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The Varex Nexus DR Digital X-ray Imaging System is a high resolution digital imaging system intended to replace conventional film techniques, or existing digital systems, in multipurpose or dedicated applications specified below. The Nexus DR Digital X-ray Imaging System enables an operator to acquire, display, process, export images to portable media, send images over a network for long term storage and distribute hard-copy images with a laser printer. Image processing algorithms enable the operator to bring out diagnostic details difficult to see using conventional imaging techniques. Images can be stored locally for temporary storage. The major system components include an image receptor, computer, monitor and imaging software.

The Varex Nexus DR Digital X-ray Imaging System is intended for use in general radiographic examinations and applications (excluding fluoroscopy, angiography, and mammography).

The Nexus DR™ Digital X-ray Imaging System (with vSharp™) is a high resolution digital imaging system designed for digital X-ray imaging through the use of an X-ray detector. Nexus DR™ Digital Xray Imaging System (with vSharp™) is designed to support general radiographic (excluding fluoroscopy, angiography, and mammography) procedures through a single common imaging platform.

The modified device consists of an X-ray imaging receptor, computer, monitor, and the digital imaging software and the optional vSharp software.

The Nexus DR™ Digital X-ray Imaging System (with vSharp™) is a configurable product platform designed to allow Varex to leverage the common components of digital X-ray imaging systems from which the following medical modalities can be served: General Radiography (excluding fluoroscopy, angiography, and mammography). Nexus DR™ Digital X-ray Imaging System (with vSharp™) is then configured to function on a computer with modality specific components, functionality and capabilities to complete the specific product package.

Like the predicate device, the modified Nexus DR™ Digital X-ray Imaging System (with vSharp™) is in a class of devices that all use similar technology to acquire digital radiographic images. These devices convert X-rays into visible light that shines onto a TFT array, which converts the visible light into a digital electronic signal. This process is ultimately used for the same purpose as Radiographic film, to create an X-ray image.

Identical to the predicate device, the modified device is capable of interfacing with flat panel detectors in v Trigger Mode or RAD Mode utilizing an external I/O box to interface with compatible X-ray generators, in non-integrated mode. The modified device also retains the ability to apply the grid suppression feature.

Similar to the already cleared Nexus DR™ Digital X-ray Imaging System with Integrated Generator the modified device, Nexus DR™ Digital X-ray Imaging System (with vSharp™), has the same intended use for the DR application. The modified device, however, adds vSharp™ scatter correction algorithm into the Nexus DR Software, the image contrast is enhanced and the images produced have similar detail contrast as images acquired with an anti-scatter grid. The Nexus DR Digital X-ray Imaging System can then store the images on the local computer, archive them to CD/DVD media, transfer them to Hard Copy format via DICOM printers, or transfer them to PACS reviewing stations in DICOM format.

The provided text does not contain detailed information about acceptance criteria and the study that proves the device meets those criteria for the Nexus DR Digital X-Ray Imaging System with vSharp. It mentions "Validation was completed in accordance with the Validation Protocols included with this submission" and "Protocols were designed, executed and documented according to the Design Validation process with predetermined test methods and corresponding acceptance criteria. In conclusion, all release criteria have been met". However, specifics of these protocols, test methods, and the actual performance results against acceptance criteria are not provided.

The document states:

• "No clinical testing was performed as a result of this modification."
• "However, both Usability Testing and Image Comparisons were performed and the results can be found in VOL 018 Appendix R Clinical Data." (This Appendix R is not provided in the input text.)

Therefore, I cannot extract the requested information regarding detailed acceptance criteria, device performance, sample sizes, expert involvement, or grand truth establishment directly from the provided text.

Based on the available information, I can only state that while the document claims acceptance criteria were met and validation was performed, the specifics of these items are not detailed within the provided pages.

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The Varex Nexus DR Digital X-ray Imaging System is a high resolution digital imaging system intended to replace conventional film techniques, or existing digital systems, in multipurpose or dedicated applications specified below. The Nexus DR Digital X-ray Imaging System enables an operator to acquire, display, process, export images to portable media, send images over a network for long term storage and distribute hard-copy images with a laser printer. Image processing algorithms enable the operator to bring out diagnostic details difficult to see using conventional imaging techniques. Images can be stored locally for temporary storage. The major system components include an image receptor, computer, monitor and imaging software.

The Varex Nexus DR Digital X-ray Imaging System is intended for use in general radiographic examinations and applications (excluding fluoroscopy, angiography, and mammography).

The Varex Nexus DR. Digital X-ray Imaging System is a high resolution digital imaging system designed for digital X-ray imaging through the use of an X-ray detector. The Nexus DR. Digital X-ray Imaging System is designed to support general radiographic (excluding fluoroscopy, angiography, and mammography) procedures through a single common imaging platform.

The modified device consists of an X-ray imaging receptor, computer, monitor, and the digital imaging software and the optional Integrated Generator GUI software.

The Varex Nexus DR. Digital X-ray Imaging System is a configurable product platform designed to allow Varex to leverage the common components of digital X-ray imaging systems from which the following medical modalities can be served: General Radiography (excluding fluoroscopy, angiography, and mammography). The Nexus DR. Digital X-ray Imaging System is then configured to function on a computer with modality specific components, functionality and capabilities to complete the specific product package.

