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Xmaru1717 Digital Flat Panel X-Ray Detector is indicated for digital imaging solution designed for general radiographic system for human anatomy. It is intended to replace film or screen based radiographic systems in all general purpose diagnostic procedures. Not to be used for mammography.

Xmaru1717 is the TFT-based Flat Panel X-Ray Detector that keeps this Digitally based World going forward by providing the most important solution converting transmitted X-Ray into Digital Information. Xmaru1717 is a medical image processing unit. Especially, advanced digital imaging process allows considerably efficient diagnosis, all kind of information management, real-time sharing of image information on network. Xmaru1717 is an X-Ray image acquisition device that is based on flat-panel. This device should be integrated with an operating PC and a X-Ray generator. It can do to utilize as digitalizing x-ray images and transfer for radiography diagnostic

The provided text does not contain detailed information about specific acceptance criteria related to device performance (beyond general safety and electromagnetic compatibility) or a study proving it meets those criteria, especially in the context of AI/human-in-the-loop performance. Instead, it describes a medical device, the Xmaru1717 Digital Flat Panel X-Ray Detector, and its 510(k) submission process. The submission focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and general safety and performance standards.

Here's an analysis based on the information available in the text, addressing the requested points where possible, and noting where information is not provided:

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

The document does not provide a table of specific quantitative acceptance criteria for device performance (e.g., spatial resolution, DQE, MTF values) or associated reported performance values. The closest statement regarding performance is:

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

Not applicable. The submission is for a digital X-ray detector, which is a hardware component. There is no mention of a "test set" of patient data in the context of evaluating diagnostic accuracy or AI performance. The performance tests mentioned (EN/IEC 60601-1, EN/IEC 60601-1-2) refer to engineering and safety standards, not clinical data sets.

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

Not applicable. As there's no mention of a clinical "test set" for diagnostic performance or AI evaluation, there's no information about experts establishing ground truth.

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

Not applicable. See point 3.

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. The document presents a 510(k) submission for a digital flat panel X-ray detector. This product is a hardware component for capturing X-ray images, not an AI-powered diagnostic system. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this submission and is not mentioned.

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

No. This device is a hardware component (a digital X-ray detector). It does not contain an "algorithm" in the sense of an AI-based diagnostic tool that would perform standalone interpretations. Its function is to convert X-rays into digital information.

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

Not applicable. Given the device is an X-ray detector, the "ground truth" for its performance would typically relate to engineering specifications and image quality metrics, not clinical outcomes or pathology.

8. The sample size for the training set

Not applicable. This device is a hardware component and does not involve AI algorithms that require a "training set."

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

Not applicable. See point 8.

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The EzSensor is used to collect dental x-rays photons and convert them into electronic impulses that may be stored, viewed and manipulated for diagnostic use by dentists.

The EzSensor is a solid state x-ray imager designed for dental radiographic applications. The EzSensor provides digital image capture for conventional film/screen radiographic dental examinations. The device is used to replace radiographic film/screen systems in general dental diagnostic procedures. The captured digital image is transferred to Personal Computer via USB interface port.

The provided 510(k) summary (K090526) describes a new dental X-ray imager, EzSensor, seeking substantial equivalence to a predicate device, Schick's CDR (K072134). However, the document primarily focuses on demonstrating device characteristics and safety/performance testing in comparison to the predicate, rather than providing details of a clinical study with specific acceptance criteria and outcome data for the EzSensor's diagnostic performance for the purposes of this request.

Therefore, many of the requested sections below cannot be fully populated as the document does not contain the detailed clinical study information.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary does not explicitly state acceptance criteria in terms of diagnostic performance (e.g., sensitivity, specificity, accuracy) for the EzSensor. It focuses on demonstrating substantial equivalence to the predicate device through technical specifications and safety/performance testing.

