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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 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 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.

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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.

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