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The System is intended for use in Radiographic / Fluoroscopic applications including general radiographic / fluoroscopic diagnostic, and interventional X-Ray imaging for General and Pediatric Populations.

The Soteria E-View system is classified as an interventional fluoroscopic X-ray system. The fundamental performance characteristics of the Soteria E-View interventional fluoroscopic X-ray system consists of:

• The patient table and C- arm with X-ray source on one side and the flat panel detector on the opposite side. The C-arm can be angulated in both planes, and the flat panel detector can be lifted vertically. The tabletop can be shifted from side to side and move forward/backward by an operator.
• Real-time image visualization of patient anatomy during procedures.
• Imaging techniques and tools to assist interventional procedures.
• . Post-processing functions after interventional procedures.
• Storage of reference/control images for patient records.
• Compatibility to images of other modalities via DICOM.
• . Built-in radiation safety controls-with the already FDA cleared CA-100S /FluoroShield (K182834).
  This array of functions provides the physician with the imaging information required to achieve minimally invasive interventional procedures.
  The Soteria E-View system is available as a Model GI-100 configuration. It is similar to the currently marketed predicate Soteria.Al consisting of an X-ray generator, image processor, collimator, X-ray Tube, Positioner, and patient table with CA-100S / FluoroShield Accessory, (K212336).

This document describes the Omega Medical Imaging, LLC Soteria E-View (K242488) system, which is a fluoroscopic/radiographic X-ray system. The submission aims to demonstrate substantial equivalence to its predicate device, the Soteria.AI (K212336).

The provided text details the device's technical specifications and comparisons to the predicate, as well as adherence to various safety standards and guidance documents. However, it does not contain information regarding specific acceptance criteria, corresponding device performance data, or detailed study results (including sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance studies).

The document primarily focuses on demonstrating substantial equivalence through:

• Indications for Use: The Soteria E-View has similar indications, but with cardiac and vascular applications removed and gastrointestinal/ERCP applications added.
• Technological Characteristics: Changes include an updated flat panel detector (Varex Azure 3131Z CXP Detector with IGZO technology) with improved specifications like resolution and MTF, a different X-ray generator, positioner configuration, power supplies, control buttons, actuators, table size, and power unit.
• Non-Clinical Performance: States that non-clinical and "Sample clinical images" were used to validate image performance and demonstrate conformance to intended use, claims, user, and service needs. It also mentions software verification testing for functional requirements, performance, reliability, and safety.
• Safety and Effectiveness: Asserts that the differences do not raise new safety or effectiveness concerns, and the device complies with relevant 21 CFR regulations and international safety standards.

Therefore, many of the requested details about acceptance criteria and the study proving adherence cannot be extracted from this document.

Based on the provided text, here is what can be inferred or explicitly stated:

1. Table of Acceptance Criteria and Reported Device Performance

Specific, quantifiable "acceptance criteria" and direct "reported device performance" against those criteria are not explicitly laid out in a table format in the provided text. The document focuses on demonstrating substantial equivalence to a predicate device, meaning the new device performs at least as well as the predicate and does not raise new safety or effectiveness concerns.

However, some performance characteristics are compared to the predicate, implying they meet or exceed the predicate's performance, which can be seen as an indirect form of demonstrating acceptance.

Note: The table above extracts direct comparisons from Section "PRODUCT OVERVIEW" within the 510(k) summary. For other aspects like software performance, safety, and functional requirements, the document only states that "Results demonstrated that the executed verification test was passed" without providing specific criteria or data.

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 states: "Non-clinical and Sample clinical images were used to validate image performance." It also mentions: "Non- clinical and Sample clinical images were used for validation testing of the Soteria E-View system to demonstrate conformance to the intended use, claims, user, and service needs..."
However, no specific sample size for the test set (number of images, number of cases, number of patients) is provided.
The data provenance (country of origin, retrospective/prospective) is not mentioned.

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.

4. Adjudication method (e.g. 2+1, 3+1, none) 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

The document does not mention an MRMC study or any AI components for human reader assistance. The device is an X-ray system, and while the predicate device is named "Soteria.AI", the specific AI functionality (automatic region of interest to reduce exposure) is a built-in feature of the system and not framed as an AI-assistance tool for human readers in the context of comparative effectiveness for diagnosis. The focus is on the device's technical performance and safety.

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

This information is not provided in the document, as the device is a complete X-ray system, not a standalone algorithm. The "FluoroShield / CA-100S device to provide an automated Region of interest that reduces exposure to the patient and operator" is described as an integrated hardware/software component of the system.

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

This information is not provided in the document. The text only mentions "Sample clinical images" were used for validation testing, but how their "ground truth" was established is not detailed.

8. The sample size for the training set

The document primarily discusses validation and substantial equivalence, not the development of a specific algorithm requiring a "training set." Therefore, no information on a training set size is provided.

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

As no training set is described, this information is not applicable/provided.

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The Adora DRFi is a direct radiography and radioscopy, universal and permanently installed diagnostic X-ray system with a flat panel detector, which allows the acquisition of a wide range of Xray examinations. It is intended for use in generating diagnostic and radioscopic images of human anatomy. The Adora DRFi X-rav system is intended for use by trained and qualified personnel at the entire body of both adult and pediatric patients, and exposures may be acquired with the patient in supine, standing or sitting positions as well as with the patient in e.g., a wheelchair or on a stretcher. Radiographic procedures can take place with the detector in free position as well as fixed in the docking station: whereas radioscopic procedures may only take place when the detector is fixed in the docking station.

The Adora DRFi is not for mammography examinations.

The Adora DRFi x-ray system is a ceiling suspended universal x-ray system using direct radiography and radioscopy on flat panels for diagnostic purposes. The system can be used for acquisition of a wide range of radiographic and radioscopic x-ray examinations of the whole body, on both adult and pediatric patients. The patients may be lying on the Adora table, in a hospital bed or on a stretcher, using the flat panel's ability to be placed either inside or outside its housing for radiographic examinations. Radioscopic examinations, however, can only be made with the flat panel in the housing suspended in one of the two telescopes. The patients may also be standing on the floor, sitting on a chair or in a wheelchair. Examinations which can be performed on Adora X-ray systems; Radiography for Pelvis Supine, Pelvis Standing, Knee, and Radioscopy for Esophagus, Tube placement, knee.

The positioning of the ceiling suspended X-ray tube and the flat panel relative to the patient and each other are controlled by the operator, either through a joystick or via pre-programmed auto-positions activated by the operator.

The Adora X-ray system is a main powered, permanently installed system for use in hospitals and x-ray clinics and is intended solely for use by healthcare professionals, trained in and qualified for the use of medical xray equipment for diagnostic purposes.

