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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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Anyview-500R fluoroscopic mobile x-ray system 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.

This device is a mobile x-ray fluoroscopic imaging system used by radiation experts. This device is a fluoroscopic imaging system to visualize human body's anatomical structure using a principle that x-ray qenerates hypophonesis difference when penetrating human body depending on tissue's density and thickness. The device is composed of main body, x-ray generating equipment (x-ray controller, high voltage generator, x-ray tube, motortype collimator), image collecting equipment (Image Intensifier, CCD Camera) and digital imaging system (cart including computer and monitor). The product's arm is mobile and rotatable in X, Y and Z axes, which facilitates use of x-ray in every direction.

ANYVIEW imaging software is a Digital Imaging System (DIS) designed for C-arm, Anyview-500R. ANYVIEW imaging software provides useful functions to manage X-ray images obtained from Anyview 500R C-arm.

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

The provided text describes a 510(k) premarket notification for the "Anyview-500R Fluoroscopic Mobile X-ray System," focusing on its substantial equivalence to a predicate device, KMC-950 (K032761). The document primarily addresses the technical specifications and safety standards rather than detailed acceptance criteria for an AI-powered device or a study proving its performance against such criteria.

Therefore, many of the requested details about acceptance criteria, study design for AI evaluation, expert qualifications, and ground truth are not applicable or not provided in the given text.

Here's an attempt to answer the questions based only on the provided text:

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

The document does not explicitly define "acceptance criteria" in the context of a specific performance threshold for an AI-powered device. Instead, it demonstrates substantial equivalence by comparing the technical characteristics and adherence to safety standards of the new device (Anyview-500R) against a predicate device (KMC-950).

The performance comparison is detailed in tables on pages 6, 7, and 8. The provided text highlights differences in specifications such as Resolution, Output Power, Fluoroscopy Pulsed mode, Radiography mAs range, and Image Intensifier Contrast. However, these are technical specifications, not acceptance criteria for an AI device's clinical performance.

Note: The differences are discussed on page 9, stating that the Anyview-500R has a higher resolution CCD camera (1K x 1K vs 512 x 512) and requires less X-ray source, which leads to lower capacity for the X-ray generator and tube heat storage compared to the predicate device. These differences "do not raise additional risk concerns" and "do not have an effect on safety and effectiveness compared to the predicate device."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document explicitly states: "No clinical data is necessary to evaluate safety or effectiveness for purposes of determining substantial equivalence of the proposed modification. Bench testing was performed to assess the device safety and effectiveness." (Page 10, Section 11).

Therefore, there was no clinical test set, and hence no sample size, data provenance, or other details related to a clinical test set are provided. The evaluation was based on non-clinical (bench) testing.

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)

As per the answer to question 2, no clinical test set was used, and therefore, no experts were utilized for establishing ground truth for a clinical test set.

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

Not applicable, as no clinical test set 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

Not applicable. The device is a fluoroscopic mobile x-ray system, not an AI-assisted diagnostic tool.

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

Not applicable. The device is an X-ray imaging system, not a standalone algorithm.

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

Not applicable, as no clinical studies were performed. The "ground truth" for the device's substantial equivalence was based on its technical specifications, conformance to recognized international electrical and safety standards (e.g., IEC 60601 series, NEMA PS 3.1-3.20, 21 CFR 1020.30-32), and software validation and verification testing (page 10).

8. The sample size for the training set

Not applicable, as this is not an AI/machine learning device. The "training" for the device's development would refer to engineering design and testing, not a dataset in the context of AI.

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

Not applicable, as this is not an AI/machine learning device. The "ground truth" during development would be engineering specifications and compliance with established standards.

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This product, diagnostic X-ray system, is radiation medical equipment used by a qualified / trained physician or technician on both adult and pediatric subjects for taking diagnostic X-rays.
This product is used on hand (wrist), foot (ankle), shoulder, elbow, knee, and other body parts.

This product, portable X-ray generator, is radiation medical equipment which can only be used by professional radiologists. It controls and marks Xray dose within the range of X-ray exposure limited by hardware. Also it uses algorithm of X-ray output for processing and control. This portable Xray generator requires equipment for X-ray images. Small in size, this product is convenient to carry with, and suitable for being moved around. The main body used with a stand. And when attached to a stand, it is easy to adjust positioning for medical imaging.

Here's a breakdown of the acceptance criteria and study information for the EPX-Series Mobile X-ray System, based on the provided document:

This document is a 510(k) premarket notification, which focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device's performance against specific clinical acceptance criteria in the same way a de novo or PMA submission might.

Acceptance Criteria and Reported Device Performance

The core "acceptance criteria" here are based on demonstrating substantial equivalence to the predicate device (PORTA 100HF, K122697) by showing similar or improved technical characteristics and compliance with recognized safety standards. The table below summarizes the comparison presented.

Study Details:

This submission relies on non-clinical testing to demonstrate substantial equivalence, not a clinical study to prove device performance against specific clinical acceptance criteria or human reader improvement.

1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

   • No clinical test set of images/patients is described. The "test set" for this type of submission refers to the physical device and its components undergoing engineering and safety testing.
   • Provenance: The device manufacturer (ECOTRON Co., Ltd.) is located in Seoul, Korea. The testing labs are mentioned as "3rd party testing lab A" and "In-house Test Report A." No further details on geographic location or specific data provenance for the non-clinical tests are provided.
   • Retrospective/Prospective: Not applicable to the non-clinical testing described.

2. 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. As this is a non-clinical performance and safety assessment for substantial equivalence, clinical ground truth established by medical experts for image interpretation is not part of this specific submission. The "ground truth" for the non-clinical tests would be the established engineering and safety standards.

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

   • Not applicable. No clinical test set or subjective assessment requiring adjudication is mentioned.

4. 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 or comparative effectiveness study was performed or cited. This device is a basic X-ray system, not an AI-powered diagnostic tool.

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

   • Not applicable. This is an X-ray hardware system, not an algorithm.

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

   • For the non-clinical testing, the "ground truth" is defined by recognized international and FDA standards such as IEC 60601-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-2-54, IEC 60601-2-28, FDA EPRC Performance Standard 21 CFR 1020.30 and 31, and ISO 14971 (Risk Management).

7. The sample size for the training set

   • Not applicable. This device does not use a training set as it is not an AI/ML device.

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

   • Not applicable.

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