The document mentions "Electrical, mechanical, environmental safety and performance testing according to standard EN/IEC 60601-1 was performed, and EMC testing was conducted in accordance with standard EN/IEC 60601-1-2(2001). All test results were satisfactory." and "Software testing and validation were done according to written test protocols established before testing was conducted. Test results were reviewed by designated technical professionals before software proceeded to release. Test results support the conclusion that actual device performance satisfies the design intent." However, these refer to technical and safety performance, not diagnostic efficacy.

The comparison table provided in the document focuses on technical specifications between the predicate and proposed device:

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

The document does not describe a clinical test set or data provenance for a diagnostic performance study. The testing mentioned relates to electrical, mechanical, environmental, and software validation.

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

Not applicable, as no diagnostic performance test set is described.

4. Adjudication method for the test set

Not applicable, as no diagnostic performance test set 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 MRMC study is mentioned. The device is an imaging sensor, not an AI-assisted diagnostic tool as understood in current contexts.

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

The device is a digital X-ray sensor, which requires human interpretation. Standalone "algorithm only" performance would not be relevant in the context of this device as described.

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

Not applicable, as no diagnostic performance study is described. The "ground truth" used for technical testing would be established standards and specifications for electrical, mechanical, and software functionality.

8. The sample size for the training set

Not applicable. The device is a hardware sensor. While it involves software, the document does not describe machine learning or AI models that would typically require a "training set" in the diagnostic performance sense. The software validation mentioned refers to standard software engineering practices.

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

Not applicable, for the reasons stated above.

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The Picasso-Duo is a computed tomography x-ray system which is a diagnostic x-ray system intended to produce cross-sectional images(optionally with panoramic) 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.

E-WOO Dental Imaging system Picasso-Duo is a Computed Tomography X-ray System. Computed Tomography (CT) provides valuable 3-D imaging of the dental and maxillofacial structures for diagnosis and treatment planning. Uses of CT imaging include for assessment of impacted teeth, root configurations and mandibular condyle evaluation. This technology allow for 3-D imaging but at lower equipment cost, simpler image acquisition and lower patient radiation dose.

Model Picasso-Duo is diagnostic equipment which consists of panoramic dental x-ray system and computed tomography x-ray system. The panoramic dental x-ray is a system based on digital and computed tomography (CMOS CT Sensor to Capture 3D x-ray Computerized tomogram scanned image)

The provided text is a 510(k) summary for the Picasso-Duo Computed Tomography X-ray System. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, this document does not contain information about specific acceptance criteria, a study proving the device meets those criteria, or performance metrics from such a study.

The summary focuses on regulatory compliance, electrical, mechanical, and environmental safety, and performance testing according to established IEC standards (IEC 60601-1, IEC 60601-1-1, IEC 60601-1-3, IEC 60601-2-7, IEC 60601-2-28, IEC 60601-2-32, IEC 60601-2-44, and IEC 60601-1-2 for EMC). It states that all test results were satisfactory, implying the device meets the safety and performance requirements of these standards.

Without a dedicated study section, specific details regarding acceptance criteria for diagnostic accuracy, sample sizes for test or training sets, ground truth establishment methods, or expert qualifications are not present in this document.

Therefore, I cannot populate the requested table or answer most of the questions as the information is not provided in the input text.

However, based on the information provided, here are the answers I can deduce or explicitly state:

1. Table of acceptance criteria and the reported device performance:

• Acceptance Criteria: Not explicitly stated as specific diagnostic performance metrics (e.g., sensitivity, specificity, accuracy for a particular condition). The implied acceptance criteria are compliance with the referenced IEC safety and performance standards.
• Reported Device Performance: "All test results were satisfactory" for electrical, mechanical, environmental safety, and performance testing according to the specified IEC standards. The device is also stated to provide "high quality digital image" and "A clear Tomography image upto minimum 0.1mm at any directions."

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

• Sample Size: Not specified.
• Data Provenance: Not specified.

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):

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.

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

• Not specified.