This FDA 510(k) summary for the Adora DRFi X-ray system does not contain the detailed acceptance criteria or a study proving the device meets an acceptance criterion for an AI/ML medical device.

The document describes a conventional X-ray system (Adora DRFi) and compares its technical specifications to a predicate device (Siemens Multitom Rax). The focus is on demonstrating substantial equivalence based on shared indications for use, target population, and comparable technical aspects (detector technology, generator performance, imaging modalities, positioning capabilities, and table specifications).

Therefore, I cannot provide the requested information, particularly regarding AI/ML device performance, acceptance criteria, sample sizes for test/training sets, expert adjudication, or MRMC studies, as these elements are not detailed in the provided text.

The document indicates that the Adora DRFi utilizes the Canon CXDI-RF Wireless B1 with the Canon CXDI imaging software for image acquisition and post processing, previously cleared under K232298. This suggests that any software-related "AI" aspects (if they exist) would have been cleared under a separate submission (K232298) and are not the primary focus of this 510(k) for the Adora DRFi hardware system.

The "Conclusions" section reiterates that the device is substantially equivalent and that "Testing demonstrates that this device will perform in a manner that is as safe and effective or better than the predicate device." However, the details of this testing are not provided in this summary, especially not in a way that aligns with the typical requirements for an AI/ML device study.

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The Trident Mobile Fluoroscopy System is designed to provide fluoroscopic and spot-film images of the patient during diagnostic, surgical and interventional procedures. Examples of clinical application may include cholangiography, endoscopy, urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures.

The Trident Mobile Fluoroscopy System is a mobile Image Intensified Fluoroscopic X-ray unit with a flat panel image receptor system. The Trident Mobile Fluoroscopy System consists of the following components: an X- ray generator and tube housing and a flat panel detector. An X-ray cabinet contains system elements such as the X- ray generator, power electronics for the imaging chain. The system offers an optional monitor for viewing the captured images. The X-Ray Generator is located in the base of the C-Arm. High voltage is carried to the X-Ray tube across a set of cables and the X-Ray tube emits the X-Rays that are directed toward the control of the operator. The X-Rays pass through the patient and are captured by the flat panel image detector (FPD). The flat panels used in the Trident Mobile Fluoroscopy System are Varex models 3030DX or 2121DXV. This Varex series have been used in similar cleared devices (K192541, K220871). The Varex flat panel system used in the Trident uses Cesium lodide as the image scintillator which is identical to that used in the reference device (K220871). These flat panel models differ only in the dimensions of the image receptor. FPD images are processed and can be displayed on the optional image monitor located on the Workstation. The Physician or system operator can view the images as they are displayed on the attached monitor or they may also choose to store the images for later review via the connection to the hospital DICOM system. The C-Arm is designed to move into the required positions to allow for proper x-ray locations in relation to the patient for the procedure that is being performed. These procedures can be performed with or without a patient table. In order to accomplish this, the system is designed with the ability to rotate/swivel to obtain different appropriate viewing angles. The systems movement is manually adjusted with the exception of the z-axis. This is motorized with the controls on the C-arm. The release of x-ray is controlled using a footswitch and/or a hand controller.

Here's a breakdown of the acceptance criteria and study information for the Dornier MedTech America Trident Mobile Fluoroscopy System, based on the provided FDA 510(k) summary:

This device is an X-Ray system, and the provided document is a 510(k) summary for substantial equivalence. For such devices, "acceptance criteria" and "device performance" in the context of clinical studies (like sensitivity, specificity, etc.) are generally not directly applicable in the same way as they would be for an AI-powered diagnostic device. Instead, substantial equivalence is proven through non-clinical performance testing against recognized standards and comparative image quality assessments.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The FDA 510(k) summary for this type of device (an X-ray system) primarily relies on demonstrating compliance with recognized performance standards and comparative image quality rather than traditional clinical performance metrics like sensitivity/specificity. Therefore, "acceptance criteria" here refers to successful completion of non-clinical tests and "reported device performance" refers to the results of those tests.

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

• Test Set Sample Size: The document mentions "Comparative images using the Trident Mobile Fluoroscopy System and the GE predicate device were taken to reflect usage conditions of the device. The images taken used a pelvic phantom as well as a Primus phantom." This indicates that the "test set" consisted of images generated from at least two phantoms (a pelvic phantom and a Primus phantom), but the exact number of images or imaging sequences is not specified beyond "images."
• Data Provenance: The images were acquired from phantoms, not human patients. The country of origin of the phantoms or the location of the imaging is not specified, but it would have been conducted as part of the manufacturer's non-clinical testing. This is a prospectively generated dataset for testing the device's image quality.

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

• Number of Experts: "Upon review by a certified radiologic they were found to be clinically acceptable..." This indicates that one certified radiologist reviewed the images.
• Qualifications of Experts: The expert was described as "a certified radiologist." Specific years of experience are not mentioned.

4. Adjudication Method for the Test Set

• Adjudication Method: The document states that a single certified radiologist reviewed the images and found them to be clinically acceptable. This implies no formal adjudication process (like 2+1 or 3+1 consensus) as only one expert was involved in the assessment for clinical acceptability.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No, an MRMC comparative effectiveness study was not done. The study described involves a single radiologist reviewing phantom images to assess clinical acceptability compared to a predicate device. This is not an MRMC study comparing human reader performance with and without AI assistance.

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

• Yes, in essence, standalone performance was assessed. The device itself generates images. The "image comparative testing" described focuses on the quality of the images produced by the device (Trident Mobile Fluoroscopy System) compared to a predicate device, as assessed by a radiologist. This is an assessment of the device's output and its intrinsic image quality, separate from its operation by a human user in a clinical workflow. The "algorithm" here refers to the imaging system's capabilities in producing a diagnostic image.

7. The Type of Ground Truth Used

• Expert Consensus/Opinion on Image Quality: The ground truth for the image quality assessment was based on the "clinical acceptability" determined by a certified radiologist, comparing the images from the subject device to those from the predicate GE device. Since these were phantom images, "pathology" or "outcomes data" are not relevant here.

8. The Sample Size for the Training Set

• Not Applicable: This device is an X-ray imaging system, not an AI/ML-powered diagnostic algorithm that requires a "training set" in the conventional sense. The "training set" concept is typically relevant for machine learning models that learn from data. The reference here is to standard engineering design and testing, where components and systems are tested against specifications, not trained on data.

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

• Not Applicable: As there is no "training set" for an AI/ML model for this traditional imaging device, the establishment of its ground truth is not applicable.

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ProxiDiagnost N90 / Precision CRF is a multi-functional general R/F system. It is suitable for all routine radiography and fluoroscopy exams, including specialist areas like angiography or pediatric work, excluding mammography.

