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The Ziehm Vision RFD 3D system is intended for use in providing both 2D and 3D pulsed and continuous fluoroscopic medical imaging for adult and pediatric populations.

The device provides 2D medical imaging for fluoroscopy, digital subtraction, and acquisition of cine loops during diagnostic interventional and surgical procedures where imaging and visualization of complex anatomical structures of both lower and higher contrast density are required. Such procedures may include but are not limited to those of interventional cardiology, heart surgery, hybrid procedures, interventional angiography, electrophysiology, pediatrics, endoscopic, urological, gastroenterology, orthopedic, maxillofacial surgery, neurology, neurosurgery, critical care, emergency room procedures visualizing structures of the cervical, thoracic, and lumbar regions of the spine and joint fractures of the upper and lower extremities, and where digital image data is required for Computer-Assisted Surgery procedures.

The device is also intended to provide 3D medical imaging of patients during orthopedical, intra-operative surgical procedures and where the clinician benefits from 3D visualization of complex anatomical structures, such as but not limited to those of high contrast objects, bones, joints, maxillofacial, cervical, thoracic, and lumbar regions of the spine, pelvis, acetabulum and joint fractures of the upper and lower extremities, and where digital image and C-arm positioning data is required for Computer-Assisted Surgery procedures.

The visualization of such anatomical structures assists the clinician in the clinical outcome.

This device does not support direct radiographic film exposures and is not intended for use in performing mammography. The system is not intended for use in any MRI environments.

The device Ziehm Vision RFD 3D is a medical Fluoroscopic X-ray imaging device used to assist trained physicians in the X-ray visualization of anatomical regions of a patient. The system is a non-contact device and is not intended to be in contact with patient to perform its intended use. The system provides X-ray image data by means of X-ray technique while the physician performs medical procedures and stores the image data temporarily.

The Ziehm Vision RFD 3D is intended for use to provide 2D- and 3D-image data specifically but not limited in the field of orthopedics, traumatology and oral and maxillofacial surgery. Futhermore it is intended for use specifically but not limited to the imaging of soft tissues.

The modified subject device Ziehm Vision RFD 3D consists of two physical elements. The first referred to as the "C-Arm" of Mobile Stand (MS) because of its wheeled base and C-profile shaped image gantry; the second is referred to as the Monitor Cart (MC) because it provides real-time monitor displays for visualization and records of patient anatomy.

The modified Ziehm Vision RFD 3D employs the same fundamental control, and substantially equivalent scientific technology as that of our predicate device Ziehm Vision RFD 3D (K231701). Software architecture design is substantially equivalent to that of the predicate Ziehm Vision RFD 3D.

The provided text describes the Ziehm Vision RFD 3D, an image-intensified fluoroscopic X-ray system. However, it does not contain a specific table of acceptance criteria and reported device performance metrics in numerical form. The text primarily focuses on demonstrating substantial equivalence to a predicate device (K231701) through a software update and associated testing.

Here's a breakdown of the requested information based on the provided text, with "N/A" where the information is not explicitly stated in the document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a quantitative table of acceptance criteria or reported device performance for specific metrics like sensitivity, specificity, or accuracy. It states a qualitative criterion: "the image quality acquired with the test device is better or at least equal [to the predicate]."

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

• Sample size: Not explicitly stated. The text mentions "anthropomorphic as well as motion-induced phantoms."
• Data provenance: Not explicitly stated beyond the use of "anthropomorphic phantoms so-called 'sectional phantoms'" constructed with a natural human skeleton cast in urethane material. This suggests a laboratory-based phantom study rather than patient data from a specific country or retrospective/prospective study design.

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

• Number of experts: Not explicitly stated.
• Qualifications of experts: Not explicitly stated, though the conclusions are made "From a radiological point of view," implying review by individuals with radiological expertise.

4. Adjudication method for the test set

• Not explicitly stated. The evaluation was a comparison of image quality between the test device and the predicate.

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 is a medical imaging device and the study described is a comparison of image quality against a predicate device, not an AI efficacy study with human readers.

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

• Yes, in a sense. The image quality comparison was performed on images generated by the device itself (algorithm only, as it's an imaging system), and then subject to expert review as described in point 3.

7. The type of ground truth used

• The implicit ground truth was the image quality of the legally marketed predicate device (K231701). The study aimed to demonstrate that the image quality of the modified device was "better or at least equal" to this reference. The anthropomorphic phantoms serve as a reproducible standard for image acquisition comparison.

8. The sample size for the training set

• Not applicable. This is a medical imaging device undergoing a software update and comparison, not a machine learning model requiring a distinct training set.

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

• Not applicable. (See point 8.)

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The Ziehm Vision RFD is intended for use in providing medical imaging for adult and pediations, using pulsed and continuous fluoroscopic digital imaging, as well as digital subtraction and cine image capture during diagnostic interventional and surgical procedures where intra-operative imaging and visualization of complex anatomical structures of both lower and higher contrast density are required. Such procedures may include but are not limited to those of interventional cardiology, heart surgery, hybrid procedures, interventional radiology, interventional angiography, electrophysiology, pediatrics, endoscopic, urological, gastroenterology, orthopedic, maxillofacial surgery, neurology, neurosurgery, critical care, emergency room procedures visualizing structures of the cervical, thoracic, and lumber regions of the spine and joint fractures of the upper and lower extremities, and where digital image data is required for computer aided surgery procedures and whenever the clinician benefits from the high degree of geometric imaging accuracy, and where such fluoroscopic. cine and DSA imaging is required. The visualization of such anatomical structures assists the clinician in the clinical outcome.

This device does not support direct radiographic film exposures and is not intended for use in performing mammography. The system is not intended for use in any MRI environments.

The Ziehm Vision RFD employs X-rays as its imaging technology for visualizing human anatomy. The X-ray tube in the generator produces X-rays, quided toward the patient under control of the user at the direction who determines the specific clinical procedure. The images from the system assist the physicians in visualizing the patient's anatomy. This visualization helps to localize regions of pathology and for surgical procedures. The device provides both real-time image capture visualization and of in vivo surgical procedures and post-surgical outcomes.

The Ziehm Vision RFD mobile fluoroscopy system is a flat panel detector (FPD) and fluoroscopic X-ray imaging system consisting of two mobile units: a Mobile Stand (C-Arm) and a Monitor Cart/Workstation. The Mobile Stand is comprised of a mono-block high voltage generator, X-ray control, and a C-Profile which is "C" shaped and supports the X-ray generator, and the image receptor Flat Panel Detector (FPD).

The mobile stand supports the optional wireless footswitch for the surgeon by removing the cable on the floor. The Monitor Cart is a mobile platform that connects to the Mobile Stand by a cable, and which integrates the LCD flat panel display monitors, image processing, user controls and image recording devices. Interfaces provided for optional devices such as external monitors, thermal video printers video display, wireless video server, injector connection and image storage devices (USB, DVD) and DICOM fixed wired and wireless network interfaces.

The modified Ziehm Vision RFD employs the same fundamental control, and substantially equivalent scientific technology as that of our predicate device Ziehm Vision RFD (K240099). Software architecture design is substantially equivalent to that of the predicate Ziehm Vision RFD.