Like the predicate device, the modified Nexus DR. Digital X-ray Imaging System is in a class of devices that all use similar technology to acquire digital radiographic images. These devices convert X-rays into visible light that shines onto a TFT array, which converts the visible light into a digital electronic signal. This process is ultimately used for the same purpose as Radiographic film, to create an X-ray image.

Identical to the predicate device, the modified device is capable of interfacing with flat panel detectors in RAD Mode without utilizing an external I/O box to interface with the X-ray generator. The modified device also retains the ability to apply the grid suppression feature.

Similar to the already cleared Nexus DR™ Digital X-ray Imaging System with Stitching and CPI Rad Vision the modified device, Nexus DR™ Digital X-ray Imaging System (with Integrated Generator), has the same intended use for the DR application. The modified device, however, has the ability to allow the operator to control the CPI CMP200 X-ray generator through the Nexus DR™ Graphical User Interface (GUI). All control functions currently available to the operator on the CPI Membrane Rad Console will be available via the Nexus DR GUI. The Nexus DR Digital X-ray Imaging System can then store the images on the local computer, archive them to CD/DVD media, transfer them to Hard Copy format via DICOM printers, or transfer them to PACS reviewing stations in DICOM format.

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document describes non-clinical verification and validation testing, but it does not specify quantitative acceptance criteria in a table format with corresponding reported performance metrics. Instead, it states that "All associated tests described above completed successfully without errors and the both devices preformed as intended. In conclusion, all release criteria have been met..."

However, based on the description of the testing, we can infer the types of acceptance criteria that would have been used:

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

• Sample Size: The document does not specify a numerical sample size for the test set used in the non-clinical verification and validation testing. It mentions "simulated (bench test) clinical environment" and "standard clinical workflow" without detailing the number of test cases or scenarios.
• Data Provenance: The testing was conducted in a "simulated (bench test) clinical environment." This indicates the data was not from actual patient data but rather from controlled, simulated scenarios. The country of origin is not explicitly stated beyond Varex Imaging Corporation being in Liverpool, NY, USA, which implies the testing was likely conducted in the USA. The testing was prospective in the sense that it was specifically designed and executed for the purpose of validating the device's integrated generator feature.

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

The document does not mention the use of experts to establish ground truth for the test set. The validation appears to be functional and workflow-based rather than diagnostic performance-based, meaning the "ground truth" was likely defined by the expected functional behavior and correct display/control outcomes as per the design requirements.

4. Adjudication Method for the Test Set

No explicit adjudication method is mentioned. Given that the testing focused on functional verification and workflow validation in a simulated environment, adjudication by subject matter experts (like radiologists for diagnostic decisions) would not be applicable in the way it is for diagnostic AI performance studies. The tests were designed with "predetermined test methods and corresponding acceptance criteria," suggesting an objective pass/fail determination based on those criteria.

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 explicitly states: "No clinical testing was performed as a result of this modification." Therefore, no MRMC study, or any clinical comparative effectiveness study involving human readers or AI assistance effect size, was conducted or reported.

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

No, this device is an X-ray imaging system with an integrated generator. It is a hardware and software system designed to acquire and process radiographic images, not a standalone AI algorithm for interpretation or diagnosis. The "algorithm" here refers to image processing algorithms within the system, but their performance isn't evaluated as a standalone AI diagnostic tool. The focus is on the system's functional equivalence and safety/effectiveness in acquiring and displaying images.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical verification and validation testing was based on design requirements and expected functional behavior. For example, the ground truth for "initial generator settings" would be the correct settings as defined by the system's design and user input, not a clinical diagnosis or pathology.

8. The Sample Size for the Training Set

Not applicable. This document describes the testing and clearance of an X-ray imaging system with an integrated generator, not an AI/machine learning model that requires a training set. The "image processing algorithms" are likely deterministic or rule-based, not AI trained on large datasets.

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

Not applicable for the same reason as point 8.

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The Varex Nexus DR Digital X-ray Imaging System is a high resolution digital imaging system intended to replace conventional film techniques, or existing digital systems, in multipurpose or dedicated applications specified below. The Nexus DR Digital X-ray Imaging System enables an operator to acquire, display, process, export images to portable media, send images over a network for long term storage and distribute hardcopy images with a laser printer. Image processing algorithms enable the operator to bring out diagnostic details difficult to see using conventional imaging techniques. Images can be stored locally for temporary storage. The major system components include an image receptor, computer, monitor and imaging software.

The Varex Nexus DR Digital X-ray Imaging System is intended for use in general radiographic examinations and applications (excluding fluoroscopy, angiography, and mammography).

The Varex DRTM Digital X-ray Imaging System is a high resolution digital imaging system designed for digital X-ray imaging through the use of an X-ray detector. The DR-m Digital X-ray Imaging System is designed to support general radiographic (excluding fluoroscopy, angiography, and mammography) procedures through a single common imaging platform.

The modified device consists of an X-ray imaging receptor, computer, monitor, and the digital imaging software and the optional Stitching software.

