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The DENTIOIII series is intended for dental radiographic examination of the teeth and temporomandibular joints, specifically for panoramic and cephalometric examinations. It is to be used only by dental practitioners and/or radiologists

This equipment is a dental X-ray imaging device used for diagnostic purposes in dental examination. The operating principle of this device is obtaining the panoramic images by rotating the arm to get the recombination data, having the X-ray generator and detector rotate around the patient to irradiate the X-ray, and measuring the penetrated X-ray using the detector. When the X-ray irradiates the teeth area for instance, a large amount of X-ray is attenuated because objects such as bones are highly dense. By contrast, the X-ray permeates more through small molecules with low density such as skin or tissue measuring the X-ray is reconstructed by the software for display and analysis, the anatomical structure can be viewed for the diagnosis purposes. In addition, the Cephalo arm uses the scanning method.

This document is a 510(k) summary for the DENTIOIII series, an Extraoral Source X-Ray System. The summary focuses on establishing substantial equivalence to previously cleared predicate devices, rather than presenting a standalone clinical study to prove new acceptance criteria for an AI/CADe device. Therefore, the information required to directly answer your request about acceptance criteria and study proving device meets those criteria (especially regarding AI performance, human reader improvement, and ground truth establishment methods for large datasets) is not present in this document.

The document primarily addresses the following for comparison with predicate devices:

• Technical characteristics: X-ray tube properties, detector types, pixel size, active area, MTF, DQE, geometry, software, and compliance with electrical safety and radiation protection standards.
• Intended use: Dental radiographic examination of teeth and temporomandibular joints for panoramic and cephalometric images.

However, based on the provided document, here's what can be extracted and inferred, along with explicit statements about missing information for your specific request related to AI/CADe systems:

No AI/CADe Performance Details:
This 510(k) application is for an "Extraoral Source X-Ray System," which is a device for acquiring X-ray images. It is not an AI/CADe device that performs analysis or assists human readers. Therefore, the concepts of "acceptance criteria" and "study proving the device meets acceptance criteria" as they relate to AI/CADe performance (e.g., sensitivity, specificity, human reader improvement, ground truth establishment by experts) are not applicable to this document's content. The "acceptance criteria" discussed implicitly refer to meeting technical specifications and safety standards for an imaging device.

1. A table of acceptance criteria and the reported device performance

The document does not present explicit "acceptance criteria" in the format of pass/fail metrics for a clinical study assessing diagnostic performance of an AI/CADe. Instead, it compares technical specifications of the proposed DENTIOIII series to predicate devices to establish substantial equivalence.

Implicit "Acceptance Criteria" (Technical Specifications for an Imaging Device):

The performance of the device is reported through its technical specifications, compared to predicate devices. These essentially serve as the "performance" data that needs to be "accepted" as substantially equivalent.

2. Sample size used for the test set and the data provenance

• Sample Size for Test Set: Not applicable/Not provided. This document does not describe a clinical study for diagnostic performance with a test set of patient cases. It refers to "Non-clinical performance was conducted for imaging performance... both of the predicate devices and proposed device are based on Csi scintillator designed for general radiography." It also mentions "Clinical images were provided as further [evidence] on addition to the combat system works as intended." However, no specific sample size for "test set" from a retrospective or prospective clinical study is given.
• Data Provenance: The document does not specify the country of origin of any "clinical images" or the nature of their collection (retrospective or prospective). The device manufacturer is HDX WILL CORP. from the REPUBLIC OF KOREA.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable. As this is not an AI/CADe device being evaluated for diagnostic performance, there is no mention of experts establishing ground truth for a test set. The "ground truth" for an X-ray imaging system refers to its ability to produce high-quality images that accurately represent the anatomical structures, which is assessed through technical specifications and image quality metrics (MTF, DQE, resolution).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable. No adjudication method is mentioned as there isn't a diagnostic performance study with multiple readers.

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 such study was done or reported. This device is an X-ray imaging system, not an AI or CADe system for assisting human readers.

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

• No such study was done or reported. This device is an X-ray imaging system, not an algorithm.

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

• Not applicable in the context of diagnostic AI. For an X-ray imaging system, the "ground truth" implicitly refers to the physical reality of the objects being imaged and the accuracy of the image acquisition process. This is assessed through phantom imaging, resolution targets, MTF, DQE, and clinical image review by qualified personnel (dental practitioners/radiologists) to ensure diagnostic utility. The document states: "Performance (Imaging performance) testing was conducted according to standard of IEC 61223-3-4. All test results were satisfactory." and "Non-clinical performance was conducted for imaging performance of the proposed detector in accordance with FDA Guidance 'Guidance for the submissions of 510(k)'s for Solid State X-ray Imaging Devices'. Both of the predicate devices and proposed device are based on Csi scintillator designed for general radiography. MTF (Modulation Transfer Function) and DQE (Detective Quantum Efficiency) were tested and measured by IEC 6220-1."

8. The sample size for the training set

• Not applicable/Not provided. This is an imaging device, not an AI/ML algorithm that requires a training set.

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

• Not applicable/Not provided. No training set for an AI/ML algorithm is discussed.

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