, not on how human readers perform with or without AI assistance.

6. Standalone (Algorithm Only) Performance Study

A standalone performance study for the algorithm's diagnostic accuracy is not mentioned. The "performance data" refers to the verification, validation, and testing of the software's functionality and reliability.

7. Type of Ground Truth Used

No type of ground truth (e.g., expert consensus, pathology, outcomes data) is mentioned, as no diagnostic performance study is described. The "ground truth" for the software's own functionality and reliability would relate to its adherence to design specifications.

8. Sample Size for the Training Set

No sample size for a training set (relevant for machine learning algorithms) is mentioned. The description of the device's technological characteristics does not indicate the use of AI/machine learning that requires a training set in the typical sense. It describes features like "image processing functions including adjustment of brightness and contrast" and "measurement function of length and angle," which are generally rule-based or conventional image processing techniques, not typically requiring large training datasets for their core function.

9. How Ground Truth for Training Set Was Established

Since no training set is mentioned, the method for establishing its ground truth is also not described.

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