The Varex DR™ Digital X-ray Imaging System is a configurable product platform designed to allow Varex to leverage the common components of digital X-ray imaging systems from which the following medical modalities can be served: General Radiography (excluding fluoroscopy, angiography, and mammography). The DR™ Digital X-ray Imaging System is then configured to function on a computer with modality specific components, functionality and capabilities to complete the specific product package.

Like the predicate device, the modified DR™ Digital X-ray Imaging System is in a class of devices that all use similar technology to acquire digital radiographic images. These devices convert X-rays into visible light that shines onto a TFT array, which converts the visible light into a digital electronic signal. This process is ultimately used for the same purpose as Radiographic film, to create an X-ray image.

Identical to the predicate device, the modified device is capable of interfacing with flat panel detectors in vTrigger Mode or RAD Mode utilizing an external I/O box to interface with compatible X-ray generators, in non-integrated mode. The modified device also retains the ability to apply the grid suppression feature.

However, the modified device allows the operator to generate sequential radiographic images and electronically join them to create a single electronic image (a leg from hip to foot, for example). Stitching is a post-processing feature that allows the user to merge up to four (4) DICOM images and does not alter the original images. Using a digital flat panel detector, and a non-integrated generator, the Nexus DR Digital X-ray Imaging System (with Stitching) is capable of acquiring multiple digital radiographic images, processing and then displaying them in a high quality single image format to visualize long bones or other anatomical features such as the spine. The Nexus DR Digital X-ray Imaging System can then store the images on the local computer, archive them to CD/DVD media, transfer them to Hard Copy format via DICOM printers, or transfer them to PACS reviewing stations in DICOM format.

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly list quantitative acceptance criteria in a dedicated table format with corresponding reported device performance for the stitching feature. Instead, the document focuses on demonstrating substantial equivalence through a comparison of technological characteristics and a subjective image comparison study.

However, based on the non-clinical and clinical test discussions, we can infer the acceptance criterion to be:

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

• Sample Size: The document states "Previously acquired sequential radiographic images." No specific number or range of images (sample size) is provided for the test set.
• Data Provenance: The images were "Previously acquired sequential radiographic images from the Reference Predicate Device (InfiStitch for i5™ Digital X-Ray Imaging System)." This indicates the data is retrospective, as it was collected prior to the study for the subject device. The country of origin is not specified, but the predicate device's information (K101833) would likely originate from the US given the submission to the FDA.

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

The document does not provide details on the number of experts or their qualifications used to establish ground truth for the test set. It only mentions an "image comparison study performed."

4. Adjudication Method for the Test Set

The adjudication method used is not specified. It only states an "image comparison study performed."

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly stated or implied. The study described is an "image comparison study" to demonstrate substantial equivalence to a reference predicate device, not a comparison of human readers with and without AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, the "image comparison study" and "bench testing results" described for the stitching feature appear to be a standalone performance evaluation of the algorithm's ability to stitch images, rather than involving human-in-the-loop performance measurement. The critical aspect is the quality and diagnostic utility of the stitched image itself, which is then compared (presumably by experts) to existing stitched images from a predicate device.

7. The Type of Ground Truth Used

The ground truth for the image comparison study was based on previously acquired sequential radiographic images from a legally marketed reference predicate device (InfiStitch for i5™ Digital X-Ray Imaging System). This implies that the accepted output of the predicate device serves as the "ground truth" or standard for comparison against the subject device's stitched images.

8. The Sample Size for the Training Set

The document does not provide any information regarding a training set or its sample size. This is a 510(k) submission for a device incorporating a known function (stitching) onto a new system, not a de novo submission for a novel AI algorithm requiring extensive training data. The stitching logic itself is likely rule-based or uses established image processing techniques rather than machine learning that necessitates a training set.

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

As no training set is mentioned (see point 8), there is no information on how its ground truth was established.

Ask a specific question about this device

The Varex Nexus DR™ Digital X-ray Imaging System is a high resolution digital imaging system intended to replace conventional film techniques, or existing digital systems, in multipurpose or dedicated applications specified below. The Nexus DR™ Digital X-ray Imaging System enables an operator to acquire, display, process, export images to portable media, send images over a network for long term storage and distribute hardcopy images with a laser printer. Image processing algorithms enable the operator to bring out diagnostic details difficult to see using conventional imaging techniques. Images can be stored locally for temporary storage. The major system components include an image receptor, computer, monitor and imaging software.

The Varex Nexus DR™ Digital X-ray Imaging System is intended for use in general radiographic examinations and applications (excluding fluoroscopy, angiography, and mammography).

The Varex Nexus DR™ Digital X-ray Imaging System is a high resolution digital imaging system designed for digital X-ray imaging through the use of an X-ray detector. The Nexus DR™ Digital X-ray Imaging System is designed to support general radiographic (excluding fluoroscopy, angiography, and mammography) procedures through a single common imaging platform.

The modified device consists of an X-ray imaging receptor, PaxScan 4343RC or PaxScan 4343Rv3, computer, monitor, and the digital imaging software.