This submission is for a software update to an existing device, the Ziehm Vision RFD, and also introduces new hardware options like an 8-inch IGZO panel. The provided text does not include detailed acceptance criteria or a study proving the device meets them in the context of device performance metrics (e.g., sensitivity, specificity, accuracy).

Instead, the documentation focuses on demonstrating substantial equivalence to the predicate device (K240099) through compliance with regulatory standards, design controls, and software testing. It emphasizes that no new questions regarding safety or effectiveness are raised by the modifications.

Therefore, I cannot provide a table of acceptance criteria and reported device performance from the provided text, nor can I answer specific questions about sample size for test sets, data provenance, ground truth establishment, expert involvement, or MRMC studies for measuring improvement with AI assistance. These types of studies are not typically required for software updates to established fluoroscopic X-ray systems unless there are significant changes to the imaging capabilities that would impact diagnostic performance.

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

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

   • Acceptance Criteria: Not explicitly stated as performance metrics (e.g., sensitivity, specificity) in the provided text. The criteria are implied to be compliance with relevant safety, performance, and software standards, and that the modifications do not raise new questions of safety or effectiveness compared to the predicate.
   • Reported Device Performance: Not reported in terms of diagnostic effectiveness. The document states that "system functionality is consistent with the user needs, intended uses, and performs as designed."

2. Sample size used for the test set and the data provenance: Not mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned, as performance evaluation against ground truth (in a diagnostic sense) is not described.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not mentioned.

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 mentioned. The device is an image-intensified fluoroscopic X-ray system, not an AI-powered diagnostic algorithm designed to assist human readers in image interpretation. While it includes "Image Insights" overlay and other features, the submission does not frame it as an AI-assissted diagnostic tool requiring MRMC studies for human reader improvement.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not mentioned. No standalone algorithm performance is discussed.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not mentioned.

8. The sample size for the training set: Not mentioned.

9. How the ground truth for the training set was established: Not mentioned.

Ask a specific question about this device

The Ziehm Vision RFD is intended for use in providing medical imaging for adult and pediatric populations, using pulsed and continuous fluoroscopic digital imaging, as well as digital subtraction and cine image capture during diagnostic interventional and surgical procedures where intraoperative imaging and visualization of complex anatomical structures of both lower and higher contrast density are required. Such procedures may include but are not limited to those of interventional cardiology, heart surgery, hybrid procedures, interventional radiology, interventional angiography, electrophysiology, pediatrics, endoscopic, urological, gastroenterology, orthopedic, maxillofacial surgery, neurosurgery, critical care, emergency room procedures, and those procedures visualizing structures of the cervical, thoracic, and lumber regions of the spine, and joint fractures of the upper and lower extremities, and where digital image data is required for computer aided surgery procedures and whenever the clinician benefits from the high degree of geometric imaging accuracy, and where such fluoroscopic, cine and DSA imaging is required. The visualization of such anatomical structures assists the clinician in the clinical outcome.

This device does not support direct radiographic film exposures and is not intended for use in performing mammography. The system is not intended for use in all MRI environments.

The Ziehm Vision RFD employs X-rays as its imaging technology for visualizing human anatomy. The X-ray tube in the generator produces X-rays, guided toward the patient under control of the user at the direction of a physician who determines the specific clinical procedure. The images from the system assist the physicing the patient's anatomy. This visualization helps to localize regions of pathology and for surgical procedures. The device provides both real-time image capture visualization and of in vivo surgical procedures and post-surgical outcomes.

The Ziehm Vision RFD mobile fluoroscopy system is a flat panel detector (FPD) and fluoroscopic X-ray imaging system consisting of two mobile units: a Mobile Stand (C-Arm) and a Monitor Cart/Workstation. The Mobile Stand is comprised of a mono-block high voltage generator, X-ray control, and a C-Profile which is "C" shaped and supports the X-ray generator, and the image receptor Flat Panel Detector (FPD).

The mobile stand supports the optional wireless footswitch for the surgeon by removing the cable on the floor. The Monitor Cart is a mobile platform that connects to the Mobile Stand by a cable, and which integrates the LCD flat panel display monitors, image processing, user controls and image recording devices. Interfaces provided for optional perioheral devices such as external monitors, thermal video printers, wireless video server, injector connection and image storage devices (USB, DVD) and DICOM fixed wired and wireless network interfaces.

The proposed modified Ziehm Vision RFD employs the same fundamental control, and substantially equivalent scientific technology as that of our predicate device Ziehm Vision RFD (K231692). Software architecture design is substantially equivalent to that of the predicate Ziehm Vision RFD.

The provided text is a 510(k) summary for a medical device (Ziehm Vision RFD). It describes the device, its intended use, and states that verification and validation testing was conducted. However, it does not contain the specific details required to answer your questions about acceptance criteria and a study proving the device meets those criteria.

Here's why and what information is missing:

• Acceptance Criteria and Reported Device Performance: The document states that "Verfication and Validation testing were successfully conducted..." and "No new non-clinical image comparison with sets of images with the modified device and the predicate have been performed, the device equivalent regarding image quality." This implies that there were performance criteria related to image quality and other aspects, but the actual criteria (e.g., specific metrics like SNR, spatial resolution, contrast-to-noise ratio) and the reported numerical performance against these criteria are not provided.
• Sample Size, Ground Truth, Adjudication, MRMC, Standalone Study, Training Set Details: The document is primarily focused on demonstrating substantial equivalence to a predicate device due to a software update (operating system upgrade). It does not describe a clinical study of the device's diagnostic performance in the way you've outlined. The "Software testing" and "Cybersecurity testing" mentioned are about the software functionality and security, not diagnostic efficacy or accuracy in interpreting medical images.

Therefore, based solely on the provided text, I cannot complete your request. The information about the specific performance study you're asking for is not present in this 510(k) summary.

In a typical scenario where a device is evaluated for diagnostic accuracy (e.g., an AI-powered diagnostic tool), the 510(k) summary or accompanying documentation would include the details you're looking for. For a device like the Ziehm Vision RFD, which is an imaging system (fluoroscopic X-ray system), performance evaluations typically focus on technical imaging parameters (e.g., image quality, dose, resolution) and overall system functionality and safety, rather than a diagnostic accuracy study with a "ground truth" and "experts" in the way an AI diagnostic algorithm would be evaluated.

If you had a document describing a clinical performance study (e.g., a "Clinical Data Summary" or "Performance Testing Report") for this device, it would likely contain the information you're seeking.

Ask a specific question about this device

The Ziehm Vision RFD is intended for use in providing medical imaging for adult and pediatric populations, using pulsed and continuous fluoroscopic digital imaging, as well as digital subtraction and cine image capture during diagnostic interventional and surgical procedures where intraoperative imaging and visualization of complex anatomical structures of both lower and higher contrast density are required. Such procedures may include but are not limited to those of interventional cardiology, heart surgery, hybrid procedures, interventional radiology, interventional angiography, electrophysiology, pediatrics, endoscopic, urological, gastroenterology, orthopedic, maxillofacial surgery, neurosurgery, critical care, emergency room procedures, and those procedures visualizing structures of the cervical, thoracic, and lumber regions of the spine and joint fractures of the upper and lower extremities, and where digital image data is required for computer aided surgery procedures and whenever the clinician benefits from the high degree of geometric imaging accuracy, and where such fluoroscopic, cine and DSA imaging is required. The visualization of such anatomical structures assists the clinician in the clinical outcome.