Same as the legally marketed predicate device ProxiDiagnost N90 (K212837, Substantial Equivalent (SE) date on September 21, 2021), the proposed ProxiDiagnost N90 / Precision CRF is a multi-functional general Radiography/ Fluoroscopy (R/F) system. It is suitable for all routine radiography and fluoroscopy exams, including specialist areas like angiography or pediatric work, excluding mammography.

Same as the legally marketed predicate device ProxiDiagnost N90 (K212837, SE date on September 21, 2021), the proposed ProxiDiagnost N90 / Precision CRF is a nearby controlled fluoroscopy system in combination with high-end digital radiography system consisting of a floor-mounted tilt adjustable patient support table and a scan unit consisting of a tube and a flat panel dynamic detector, Pixium FE4343F, for the fluoroscopy examinations. The tabletop can be moved by a motor in the lateral and longitudinal direction and can be tilted at -85° to +90° degrees. The scan unit tilts with the table and can be moved in the longitudinal and lateral direction, relative to the table and to the patient. The system is suitable for routine X-ray examinations and fluoroscopy examinations on patients in standing, seated, or lying positions. Same as the legally marketed predicate device ProxiDiagnost N90 (K212837, SE date on September 21, 2021), the proposed ProxiDiagnost N90 / Precision CRF retrieves images by means of a Cesium Iodide flat panel detector.

Same as the legally marketed predicate device ProxiDiagnost N90 (K212837, SE date on September 21, 2021), the proposed ProxiDiagnost N90 / Precision CRF consists of the Basic unit ("geometry" or "table unit"), Workstation Eleva Workspot (with integrated generator control, hand switch, keyboard, mouse, touch screen and PC), dual screen-monitor, Spot film device (digital camera or flat panel detector). Fixed Detector (Fluoroscopy). X-ray Generator for R/F applications, X-ray tube assembly. The optional components like wireless portable detectors small and large, Bucky tray for wireless portable detectors SkyPlate detector, Ceiling Suspension, Fixed Vertical stand, Ceiling Suspension for monitors, monitor trolley, Remote control for R/F (Radiography-fluoroscopy) viewer, accessories for "Stitching Stand", are also available.

Same as the legally marketed predicate device ProxiDiagnost N90 (K212837, SE date on September 21, 2021), the Eleva software of the proposed ProxiDiagnost N90 / Precision CRF is based on a workstation i.e., Eleva Workspot (computer, keyboard, display, and mouse) that is used by an operator to preset examination data and to generate, process and handle digital x-ray images. The Eleva Software system is decomposed into software components. These components are clustered in three component collections like the image handling focused Backend (BE), the acquisition focused Front-end (FE) and Image Processing (IP). The Eleva software is intended to acquire, process, store, display and export digital fluoroscopy and radiographic images.

The accessories for the proposed ProxiDiagnost N90 / Precision CRF are the same as the predicate device ProxiDiagnost N90 (K212837).

The list of the accessories for the proposed ProxiDiagnost N90 / Precision CRF:

• Footrest ●
• Hand Grips 0

Radiation Protection Accessories

• Flexible Radiation Protection Apron 0

• Front Radiation Protection Apron ●
  Additional Accessories (Optional)

• Monitor Trolley ●

• Monitor Ceiling Suspension

• Parking Frame for Accessories ●

• Shoulder Support ●

• Side bar ●

• Compression Belt ●

• Adjustable Lateral Cassette Holder

• Leg Supports

• o Infusion Bottle Holder

• Arm Support for Catheterization

• Ankle Clamps

• Overhead Hand Grip

• Adult Headrest

• Mattress

• Rotatable Stool for Footrest

• Pediatric Micturition Set

• Stretch Grip for Wall Stand

• Bar Code Scanner o

• Patient Support ●

• o Stitching Ruler

Accessories for the SkyPlate Detector (Optional)

• Mobile Detector Holder ●
• Detector Holder Patient Bed ●
• Portable Panel Protector ●
• Detector Handle ●
• WPD Bags ●
• o Grids for SkyPlate Detector large

The Components for the proposed ProxiDiagnost N90 / Precision CRF are the same as the predicate device ProxiDiagnost N90 (K212837).

The list of the Components for the proposed ProxiDiagnost N90 / Precision CRF:

• Eleva Workspot and RF Viewer ●
• UPS for Eleva Workspot (Optional) ●
• Table ●
• Indication Box ●
• Foot Switch
• Ceiling Suspension Motorized CSM3 (Optional) ●
• Wall Stand (Vertical Stand VS2) (Optional)
• SkyPlate / Portable Detector (Optional) 0

The proposed device complies to 'Guidance for the Submission of 510(k)'s for Solid State Xray Imaging Devices, dated September 1, 2016'. The solid-state imaging components including the detector in the proposed device have the same physical, functional, and operational characteristics as the predicate device (K212837). Also, other image chain components like Xray tube and generator, which are used for exposure characteristics and clinical performance evaluation remains the same. Hence all the features and characteristics potentially influencing image quality of the proposed are in accordance with FDA guidance document. Additionally, image quality testing has been performed on the proposed device for the changes that are affecting the image quality.

The information provided is about a regulatory submission (510(k)) to the FDA for a medical device called ProxiDiagnost N90 / Precision CRF. This type of submission aims to demonstrate that a new device is "substantially equivalent" to an already legally marketed predicate device. Therefore, the "study" referred to is primarily focused on demonstrating this equivalence rather than a traditional clinical study proving novel efficacy.

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

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes the acceptance criteria in terms of compliance with various FDA-recognized standards and guidance documents, and the reported device performance is that it "Passes" these criteria. The safety and effectiveness of the device are deemed "Equivalent" to the predicate device.

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

The document describes non-clinical performance testing and mentions "non-clinical performance test data" and "tests performed on the proposed ProxiDiagnost N90 / Precision CRF". This type of submission relies on engineering and design verification/validation, not patient data in the sense of a clinical trial. Therefore, there is no information on a "test set" sample size in terms of patient data or data provenance (country of origin, retrospective/prospective). The testing was conducted on manufactured devices and their components.

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

Again, for this type of non-clinical submission, there is no mention of experts establishing a "ground truth" for a test set in the clinical image interpretation sense. The "ground truth" for non-clinical performance refers to the device's adherence to engineering specifications and regulatory standards, which are verified through various tests and reports.

4. Adjudication Method:

Given that this is not a study involving human reader interpretation of images for diagnosis, there is no adjudication method described.