The Varex Nexus DR™ Digital X-ray Imaging System is a configurable product platform designed to allow Varex to leverage the common components of digital X-ray imaging systems from which the following medical modalities can be served: General Radiography (excluding fluoroscopy, angiography, and mammography). The Nexus DR™ Digital X-ray Imaging System is then configured to function on a computer with modality specific components, functionality and capabilities to complete the specific product package.

Like the predicate device, the modified Nexus DRTM Digital X-ray Imaging System is in a class of devices that all use similar technology to acquire digital radiographic images. These devices convert X-rays into visible light that shines onto a TFT array, which converts the visible light into a digital electronic signal. This process is ultimately used for the same purpose as Radiographic film, to create an X-ray image.

Identical to the predicate device, the modified device is capable of interfacing with a PaxScan flat panel detector in vTrigger Mode or RAD Mode utilizing an external I/O box to interface with compatible X-ray generators, in non-integrated mode. The modified device also retains the ability to apply the grid suppression feature.

However, the modified device is capable of interfacing with the Varex PaxScan 4343RC and PaxScan 4343Rv3 detectors. The main difference between the additional detector models is mechanical; the PaxScan 4343RC is a cassette-sized portable tethered version whereas the PaxScan 4343v3 is utilized in a fixed configuration. Through the use of a digital flat panel detector, and a non-integrated generator, the Nexus DR™ Digital X-ray Imaging System (with PaxScan 4343RC and PaxScan 4343Rv3) is capable of acquiring digital radiographic images, processing and then displaying them in high quality for clinical diagnosis. The Nexus DR™ Digital X-ray Imaging System can then store the images on the local computer, archive them to CD/DVD media, transfer them to Hard Copy format via DICOM printers, or transfer them to PACS reviewing stations in DICOM format.

The provided text describes the Varex Nexus DR Digital X-ray Imaging System, which is a digital X-ray imaging system. The submission is for a modified device that interfaces with additional PaxScan detectors compared to the predicate device.

Here's an analysis of the acceptance criteria and study information based on the provided text:

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

The document presents a comparison chart of technological characteristics between the predicate device and the subject device. It doesn't explicitly state "acceptance criteria" in a pass/fail format but rather shows comparative performance metrics, with the implication that "Same" indicates meeting the expectation for substantial equivalence.

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: "Clinical images were not necessary to establish substantial equivalence based on the modifications to the device (the PaxScan 4343RC and PaxScan 4343Rv3 Flat Panel Detectors use identical technology as the predicate device image detector), and bench testing results provide enough evidence that the subject device works as intended."

This indicates that no clinical test set using patient data was employed for this particular submission. The evaluation was based on non-clinical (bench) testing. Therefore, information on sample size, country of origin, or retrospective/prospective nature of a clinical test set is not applicable.

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)

Since no clinical test set was used, there were no experts involved in establishing ground truth for a clinical test set. The evaluation primarily relied on engineering and performance metrics from bench testing.

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

Not applicable, as no clinical test set was utilized.

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 an X-ray imaging system, not an AI-based diagnostic tool for interpretation assistance, and no MRMC study was conducted.

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

Not applicable. The device is a digital X-ray imaging system; it is not an algorithm for standalone diagnostic performance.

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

For the non-clinical tests, the ground truth was based on engineering specifications, physical measurements, and industry standards (e.g., lp/mm for spatial resolution, QVAL for uniformity, DQE values).

8. The sample size for the training set

Not applicable. The device is a medical imaging hardware system with associated software, not a machine learning algorithm that requires a training set of images in the typical sense. The software aspects would have undergone verification and validation testing, but not "training" with a dataset as an AI algorithm would.

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

Not applicable, as there was no training set for a machine learning model.

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The Varex Nexus DR™ Digital X-ray Imaging System is a high resolution digital imaging system intended to replace conventional film techniques, or existing digital systems, in multipurpose or dedicated applications specified below. The Nexus DR™ Digital X-ray Imaging System enables an operator to acquire, display, process, export images to portable media, send images over a network for long term storage and distribute hardcopy images with a laser printer. Image processing algorithms enable the operator to bring out diagnostic details difficult to see using conventional imaging techniques. Images can be stored locally for temporary storage. The major system components include an image receptor, computer, monitor and imaging software.

The Varex Nexus DR™ Digital X-ray Imaging System is intended for use in general radiographic examinations and applications (excluding fluoroscopy, angiography, and mammography).

The Varex Nexus DR™ Digital X-ray Imaging System is a high resolution digital imaging system designed for digital X-ray imaging through the use of an X-ray detector. The Nexus DR™ Digital X-ray Imaging System is designed to support general radiographic (excluding fluoroscopy, angiography, and mammography) procedures through a single common imaging platform.

The modified device consists of an X-ray imaging receptor. Varian PaxScan 4336Wv4, computer, monitor, and the digital imaging software.

The Varex Nexus DR™ Digital X-ray Imaging System is a configurable product platform designed to allow Varex to leverage the common components of digital X-ray imaging systems from which the following medical modalities can be served: General Radiography (excluding fluoroscopy, angiography, and mammography). The Nexus DR™ Digital X-ray Imaging System is then configured to function on a computer with modality specific components, functionality and capabilities to complete the specific product package.