This device does not support direct radiographic film exposures and is not intended for use in performing mammography. The system is not intended for use near MRI systems.

The Ziehm Vision RFD mobile fluoroscopy system is a flat panel detector (FPD) and fluoroscopic X-ray imaging system consisting of two mobile units: a Mobile Stand (C-Arm) and a Monitor Cart/Workstation. The Mobile Stand is comprised of a mono-block high voltage generator, X-ray control, and a C-Profile which is "C" shaped and supports the X-ray generator, and the image receptor Flat Panel Detector (FPD). The mobile stand supports the optional wireless footswitch for optimum positioning for the surgeon by removing the cable on the floor. The Monitor Cart is a mobile platform that connects to the Mobile Stand by a cable, and which integrates the LCD flat panel display monitors, image processing, user controls and image recording devices. Interfaces provided for optional peripheral devices such as external monitors, thermal video printers, wireless video display, wireless video server, injector connection and image storage devices (USB, DVD) and DICOM fixed wired and wireless network interfaces.

The document provided describes the Ziehm Vision RFD, an image-intensified fluoroscopic X-ray system. The submission (K231692) is for a modified version of a previously cleared device (K203428). The key modification is the addition of a new 12-inch IGZO (Indium gallium zinc oxide) flat panel detector (FPD) to the existing a-Si and CMOS FPD options.

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 submission declares "substantial equivalence" to the predicate device (K203428). This implies that the new device is intended to meet or exceed the performance of the predicate device, especially regarding image quality, safety, and effectiveness. The acceptance criteria are primarily based on established regulatory standards and guidance, with comparative performance against the predicate.

For the new IGZO detector, the performance is reported as an improvement in resolution compared to aSi detectors.

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

The document states: "Non-clinical image comparison with sets of images with the modified device and the predicate shows equivalence regarding image quality." and "Anatomical simulation phantoms were employed, image comparison sets taken were representative of both the adult and pediatric populations."

• Sample Size for Test Set: Not explicitly stated regarding the number of images or cases. It mentions "sets of images" and "anatomical simulation phantoms."
• Data Provenance: "Non-clinical image and dose Lab testing." The country of origin for the data is not specified. It appears to be prospective data generated specifically for this submission through lab testing on phantoms.

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

The document states: "A Radiologist performed an assessment of individual image sets. Radiologist conclusion, the image quality of the Ziehm Vision RFD results in a comparable patient care to the Predicate device Ziehm Vision RFD (K203428) and fulfils the requirements as stated by the intended use."

• Number of Experts: "A Radiologist" (singular).
• Qualifications of Experts: Assumed to be a qualified radiologist, but specific years of experience or specialization are not detailed.

4. Adjudication method for the test set

The document mentions "A Radiologist performed an assessment" and provided a "conclusion." It does not specify any formal adjudication method like 2+1 or 3+1. It appears to be a single-reader assessment.

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 describe a multi-reader multi-case (MRMC) comparative effectiveness study, nor does it refer to AI or human reader improvement with AI assistance. The device is an X-ray system, and the study focuses on the image quality and performance compared to a predicate device, not on diagnostic aids or AI.

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

This refers to an X-ray imaging system, not an algorithm. The assessment described in the document is about the physical device's performance (image quality, dose, safety) as a standalone imaging system.

7. The type of ground truth used

The "ground truth" for image quality assessment was established through:

• Expert Consensus / Assessment: A radiologist's assessment of image sets.
• Performance Metrics: Objective measurements such as DQE, MTF, pixel size, and system resolution (Nyquist) for the detectors.
• Phantom Studies: Use of anatomical simulation phantoms.
• Compliance with Standards: Meeting criteria defined by various IEC, ANSI, and 21 CFR standards.

8. The sample size for the training set

The document does not mention a "training set" as this device is an X-ray system and not an AI/ML algorithm that requires training data in the typical sense. The development and verification processes involve extensive testing and compliance with standards, but not a distinct "training set" for an algorithm.

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

As there is no mention of a "training set" in the context of an AI/ML device, this question is not applicable based on the provided text. The device is a hardware X-ray system with integrated software for image acquisition and processing.

Ask a specific question about this device

The Ziehm Vision RFD 3D system is intended for use in providing both 2D and 3D pulsed and continuous fluoroscopic medical imaging for adult and pediatric populations.

The device provides 2D medical imaging for fluoroscopy, digital subtraction, and acquisition of cine loops during diagnostic interventional and surgical procedures where intra-operative imaging and visualization of complex anatomical structures of both lower and higher contrast density are required. Such procedures may include but are not limited to those of interventional cardiology, heart surgery, hybrid procedures, interventional radiology, interventional angiography, electrophysiology, pediatrics, endoscopic, urological, gastroenterology, orthopedic, maxillofacial surgery, neurology, neurosurgery, critical care, emergency room procedures, and those procedures visualizing structures of the cervical, thoracic, and lumbar regions of the spine and joint fractures of the upper and lower extremities, and where digital image data is required for Computer-Assisted Surgery procedures.

The device is also intended to provide 3D medical imaging of patients during orthopedic, neurological, intra-operative surgical procedures and where the clinician benefits from 3D visualization of complex anatomical structures, such as but not limited to those of high contrast objects, bones, joints, maxillofacial, cervical, thoracic, and lumbar regions of the spine, pelvis, acetabulum and joint fractures of the upper and lower extremities, and where digital image and Carm positioning data is required for Computer-Assisted Surgery procedures.

The visualization of such anatomical structures assists the clinical outcome. This device does not support direct radiographic film exposures and is not intended for use in performing mammography. The system is not intended for use near MRI systems.

The device Ziehm Vision RFD 3D is a medical Fluoroscopic X-ray imaging device used to assist trained physicians in the X-ray visualization of anatomical regions of a patient. The system is a non-contact device and is not intended to be in contact with patient to perform its intended use. The system provides X-ray image data by means of X-ray technique while the physician performs medical procedures and stores the image data temporarily.

The device Ziehm Vision RFD 3D consists of two physical elements. The first referred to as the "C-Arm" or Mobile Stand (MS) because of its wheeled base and C-profile shaped is referred to as the Monitor Cart (MC) because it provides real-time monitor displays for visualization and records of patient anatomy.

The provided text is a 510(k) summary for the Ziehm Vision RFD 3D, and it primarily focuses on establishing substantial equivalence to a predicate device due to a software update. It does not contain the detailed information required to describe acceptance criteria, performance studies, ground truth establishment, or human reader studies.

Specifically, the document states:

• "The key modification pertains to an updated release of the software, which incorporates an operating system upgrade from Ubuntu 16.04 to Ubuntu 20.04."
• "Ziehm Vision RFD 3D is based on the direct modifications to cleared predicate devices Ziehm Vision RFD 3D (K202360); The design changes were completed in accordance with Ziehm Imaging GmbH Quality Management System Design Controls and Engineering, standards compliance, and Verification and Validation testing were successfully conducted on the Ziehm Vision RFD 3D. Further compliance testing for the modified device to all FDA requirements as stated in 'Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices' as applicable including software risk hazards was done. Tests performed on the Ziehm Vision RFD 3D, demonstrated that the device is safe and effective, performs comparably to the predicate devices, and substantially equivalent to the predicate devices."