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

No, a MRMC comparative effectiveness study was not done. The submission explicitly states: "There is no clinical data submitted in this 510(k) premarket notification." The purpose is to demonstrate substantial equivalence to a predicate device, primarily through non-clinical performance and a comparison of technological characteristics.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

Based on the information, this is an X-ray system, not an AI algorithm for image interpretation. The "Eleva software" is described as used by an operator to "preset examination data and to generate, process and handle digital x-ray images." While software verification testing was done, it pertains to the functionality of the system's control and image processing, not a standalone diagnostic algorithm. Therefore, a standalone AI algorithm study was not performed.

7. Type of Ground Truth Used:

For the non-clinical performance testing, the "ground truth" is effectively the engineering specifications and the requirements outlined in the FDA-recognized consensus standards and guidance documents. For example, the "System Verification testing" aims to confirm that the "system conforms to the system requirements," which serve as the ground truth for that specific test.

8. Sample Size for the Training Set:

Not applicable. As this is not an AI diagnostic algorithm, there is no "training set" in the context of machine learning. The device is a traditional X-ray imaging system with integrated software for image acquisition and processing.

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

Not applicable for the same reasons as point 8.

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The CombiDiagnost R90 is a multi-functional general R/F system. It is suitable for all routine radiography and fluoroscopy exams, including specialist areas like angiography or pediatric work, excluding mammography.

The CombiDiagnost R90 is a multi-functional general Radiography/Fluoroscopy (R/F) system. It is suitable for all routine radiography and fluoroscopy exams, including specialist areas like angiography or pediatric work, excluding mammography.

The CombiDiagnost R90 is a remote-controlled fluoroscopy system in combination with high-end digital radiography. The system is suitable for routine X-ray examinations and special examinations on patients in standing, seated or laying positions. The CombiDiagnost R90 retrieves images by means of a Cesum Iodide flat panel detector.

Philips fluoroscopy systems consist of the following components (standard configuration):

• Basic unit (also called "geometry" or "table unit")
• Workstation Eleva Workspot with integrated generator control, hand switch, keyboard, mouse, touch screen and PC
• Equipped with a dual screen-monitor as standard
• Spot film device (digital camera or flat panel detector)
• X-ray Generator Velara
• X-ray tube assembly mounted in above table mode to be remote controlled
• Receptor: Flat panel detector

Optional components:

• Skyplate wireless portable detectors small and large
• Ceiling Suspension (CSM3)
• Vertical Wall stand (VS2)
• Ceiling Suspension for monitors
• Monitor trolley
• Remote control for RF viewer
• Accessories for "Stitching on the Table"

The CombiDiagnost R90 uses the same workflow from the currently marketed and predicate device, CombiDiagnost R90 (K163210) with only the following modifications:

• additional optional components (like the reference monitor, remote control),
• Eleva Workspot updated to incorporate new imaging features mainly from the previously approved reference device, DigitalDiagnost C90 (K182973) along with functional clusters like Digital Subtraction Imaging and stitching on the table
• updates to improve usability and serviceability.

The Eleva software of the proposed CombiDiagnost R90 is based on a workstation i.e., Eleva Workspot (computer, keyboard, display, and mouse) that is used by an operator to preset examination data and to generate, process and handle digital x-ray images. The Eleva Software system is decomposed into software components. These components are clustered in three component collections like the image handling focused Back-end (BE), the acquisition focused Front-end (FE) and Image Processing (IP). The Eleva software is intended to acquire, process, store, display and export digital fluoroscopy and radiographic images.

The proposed CombiDiagnost R90 is same as the predicate device (K203087) with some modifications as described.

The proposed device complies to 'Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices, dated September 1, 2016'. The solid-state imaging components including the detector in the proposed device have the same physical, functional, and operational characteristics as the predicate device (K203087). Also, other image chain components like X-ray tube and generator, which are used for exposure characteristics and clinical performance evaluation remains the same. Hence all the features and characteristics potentially influencing image quality of the proposed are in accordance with FDA guidance document. Additionally, image quality testing has been performed on the proposed device for the changes that are affecting the image quality.

The provided text is a 510(k) Summary for the Philips Medical Systems DMC GmbH CombiDiagnost R90, which is an X-ray system. This document focuses on demonstrating that the proposed device is substantially equivalent to a previously cleared predicate device, rather than proving a new medical diagnosis or treatment effectiveness. Therefore, the traditional acceptance criteria and study designs typically associated with AI/ML diagnostic devices (e.g., sensitivity, specificity, clinical accuracy, MRMC studies) are not directly applicable or reported in this type of submission.

Instead, the acceptance criteria and studies here are aimed at demonstrating that the modified device maintains the safety and effectiveness of the predicate device and complies with relevant standards and regulations.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Image Quality Details (from document):

Modulation Transfer Function (MTF) (according to IEC 62220-1-3 standard)

Detective Quantum Efficiency (DQE) (according to IEC 62220-1-3 standard) at 2 µGy

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

The document does not specify a "test set" in the context of clinical images or patient data for evaluating a diagnostic algorithm. This submission is for an X-ray imaging system, not an AI diagnostic algorithm. The "tests" mentioned are non-clinical engineering and conformity tests.

• Test Set Sample Size: Not applicable/not specified in the context of clinical images. The testing refers to verification and validation of the system's hardware and software components.
• Data Provenance: Not applicable in the context of clinical images or patient data. The tests are focused on the device's technical specifications and compliance with standards.

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

Not applicable. This is not a study requiring expert-established ground truth for diagnostic accuracy, as it's a submission for an imaging device, not an AI diagnostic tool. The "ground truth" for the engineering tests would be the established technical standards and specifications.

4. Adjudication Method for the Test Set

Not applicable. No clinical image test sets requiring adjudication are mentioned. The testing involves compliance with standards and internal system verification.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. This type of study is not mentioned as it is not relevant for demonstrating substantial equivalence of an X-ray imaging system through non-clinical performance testing.

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

Not applicable. The CombiDiagnost R90 is an X-ray imaging system, not a standalone AI algorithm. While it contains "Eleva software" with imaging features, the submission focuses on the system's overall safety and performance, not a new AI algorithm's standalone diagnostic capability.

7. The Type of Ground Truth Used

The "ground truth" for the evaluations performed in this submission are:

• Engineering Specifications: The defined technical parameters and performance metrics for the device components (e.g., MTF, DQE values, electrical safety, EMC).
• Regulatory Standards: The requirements outlined in FDA recognized consensus standards (e.g., IEC 60601 series) and FDA guidance documents.
• Predicate Device Performance: The established performance and safety characteristics of the legally marketed predicate device (CombiDiagnost R90, K203087), against which the proposed device's performance is compared for substantial equivalence.

8. The Sample Size for the Training Set

Not applicable. This is an X-ray imaging device, not an AI algorithm that requires a training set for machine learning.

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

Not applicable, as there is no training set for an AI algorithm mentioned.