Like the predicate device, the modified Nexus DR™ Digital X-ray Imaging System is in a class of devices that all use similar technology to acquire digital radiographic images. These devices convert X-rays into visible light that shines onto a TFT array, which converts the visible light into a digital electronic signal. This process is ultimately used for the same purpose as Radiographic film, to create an X-ray image.

Identical to the predicate device, the modified device is capable of interfacing with the same wireless PaxScan 4336Wv4 flat panel detector in vTrigger Mode.

However, the modified device is also capable of operating in RAD Mode utilizing an external I/O box to interface with compatible X-ray generators, in non-integrated mode. Through the use of a digital flat panel detector, and a non-integrated generator, the Nexus DR™ Digital X-ray Imaging System (with Grid Suppression) is capable of acquiring digital radiographic images, processing and then displaying them in high quality for clinical diagnosis. The Nexus DR™ Digital X-ray Imaging System can then store the images on the local computer, archive them to CD/DVD media, transfer them to Hard Copy format via DICOM printers, or transfer them to PACS reviewing stations in DICOM format.

Anti-scatter grids play an important role for enhancing image quality in radiography by transmitting a majority of primary radiation and selectively rejecting scattered radiation. When anti-scatter grids are utilized by the end user, the modified device includes an additional feature that can detect and suppress the line artifacts caused by these grids.

This FDA 510(k) K171138 submission describes the Varex Nexus DR™ Digital X-ray Imaging System, specifically focusing on the addition of a 'Grid Suppression' feature. The submission aims to demonstrate substantial equivalence to a previously cleared device (K161459).

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily focuses on demonstrating that the new feature (Grid Suppression) does not negatively impact the existing performance characteristics and that the device remains substantially equivalent to its predicate. Therefore, the "acceptance criteria" discussed are largely qualitative and related to maintaining equivalence rather than new quantitative performance metrics for the grid suppression itself.

The acceptance criteria throughout the document for the new Grid Suppression feature and RAD Mode are primarily based on maintaining the existing safety and effectiveness and image quality characteristics of the predicate device, while the new features perform their intended function (e.g., suppressing grid lines, interfacing with generators). The study relies on non-clinical bench testing to demonstrate this.

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

The document states: "Non-clinical Data submitted is consistent with FDA guidance document... Validation was completed in accordance with the Validation Protocols included with this submission. Protocols were designed, executed and documented according to the Design Validation process with predetermined test methods and corresponding acceptance criteria."

• Sample Size: Not explicitly stated for specific tests. The validation likely involved a sufficient number of test cases and images to demonstrate the functionality and non-degradation of image quality due to the new features. Given it's non-clinical, controlled test images/data would have been used.
• Data Provenance: The data is generated from non-clinical bench testing and validation. It is prospective in the sense that the testing was performed specifically for this submission. The country of origin of the data is not specified but is presumed to be from Varex Imaging Corporation's testing facilities.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

• Not Applicable. This submission relies on non-clinical testing and benchmarking against the predicate device's established performance metrics. Clinical images and expert review for ground truth are explicitly stated as not necessary to establish substantial equivalence for the modifications.

4. Adjudication Method for the Test Set:

• Not Applicable. Since clinical experts were not used to establish ground truth for this non-clinical submission, no adjudication method was employed.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No. An MRMC study was not conducted. The document explicitly states: "Clinical images were not necessary to establish substantial equivalence based on the modifications to the device (the PaxScan 4336Wv4 Flat Panel Detector uses identical technology as the predicate device image detector), and bench testing results provide enough evidence that the subject device works as intended."
• Effect Size: Not applicable as no such study was performed.

6. Standalone (Algorithm Only) Performance:

• Yes, implicitly. The grid suppression feature is described as "an intuitive software algorithm to detect and suppress the line artifacts caused by anti-scatter grids." The validation testing, being non-clinical, would have assessed the performance of this algorithm in a standalone manner (i.e., algorithm only without human-in-the-loop performance evaluation) to confirm its effectiveness in suppressing grid lines without introducing new artifacts or degrading image quality. The performance metrics listed (spatial resolution, SNR, MTF, DQE maintain "Same") indicate that the overall system performance, even with the new algorithm, remained consistent with the predicate.

7. Type of Ground Truth Used:

• Benchmarking/Predicate Device Equivalence (established performance metrics). For the core imaging performance metrics (Spatial Resolution, SNR, MTF, DQE, etc.), the ground truth is the established performance of the predicate device, which the modified device is shown to match. For the new grid suppression feature, the "ground truth" would be the successful removal of grid artifacts from test images while preserving diagnostic quality, as determined by technical validation protocols.

8. Sample Size for the Training Set:

• Not explicitly stated. The document refers to "an intuitive software algorithm" for grid suppression. For such an algorithm, a training set would likely be used during its development. However, the specific size of this training set is not disclosed in the provided FDA summary.

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

• Not explicitly stated in the provided document. If machine learning was involved in developing the "intuitive software algorithm" for grid suppression, the training set ground truth would typically be established by presenting the algorithm with a dataset of images, some with grid artifacts and some without, and potentially images where the presence/absence of grid lines and their characteristics have been manually labeled or synthetically generated. This is standard algorithm development practice, but the specifics are not detailed in this 510(k) summary.