This indicates that the submission is for a minor software update on an already cleared device. The focus is on demonstrating that the updated software does not negatively impact the existing performance and safety, rather than presenting a new clinical performance study for a novel AI algorithm or a significant hardware change.

Therefore, I cannot provide the requested information from the provided document because it is not present. The document focuses on regulatory compliance for a software update rather than detailed performance study results that would typically be required for a new or significantly modified AI-powered medical device.

To answer your specific questions based on the absence of this information in the provided text:

1. A table of acceptance criteria and the reported device performance: Not provided. The document states "Tests performed on the Ziehm Vision RFD 3D, demonstrated that the device is safe and effective, performs comparably to the predicate devices..." but does not list specific performance metrics or acceptance criteria.
2. Sample size used for the test set and the data provenance: Not provided. No specific test set or data provenance details are mentioned beyond general "Verification and Validation testing."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided. The concept of "ground truth" as typically used in AI/image analysis studies is not discussed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not provided.
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 provided. This scenario (AI assistance to human readers) is not described or studied in the document.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not provided. The device is an imaging system, not an AI algorithm for image analysis per se.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not provided.
8. The sample size for the training set: Not applicable/Not provided. This is a software update for an imaging device; there is no mention of an "AI training set" in the context of this submission.
9. How the ground truth for the training set was established: Not applicable/Not provided.

Ask a specific question about this device

The Ziehm Vision RFD is intended for use in providing medical imaging for adult and pediatric populations, using pulsed and continuous fluoroscopic digital imaging, as well as digital subtraction and cine image capture during diagnostic interventional and surgical procedures where intra-operative imaging and visualization of complex anatomical structures of both lower and higher contrast density are required. Such procedures may include but are not limited to those of interventional cardiology, heart surgery, hybrid procedures, interventional radiology, interventional angiography, electrophysiology, pediatrics, endoscopic, urological, gastroenterology, orthopedic, maxillofacial surgery, neurology, neurosurgery, critical care, emergency room procedures, and those procedures visualizing structures of the cervical, thoracic, and lumber regions of the spine, and joint fractures of the upper and lower extremities, and where digital image data is required for computer aided surgery procedures and whenever the clinician benefits from the high degree of geometric imaging accuracy, and where such fluoroscopic, cine and DSA imaging is required. The visualization of such anatomical structures assists the clinician in the clinical outcome.

This device does not support direct radiographic film exposures and is not intended for use in performing mammography. The system is not intended for use near MRI systems.

The ZIEHM VISION RFD employs X-rays as its imaging technology for visualizing human anatomy. The X-ray tube in the generator produces Xrays, quided toward the patient under control of the user at the direction of a physician who determines the specific clinical procedure. The images from the system assist the physicians in visualizing the patient's anatomy. This visualization helps to localize regions of pathology and for surgical procedures. The device provides both real-time image capture and post capture visualization and of in vivo surgical procedures and post-surgical outcomes.

The Ziehm Vision RFD mobile fluoroscopy system is a flat panel detector (FPD) Computed tomography x-ray system and fluoroscopic X-ray imaging system consisting of two mobile units: a Mobile Stand (C-Arm) and a Monitor Cart/Workstation. The Mobile Stand is comprised of a mono-block high voltage generator, X-ray control, and a C-Profile which is "C" shaped and supports the X-ray generator, and the image receptor Flat Panel Detector (FPD).

Motorization of vertical axis as well as manual or optionally motorized three axes provides the user/operator the option to use manual or motorized linear and rotational movements of the C- Profile for positioning of the imaging components at various angles and distances with respect to the patient using a control interface, Vision Center, Remote Vision Center or remote Position Control Center.

The motorization of the 4 axes provides the user an alternative for visualizing anatomical structures using a variable iso-centric location. The system working with a variable iso-center allows freely selectable positions of patient anatomy. The variable iso-center and distance control ensures that anatomical structures are safely visualized from different angles without re-adjusting the C-arm or moving the patient. The iso-center is not restricted to orbital movements and can hold this iso-center during angulations and vertical travel using the 4 motorized axes.

The Distance Control surface detection integrated around the lower edge of the flat panel detects objects, such as patients. When the flat panel approaches an object, the device reduces speed, slowing the motorized movement. The movement stops immediately before entering a defined safety zone.

The mobile stand supports the optional wireless footswitch for optimum positioning for the surgeon by removing the cable on the floor.

The Monitor Cart is a mobile platform that connects to the Mobile Stand by a cable, and which integrates the LCD flat panel display monitors, image processing, user controls and image recording devices. Interfaces provided for optional peripheral devices such as external monitors, thermal video printers, wireless video display, wireless video server, injector connection and image storage devices (USB, DVD) and DICOM fixed wired and wireless network interfaces.

The provided text describes a 510(k) premarket notification for the Ziehm Vision RFD, an image-intensified fluoroscopic x-ray system. The document focuses on demonstrating substantial equivalence to a legally marketed predicate device (K132904), rather than detailing specific acceptance criteria and a standalone human reader study with quantitative metrics for AI performance.

Therefore, many of the requested details about acceptance criteria, specific performance metrics, sample sizes, expert qualifications, and ground truth establishment for an AI-driven device are not explicitly present in this regulatory submission. This document primarily focuses on demonstrating that the modified device (Ziehm Vision RFD) is substantially equivalent to its predicate device (also Ziehm Vision RFD, K132904), which is a conventional fluoroscopic x-ray system, not an AI-assisted one in the typical sense of a diagnostic AI algorithm.

However, I can extract the information provided that is relevant to "device acceptance criteria" in broad terms and the "study" (non-clinical testing) that supports these criteria for this imaging device.

Here's an interpretation based on the provided text:

Device Name: Ziehm Vision RFD (Modified)

Type of Device: Image-intensified fluoroscopic x-ray system (medical imaging device)

Acceptance Criteria (Interpreted from the document's focus on substantial equivalence and safety/performance):

The primary "acceptance criterion" for this 510(k) submission is demonstrating substantial equivalence to the predicate device (Ziehm Vision RFD, K132904) in terms of:

• Indications for Use
• Technological Characteristics (including x-ray generator, image detector, controls, and software architecture)
• Safety and Effectiveness (including radiation safety, electrical safety, electromagnetic compatibility, and image quality).

Given this context, the performance is generally described in relation to the predicate, with a focus on maintaining or improving upon key aspects without introducing new safety or effectiveness concerns.

