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The DT-703 is a portable dental X-ray system that captures radiographic images for dental diagnosis using intraoral imaging sensors. Only trained and qualified dental practitioner or radiologist shall use DT-703 to diagnose and treat diseases related to the teeth, jaws, and/or other oral structures in adults and children.

DT-703 is a handheld X-ray system powered by a rechargeable Li-ion polymer battery pack. DT-703 is an extra source X-ray generating device that is mainly designed for dental examination (on teeth, etc.). DT-703 is composed of X-ray generator with X-ray tube including device controller, power controller, user interface, beam limiting part, backscatter shielding glass, and optional remote exposure switch. DT-703 is designed to diagnose teeth and jaw through X-ray irradiation using an intra-oral image receptor. DT-703 is controlled by software (firmware) and the software level of concern is Moderate. The x-ray image detector (an integral part of a complete dental diagnostic system) is not part of the DT-703 X-ray device.

The provided text describes a 510(k) premarket notification for the DT-703 dental X-ray system. It details the device's characteristics, intended use, and comparison to a predicate device (KaVo NOMAD Pro 2). However, it explicitly states:

"Clinical data is not needed to characterize performance and establish substantial equivalence. The non-clinical test data characterize all performance aspects of the device based on well-established scientific and engineering principles. Clinical testing has not been conducted on this product."

Therefore, I cannot provide information on acceptance criteria and a study that proves the device meets clinical acceptance criteria, a multi-reader multi-case (MRMC) study, or standalone performance, because no clinical studies were performed. The submission relies solely on non-clinical (engineering and safety) testing and comparison to a predicate device.

Here's a breakdown of what can be extracted or inferred based on the provided text, while acknowledging the explicit lack of clinical performance data:

Clinical Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

The document explicitly states that "Clinical testing has not been conducted on this product." Therefore, there are no acceptance criteria related to clinical performance, nor any clinical study to prove the device meets such criteria.

The substantial equivalence determination for this device (DT-703) is based on non-clinical test data that characterize performance, and a comparison of its technological characteristics, intended use, and principle of operation to a legally marketed predicate device (KaVo NOMAD Pro 2).

Non-Clinical Acceptance Criteria and Supporting Information

While no clinical acceptance criteria or studies are presented, the submission implies acceptance criteria based on compliance with various electrical, safety, and electromagnetic compatibility (EMC) standards.

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

2. Sample sized used for the test set and the data provenance:

• Sample Size: The document does not specify sample sizes for individual non-clinical tests (e.g., how many units were subjected to electrical safety testing). The assumption is that standard engineering testing practices were followed, which typically involve a limited number of test units to demonstrate compliance with standards.
• Data Provenance: The testing was "performed in accordance with the following international standards." This indicates the tests were likely conducted in a controlled laboratory environment, presumably by or for the manufacturer (ECOTRON Co., Ltd, based in South Korea) or a certified testing body. The data is non-clinical, related to product design and safety specifications.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

• This question is not applicable as the document explicitly states "Clinical testing has not been conducted on this product" and relies on non-clinical data. Therefore, no medical experts (like radiologists) were involved in establishing "ground truth" for a test set in the conventional sense of a clinical study. The "ground truth" for non-clinical testing refers to compliance with established engineering and safety standards.

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

• This question is not applicable as clinical testing, which would involve reader adjudication, was not performed.

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 study was done. The device (DT-703) is a conventional dental X-ray system, not an AI-powered image analysis tool. The submission 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:

• No standalone performance study was done in the context of an algorithm or AI. The device is a hardware X-ray system. The "performance" assessment refers to its compliance with safety and electrical standards, not the diagnostic accuracy of an algorithm.

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

• For the non-clinical tests, the "ground truth" is defined by the specifications within the international standards (e.g., acceptable leakage current, proper radiation shielding, electromagnetic compatibility limits, battery performance). The device either meets these predefined technical criteria or it does not. There is no biological or diagnostic "ground truth" involved.