Ask a specific question about this device

The Varian Nexus DR™ Digital X-ray Imaging System is a high resolution digital imaging system intended to replace conventional film techniques, or existing digital systems, in multipurpose or dedicated applications specified below. The Nexus DR™ Digital X-ray Imaging System enables an operator to acquire, display, process, export images to portable media, send images over a network for long term storage and distribute hardcopy images with a laser printer. I mage processing algorithms enable the operator to bring out diagnostic details difficult to see using conventional imaging techniques. Images can be stored locally for temporary storage. The major system components include an image receptor, computer, monitor and imaging software.

The Varian Nexus DR™ Digital X-ray Imaging System is intended for use in general radiographic examinations and applications (excluding fluoroscopy, angiography, and mammography).

The Varian Nexus DR™ Digital X-ray Imaging System is a high resolution digital imaging system designed for digital X-ray imaging through the use of an X-ray detector. The Varian Nexus DR™ Digital X-ray Imaging System is designed to support general radiographic (excluding fluoroscopy, angiography, and mammography) procedures through a single common imaging platform.

The modified device consists of an X-ray imaging receptor, Varian PaxScan 4336Wv4, computer, monitor, and the digital imaging software.

The provided document is a 510(k) premarket notification for the Nexus DR 100 Digital X-ray Imaging System (with PaxScan 4336Wv4). It focuses on establishing substantial equivalence to existing predicate devices.

Based on the provided text, the document primarily discusses non-clinical testing and general validation, rather than a specific study designed to meet predetermined acceptance criteria for a new AI or diagnostic algorithm's performance. The information requested in the prompt is highly relevant for studies proving the performance of AI/CADe/CADx devices. This submission, however, is for a digital X-ray imaging system, which is a hardware and software system for image acquisition and display, and not explicitly an AI-driven diagnostic tool in the sense of the prompt's questions.

Therefore, many of the questions regarding specific acceptance criteria for diagnostic performance, sample sizes for test sets, experts for ground truth, adjudication methods, MRMC studies, and training set details are not fully addressable from this document as it does not describe such a study for the device's diagnostic performance.

However, I can extract information related to the technological characteristics comparison which serves as a form of "acceptance criteria" for substantial equivalence.

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

For this 510(k) submission, "acceptance criteria" are not framed in terms of diagnostic performance metrics like sensitivity or specificity for a specific condition. Instead, the device's performance is compared against predicate devices based on technological characteristics and physical image quality parameters to demonstrate substantial equivalence. The "acceptance" is that these characteristics are equivalent or better than the predicates.

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 primarily describes non-clinical tests and a technological characteristics comparison to establish substantial equivalence. It refers to "Validation Protocols" and "predetermined test methods and corresponding acceptance criteria" but does not detail a specific "test set" of clinical images or patients in the sense of a diagnostic performance study. The data presented is characteristic measurements of the detector and system, not image data from patients for a diagnostic evaluation.

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

Not applicable. The document does not describe a clinical study where experts established ground truth for diagnostic decisions.

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

Not applicable. This type of adjudication method is used in diagnostic performance studies, which are not detailed in this submission.

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. This submission is for a digital X-ray imaging system, not an AI-assisted diagnostic device, and thus no MRMC study for AI assistance is described.

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

Not applicable, as this device is an imaging system and not primarily a standalone diagnostic algorithm.

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

Not applicable in the context of a diagnostic performance study. The "ground truth" for the non-clinical tests would be the measured physical properties of the system and detector according to standard testing methodologies (e.g., those detailed in the referenced FDA guidance for solid-state X-ray imaging devices).

8. The sample size for the training set

Not applicable. The document does not describe an AI/ML component with a "training set" for diagnostic performance. The device involves image processing algorithms, but these are typically deterministic or rule-based for image enhancement, not machine learning algorithms trained on large datasets for diagnostic classification.

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

Not applicable, as there is no mention of a training set for a diagnostic AI/ML algorithm.

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The InfiMed i?™ Digital X-ray Imaging System is a high resolution digital imaging system intended to replace conventional film techniques, or existing digital systems, in multipurpose or dedicated applications specified below. The i-TM Digital X-ray Imaging System enables an operator to acquire, display, process, export images to portable media, send images over a network for long term storage and distribute hardcopy images with a laser printer. Image processing algorithms enable the operator to bring out diagnostic details difficult to see using conventional imaging techniques. Images can be stored locally for temporary storage. The i Digital X-ray Imaging System has the ability to interface with a variety of image receptors from CCD cameras to commercially available flat panel detectors. The major system components include an image receptor, computer, monitor and imaging software.

For the DR application, the InfiMed is TM Digital X-ray Imaging System is intended for use in general radiographic examinations and applications (excluding fluoroscopy, angiography, and mammography).

For the RF/DSA application, the InfiMed i2m Digital X-ray Imaging System is intended for use where general fluoroscopy, interventional fluoroscopy or angiography imaging procedures are performed.