• Enhanced Vessel Visualization (Option): New function not present in predicate. No specific performance criterion mentioned, but deemed to not raise new questions of safety/effectiveness.
• 2D Measurement Function (within AMT Option): New function not present in predicate (predicate only had "Mark anatomical structures"). Deemed similar to predicate's general functionality and not raising new safety/effectiveness questions.
  Data Organization (Radiation Dose): New features for "Calculated Dose Area Product (DAP) value tagged to stored image" and "Air Kerma dose display/value tagged to stored image". These features "improve the clinician's ability to obtain more information as to the dose for each image" and are therefore an improvement over the predicate, supporting substantial equivalence.
  Software: Architecture "nearly identical" with modifications to support new features (Enhanced Vessel Visualization, 2D measurement). |
  | Safety and Performance| Compliance with relevant FDA regulations, recognized consensus standards (e.g., IEC 60601 series, ANSI/AAMI ES60601-1, ISO 14971), and FDA guidance documents. Risk analysis and verification/validation testing should confirm designed performance and not raise new safety/effectiveness concerns. Image quality should be "comparable" to the predicate. | Demonstrated compliance with:
  • 21 CFR 1020.30-32 (Federal Performance Standard for Diagnostic X-ray Systems)
  • ANSI/AAMI ES60601-1 (Electrical Safety)
  • IEC 60601-1-2 (EMC)
  • IEC 60601-1-3 (Radiation Protection)
  • IEC 60601-1-6 (Usability)
  • IEC 60601-2-43 (X-ray for interventional procedures)
  • IEC 60601-2-54 (X-ray for radiography and radioscopy)
  • IEC 60825-1 (Laser Safety)
  • ISO 14971 (Risk Management)
  • FDA guidance documents for diagnostic X-ray systems, wireless technology, interoperable devices, solid-state X-ray imaging devices, pediatric medical devices, and software in medical devices.

Image Quality: "Non-clinical image comparison with sets of images with the modified device and the predicate shows equivalence regarding image quality."
Dose: "An assessment regarding the low dose functionality of the modified Ziehm Vision RFD shows the ability to reduce dose for certain applications." "Non-clinical imaging and dose testing methods demonstrated the device capability to provide both reduced dose while maintaining image quality." |

Study Proving Device Meets Acceptance Criteria (Non-Clinical Testing):

The document explicitly states: "Summary of Non-Ziehm Vision RFD is based on direct modifications to cleared predicate device Clinical Test Data: Ziehm Vision RFD (K132904)." This means they did not perform new clinical studies but relied on bench testing and comparisons to the predicate.

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

   • Test Set Description: "Non-clinical image and dose Lab testing, were employed."
   • Data Provenance: Not explicitly stated (e.g., country of origin), but implies lab-based, phantom testing.
   • Sample Size:
     • "Anthropomorphic (PMMA material) phantoms and anatomical simulation phantoms were employed."
     • "image comparison sets taken were representative of both the adult and pediatric populations."
     • Specific number of phantoms or images is NOT provided.

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

   • Number of Experts: "A Radiologist performed an assessment of individual image sets." (Implies one radiologist)
   • Qualifications of Experts: "A Radiologist" - no further details provided regarding experience, subspecialty, or board certification.

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

   • "A Radiologist performed an assessment of individual image sets." This suggests no formal adjudication among multiple readers was performed for the non-clinical image comparison. It was a single-reader assessment.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • NO. An MRMC study was not performed as this is a traditional imaging device, not an AI-assisted diagnostic algorithm in the sense of comparing human performance with and without AI. The comparison was for image quality equivalence between the modified device and its predicate.

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

   • N/A. This is a hardware/software imaging system, not a standalone AI algorithm that performs a diagnostic task. Its "performance" is in generating images and enabling certain features, not in making a call by itself. The "Enhanced Vessel Visualization" is an imaging feature, not a standalone diagnostic AI.

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

   • For image quality comparison: Radiologist assessment of images acquired from anthropomorphic and anatomical simulation phantoms. This is a form of expert assessment of image quality based on known phantom characteristics, rather than true clinical ground truth (like a biopsy or outcome).

7. The sample size for the training set:

   • N/A. This approval is for an imaging system, not a machine learning model that requires a "training set" in the typical ML sense. The software modifications are described as supporting "functionality, image processing applications related to the optional device specific features," implying traditional software development and image processing rather than deep learning.

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

   • N/A. As above, no training set for a machine learning model is mentioned or implied.

Ask a specific question about this device

The Ziehm Vision RFD 3D system is intended for use in providing both 2D and 3D pulsed and continuous fluoroscopic medical imaging for adult and pediatric populations.

The device provides 2D medical imaging for fluoroscopy, digital subtraction, and acquisition of cine loops during diagnostic interventional and surgical procedures where intra-operative imaging and visualization of complex anatomical structures of both lower and higher contrast density are required. Such procedures may include but are not limited to those of interventional cardiology, heart surgery, hybrid procedures, interventional angiography, electrophysiology, pediatrics, endoscopic, urological, gastroenterology, orthopedic, maxillofacial surgery, neurology, neurosurgery, critical care, emergency room procedures visualizing structures of the cervical, thoracic, and lumbar regions of the spine and joint fractures of the upper and lower extremities, and where digital image data is required for Computer-Assisted Surgery procedures.

The device is also intended to provide 3D medical imaging of patients during orthopedic, neurological, intra-operative surgical procedures and where the clinician benefits from 3D visualization of complex anatomical structures, such as but not limited to those of high contrast objects, bones, joints, maxillofacial, cervical, thoracic, and lumbar regions of the spine, pelvis, acetabulum and joint fractures of the upper and lower extremities, and where digital image and C-arm positioning data is required for Computer-Assisted Surgery procedures.

The visualization of such anatomical structures assists the clinical outcome. This device does not support direct radiographic film exposures and is not intended for use in performing mammography. The system is not intended for use near MRI systems.

The ZIEHM VISION RFD 3D employs X-rays as its imaging technology for visualizing human anatomy in both 2D and 3D imaging. The Xray tube in the generator produces X-rays, quided toward the patient under control of the user at the direction of a physician who determines the specific clinical procedure. The images from the system assist the physicians in visualizing the patient's anatomy. This visualization helps to localize regions of pathology and for surgical procedures. The device provides both real-time image capture and post capture visualization and of in vivo surgical procedures and post-surgical outcomes.

The Ziehm Vision RFD 3D mobile fluoroscopy system is a flat panel detector (FPD) Computed tomography x-ray system and fluoroscopic X-ray imaging system consisting of two mobile units: a Mobile Stand (C-Arm) and a Monitor Cart/Workstation. The Mobile Stand is comprised of a mono-block high voltage generator, X-ray control, and a C-Profile which is "C" shaped and supports the X-ray generator, and the image receptor Flat Panel Detector (FPD).

The device performs both 2D medical imaging and the specialized 4 axes of motorized movement necessary for the 3D imaging. This provides the user/operator the option to use manual or motorized linear and rotational movements of the C- Profile for positioning of the imaging components at various angles and distances with respect to the patient using a control interface, Vision Center, Remote Vision Center or remote Position Control Center.

The motorization of the 4 axes provides the user an alternative for visualizing anatomical structures using a variable iso-centric location. The system working with a variable iso-center allows freely selectable positions of patient anatomy. The variable iso-center and distance control ensures that anatomical structures are safely visualized from different angles without re-adjusting the C-arm or moving the patient. The iso-center is not restricted to orbital movements and can hold this iso-center during angulations and vertical travel using the 4 motorized axes. This same motion control provides the bases for 3D views of the patient anatomy. These 3D views are generated by means of an iterative algorithm. The system uses the images of a scan captured with relation to a predefined scan center to compute the three-dimensional representation of an object. The 3D views are always displayed on the reference screen of the monitor cart. It is possible to display multiplanar reconstructions, orthogonal or freely selectable sections, and different surface reconstructions.