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 mention of an MRMC study or AI assistance. This device is a Computed Tomography X-ray system, not an AI-powered diagnostic tool in this context.

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

• Not applicable, as this is a medical imaging device, not a standalone algorithm in the context of diagnostic performance evaluation mentioned in the request.

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

• Not specified. (Likely relies on physical measurements and image quality metrics rather than clinical ground truth for a diagnostic accuracy study, as none is described).

8. The sample size for the training set:

• Not specified. (Not applicable for this type of device submission which doesn't describe an AI training process).

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

• Not specified. (Not applicable).

Summary of what the document DOES state regarding performance/testing:

The device's safety and performance are affirmed by compliance with a series of IEC standards:

• IEC 60601-1 (General requirements for basic safety and essential performance)
• IEC 60601-1-1 (Safety requirements for medical electrical systems)
• IEC 60601-1-3 (General requirements for radiation protection in diagnostic X-ray equipment)
• IEC 60601-2-7 (Particular requirements for the safety of high-voltage generators for diagnostic X-ray equipment)
• IEC 60601-2-28 (Particular requirements for the safety of X-ray source assemblies and X-ray tube assemblies)
• IEC 60601-2-32 (Particular requirements for the safety of associated equipment for X-ray equipment)
• IEC 60601-2-44 (Particular requirements for the safety of X-ray equipment for computed tomography)
• IEC 60601-1-2 (Electromagnetic compatibility - Requirements and tests)

The document asserts that "All test results were satisfactory" for these standards tests. It also mentions features like "high quality digital image" and "A clear Tomography image upto minimum 0.1mm at any directions."

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The PaX-REVE3D 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 device is operated and used by physicians, dentists, and x-ray technologists.

The PaX-REVE3D 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 device is operated and used by physicians, dentists, and x-ray technologists.

The provided document pertains to a 510(k) premarket notification for the PaX-Reve3D, a Computed Tomography X-Ray System for dental use. However, it does not contain information about specific acceptance criteria, a study proving device performance against those criteria, sample sizes for test or training sets, ground truth establishment methods, expert qualifications, adjudication methods, or multi-reader multi-case (MRMC) studies.

The document primarily focuses on:

• Device Identification: Name (PaX-Reve3D), common name, classification, and predicate devices.
• Description: General overview, product features including input conditions, capture modes (Panoramic, Cephalometric, CT), and X-ray generator specifications.
• Intended Use/Indications for Use: Diagnostic imaging for dental examination and diagnosis of diseases of teeth, jaw, and oral structure.
• Comparison to Predicate Devices: Stating substantial equivalence based on intended use, form factor, material, performance, and safety.
• Safety, EMC, and Performance Data: General statement that testing according to relevant EN/IEC standards was performed and results were satisfactory. This is a very high-level statement and does not provide detailed acceptance criteria or study results.
• Conclusion: Claim of safety, effectiveness, and substantial equivalence.
• FDA Clearance Letter: Official communication from the FDA clearing the device for market.

Therefore, based solely on the provided text, I cannot complete the requested tables and information regarding acceptance criteria and performance study details.

The document only states that "Electrical, mechanical, environmental safety and performance testing according to standard EN/IEC 60601-1, EN/IEC 60601-1-3, EN/IEC 60601-2-7, EN/IEC 60601-2-28, EN/IEC 60601-2-32 and EN/IEC 60601-1-44 was performed, and EMC testing was conducted in accordance with a standard EN/IEC 60601-1-2. All test results were satisfactory." This is not specific enough to extract acceptance criteria or performance metrics for image quality or clinical efficacy studies.

To answer your request, detailed performance report documents, which are typically referenced in a 510(k) but not always fully included in the publicly available summary, would be needed.

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The Master3DS is a X-ray, tomography, computed, dental that provides 3D imaging of dental and maxillofacial for diagnosis and treatment planning.