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The Angio Workstation (XIDF-AWS801) is used in combination with an interventional angiography system (Alphenix series systems, Infinix-i series systems and INFX series systems) to provide 2D and 3D imaging of selective catheter angiography procedures for the whole body (includes heart, chest, abdomen, brain and extremity).

When XIDF-AWS801 is combined with Dose Tracking System (DTS), DTS is used with selective catheter angiography procedures for the heart, chest abdomen, pelvis and brain.

The XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.5 is used for images input from Diagnostic Imaging System and Workstation, image processing and display. The processed images can be outputted to Diagnostic Imaging System and Workstation.

Please note that the provided text is a 510(k) summary for a medical device (Angio Workstation) and primarily focuses on demonstrating substantial equivalence to a predicate device due to minor software changes. It does not contain a detailed clinical study demonstrating the performance of an AI algorithm against specific acceptance criteria in the way a new, high-risk AI device submission typically would.

The only AI-related change mentioned is the improvement to the "Dynamic Device Stabilizer (DDS) software with deep learning" to "improve the detection rate of the stent marker." The document states "Testing was conducted to verify the fixed display performance was improved in V9.5 algorithm compared to V9.3 algorithm for Dynamic Device Stabilizer (DDS)..." However, it does not provide the specifics of this test in terms of acceptance criteria, sample size, or ground truth establishment relevant to an AI model's performance as you've requested. It implies that the test was a "bench test" and verified "fixed display performance," which is more aligned with system-level performance rather than the diagnostic performance of an AI.

Therefore, I cannot fully answer your request based on the provided text, as it lacks the detailed AI study information you've asked for.

However, I can extract the limited information present and highlight what is missing.

Acceptance Criteria and Device Performance (Limited Information)

The document mentions that the DDS software with deep learning was changed to "improve the detection rate of the stent marker" and that "Testing was conducted to verify the fixed display performance was improved in V9.5 algorithm compared to V9.3 algorithm."

Missing Information:

• Specific quantitative acceptance criteria for "detection rate of the stent marker" (e.g., minimum sensitivity, precision, F1-score).
• The actual reported performance metric for the stent marker detection by the V9.5 algorithm.
• The definition of "fixed display performance" in quantitative terms and its relationship to the deep learning component's performance.

Given the limited information, a table of acceptance criteria and reported device performance cannot be fully constructed as requested. The document only broadly states "performance was improved" without quantitative metrics.

Study Details (Based on Available Information)

As the document only mentions an improvement to an existing feature (DDS with deep learning for stent marker detection) and treats it as a "modification of a cleared device" under a Special 510(k), it does not describe a full standalone clinical validation study for a novel AI device. The information below extracts what can be inferred or is explicitly stated, and highlights significant gaps.

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

   Feature/Metric Targeted by AI	Acceptance Criteria (Stated/Inferred)	Reported Device Performance (Stated/Inferred)
   Stent Marker Detection Rate	"Improve the detection rate"	"performance was improved" (V9.5 vs V9.3)
   "Fixed Display Performance"	Improved	"was improved" (V9.5 vs V9.3)

   Note: These are qualitative statements of improvement, not specific quantitative acceptance criteria or performance metrics as typically seen for AI device validation.

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

   • Sample Size: Not specified. The document states "Testing was conducted to verify the fixed display performance..." The nature of this "testing" is unclear in terms of data samples.
   • Data Provenance: Not specified (e.g., country of origin).
   • Retrospective or Prospective: Not specified, but "bench testing" usually implies retrospective analysis of existing data.

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

   • Number of Experts: Not specified.
   • Qualifications of Experts: Not specified.
   • Method of Ground Truth Establishment: Unclear. For "stent marker detection," ground truth would typically involve manual annotation by expert radiologists or cardiologists. This is not described.

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

   • Adjudication Method: 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:

   • MRMC Study: Not mentioned or implied. The focus is on the performance of the software modification itself, not on human-in-the-loop performance.
   • Effect Size: Not applicable as no MRMC study is mentioned.

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

   • Standalone Performance: The description "To improve the detection rate of the stent marker" and "Testing was conducted to verify the fixed display performance was improved" suggests that some form of standalone evaluation of the algorithm's output was done. However, specific metrics (e.g., sensitivity, specificity, F1-score for detection) are not provided. The term "fixed display performance" might refer to the accuracy of the algorithm's output as displayed.

7. The type of ground truth used:

   • Type of Ground Truth: Not specified. For "stent marker detection," it would typically be expert annotation of stent markers on imaging data.

8. The sample size for the training set:

   • Training Set Sample Size: Not specified. The document refers to "deep learning" but provides no details on its training.

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

   • Training Set Ground Truth Establishment: Not specified.

Summary of Gaps:

The document is a regulatory submission focused on demonstrating substantial equivalence for a minor software upgrade. It does not provide the level of detail typically found in a clinical study report for a new or significantly modified AI/ML-based medical device. Specifically, for the deep learning component, there is a lack of quantitative acceptance criteria, specific performance metrics, detailed information on test and training datasets (size, provenance), and the methodology for establishing ground truth and expert involvement. The "testing" mentioned appears to be more focused on system-level performance verification ("fixed display performance") rather than a rigorous diagnostic performance study of the AI algorithm.

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The Dornier Nautilus is an image intensified, fluoroscopic x-ray system that is intended for use in a wide field of applications, including all general examinations in urology and gynecology, as well as endoscopic and contrast examinations, imaging with radiography and/or fluoroscopy on patients in either the horizontal or vertical position.

The Dornier Nautilus is an Image Intensified Fluoroscopic X-ray System with a flat panel image receptor system. The Nautilus consists of the following components: an X- ray generator and tube housing, flat panel detector, monitors and procedure table. An X-ray cabinet contains system elements such as the X-ray generator, power electronics for the imaging chain.

The Dornier Nautilus is a radiographic and fluoroscopy examination table with the X-ray tube housing mounted under the table on a fixed arm. A flat panel detector is mounted above the patient table. The flat panel used is a Varex model 4343DXV. These Varex 4343 series have been used in similar cleared devices (K192541). The Varex flat panel system uses Cesium lodide as the image scintillator which is identical to that used in the predicate device. While the X-ray tube and detector are fixed in their positions relative to each other when the system is in use, the table top and X-ray/detector unit can be moved in a variety of planes to position the patient in the desired imaging position. The captured images are processed and can be stored in the users DICOM system.

The provided text describes the Nautilus, an image intensified fluoroscopic x-ray system. However, it does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of device performance metrics like sensitivity, specificity, or accuracy.

The "Performance Data" section primarily addresses adherence to electrical safety and electromagnetic compatibility (EMC) standards, and software verification and validation. These are crucial for the safety and basic functionality of the device, but they are not the typical performance metrics associated with demonstrating the clinical efficacy or diagnostic accuracy of an imaging system compared to a ground truth or a human reader.

