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The NAOMI-DPX D100 is indicated for use in acquiring Panoramic radiographic images at the dento-maxillofacial region. The image generated is displayed on a computer monitor. It is intended to replace radiographic film/screen system in dental diagnostic procedures

The NAOMI-DPX-D100 provided digital image capture for conventional film/screen systems. It is intended to replace the radiographic film/screen systems.

The x-ray photons incident to the NAOMI-DPX-D100 are detected and converted into the light photons at the scintillator. The light photons are detected and converted into the electrical signal at the CCD. NAOMI-DPX software captures and displays the image.

The provided text does not contain information about acceptance criteria and a study proving the device meets those criteria. The document is a 510(k) summary for a Digital X-Ray Imaging System (NAOMI-DPX-D100), primarily focusing on its general information, device description, indications for use, and a comparison to predicate devices to establish substantial equivalence.

Specifically, the document states:

• Comparison to predicate: "The performance data demonstrate that NAOMI-DPX-D100 is as safe and effective as the predicate devices (CDR-PAN MODEL4700, Signet DXIS and DIGIPAN DPI)."
• Conclusion: "It is opinion of RF Co.,Ltd. strongly believe that the NAOMI-DPX-D100 described in this submission is substantially equivalence to predicate device (NAOMI)."

This indicates that the device's performance was compared to predicate devices for substantial equivalence, but it does not detail specific acceptance criteria, the study design, or the results that would allow for filling out the requested table and answering the subsequent questions. The document mainly highlights that the device is intended to replace conventional film/screen systems and its specifications are "the same or better than NAOMI" (a previous version from the same manufacturer).

Therefore, I cannot provide the requested information.

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Digital X-ray Imaging System, DRC-1000, is intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, extremities, and other body parts. Not to be used for fluoroscopy, angiography, or screening mammography. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position.

DRC-1000 is a digital diagnostic x-ray system which consists of Solid State Xray Imager (Flat Panel), tube-collimator assembly mounted on a U-Arm, generator and operation control unit. DRC-1000 is designed for adult and pediatric subjects for taking diagnostic exposures of the skull, spinal column, chest, extremities and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position.

The provided 510(k) summary for the DRC-1000 Digital X-ray Imaging System does not contain information about specific acceptance criteria or a dedicated study proving the device meets particular clinical performance criteria.

This 510(k) submission focuses on demonstrating substantial equivalence to a predicate device (Sedecal X-Plus LP Plus Digital) primarily based on technical specifications and adherence to electrical, mechanical, environmental safety, and EMC standards.

Therefore, many of the requested details cannot be extracted from the provided text.

Here is a summary of what can be inferred or explicitly stated from the document:

1. Table of Acceptance Criteria and Reported Device Performance:

• No specific clinical acceptance criteria (e.g., sensitivity, specificity, image quality metrics) are provided in the document.
• The device performance is described in terms of its ability to meet safety and electrical standards rather than clinical diagnostic performance.

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

• Not specified. The document does not describe a clinical test set or data involving patient images for performance evaluation. The "test results" mentioned pertain to engineering and safety standards.

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

• Not applicable. No clinical ground truth establishment is described.

4. Adjudication method for the test set:

• Not applicable. No clinical test set or adjudication process is described.

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. This is a traditional X-ray system, not an AI-assisted diagnostic device. Therefore, no MRMC study or AI-related effectiveness is discussed.

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

• Not applicable. This is a hardware device; "standalone algorithm performance" is not relevant here.

7. The type of ground truth used:

• Not applicable for clinical performance. The "ground truth" for the reported tests would be adherence to the specifications of the mentioned IEC standards (e.g., electrical parameters, radiation output, mechanical stability).

8. The sample size for the training set:

• Not applicable. This is not an AI/machine learning device that would require a "training set."

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

• Not applicable. As above, no training set is relevant.

In summary: The provided 510(k) summary demonstrates substantial equivalence for the DRC-1000 by

1. Comparing its general description and indications for use to a legally marketed predicate device.
2. Stating successful completion of various electrical, mechanical, environmental safety, performance, and EMC standard tests (IEC 60601 series).

It does not include any information regarding clinical performance studies, such as those involving image analysis, diagnostic accuracy, or reader performance, which would typically involve specific acceptance criteria, test sets, expert readers, and ground truth establishment. This is common for traditional imaging hardware where regulatory clearance hinges on safety, basic performance, and equivalence to existing technology, rather than novel clinical diagnostic claims.

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PaX-Primo is a digital panoramic dental X-ray imaging system that uses a CMOS detector for a real time digital image acquisition. It is intended for producing diagnostic X-ray radiographic images of skull, dentition, and oral smictures of the patient population targeting men. women and children. The device is operated and used by physicians. dentists and X-ray technologists.

PaX-Primo diagnostic equipment is a dental panoramic X-ray system which consists of X-ray generator, X-ray controller, X-ray beam limiting device, image process unit and exposure switch. This device utilizes a high voltage generator to generate X-ray by inputting energy to the anode and the cathode. The X-ray is exposed on the oral maxillofacial area of a patient before reaching CMOS digital sensor. The CMOS sensor converts resulting X-ray into clectrical charge. The clectrical pattern is further converted to voltage and a digital signal which is interpreted by a computer to produce a digital image.