E-WOO Dental Imaging system Master3DS is a Computed Tomography X-ray System. Computed Tomography (CT) provides valuable 3-D imaging of the dental and maxillofacial structures for diagnosis and treatment planning. Uses of CT imaging include for assessment of impacted teeth, root configurations and mandibular condyle evaluation. This technology allow for 3-D imaging but at lower equipment cost, simpler image acquisition and lower patient radiation dose. Model Master3DS is diagnostic equipment which consists of panoramic dental x-ray system and computed tomography x-ray system. The panoramic dental x-ray is a system based on digital and computed tomography (CMOS CT Sensor to Capture 3D x-ray Computerized tomogram scanned image)

The provided 510(k) summary for the E-WOO Dental Imaging system Master3DS does not contain details about specific acceptance criteria, a study proving device performance against those criteria, or most of the requested information about a clinical study.

The submission focuses on establishing substantial equivalence to a predicate device (i-CAT) based on general device features and compliance with electrical, mechanical, and safety standards. It does not provide performance metrics or details of a clinical study designed to demonstrate a given level of diagnostic accuracy or effectiveness.

Therefore, many of the requested fields cannot be populated from the provided text.

Here's a breakdown of what can and cannot be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified.
• Data Provenance: Not specified. The submission does not describe a clinical study with a test set.

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

• Not specified, as no clinical study with a ground truth assessment is described.

4. Adjudication method for the test set

• Not applicable, as no clinical study with a test set requiring adjudication 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, a multi-reader multi-case (MRMC) comparative effectiveness study was not described. The device is a diagnostic imaging system, not an AI-assisted diagnostic tool for human readers in the context of this 510(k).

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

• Not applicable. The device is an imaging system; its performance is inherent in the image quality it produces, not in an algorithm's standalone diagnostic capability in the absence of a human interpreter.

7. The type of ground truth used

• Not specified, as no clinical study requiring a ground truth is described.

8. The sample size for the training set

• Not applicable. This device is an X-ray imaging system, not an AI/machine learning algorithm requiring a "training set" in the conventional sense for diagnostic performance.

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

• Not applicable (see point 8).

Summary of the Study Mentioned (Non-Clinical):

The provided text mentions non-clinical testing to ensure the safety and performance of the Master3DS. This testing included:

• Electrical, mechanical, and environmental safety and performance testing: According to standards EN/IEC 60601-1, EN/IEC 60601-2-7, EN/IEC 60601-2-28, EN/IEC 60601-2-32, and EN/IEC 60601-2-44.
• EMC testing: Conducted in accordance with standard EN/IEC 60601-1-2 (2001).

The conclusion was that "All test results were satisfactory," indicating that the device met the requirements of these engineering and safety standards. This type of testing ensures the device is built safely and functions as intended from an engineering perspective, but it does not evaluate its diagnostic accuracy or clinical effectiveness in a patient population.

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"Picasso-Master also known as ECT and Master3D" is a computed tomography x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. It provides diagnostic details of the anatomic structures for surgical planning of oral and maxillofacial area by acquiring 360° rotational image sequences of the head and neck areas, including the ENT and dentomaxillofacial area. The device is operated and used by physicians, dentists, and x-ray techniciana.

"Picasso-Master also known as ECT and Master3D" is equipped with state-of-the-art CMOS-CT sensor to capture 3D x-ray computerized tomography scanned image. It is capable of real time-image acquisition through an advanced digital imaging process which allows considerably efficient diagnosis, information management, and real-time sharing of image information on network.

Here's a breakdown of the acceptance criteria and the study information for the "Picasso-Master also known as ECT and Master3D" device, based on the provided 510(k) summary:

This device is an X-ray tomography system. As such, acceptance criteria generally focus on demonstrating that the new device functions similarly and produces comparable image quality to a legally marketed predicate device, especially considering the lack of an AI component explicitly described in this document.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state "acceptance criteria" for performance metrics in a quantitative manner. Instead, the demonstration of substantial equivalence relies on showing that the new device has similar design, function, and intended use as the predicate devices, and that it has undergone appropriate testing according to internal company procedures. The "acceptance criteria" here are implicitly linked to demonstrating equivalency in technical specifications and image generation capabilities.