Here's a breakdown of what is and isn't present, based on your request:

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

• Acceptance Criteria Mentioned: The text implicitly states acceptance criteria by listing the standards that the Nautilus was tested against (e.g., IEC 60601-1, IEC 60601-1-2). The "Performance Data" states that "Performance testing confirmed that the Nautilus met the requirements of the following standards."
• Reported Device Performance: The document only reports conformance to these safety and software standards, not specific performance metrics in terms of image quality, diagnostic accuracy, or clinical outcomes. There are no numerical results (e.g., contrast-to-noise ratio, spatial resolution, diagnostic sensitivity/specificity) provided.

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

• Not Applicable. No clinical or diagnostic performance test set is described. The testing mentioned is for electrical safety, EMC, and software, which typically involves engineering tests, not patient data sets.

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

• Not Applicable. No ground truth establishment for diagnostic performance is mentioned.

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

• Not Applicable. No diagnostic performance 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. The document explicitly states: "Clinical testing is not necessary for the subject system Nautilus, based on the same basic technology as the predicate device and based on existing minor differences." This indicates that an MRMC study or any clinical effectiveness study was not performed or deemed necessary for this 510(k) submission. There is no AI assistance mentioned, so no effect size for human readers with AI vs. without AI assistance can be provided.

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

• No. This device is an imaging system (fluoroscopic x-ray system) and not an AI algorithm. Its performance is evaluated fundamentally in conjunction with a human operator / clinician interpreting the images. No standalone algorithm performance is applicable or discussed.

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

• Not Applicable. No diagnostic ground truth is mentioned. The "ground truth" for the non-clinical tests would be the requirements defined by the referenced international standards for electrical safety, EMC, and software quality.

8. The sample size for the training set

• Not Applicable. As no AI algorithm or diagnostic performance study is described, there's no training set for such a purpose.

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

• Not Applicable. See point 8.

Summary of Device Acceptance and Study as Described in the Document:

The Nautilus device's acceptance is based on its substantial equivalence to a predicate device (Dornier Genesis K151485) and its demonstrated conformance to established international standards for:

• Electrical Safety: IEC 60601-1, EN 60601-1-6, IEC 60601-1-3, IEC 60601-2-28, IEC 60601-2-54
• Electromagnetic Compatibility (EMC): IEC 60601-1-2
• Usability: EN 60601-1-6, IEC 62366-2
• Software Verification and Validation: Adherence to FDA's "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (Moderate Level of Concern).

The study that "proves the device meets the acceptance criteria" is non-clinical testing (bench testing) against these referenced standards. No clinical studies, human reader studies, or diagnostic performance studies with explicit acceptance criteria (e.g., sensitivity/specificity thresholds) and corresponding test results are provided in this submission document. The rationale provided for not conducting clinical testing is that the device uses "the same basic technology as the predicate device and based on existing minor differences."

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The Omega Medical Imaging, LLC Nyquist.IQ Image Processor is intended for use in Radiographic/fluoroscopic applications including cardiac, general radiographic/fluoroscopic diagnostic, and interventional x-ray imaging. The Nyquist.IQ is intended solely to be integrated only with Omega Medical Imaging CS-series-FP Systems.

Nyquist.IQ is a dynamic digital image processing system. The system application is based on a PC Windows operating system functioning on a PC based CPU. The object-oriented software performs real-time image processing and full procedure storage. The DICOM compliant connectivity provides the tools to transmit patient demographics, examination, and image data digitally.

Nyquist.IQ is not a standalone device, but functions as a component for FDA cleared Omega CS-series-FP platform. Nyquist IQ is an image processor that interfaces, with to acquire and digitize x-ray exposure from the Omega medical CS-series-FP.

The Nyquist.IQ operates in connection with the Varex's 3030 or the Teledyne 3030 flat panel detectors. This is demonstrated in the substantial equivalence section of the Nyquist.IQ is intended for the Omega CS-series-FP with Optional Accessory Device CA-100S / FluoroShield platform.

The Nyquist.IQ is intended solely to be integrated only with Omega Medical Imaging CS-series-FP systems.

The Nyquist.IQ image processor. The fundamental performance characteristics of the Nyquist.IQ interventional fluoroscopic imaging Processor system consists of:

• ) Real-time image visualization of patient anatomy during procedures

• Imaging techniques and tools to assist interventional procedures.

• 2 Post-processing functions after interventional procedures.
• 2 Storage of reference/control images for patient records.
• Σ Compatibility to images of other modalities via DICOM
• 2 Compatibility with the already FDA cleared CA-100S / FluoroShield AI Exposure Reduction Technology. (K182834)

This array of functions provides the physician the imaging information required to achieve minimally invasive interventional procedures.

The Nyquist.IQ image processor is available as a Model IPS-100 configuration and is similar to the currently marketed and predicate image processor MX-200 in CS-series-FP with optional CA-100S / FluoroShield Device.

This document is an FDA 510(k) clearance letter for the Omega Medical Imaging, LLC Nyquist.IQ Image Processor. It is a declaration of substantial equivalence to a predicate device, not a detailed study report with acceptance criteria and performance metrics for an AI/ML-driven device.

Therefore, this document does not contain the specific information required to answer your request regarding acceptance criteria and a study proving a device meets those criteria for an AI/ML product.

The information provided in the input primarily focuses on regulatory classification, indications for use, technological characteristics, and a comparison to predicate devices for a traditional medical imaging processor. It explicitly states:

• "The Nyquist.IQ did not require clinical study data since substantial equivalence to the currently marketed predicate device Omega CS-series-FP with Optional Accessory Device CA-100S / FluoroShield was demonstrated with the following attributes:
  • ∑ Indication for use.
  • A Technological characteristics.
  • ) Non-clinical performance testing; and
  • ∑ Safety and effectiveness." (Page 6)
• It also mentions a "FluoroShield AI Exposure Reduction Technology" associated with a predicate device (K182834), but it does not describe a performance study for the Nyquist.IQ as an AI/ML device itself. The Nyquist.IQ appears to be an image processor that interfaces with this existing technology, rather than being the AI/ML device itself.

To answer your specific questions, I would need a document that details a performance study, including acceptance criteria, for a software component with AI/ML functionality. This document does not provide such details.

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ProxiDiagnost N90 is a multi-functional general R/F system. It is suitable for all routine radiography and fluoroscopy exams, including specialist areas like angiography or pediatric work, excluding mammography.

The ProxiDiagnost N90 is a multi-functional general Radiography/ Fluoroscopy (R/F) system. It is suitable for all routine radiography and fluoroscopy exams, including specialist areas like angiography or pediatric work, excluding mammography.