The InfiMed if TM Digital X-ray Imaging System is a high resolution digital imaging system designed for digital X-ray imaging through the use of an X-ray detector. The InfiMed i " Digital X-ray Imaging System is designed to support general radiography (excluding mammography), fluoroscopy, interventional fluoroscopy or angiography imaging procedures through a single common imaging platform.

The modified InfiMed i TM Digital X-ray Imaging System consists of an X-ray imaging receptor (any of the following: CCD Camera, Trixell Pixium 3543, Trixell Pixium 4600, Varian PaxScan 4336R, Varian PaxScan 4343R, Carestream Health Detector, Samsung LTX240AA01-A, Toshiba FDX 4343R, Trixell Pixium RF4343. Varian PaxScan 4343CB), computer, monitor, and the digital imaging system.

The provided text describes a 510(k) submission for the Varian Medical Systems Nexus DRF Digital X-ray Imaging System (with PaxScan 4343CB). This submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study proving the device meets specific performance acceptance criteria in terms of diagnostic accuracy or impact on human readers.

Here's a breakdown of the requested information based on the provided text, along with notes on what is not present:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states that "Validation was completed in accordance with the Validation Protocols included with this submission" and that "Protocols were designed, executed and documented according to the Design Validation process with predetermined test methods and corresponding acceptance criteria." However, the specific acceptance criteria and quantitative results of these validation protocols are not provided in the summary. The acceptance criteria above are implied from the statements about "substantial equivalence."

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

The document does not provide details about a specific "test set" in the context of a clinical performance study with human readers or diagnostic accuracy. It mentions "Clinical Data submitted is consistent with FDA guidance document 'Guidance for Industry and/or for FDA Reviewers/Staff and/or Compliance: Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices'." This suggests that any clinical data submitted would be in line with general requirements for imaging devices, but specific details about a test set, sample size, or data provenance (e.g., country of origin, retrospective/prospective) are not included in this summary.

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 in the document. The submission focuses on demonstrating technical equivalence and safety/effectiveness relative to a predicate, not on a new clinical study involving expert interpretation for ground truth establishment.

4. Adjudication method for the test set

This information is not provided in the document.

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

There is no indication that an MRMC comparative effectiveness study was done, especially one involving "AI assistance." The device is described as a "Digital X-ray Imaging System," and the "Image processing algorithms enable the operator to bring out diagnostic details difficult to see using conventional imaging techniques." This refers to standard image processing, not necessarily AI in the modern sense, and no comparative effectiveness study results are given.

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

There is no indication that a standalone algorithm performance study was conducted or reported in this summary. The device is an imaging system, not a diagnostic AI algorithm in itself.

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

The document does not specify the type of ground truth used for any clinical performance evaluation. Given the nature of a 510(k) for an imaging system upgrade (adding a new receptor), the clinical data likely involves demonstrating image quality and diagnostic utility in comparison to the predicate, rather than establishing new ground truth for specific pathologies.

8. The sample size for the training set

This information is not provided in the document. The device is an imaging system, and while it has image processing algorithms, the concept of a "training set" in the context of modern machine learning algorithms used for diagnostic purposes is not explicitly discussed or applicable here.

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

This information is not provided in the document, and the concept of a training set ground truth is not applicable given the details provided.

In summary:

This 510(k) summary is primarily focused on demonstrating substantial equivalence of a modified digital X-ray imaging system to an existing predicate device, largely based on technological characteristics and the claim of equivalent or better image quality. It does not contain the detailed clinical study information (sample sizes, expert qualifications, ground truth methods, MRMC studies, or AI performance metrics) that would be expected for a submission involving a novel diagnostic AI algorithm or a device requiring new clinical performance claims beyond equivalence to a predicate. The "clinical data" referenced is likely related to general image quality and functional performance as per the FDA guidance for solid-state X-ray imaging devices, rather than a specific study comparing diagnostic accuracy.

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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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The InfiMed i*™ Digital X-ray Imaging System is a high resolution digital imaging system intended to replace conventional film techniques, or existing digital systems, in multipurpose or dedicated applications specified below. The iSm Digital X-78V Imaging System enables an operator to acquire, display, process, export images to portable media, send images over a network for long term storage and distribute hardcopy images with a laser printer. Image processing algorithms enable the operator to bring out diagnostic details difficult to see using conventional imaging techniques. Images can be stored locally for temporary storage. The ism Digital X-ray Imaging System has the ability to interface with a variety of image receptors from CCD cameras to commercially available flat panel detectors. The major system components include an image receptor, computer, monitor and imaging software.

For the DR application, the InfiMed i *** Digital X-ray Imaging System is intended for use in general radiographic examinations and applications (excluding fluorosopy, angiography, and mammography).

For the RF/DSA application, the InfiMed if TM Digital X-ray Imaging System is intended for use where general fluoroscopy, interventional fluoroscopy or anglography imaging procedures are performed.

The InfiMed i*™ Digital X-ray Imaging System is a high resolution digital imaging system designed for digital X-ray imaging through the use of an X-ray detector. The InfiMed i-TM Digital X-ray Imaging System is designed to support general radiography (excluding mammography), fluoroscopy, interventional fluoroscopy or angiography imaging procedures through a single common imaging platform.