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

The document does not explicitly state the sample size used for a clinical test set in terms of patient cases or images. The testing mentioned refers to "Software testing and validation" and "internal company procedures," which suggests laboratory or engineering testing rather than a clinical trial with a specific test set of patient data.

• Sample Size (Test Set): Not specified.
• Data Provenance: Not specified, but given it's an X-ray imaging system, data would typically be derived from phantom studies, cadaver studies, or potentially a limited number of human scans (though not detailed here). The manufacturer is E-Woo Technology Co., Ltd. from Korea, so if any human data was used, it would likely be from Korea.
• Retrospective/Prospective: Not specified.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

Since this is a 510(k) for an X-ray medical device (hardware and reconstruction software), and not an AI/CADe/CADx system that interprets images, the concept of "ground truth" established by human experts for a "test set" in the context of diagnostic accuracy is not directly applicable in the same way as it would be for an AI algorithm. The device's performance is assessed on its ability to produce images with certain technical specifications and quality, not on its diagnostic interpretation.

• Number of Experts: Not specified, and likely not applicable in the context of establishing ground truth for diagnostic performance of the device itself. Technical professionals would have reviewed test results.
• Qualifications of Experts: "Designated technical professionals" reviewed test results. Specific qualifications not provided.

4. Adjudication Method for the Test Set

Not applicable. There is no mention of an adjudication method as would be used for assessing diagnostic interpretations of images by human readers or AI. The testing described is for the device's technical performance and software validation.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document describes a medical imaging device, not an AI or CAD system that assists human readers. Therefore, there is no mention of human reader improvement with or without AI assistance, or an effect size.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The device itself is a standalone X-ray CT system. Its performance refers to its ability to acquire and reconstruct images, not to an algorithm that provides diagnostic output independent of a human. There is no AI algorithm being described that would have a "standalone performance" in the context of diagnostic decision-making. The device is operated by physicians, dentists, and x-ray technicians.

7. The Type of Ground Truth Used

For a pure imaging device, "ground truth" typically refers to the accuracy of the physical measurements, image quality metrics (e.g., spatial resolution, contrast resolution, noise levels), and geometric accuracy of the reconstructed images against known phantoms or established imaging standards. The document states that "Test results support the conclusion that actual device performance satisfies the design intent," which implies that these types of technical ground truths were used for validation. There is no mention of pathology, outcomes data, or expert consensus on diagnostic findings as ground truth for evaluating the device itself.

8. The Sample Size for the Training Set

Not applicable. This document describes an X-ray CT device, not an AI algorithm that requires a training set of data.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no AI algorithm training set described.

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"AnyRay" is Portable X-Ray System intended to be used by trained dentists and technicians as an extraoral x-ray source for producing diagnostic x-ray images using intraoral image receptors. Its use is intended for both adult and pediatric subjects.

"AnyRay" is a wireless Portable X-Ray System that operates on DC22.5V supplied by a rechargeable Lithum-Polymer battery pack. The X-ray tubehead, X-ray controls and power source are ssembled into a single hand-held enclosure. The Package includes DC adaptor and Chair (Option) This equipment generates and controls X-ray in order to diagnose of tooth and jaw. It is composed of xray generator, controller, beam limiting device and chair (Option). Operating principle is that x-ay generated by high voltage electricity into x-ray tube, which (Openatifs primelpes in this x-ray images on receptor.

Here's a breakdown of the acceptance criteria and the study information based on the provided text for the "AnyRay" Portable X-Ray System:

1. Table of Acceptance Criteria and Reported Device Performance:

The document provided does not specify explicit "acceptance criteria" in terms of performance metrics like accuracy, sensitivity, or specificity for the device itself in producing diagnostic images. Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (NOMAD Dental X-Ray System, K051795) based on technical and safety specifications.