8. The sample size for the training set:

• This question is not applicable. The device is a hardware X-ray system, not an AI/ML algorithm that requires a training set.

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

• This question is not applicable as no training set for an AI/ML algorithm was used.

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The ANY VIEW DR SERIES (Anyviw-500DR, Anyview-240DR) is radiation medical equipment only used by professional radiologists. This product is designed to provide fluoroscopic and spot film images of the patient during diagnostic and interventional procedures.

This system can be applied in emergency room, operation room, cast room or etc. of hospital.

The ANYVIEW DR SERIES (Anyviw-500DR, Anyview-320DR, Anyview-240DR) are mobile x-ray fluoroscopic imaging systems used by radiation experts. ANYVIEW DR SERIES are a digital fluoroscopic imaging systems with Flat Panel Detector (FPD) used in diagnostic and interventional procedures. ANYVIEW DR SERIES are composed of C-arm, x-ray generating equipment (x-ray controller, high voltage generator, x-ray tube, motor-type collimator), FPD, and workstation (console computer and monitor).

ANYVIEW imaging software is a Digital Imaging System (DIS) designed for C-arm, ANYVIEW FPD Fluoroscopic Mobile X-ray System. ANYVIEW imaging software provides useful functions to manage X-ray images obtained from ANYVIEW DR SERIES FPD Fluoroscopic Mobile X-ray System.

ANYVIEW imaging software provides various image tools. One of the most noticeable features is that the C-arm imaqes taken during an exam are stored in the database for further review. I Image data is integrated with the patient information in DICOM(OPTION) compatible format which allows compatibility with existing DICOM and PACS system.

The ECOTRON Co., Ltd. ANYVIEW DR SERIES FPD Fluoroscopic Mobile C-Arm (ANYVIEW-240DR, ANYVIEW-320DR, ANYVIEW-500DR) is a radiation medical equipment designed to provide fluoroscopic and spot film images for diagnostic and interventional procedures. The device was found to be substantially equivalent to its predicate device, Anyview-500R Fluoroscopic Mobile X-ray System (K160279), based on non-clinical performance data.

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document does not explicitly state formal "acceptance criteria" in a go/no-go format for performance metrics. Instead, it presents a comparison of technical characteristics and performance data of the subject device against its predicate and reference devices, demonstrating equivalent or improved performance without raising new safety or effectiveness concerns.

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

• Test Set: The study primarily relies on bench testing and comparative performance data of components (specifically the Flat Panel Detector, FPD) for non-clinical evaluation. There is no mention of a traditional "test set" of patient images.
• Data Provenance: The data provenance for the performance characteristics (MTF, DQE, Spatial Resolution) of the detectors is from the respective manufacturers (VIEWORKS for Subject Device, TOSHIBA for Predicate Device, and Thales for Reference Device). This is non-clinical, technical performance data. The document does not specify country of origin for this component-level data, nor whether it is retrospective or prospective, though it is typically collected during product development/testing by the manufacturer.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

Not applicable. The study is a 510(k) submission for substantial equivalence based on technical and performance characteristics of medical hardware, not on clinical image interpretation or diagnostic accuracy by experts. No ground truth was established by human experts for a test set of images.

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

Not applicable, as no test set requiring expert adjudication was used.

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 device described is an X-ray imaging system, not an AI-powered image analysis tool.

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

Not applicable. The device is an imaging system, not an algorithm, and its performance evaluation does not involve standalone algorithm assessment.

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

Not applicable. The equivalence is established through engineering and technical performance comparisons of the device and its key components against predicate and reference devices, not against clinical ground truth. Performance metrics like MTF, DQE, and spatial resolution are derived from physical measurements and scientific testing of the imaging system and its components.

8. The sample size for the training set:

Not applicable. This is a medical device for imaging acquisition, not a machine learning or AI algorithm, so there is no concept of a "training set."

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

Not applicable.

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