The ProxiDiagnost N90 is a nearby controlled fluoroscopy system in combination with high-end digital radiography system consisting of a floor-mounted tilt adjustable patient support table and a scan unit consisting of a tube and a flat panel dynamic detector, Pixium FE4343F, for the fluoroscopy examinations. The tabletop can be moved by a motor in the lateral and longitudinal direction and can be tilted by -85° to +90° degrees. The scan unit tilts with the table and can be moved in the longitudinal and lateral direction, relative to the table and to the patient. The system is suitable for routine X-ray examinations and fluoroscopy examinations on patients in standing, seated or lying positions. The ProxiDiagnost N90 retrieves images by means of a Cesium Iodide flat panel detector.

Philips fluoroscopy systems (standard configuration) consist of the Basic unit ("geometry" or "table unit"), Workstation Eleva Workspot (with integrated generator control, hand switch, keyboard, mouse, touch screen and PC), dual screen-monitor, Spot film device (digital camera or flat panel detector), Fixed Detector (Fluoroscopy), X-ray Generator for R/F applications, X-ray tube assembly. The optional components like wireless portable detectors small and large, Bucky tray for wireless portable detectors (SkyPlate) detector, Ceiling Suspension, Fixed Vertical stand, Ceiling Suspension for monitors, monitor trolley, Remote control for R/F (Radiography-fluoroscopy) viewer, accessories for “Stitching Stand", are also available.

The Eleva software of the proposed ProxiDiagnost N90 is based on a workstation i.e., Eleva Workspot (computer, keyboard, display, and mouse) that is used by an operator to preset examination data and to generate, process and handle digital x-ray images. The Eleva Software system is decomposed into software components. These components are clustered in three component collections like the image handling focused Back-end (BE), the acquisition focused Front-end (FE) and Image Processing (IP). The Eleva software is intended to acquire, process, store, display and export digital fluoroscopy and radiographic images.

The ProxiDiagnost N90 uses the same workflow from the currently marketed and predicate device, ProxiDiagnost N90 (K173433) with only the following modifications:

• Inclusion of Extended reviewing options (like the optional reference monitor & remote control),
• Inclusion of some image processing features
• Updates to Operating system and Eleva application Software to include state-of-art operating system and incorporate the changes
• Replacement of the ceiling suspension with that of reference device, DigitalDiagnost C90 (K202564)
• Updates to improve serviceability
• Option for upgradability of Predicate device (K173433) to include the above changes

The provided text is a 510(k) summary for the Philips ProxiDiagnost N90, an X-ray system. It primarily focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study proving the device meets specific acceptance criteria through an AI/human comparative effectiveness study or a standalone algorithm performance study.

The document does not describe acceptance criteria for an AI algorithm or a study proving an AI algorithm meets those criteria. Instead, it outlines the changes from a predicate device (K173433) and refers to the performance of other reference devices (K203087 and K202564) as justification for the modifications. The "acceptance criteria" discussed are in the context of device safety and effectiveness testing for a conventional medical device (X-ray system), aligning with recognized standards and guidance documents (e.g., IEC 60601 series, ISO 14971).

Therefore, I cannot provide the requested information regarding AI acceptance criteria and performance study details from the given text.

However, I can extract information about the overall device acceptance criteria and testing methodology as described for this X-ray system:

Overall Device Acceptance Criteria (Implied by Testing):

The acceptance criteria for the ProxiDiagnost N90 are implicitly demonstrated through adherence to various international standards and FDA guidance documents related to X-ray systems, electrical safety, electromagnetic compatibility, radiation protection, usability, software lifecycle processes, risk management, and biological evaluation. The testing performed is aimed at ensuring the device's safety and effectiveness compared to its predicate and reference devices, despite the noted modifications.

Study Proving the Device Meets Acceptance Criteria (as described in the document):

The "study" described is a series of non-clinical performance tests and verifications rather than a comparative clinical study with human readers or standalone AI performance.

Information Extracted from the Document (to the extent possible given the context):

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

   The document does not present a table of specific quantitative performance acceptance criteria for an AI algorithm or human reading performance. Instead, it states that "Tests were performed on the proposed ProxiDiagnost N90 according to the following FDA recognized standards and guidance documents." The reported "performance" is that these tests support the device being "safe and effective" and "substantially equivalent" to the predicate.

   Acceptance Criterion Category (Implied)	Reported Device Performance/Verification Method
   General Safety & Performance	- Compliance with ANSI AAMI ES60601-1:2005/(R)2012 And A1:2012 (Medical electrical equipment - Part 1: General requirements for basic safety and essential performance).

• Compliance with IEC 60601-1-2 Edition 4.0 2014-02 (Electromagnetic disturbances - Requirements and tests).
• Compliance with IEC 60601-1-3 Edition 2.1 2013-04 (Radiation protection in diagnostic X-ray equipment).
• Compliance with IEC 60601-1-6 Edition 3.1 2013-10 (Usability).
• Compliance with IEC 60601-2-54 Edition 1.1 2015-04 (Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy).
• Compliance with ANSI AAMI ISO 14971: 2007/(R)2010 (Medical devices-Application of risk management to medical devices).
• Compliance with ISO 10993-1, Fifth edition 2018-08 (Biological evaluation of medical devices).
• System and software verification testing was performed for all modifications to demonstrate safety and effectiveness. |
  | New Features Performance | - Extended Reviewing Options: System Verification for Bluetooth remote control and additional reference monitor (test protocol identical to CombiDiagnost R90 K203087).
• Image Processing Features:
  • Digital Subtraction Angiography: Sub-system (Eleva software) & System Verification (test protocol identical to CombiDiagnost R90 K203087).
  • Predefined annotations: Sub-system (Eleva software) & System Verification (test protocol identical to CombiDiagnost R90 K203087).
  • Bone Suppression: Sub-system (Eleva software) & System Verification (test protocol identical to DigitalDiagnost C90 K202564).
  • UNIQUE 2 (radiography): Sub-system (Eleva software) & System Verification (test protocol identical to DigitalDiagnost C90 K202564).
  • Intuitive User Interface for Processing Parameters: Sub-system Verification (Eleva software) (test protocol identical to DigitalDiagnost C90 K202564).
  • Deviation and Target Exposure Indices: Sub-system (Eleva software) & System Verification (test protocol identical to DigitalDiagnost C90 K202564).
  • Update of optional Skyflow feature: Sub-system (Eleva software) & System Verification (test protocol identical to DigitalDiagnost C90 K202564).
  • Access to and Export of Original Image Data: System Verification.
  • Improved OBSA: Sub-system (Eleva software) & System Verification (test protocol identical to DigitalDiagnost C90 K202564).
  • View Selection for Changed X-Ray Generation Data Sets: Sub-system Verification (Eleva software) (test protocol identical to DigitalDiagnost C90 K202564).
  • Avoid Ghosting in Verification Images of Portable Detectors: System Verification (test protocol identical to DigitalDiagnost C90 K202564).
• Software Updates:
  • Operating system upgrade to Microsoft Windows 10: Sub-system (Eleva software) & System Verification (test protocol identical to CombiDiagnost R90 K203087).
  • Upgrade of Eleva Application software to increment 42: All relevant software functions tested at system and subsystem level (referencing tests for change #1, 2, 4 and 5).
• Ceiling Suspension & Service Features:
  • Tube head control: System Verification (test protocol identical to DigitalDiagnost C90 K202564).
  • Collimator: System Verification (test protocol identical to DigitalDiagnost C90 K202564).
  • Monitoring and Firmware Updates for Field Service: System Verification (test protocol identical to CombiDiagnost R90 K203087).
  • Remote access for the field service Engineer: Sub-system Verification (Eleva software).
  • Service Diagnostic: System Verification (test protocol identical to CombiDiagnost R90 K203087 & DigitalDiagnost C90 K202564).
  • Hardware upgrades (Alpha drive Upgradeability): System Verification (test protocol identical to DigitalDiagnost C90 K202564). |
    | Upgradeability of Predicate Device | All relevant Software functions are tested at system and subsystem level (referencing tests for change #1, 2, 3 and 5 a,b,c). |

