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The Ziehm Solo FD is intended for use in providing medical imaging for adults and pediatric populations, using pulsed and continuous fluoroscopic imaging.

The device provides contactless fluoroscopic image capture, temporarily storing, and display of digital subtraction, and acquisition of cine loops during diagnostic, interventional and surgical procedures. Examples of clinical application may include pediatric, cholangiography, endoscopic, lithotripsy, orthopedic, neurologic, vascular, cardiac, angiographic, critical care, and emergency room fluoroscopy 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 in any MRI environments.

Ziehm Solo FD uses X-ray imaging technology to visualize the human anatomy. The X-ray tube in the generator produces X-rays that penetrate the patient and then hit a special detector that converts them into digital images. This is done under the user and at the direction of a physician who determines the specific clinical procedure. This visualization assists the physician in localizing pathological areas or during surgical procedures. The image acquisition as well as visualization of in vivo surgical procedures and post-operative results.

The Ziehm Solo FD consist of one mobile Stand. Optionally the device can be ordered with a Viewing Station (Monitor Cart). The Mobile Stand incorporates a small compact design making the C-arm in relation to the patient easier for the operator. The generator with X-ray tube, advanced heat management system, X-ray control and collimators are assembled in one housing in a mono-block generator. The system control is handled via CAN BUS control system.

The mechanical C-Profile supports the flat panel detector and an integrated laser positioning device. The optional available Viewing Station (Monitor Cart) provides a remote touch Solo Center that duplicates the touch Solo Center mounted on the Mobile Stand.

This FDA 510(k) summary describes the Ziehm Solo FD, an image-intensified fluoroscopic X-ray system. The submission mainly focuses on a software update (version 7.10.0) that incorporates the 2k imaging chain "QuantumStream" and a new "Image Insights" overlay, along with the introduction of a new 12-inch IGZO flat panel detector in addition to the existing 8-inch IGZO panel.

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

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: Not explicitly stated as a number of patients or images. The study used "anthropomorphic as well as motion-induced phantoms." "Anthropomorphic phantoms so-called 'sectional phantoms' were used and are constructed with a natural human skeleton cast inside a proprietary urethane material that has the same number as the body's soft tissue."
• Data Provenance: The study was conducted using phantoms, not human patient data. Therefore, the concept of country of origin or retrospective/prospective does not directly apply in the usual sense for clinical data. This appears to be lab-based testing.

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

• Number of Experts: Not explicitly stated.
• Qualifications of Experts: The evaluation included a "radiological point of view," implying evaluation by radiologists, but specific qualifications (e.g., years of experience, board certification) are not detailed.

4. Adjudication Method for the Test Set

• Adjudication Method: Not specified. The text mentions "The image comparison... shows that the image quality acquired with the test device is better or at least equal." This suggests a comparative assessment, but the method of consensus or individual expert judgment is not described.

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

• MRMC Study: No, an MRMC comparative effectiveness study involving human readers with and without AI assistance was not mentioned or indicated. The study focused on technical image quality comparison using phantoms. The "Image Insights" overlay is mentioned but no study on its impact on human reader performance is detailed.

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

• Standalone Study: This isn't strictly an AI algorithm-only standalone study in the sense of predictive or diagnostic performance. Instead, it's a standalone technical performance study of the updated imaging system (including hardware and software components). The "2k imaging chain 'QuantumStream'" and "Image Insights" overlay are software features that are part of the device's overall technical performance, and their contribution to image quality was assessed. The cybersecurity testing is also a standalone evaluation of the software's robustness.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

• Ground Truth Type: For image quality, the ground truth was based on a comparative assessment against images from the predicate device and a radiological evaluation of whether the images "fulfil the requirements as stated by the intended use." For compliance (safety and performance standards), the ground truth was demonstrably meeting the specified requirements. For cybersecurity, the ground truth was the identification and assessment of vulnerabilities against established security best practices.

8. The Sample Size for the Training Set

• Training Set Sample Size: Not applicable or not provided. This submission describes modifications to a fluoroscopic X-ray system and its imaging chain, not a machine learning model that would typically require a distinct training set for its core function. While software updates are involved, the description doesn't indicate a new AI model being trained for diagnostic purposes in this context.

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

• Ground Truth for Training Set: Not applicable as no distinct training set for a machine learning model is described.

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The Ziehm Vision FD is intended for use in providing medical imaging for general populations. The device provides pulsed and continuous fluoroscopic imaging of patients during diagnostic, interventional and surgical procedures. It is intended for use in visualizing complex anatomical structures such as vascular cardiac, angiographic, cholangiography, endoscopic, urologic, orthopedic, neurologic, critical care, enom procedures, and where higher accuracy in Image geometry is required. This device does not support direct radiographic film exposures and is not in performing mammography. The system is not intended for use near MRI systems.