The table below summarizes the key features and performance parameters compared to the predicate device, which implicitly serve as the "acceptance criteria" for demonstrating equivalence in a 510(k) submission of this nature. The "Reported Device Performance" column directly reflects the information provided for the "AnyRay" device.

Study Proving Device Meets Acceptance Criteria:

The provided document describes a 510(k) premarket notification, which is a submission to the FDA to demonstrate substantial equivalence to an existing legally marketed device (the predicate device). It is not a clinical study in the traditional sense designed to prove superior performance or a specific diagnostic accuracy.

The "study" here is essentially the comparative analysis of the technical specifications and safety standards between the "AnyRay" device and its predicate, the NOMAD Dental X-Ray System (K051795). The conclusion states: "E-Woo Technology Co.,Ltd. concludes that the Portable X-Ray System "AnyRay" 's safety and effectiveness are substantially equivalent to predicate devices..." This conclusion is drawn from the detailed technical comparison presented in the table.

Here's an analysis of the requested information based on the 510(k) submission content:

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

• Test Set: There is no "test set" in the context of image data for diagnostic performance evaluation mentioned in this document. The evaluation is based on a comparison of device specifications and adherence to recognized standards.
• Data Provenance: The data provenance is the device specifications provided by the manufacturer, E-Woo Technology Co., Ltd. for the "AnyRay" and specifications of the predicate device (NOMAD).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:

• This information is not applicable to this type of 510(k) submission. There was no diagnostic image-based "ground truth" to be established for a test set by external experts.

4. Adjudication Method for the Test Set:

• This information is not applicable. There was no test set requiring expert 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:

• No, an MRMC comparative effectiveness study was not done. This document pertains to an X-ray device (hardware) and its substantial equivalence in terms of technical specifications and safety, not an AI or software algorithm that assists human readers.

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

• No, a standalone algorithm performance study was not done. This document is for a physical X-ray device, not an algorithm.

7. The Type of Ground Truth Used:

• Not applicable in the context of diagnostic performance. The "ground truth" here is effectively the accepted technical specifications and safety compliance demonstrated by the predicate device and relevant industry standards (e.g., IEC, FDA regulations).

8. The Sample Size for the Training Set:

• Not applicable. There is no "training set" as this is not an AI/machine learning device.

9. How the Ground Truth for the Training Set was Established:

• Not applicable. There is no "training set" for which ground truth would be established.

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EPX-Impla is a computed tomography x-ray system that acquires a 360° rotational sequence of the head and neck areas, including the ENT and dentomaxillofacial area for use in diagnostic support. The device is operated and used by physicians, dentists, and x-ray technologists.

E-Woo Dental Imaging System Model EPX-Impla is a computed tomography x-ray system.

The provided text describes an FDA 510(k) clearance letter for the "E-WOO Dental Imaging System Model EPX Impla." This document is notification of substantial equivalence, not a study report. Therefore, it does not contain the detailed information about acceptance criteria, device performance, study design, or ground truth establishment that would typically be found in a clinical study report or a pre-market approval application (PMA).

The letter indicates that the device has been found substantially equivalent to legally marketed predicate devices, meaning that "the device is at least as safe and effective as the predicate device." However, it does not provide specific performance metrics or the study that demonstrates this.

Therefore, I cannot provide the requested information from the given text. The text does not elaborate on:

1. A table of acceptance criteria and the reported device performance.
2. Sample size used for the test set and data provenance.
3. Number of experts used to establish ground truth and their qualifications.
4. Adjudication method for the test set.
5. Whether an MRMC comparative effectiveness study was done or its effect size.
6. Whether a standalone performance study was done.
7. The type of ground truth used.
8. The sample size for the training set.
9. How the ground truth for the training set was established.

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