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

   • Test Set Sample Size: Not specified in terms of number of patient cases or images. The testing appears to be primarily system-level, software-level, and component-level verification, rather than evaluation on a diagnostic image dataset.
   • Data Provenance: The document explicitly states "There is no clinical data submitted in this 510(k) premarket notification." Therefore, there is no information on country of origin or retrospective/prospective nature of data for clinical evaluation, as none was performed.

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

   Not applicable. No clinical data or expert-established ground truth for diagnostic image interpretation was used or provided in this 510(k) submission.

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

   Not applicable, as no clinical image evaluation requiring adjudication was 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 was performed or described. This submission is for an X-ray system, not an AI-powered diagnostic algorithm requiring such a study for its clearance.

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

   No standalone algorithm performance study was performed or described, as this submission is for an X-ray system, not a standalone AI diagnostic algorithm.

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

   Not applicable. No clinical ground truth (expert consensus, pathology, outcomes data) was used in this 510(k) submission, as it explicitly states "There is no clinical data submitted." The testing relies on engineering and regulatory compliance standards.

8. The sample size for the training set:

   Not applicable. The document describes an X-ray imaging system, not an AI model that would require a training set.

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

   Not applicable, as there is no training set for an AI model discussed.

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The DR 800 with DSA system is indicated for performing dynamic imaging examinations (fluoroscopy and/or rapid sequence) of the following anatomies/procedures:

• · Positioning fluoroscopy procedures
• · Gastro-intestinal examinations
• · Urogenital tract examinations
• · Angiography
• · Digital Subtraction Angiography

It is intended to replace fluoroscopic images obtained through image intensifier technology. In addition, the system is intended for projection radiography of all body parts.

In addition, the system provides the Agfa Tomosynthesis option, which is intended to acquire tomographic slices of human anatomy and to be used with Agfa DR X-ray systems. Digital Tomosynthesis is used to synthesize tomographic slices from a single tomographic sweep.

Not intended for cardiovascular and cerebrovascular contrast studies. Not intended for mammography applications.

Agfa's DR 800 with DSA medical device is a fluoroscopic x-ray system that includes digital angiography (product code JAA) intended to capture tomographic, static and dynamic images of the human body. The DR 800 is a floor-mounted radiographic, fluoroscopic and tomographic system that consists of a tube and operator console with a motorized tilting patient table. FLFS overlay and bucky with optional wall stand and ceiling suspension. The new device uses Agfa's NX workstation with MUSICA image processing and flat-panel detectors for digital, wide dynamic range and angiographic image capture. It is capable of replacing other direct radiography, tomography, image intensifying tubes and TV cameras, including computed radiography systems with conventional or phosphorous film cassettes.

This submission is to add the newest version of the DR 800 with Digital Subtraction Angiography (DSA) to Agfa's radiography portfolio.

Here's an analysis of the acceptance criteria and study information for the Agfa DR 800 with DSA, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly list quantitative acceptance criteria in a table format for performance metrics. Instead, it describes a more qualitative approach, focusing on equivalence to predicate devices and confirmation through expert evaluation.

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

• Test Set Sample Size: Not explicitly stated in terms of number of images or cases. The document mentions "anthropomorphic phantoms" for clinical image validation.
• Data Provenance: The study used "anthropomorphic phantoms," which are physical models designed to simulate human anatomy for imaging purposes. This indicates a laboratory/phantom study rather than real patient data. The country of origin for the phantom data is not specified, but the submission is from Agfa N.V. (Belgium). It is a prospective study in the sense that the new device was evaluated with these phantoms.

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

• Number of Experts: Not explicitly stated. The document mentions "qualified experts" and "radiographers."
• Qualifications of Experts: Described as "qualified experts" and "radiographers." No specific experience levels (e.g., "10 years of experience") are provided.

4. Adjudication Method for the Test Set

Not specified. The document states "evaluated by qualified experts" and "radiographers evaluated...by comparing overall image quality with the primary predicate A device," implying a comparative evaluation rather than a strict adjudication process for ground truth establishment.

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 conducted. This is not an AI-assisted diagnostic device; it's a conventional X-ray system with digital image processing and DSA capabilities. The study compared the device's image quality to a predicate device, focusing on equivalence, not human reader improvement with AI.

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

Yes, in essence, the "Bench Testing" and "Software Verification and Validation Testing" sections describe standalone performance evaluations of the device's functions and image processing algorithms. The "Clinical image validation" with phantoms also focuses on the device's output (image quality) rather than human interaction with the device in a diagnostic workflow where the human acts as the ultimate decision-maker for the study’s performance outcome.

7. The Type of Ground Truth Used

The "ground truth" for the image quality evaluation was based on expert comparison and qualitative assessment of images produced by the device, specifically assessing "diagnostic confidence for DSA image quality and roadmapping" as "between good and excellent" when compared to a predicate device. This is primarily an expert consensus on image quality rather than pathology, clinical outcomes, or a gold standard.

8. The Sample Size for the Training Set

Not applicable. This device is an X-ray imaging system, not a machine learning or AI algorithm that requires a training set of data. The image processing algorithms are described as being "similar to those previously cleared" or "similar to the primary predicate device."

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

Not applicable, as this device does not utilize a machine learning model that would require a ground truth for a training set.

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