The Ziehm Vision FD mobile fluoroscopy system is comprised of a mobile stand with a C-Profile shaped support with both a mono-block high voltage generator assembly and Flat Panel image receptor. Tehse attach to either end of a C-Profile providing a fixed SID. The device performs 2D medical imaging using 4 axes of manual movement and one vertical axes of motorized movement. A user touch screen provides for concise user selectable anatomical programs and X-ray technique control. Integrated high-resolution flat panel display monitors directly mounted on the clinican with a precise angle for visualization of live fluoroscopy images of the patient's anatomy. This visualization helps to localize reqions of pathology for surgical procedures. The mobile stand supports both a cable bound and optional wireless fluoroscopic footswitch operation allows for optimum positioning for the surgeon by removing the cable on the floor. The optional interface panel of the Ziehm Vision FD provides connection of peripheral devices such as external monitors, thermal video printers, and image storage devices (USB, DVD) and Dice and wireless network interfaces.

The proposed modified Ziehm Vision FD employs the same fundamental control, and substantially equivalent scientific technology as that of our predicate device Ziehn Vision FD (K240020). Software architecture design is substantially equivalent to that of the predicate Ziehm Vision FD.

The provided FDA 510(k) summary does not contain detailed information regarding acceptance criteria or a specific study proving the device meets those criteria in the typical format of a clinical trial or performance evaluation with specific metrics. Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (Ziehm Vision FD K240020) by highlighting updates in software and detector technology.

However, based on the text, we can infer some general acceptance criteria and the types of studies/testing performed to support the device's performance.

Here's an attempt to structure the information based on your request, acknowledging the limitations of the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document does not specify a numerical sample size for the test set of images or patients. It mentions "anthropomorphic as well as motion-induced phantoms" for image quality testing and "anthropomorphic phantoms" for pediatric dose testing. This suggests the tests were performed on a set of phantom images, not human patient data in the context of specific image count.
• Data Provenance: The testing was performed using phantoms, which are simulated patient data. The origin of the phantoms (e.g., specific manufacturer or dataset) is not explicitly stated. The tests are non-clinical, implying they were conducted in a controlled environment, likely at the manufacturer's facility in Germany.

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

• The document implies an expert evaluation for image quality: "From a radiological point of view the image quality of the presented images that were acquired fulfill the requirements as stated by the intended use."
• However, it does not specify the number of experts used, nor their specific qualifications (e.g., X years of experience, specific board certifications).

4. Adjudication Method for the Test Set

• The document does not specify an adjudication method (e.g., 2+1, 3+1). The statement regarding image quality being acceptable "from a radiological point of view" suggests a qualitative assessment, but the process is not detailed.

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

• The document does not mention or describe a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. The device is an image-intensified fluoroscopic X-Ray system, and the submission focuses on hardware and software updates related to image acquisition and processing ("QuantumStream" and "Image Insights" overlay), not an AI-assisted diagnostic tool that would typically involve human reader improvement metrics.
• The text does not refer to "AI assistance" in the context of improving human reader performance.

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

• This evaluation is on an X-ray imaging system, not a standalone algorithm. The device's performance is inherently tied to the images it produces. The image quality tests described ("better or at least all images show more detectability and are sharper") are a form of standalone performance evaluation of the system's output, comparing it to a reference.

7. The Type of Ground Truth Used

• For image quality testing, the "ground truth" was established by comparing the images produced by the modified device to "corresponding reference images" from the predicate system, and evaluating them against general "radiological requirements" and criteria like "detectability" and "sharpness." Phantoms were used to generate these images.
• For compliance, the ground truth was regulatory standards (21 CFR 1020.30-32 to 21 CFR 892.1650, ANSI/IEC safety standards) and specific guidance documents (e.g., "Guidance for submission of 510(k)s for Solid State X-Ray Imaging Devices").
• For cybersecurity, ground truth involved identifying vulnerabilities and assessing the security posture through established security testing methodologies.

8. The Sample Size for the Training Set

• The document does not mention a traditional "training set" in the context of machine learning, as the update primarily involves a software update to an imaging chain and a new display overlay ("QuantumStream" and "Image Insights") rather than a new AI algorithm that would typically require a large training dataset for development. The "optimized system settings" likely refer to engineering adjustments and calibration rather than algorithm training.

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

• As no "training set" (in the machine learning sense) is explicitly mentioned, the establishment of ground truth for such a set is not described. The improvements are described as arising from an updated 2k imaging chain.