The Distance Control surface detection integrated around the lower edge of the flat panel detects objects, such as patients. When the flat panel approaches an object, the device reduces speed, slowing the motorized movement. The movement stops immediately before entering a defined safety zone.

The mobile stand supports the optional wireless footswitch for optimum positioning for the surgeon by removing the cable on the floor.

The Monitor Cart is a mobile platform that connects to the Mobile Stand by a cable, and which integrates the LCD flat panel display monitors, 2D image processing, Optional 3D image processing, user controls and image recording devices. Interfaces provided for optional peripheral devices such as external monitors, thermal video printers, wireless video display, wireless video server, injector connection and image storage devices (USB, DVD) and DICOM fixed wired and wireless network interfaces.

The provided text is a 510(k) Premarket Notification for the Ziehm Vision RFD 3D system. This document is a summary demonstrating substantial equivalence to a predicate device (K142740), rather than a detailed report of a clinical study designed to measure specific performance criteria with acceptance thresholds.

Therefore, the document does not contain the direct acceptance criteria or a detailed study report with quantitative performance metrics for the device's image quality or clinical efficacy in the format requested.

Instead, it relies on demonstrating that the modified device's performance, particularly image quality and dose, is comparable to the predicate device and meets relevant regulatory standards. The "study" mentioned is primarily non-clinical bench testing and image comparison rather than a multi-reader, multi-case (MRMC) clinical efficacy trial or a standalone AI performance study.

Here's an attempt to extract and infer information based on the provided text, while highlighting what is not present:

Acceptance Criteria and Device Performance Study

The provided 510(k) summary does not outline specific, quantitative acceptance criteria in the format of a table with numerical thresholds for performance (e.g., minimum sensitivity, AUC, or Dice scores). Since this is a submission demonstrating substantial equivalence to a predicate device (K142740), the "acceptance criteria" are implicitly met by demonstrating that the modified device performs comparably to the predicate and complies with relevant safety and performance standards.

The "study" conducted for performance evaluation was primarily non-clinical bench testing and image comparison, not a large-scale clinical trial.

1. Table of Acceptance Criteria and Reported Device Performance

As noted, explicit quantitative acceptance criteria for image quality or clinical performance are not stated in this 510(k) summary. The "performance" assessment is based on comparability to the predicate device and compliance with general radiographic performance standards.

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

• Test Set Sample Size: Not explicitly stated as a numerical count of cases/patients. "Sets of images" were used for non-clinical image comparison. For the dose and image quality assessment, "Anthropomorphic (PMMA material) phantoms and anatomical simulation phantoms were employed."
• Data Provenance: The data appears to come from non-clinical bench testing in a controlled lab environment, likely in Germany (where Ziehm Imaging GmbH is located) or at certified testing facilities. It is retrospective in the sense that it's performed on phantoms and not derived from new clinical patient studies. No mention of country of origin for clinical patient data, as this was not a clinical trial.

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

• Number of Experts: "A Radiologist performed an assessment of individual image sets." This implies one radiologist.
• Qualifications: "A Radiologist." No specific details on years of experience or sub-specialty are provided in this summary.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable or not specified beyond a single radiologist's assessment. There is no mention of consensus reading, 2+1, or 3+1 methods, typically used in multi-reader studies.

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

• No, an MRMC comparative effectiveness study was NOT done. The document explicitly states "Non-clinical image comparison... shows equivalence regarding image quality." The assessment was performed by "A Radiologist." There is no mention of multiple readers or a comparative study measuring how human readers improve with or without AI assistance, as this is an imaging device, not an AI-assisted diagnostic tool.

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

• This question is not applicable in the context of this 510(k). The device is an X-ray fluoroscopic system, not an AI algorithm intended for standalone diagnostic performance. The "algorithm" refers to iterative reconstruction for 3D views, which is an intrinsic part of the image generation process, not a separate diagnostic algorithm.

7. The Type of Ground Truth Used

• For Image Quality: The ground truth for image quality was established by a Radiologist's assessment of image sets from anthropomorphic phantoms and anatomical simulation phantoms, comparing them to images from the predicate device. This is a form of "expert qualitative assessment" on phantom data simulating real anatomy, rather than ground truth from pathology, outcomes data, or deep consensus of multiple experts on patient cases.

8. The Sample Size for the Training Set

• Not applicable / Not explicitly stated. This device is an X-ray imaging system. While it uses digital image processing and potentially iterative reconstruction algorithms for 3D views, the document does not describe it as an AI/ML device in the sense of requiring a "training set" for a learning algorithm that generates diagnostic outputs. The underlying "algorithms" (e.g., for 3D reconstruction) are likely deterministic or model-based, not machine learning algorithms trained on large datasets.

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

• Not applicable. As above, no "training set" is described for this device in the context of AI/ML.

Ask a specific question about this device

The Ziehm Vision RFD 3D system is intended for use in providing both 2D and 3D medical imaging for all adult and pediatric populations, using pulsed and continuous fluoroscopic imaging.

The device provides 2D medical imaging for fluoroscopy, digital subtraction, and acquisition of cine loops during diagnostic interventional and surgical procedures where intra-operative imaging and visualization of complex anatomical structures of both lower and higher contrast density are required. Such procedures may include but are not limited to those of interventional cardiology, heart surgery, hybrid procedures, interventional radiology, interventional angiography, electrophysiology, pediatrics, endoscopic, urological, gastroenterology, orthopedic, maxillofacial surgery, neurosurgery, critical care, emergency room procedures, and those procedures visualizing structures of the cervical, thoracic, and lumbar regions of the spine and joint fractures of the upper and lower extremities, and where digital image data is required for Computer-Assisted Surgery procedures.

The device is also intended to provide 3D medical imaging of patients during orthopedic, neurological, intra-operative surgical procedures and where the clinician benefits from 3D visualization of complex anatomical structures, such as but not limited to those of high contrast objects, bones, joints, maxillofacial, cervical, thoracic, and lumbar regions of the spine, pelvis, acetabulum and joint fractures of the upper and lower extremities, and where digital image and C-arm positioning data is required for Computer-Assisted Surgery procedures.

The visualization of such anatomical structures assists the clinical outcome. At the discretion of a physician, the device may be used for other imaging applications. This device does not support direct radiographic film exposures and is not intended for use in performing mammography. The system is not intended for use near MRI systems.

The ZIEHM VISION RFD 3D employs X-rays as its imaging technology for visualizing human anatomy in both 2D and 3D imaqing. The X-ray tube in the generator produces X-rays, quided toward the patient under control of the user at the direction of a physician who determines the specific clinical procedure. The images from the system assist the physicians in visualizing the patient's anatomy. This visualization helps to localize regions of pathology and for surgical procedures. The device provides both real-time image capture and post capture visualization and of in vivo surgical procedures and post-surgical outcomes.