Based on the provided text, the device in question is the Vatech Co., Ltd. PaX-Primo, a digital panoramic dental X-ray imaging system. The submission focuses on demonstrating substantial equivalence to a predicate device (PaX-P&P) rather than establishing novel performance criteria through extensive clinical studies.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not present explicit acceptance criteria in the form of numerical thresholds for clinical performance metrics (e.g., sensitivity, specificity, accuracy). Instead, the acceptance is based on demonstrating substantial equivalence to a predicate device. Therefore, the "acceptance criteria" are implied to be the characteristics of the predicate device, and the "reported device performance" are the corresponding characteristics of the PaX-Primo, showing them to be "the same" or "similar."

Study Proving Acceptance Criteria:

The study that proves the device meets the acceptance criteria is primarily a substantial equivalence comparison to the predicate device, supplemented by non-clinical testing for safety and performance standards.

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

The document does not specify any clinical test set for evaluating the PaX-Primo's performance against specific diagnostic criteria or a ground truth. The acceptance is based on engineering specifications and comparison to the predicate.
The document mentions "Non-clinical & Clinical considerations according to FDA Guidance for the Submissions of 510(k)'s for Solid State X-ray Imaging Devices" was performed, but no details on specific clinical data, sample size, or provenance of such data are provided. This typically means the reliance is on the equivalence of technical specifications rather than new clinical trials.

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

This information is not provided as there is no described clinical test set with a ground truth established by experts.

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

This information is not provided as there is no described clinical test set requiring adjudication.

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:

An MRMC study was not conducted and is not mentioned in the provided text. The device is a digital X-ray imaging system, not an AI-assisted diagnostic tool.

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

This is not applicable. The device is an X-ray imaging system, not an algorithm, and its output is intended for human interpretation. No standalone algorithm performance is discussed.

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

This information is not provided as there is no described clinical test set with a ground truth. The "ground truth" for the device's acceptability is essentially its technical specifications matching or being equivalent to those of the predicate device, as well as meeting relevant safety standards.

8. The sample size for the training set:

This information is not provided. The device is a hardware imaging system. If any internal calibration or image processing algorithms were developed, details about their training sets are not included here. Given the 2010 submission date, sophisticated deep learning models requiring large training sets were less common for this type of device.

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

This information is not provided as there is no described training set.

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The PaX-Uni3D is a computed tomography x-ray system which is a diagnostic x-ray system intended to produce panoramic, cephalometric and cross-sectional images for dental examination and diagnosis of diseases of the teeth, jaw and oral structure by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles.

The PaX-Uni3D diagnostic equipment consists of Digital Computed Tomography, Panoramic, and Cephalometric dental X-ray system. This device is a system based on Digital X-ray Imaging System (Computed Tomography Sensor to Capture X-ray Digital Computed Tomogram Scanned Image)

The provided document is a 510(k) summary for a dental X-ray imaging system (PaX-Uni3D). It describes the device, its intended use, and its comparison to a predicate device. However, it does not contain any information about acceptance criteria or a study proving the device meets specific performance criteria related to AI or algorithm performance.

The safety and effectiveness data mentioned in section 8 refers to compliance with electrical, mechanical, environmental, and EMC standards (IEC 60601 series). This is standard for medical devices but does not involve AI performance evaluation.

Therefore, I cannot provide the requested table and study details as the information is not present in the provided text. The document focuses on showing substantial equivalence to a predicate device based on general safety and performance standards for an imaging system, not on the performance of a diagnostic algorithm or AI.

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The CXD-DR80D Digital X-ray Imaging System is indicated for use in generating radiographic images of human anatomy. This device is not intended for mammographic applications.

The CXD-DR80D Digital X-ray Imaging System utilizes the FLAATZ 750 Detector, manufactured by DRTECH Co. (K080064)

The digital X-ray imaging system consists of a high voltage (HV) generator, a tube support unit, an X-ray beam limiting device, a wall stand unit, a bucky table unit, a detector, operating software, and a tube, operates on a high-frequency inverter method, and is primarily used in a hospital for diagnosis of diseases in skeletal, respiratory and urinary systems.

The provided text is a 510(k) summary for a Digital X-ray Imaging System, CXD-DR80D. It describes the device, its intended use, and its substantial equivalence to predicate devices based on safety, EMC, and performance data.

However, it does not contain any information about acceptance criteria, detailed device performance metrics, or study designs that would typically involve sample sizes, ground truth establishment, expert adjudication, or comparative effectiveness studies (MRMC or standalone algorithm performance).

The summary primarily focuses on:

• Device Description: What the X-ray system is and how it works.
• Predicate Devices: Identifying similar devices already cleared by the FDA.
• Safety and Performance Testing: Stating that electrical, mechanical, environmental safety, and EMC testing were performed according to a list of EN/IEC standards and that results were satisfactory. This is a general statement about compliance with established standards, not a specific performance study with acceptance criteria.
• Indications for Use: What the device is approved for (generating radiographic images of human anatomy, not mammographic applications).

Therefore, based solely on the provided text, I cannot complete a table of acceptance criteria and reported device performance or describe a study that proves the device meets those criteria, as this information is not present. The document focuses on regulatory compliance through substantial equivalence to existing devices, primarily by meeting safety and EMC standards.

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