The modified InfiMed i'm Digital X-ray Imaging System consists of an X-ray imaging receptor (any of the following: CCD Camera, Trixell Pixium 3543, Trixell Pixium 4600, Varian PaxScan 4336R, Varian PaxScan 4343R, Carestream Health Detector, Samsung LTX240AA01-A, Toshiba FDX 4343R, DRTECH FLAATZ 560, Samsung SDX-4336CP), computer, monitor, and the digital imaging system.

I am sorry, but the provided text does not contain the detailed information necessary to complete the acceptance criteria table or answer most of the questions about the study.

The document discusses validation tests and states that "all release criteria have been met," but it does not provide the specific acceptance criteria or the reported device performance metrics. It also mentions "Clinical Data submitted is consistent with FDA guidance document...," but it does not describe the actual clinical study design, sample sizes, ground truth establishment, or expert involvement.

Therefore, I cannot fulfill your request for this specific document.

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The InfiMed i5TM Digital X-ray Imaging System is a high resolution digital imaging system intended to replace conventional film techniques, or existing digital systems, in multipurpose or dedicated applications specified below. The i5TM Digital X-ray Imaging System enables an operator to acquire, display, process, export images to portable media, send images over a network for long term storage and distribute hardcopy images with a laser printer. Image processing algorithms enable the operator to bring out diagnostic details difficult to see using conventional imaging techniques. Images can be stored locally for temporary storage. The i5TM Digital X-ray Imaging System has the ability to interface with a variety of image receptors from CCD cameras to commercially available flat panel detectors. The major system components include an image receptor, computer, monitor and imaging software.

For the DR application, the InfiMed i5TM Digital X-ray Imaging System is intended for use in general radiographic examinations and applications (excluding fluoroscopy, angiography, and mammography).

For the RF/DSA application, the InfiMed i5TM Digital X-ray Imaging System is intended for use where general fluoroscopy, interventional fluoroscopy or angiography imaging procedures are performed.

The InfiMed i5TM Digital X-ray Imaging System is a high resolution digital imaging system designed for digital X-ray imaging through the use of an X-ray detector. The InfiMed i5TM Digital X-ray Imaging System is designed to support general radiography (excluding mammography), fluoroscopy, interventional fluoroscopy or angiography imaging procedures through a single common imaging platform.

The modified InfiMed i5TM Digital X-ray Imaging System consists of an X-ray imaging receptor (any of the following: CCD Camera, Trixell Pixium 3543, Trixell Pixium 4600, Varian PaxScan 4336R, Varian PaxScan 4343R, Carestream Health Detector, Samsung LTX240AA01-A, Toshiba FDX 4343R, DRTECH FLAATZ 560), computer, monitor, and the digital imaging system.

This document is a 510(k) premarket notification for the InfiMed i5TM Digital X-ray Imaging System (with FLAATZ 560). It asserts substantial equivalence to a predicate device (InfiStitch for i5TM, K101833) and does not contain detailed acceptance criteria and performance data for a standalone or comparative effectiveness study.

Here's what can be extracted and what is explicitly not available based on the provided text:

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

This information is not provided in the document. The text states: "Validation was completed in accordance with the Validation Protocols included with this submission. Protocols were designed, executed and documented according to the Design Validation process with predetermined test methods and corresponding acceptance criteria. In conclusion, all release criteria have been met and the modified i5TM Digital X-ray Imaging System is as safe and effective as the predicate device." However, the specific acceptance criteria and the quantitative or qualitative results of the device performance against those criteria are not detailed.

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

This information is not provided. The document makes a general statement about "Clinical Data submitted" being consistent with FDA guidance, but does not specify the sample size, provenance, or whether the data was retrospective or prospective.

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 information is not provided. The document does not describe the establishment of a ground truth with experts. Since this is a 510(k) submission primarily focused on substantial equivalence to a predicate device rather than a de novo clinical trial, such detailed expert review might not have been a primary component of the submission described here.

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

This information is not provided. As no details about expert review or ground truth establishment are given, adjudication methods are also absent.

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:

This information is not provided. The document describes the device as a "high resolution digital imaging system" and mentions "Image processing algorithms enable the operator to bring out diagnostic details difficult to see using conventional imaging techniques," but it does not present itself as an AI-assisted diagnostic tool for which an MRMC study demonstrating improvement with AI would be conducted. The focus is on replacing conventional film techniques or existing digital systems and achieving equivalent or better image quality than the predicate device.

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

This information is not explicitly stated or detailed. The document refers to "Validation Protocols" and "release criteria" being met, suggesting some form of internal testing. However, it does not delineate specific standalone performance metrics for an algorithm without human intervention, especially not in the context of diagnostic accuracy. The device is described as an "imaging system" where an "operator" acquires, displays, and processes images.

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

This information is not provided. The document refers to "Clinical Data" but does not specify how the ground truth for that data (if any was used for specific performance evaluation) was established.

8. The sample size for the training set:

This information is not provided. The document does not describe the use of a "training set" in the context of machine learning model development. The "Image processing algorithms" mentioned are likely traditional image processing techniques rather than contemporary machine learning algorithms that require large training sets.

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

This information is not provided, as there is no mention of a training set or its ground truth.

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