The Ziehm Vision RFD 3D mobile fluoroscopy system is a flat panel detector (FD) Computed tomography x-ray system and fluoroscopic X-ray imaging system consisting of two mobile units: a Mobile Stand (C-Arm) and a Monitor Cart/Workstation. The Mobile Stand is comprised of a mono-block high voltage generator, X-ray control, and a C-Profile which is "C" shaped and supports the X-ray generator, and the image receptor Flat Panel Detector (FD).

The device performs both 2D medical imaging and the specialized 4 axes of motorized movement necessary for the 3D imaging. This provides the user/operator the option to use manual or motorized linear and rotational movements of the C- Profile for positioning of the imaging components at various angles and distances with respect to the patient using a control interface, Vision Center, Remote Vision Center or remote Position Control Center.

The motorization of the 4 axes provides the user an alternative for visualizing anatomical structures using a variable iso-centric location. The system working with a variable iso-center allows freely selectable positions of patient anatomy. The variable isocenter and distance control ensures that anatomical structures are safely visualized from different angles without re-adjusting the Carm or moving the patient. The iso-center is not restricted to orbital movements and can hold this iso-center during angulations and vertical travel using the 4 motorized axes. This same motion control provides the bases for 3D views of the patient anatomy. These 3D views are generated by means of an iterative algorithm.

The system uses the images of a scan captured with relation to a predefined scan center to compute the three-dimensional representation of an object. The 3D views are always displayed on the reference screen of the monitor cart. It is possible to display multiplanar reconstructions, orthogonal or freely selectable sections, and different surface reconstructions.

The Distance Control surface detection integrated around the lower edge of the flat panel detects objects, such as patients. When the flat panel approaches an object, the device reduces speed, slowing the motorized movement. The movement stops immediately before entering a defined safety zone.

The mobile stand supports the optional wireless footswitch for optimum positioning for the surgeon by removing the cable on the floor.

The Monitor Cart is a mobile platform that connects to the Mobile Stand by a cable, and which integrates the LCD flat panel display monitors, 2D image processing, Optional 3D image processing, user controls and image recording devices. Interfaces provided for optional peripheral devices such as external monitors, thermal video printers, wireless video display, wireless video server, injector connection and image storage devices (USB, DVD) and DICOM fixed wired and wireless network interfaces.

The provided document is a 510(k) summary for the Ziehm Vision RFD 3D. While it details the device's indications for use, technological characteristics, and comparison to predicate devices, it does not contain information regarding a specific clinical study with acceptance criteria and reported device performance related to diagnostic accuracy or clinical outcomes.

The "Summary of Non-Clinical Test Data" section primarily focuses on:

• Compliance with internal functional specifications, design controls, and engineering standards.
• Verification and validation testing.
• Non-clinical image comparisons with predicate devices (Ziehm Vision RFD K132904 and Ziehm Vision2 FD Vario 3D K073346).
• Software verification/validation testing aligning with FDA guidance.
• Compliance with federal performance standards for X-Ray Fluoroscopic equipment (21 CFR 1020.30-32) and relevant voluntary safety standards (IEC standards).

Therefore, I cannot provide the specific information requested in the format of the questions, as the document primarily addresses substantial equivalence based on technological characteristics and compliance with safety and performance standards for an imaging device, rather than a clinical study evaluating diagnostic performance against predefined acceptance criteria for a specific clinical task.

Specifically, the document does not include:

1. A table of acceptance criteria and reported device performance from a clinical study.
2. Sample size used for a test set or data provenance for a clinical study.
3. Number of experts or their qualifications for establishing ground truth in a clinical study.
4. Adjudication method for a clinical study.
5. Information about a multi-reader multi-case (MRMC) comparative effectiveness study, or effect sizes for AI assistance.
6. Results of a standalone algorithm performance without human-in-the-loop.
7. The type of ground truth used for a clinical study.
8. Sample size for a training set.
9. How ground truth for a training set was established.

The document's purpose is to demonstrate substantial equivalence to predicate devices based on technical specifications and non-clinical testing, not to present the results of a clinical performance study with specific acceptance criteria for diagnostic accuracy.

Ask a specific question about this device

The ZIEHM VISION RFD is intended for use in providing medical imaging, using pulsed and continuous fluoroscopic digital imaging, as well as digital subtraction and cine image capture during diagnostic interventional and surgical procedures where intra-operative imaging and visualization of complex anatomical structures of both lower and higher contrast density are required. Such procedures may include but are not limited to those of interventional cardiology, heart surgery, hybrid procedures, interventional radiology, interventional angiography, electrophysiology, pediatrics, endoscopic, urological, gastroenterology, orthopedic, maxillofacial surgery, neurology, neurosurgery, critical care, emergency room procedures, and those procedures visualizing structures of the cervical, thoracic, and lumber regions of the spine and joint fractures of the upper and lower extremities, and where digital image data is required for computer aided surgery procedures, and whenever the clinician benefits from the high degree of geometric imaging accuracy, and where such fluoroscopic, cine and DSA imaging is required in and around high magnetic fields. The visualization of such anatomical structures assists the clinician in the clinical outcome. At the discretion of a physician, the device may be used for other imaging applications.

This device does not support direct radiographic film exposures and is not intended for use in performing mammography. The system is not intended for use near MRI systems.

The Ziehm Vision RFD mobile fluoroscopy system is a flat panel detector (FD) fluoroscopic X-ray imaging system consisting of two mobile units: a Mobile Stand (C-Arm) and a Monitor Cart/Workstation. The Mobile Stand is comprised of a mono-block high voltage generator, X-ray control, and a C-Profile which is "C" shaped and supports the X-ray generator and the image receptor Flat Panel Detector (FD).

The proposed device will add motorized movement to three additional axes of the predicate device vertical motorized movement. This provides the user/operator the option to use manual or motorized linear and rotational movements of the C- Profile for positioning of the imaging components at various angles and distances with respect to the patient using a control interface, Vision Center, Remote Vision Center or remote Position Control Center.

The motorization of the three axes provides the user an alternative for visualizing anatomical structures using a selectable iso-centric location. With the freely selectable iso-center and distance control, any given anatomical structure can be safely visualized from different angles without having to re-adjust the C-arm. The iso-center is not restricted to orbital movements, but is held during angulations and vertical travel using the now available 4 motorized axes. The Distance Control surface detection integrated around the lower edge of the flat panel detects objects, such as patients. When the flat panel approaches an object, the device reduces speed, slowing the motorized movement. The movement stops immediately before entering a defined safety zone.

The Monitor Cart is a mobile platform that connects to the Mobile Stand by a cable, and which integrates the LCD flat panel display monitors, image processing user controls and image recording devices. Interfaces provided for optional peripheral devices such as external monitors, thermal video printers, injectors and image storage devices (USB, DVD) and DICOM Network interfaces.

This document is a 510(k) Summary for the Ziehm Vision RFD, a mobile fluoroscopic C-Arm. It describes the device, its intended use, and affirms its substantial equivalence to a predicate device (K083545 Ziehm Vision RFD). The core of the submission focuses on modifications to an existing cleared device rather than presenting a novel AI-powered diagnostic system requiring specific performance metrics like sensitivity and specificity for disease detection.

Therefore, the provided text does not contain the acceptance criteria and study details in the format requested for an AI/ML-powered diagnostic device. Instead, it details regulatory compliance and verification/validation of design changes for an imaging hardware system.

Here's a breakdown of why the requested information isn't present in the document:

• Type of Device: The Ziehm Vision RFD is a fluoroscopic X-ray imaging system (hardware), not an AI-powered diagnostic algorithm designed to detect or classify medical conditions.
• Nature of Submission: This is a "Special 510(k) Submission" for modifications (adding motorized movement to three additional axes) to an already cleared predicate device. The focus is on demonstrating that the changes do not raise new questions of safety or effectiveness and that the modified device remains substantially equivalent to the predicate.
• Performance Metrics: The document discusses compliance with safety standards (e.g., IEC, 21 CFR 1020.30-32) and verification/validation testing for internal functional specifications and nonclinical image comparisons. It does not provide diagnostic performance metrics such as sensitivity, specificity, or AUC, which would be relevant for an AI diagnostic device.

To directly answer your request based on the provided text, while acknowledging its limitations for an AI/ML context:

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

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 mentions "nonclinical image comparisons involving flat panel display images taken with the new device and the predicate device."
• Sample Size: Not specified. It refers to "images" generally.
• Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). Given it's "nonclinical image comparisons," it likely refers to phantoms or test objects rather than patient data.

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

• Not applicable/Not mentioned. The testing described is primarily about technical performance, safety, and functional equivalence, not diagnostic accuracy requiring expert interpretation of medical images.

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

• Not applicable/Not mentioned. No expert adjudication process is described for this type of hardware performance testing.

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 MRMC comparative effectiveness study was not done. This document is for a medical imaging hardware system, not an AI-powered diagnostic tool, so such a study would not be relevant.

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

• Not applicable. This is not an algorithm. The device is a fluoroscopic X-ray system.

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

• The term "ground truth" as it applies to diagnostic accuracy for AI/ML models is not relevant here. The "truth" for the performance testing cited would be adherence to engineering specifications, safety standards, and image quality metrics verified against established benchmarks or the predicate device. For the "nonclinical image comparisons," the ground truth would be the known properties of the phantoms or test objects used.

8. The sample size for the training set

• Not applicable. The document describes a hardware device, not an AI/ML model that requires a training set.

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

• Not applicable. (See #8)

Ask a specific question about this device

The ZIEHM VISION RFD is intended for use in providing medical imaging, using pulsed and continuous fluoroscopic digital imuging, as well as digital subtraction and cine image capture during diagnostic interventional, and surgical procedures where intra-operative imaging and visualization of complex anatomical structures of both lower and higher contrast density are required, such procedures may included but are not limited to those of interventional cardiology, heart surgery, hybrid procedures, interventional radiology, interventional electrophysiology, angiography, pediatrics, endoscopic, urological, gastroenterology, orthopedic, maxillofacial surgery, neurology, neurosurgery, critical care, emergency room procedures, and those procedures visualizing structures of the cervical, thoracic, and lumber regions of the spine and joint fractures of the upper and lower extremities, and where digital image data is required for computer aided surgery procedures and whenever the clinician benefits from the high degree of geometric imaging accuracy, and where such fluoroscopic, cine and DSA imaging is required in and around high magnetic ficids. The visualization of such unatomical structures assists the clinician in the clinical outcome. At the discretion of a physician the device may be used for other imaging applications.

This device does not support direct radiographic film exposures and is not intended for use in performing mammography.

The ZIEIIM VISION RFD Mobile Stand incorporates a small compact design making the positioning of the c-arm in relation to the patient easier for the operator. The C-profile provides fixed distance mounting of the generator and Flat-panel Detector (SSXI) and manual rotation around a non iso-centric location. The mobile stand allows manual rotational and linear movements with a motorized vertical movement for positioning the c-arm at various angles and distances for visualization of pation's anatomical structures. The high frequency generator with dual focus rotating anode x-ray lube, advanced active cooling, x-ray control, are assembled in one housing in a single mono-block generator tube housing assembly, with the virtual collimator mounting to the housing assemble. The Zichm Vision RFD can have one of the following two generators 7.5 kW or optional 20 kW. They both provide pulsed and continuous fluoroscopy operations including a special digital radiography (snapshot) mode. The VisionCenter is a ccuralized touch screen panel providing the uscr/operator with a clear graphicul user Interface including the xray control panel. The ZIEHM VISION RFD Monitor Cart workstation consists of a mechanical cart assembly, supporting dual high-resolution flat panel LCD display monitors and interfaces are provided for preinherial devices such as external monitors, video printers, injectors and storage devices (USB, DVD).

This K083545 submission pertains to a conventional medical device (X-ray system), not an AI/ML-driven device. As such, the concept of "acceptance criteria" and a "study that proves the device meets the acceptance criteria" in the context of AI/ML performance metrics (like sensitivity, specificity, or reader studies) is not directly applicable.

Instead, the submission focuses on demonstrating substantial equivalence to predicate devices by complying with established performance standards for X-ray systems and ensuring safety and effectiveness.

Here's how the provided information relates to your request, interpreted for a conventional medical device submission:

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

The document lists several international and federal standards that the device must meet. These standards themselves define the "acceptance criteria" for various aspects of the X-ray system's performance, safety, and electromagnetic compatibility. The "reported device performance" is implicitly that the device has been tested and shown to meet all applicable requirements of these standards.

The study that "proves the device meets the acceptance criteria" in this context would be the detailed testing and verification reports that demonstrate compliance with each listed standard. These reports are typically part of the full 510(k) submission, though not fully detailed in this summary. The summary concludes that the device "shall be tested and be shown to meet the appropriate requirements of the following standards prior to being marketed," implying that these tests were conducted and compliance was achieved.

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 applicable and therefore, not provided in this 510(k) summary for a conventional X-ray system. These details are pertinent to AI/ML diagnostic or prognostic devices that analyze medical images or data. For an X-ray machine, the "test set" would be the physical device itself undergoing engineering and performance tests according to the standards.

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 is not applicable to this type of device. "Ground truth" for an X-ray machine's performance involves objective physical measurements (e.g., radiation output, image resolution, dose levels) evaluated against engineering specifications and regulatory standards, not expert clinical interpretation of images.

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

This is not applicable to this type of device. Adjudication methods are relevant in clinical studies where human interpretation of medical data is being evaluated, particularly for AI/ML devices.

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 is not applicable to this type of device. MRMC studies are specific to evaluating the clinical impact of AI/ML systems on human reader performance. This submission is for the X-ray imaging hardware itself.

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

This is not applicable to this type of device. "Standalone" performance refers to AI algorithms operating independently, which is not the function of an X-ray machine.

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

As mentioned, "ground truth" for this device refers to objective physical and technical specifications and compliance with regulatory standards. For example, the accuracy of the X-ray tube output, the resolution of the flat-panel detector, radiation leakage, and electrical safety are all measured against defined engineering and regulatory benchmarks.

8. The sample size for the training set

This is not applicable to this type of device. A "training set" is used in the development of AI/ML algorithms, not for the manufacturing and testing of conventional medical hardware.

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

This is not applicable to this type of device.

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