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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.

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The Ziehm Vision FD is intended for use in providing medical imaging for general populations. The device provides pulsed and continuous fluoroscopic imaging of patients during diagnostic, interventional and surgical procedures. It is intended for use in visualizing complex anatomical structures and procedures such as vascular, cardiac, angiographic, cholangiography, endoscopic, urologic, orthopedic, neurologic, critical care, emergency room procedures, and where higher accuracy in image geometry is required. 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 FD mobile fluoroscopy system is comprised of a mobile stand with a C-Profile shaped support with both a mono-block high voltage generator assembly and Flat Panel image receptor. Tehse attach to either end of a C-Profile providing a fixed SID. The device performs 2D medical imaging using 4 axes of manual movement and one vertical axes of motorized movement. A user touch screen provides for concise user selectable anatomical programs and X-ray technique control. Integrated high-resolution flat panel display monitors directly mounted on the clinican with a precise angle for visualization of live fluoroscopy images of the patient´s anatomy. This visualization helps to localize regions of pathology for surgical procedures. The mobile stand supports both a cable bound and optional wireless floorswitch. The Wireless footswitch operation allows for optimum positioning for the surgeon by removing the cable on the floor. The optional interface panel of the Ziehm Vision FD provides connection of peripheral devices such as external video printers, and image storage devices (USB, DVD) and DICOM fixed wire and wireless network interfaces.

There is no information in the provided text regarding acceptance criteria for a device, nor is there a study described that proves the device meets specific acceptance criteria.

The document is an FDA 510(k) clearance letter for a medical device (Ziehm Vision FD) and its accompanying 510(k) summary. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving performance against pre-defined acceptance criteria through a specific study with statistical endpoints.

The document states:

• "The key modification refers to an updated release of the software, which incorporates an operating system upgrade from Ubuntu 16.04 to Ubuntu 20.04."
• "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."
• "Software testing was performed as required by "Content of Premarket Submissions for Device Software Functions". The Cybersecurity of the device has been improved."

This indicates that the focus of the submission was on validating the software upgrade and ensuring that the device's overall safety and effectiveness are maintained and equivalent to the predicate, not on a new clinical study to meet specific performance metrics.

Therefore, I cannot provide the requested information, specifically:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set and data provenance.
3. Number of experts and their qualifications for ground truth establishment.
4. Adjudication method for the test set.
5. MRMC comparative effectiveness study results or effect size.
6. Standalone performance results.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

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The Ziehm Solo FD is intended for use in providing medical imaging for adults and pediatric populations, using pulsed and continuous fluoroscopic imaging.

The device provides contactless fluoroscopic image capture, temporarily storing, and display of digital subtraction, and acquisition of cine loops during diagnostic, interventional and surgical procedures. Examples of clinical application may include pediatric, cholangiography, endoscopic, urologic, lithotripsy, orthopedic, neurologic, vascular, cardiac, angiographic, critical care, and emergency room fluoroscopy 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 near MRI systems.

Ziehm Solo FD uses X-ray imaging to visualize the human anatomy. The X-ray tube in the generator produces X-rays that penetrate the patient and then hit a special detector that converts them into digital images. This is done under the user and at the direction of a physician who determines the specific clinical procedure. This visualization assists the physician in localizing pathological areas or during surgical procedures. The device enables real-time image acquisition of in vivo surgical procedures and post-operative results.

The Ziehm Solo FD consist of one mobile unit, the Mobile Stand. Optionally the device can be ordered with a Viewing Station (Monitor Cart). The Mobile Stand incorporates a small compact design making the C-arm in relation to the patient easier for the operator. The generator with X-ray tube, advanced heat management system, X-ray control and collimators are assembled in one housing in a mono-block generator. The system control is handled via CAN BUS control system.

The mechanical C-Profile supports the flat panel detector and an integrated laser positioning device. The optional available Viewing Station (Monitor Cart) provides a remote touch Solo Center that duplicates the touch Solo Center mounted on the Mobile Stand.

The provided text concerns the FDA 510(k) clearance for the Ziehm Solo FD, an image-intensified fluoroscopic x-ray system. The core of the submission revolves around a software update (Ubuntu 16.04 to Ubuntu 20.04) and asserting substantial equivalence to a predicate device.

However, the provided document DOES NOT contain information about a study that proves the device meets specific acceptance criteria in terms of performance (e.g., diagnostic accuracy, sensitivity, specificity, or human reader improvement with AI assistance). The document primarily focuses on regulatory compliance, technological comparison with a predicate device, and software updates, rather than a detailed performance study with defined acceptance criteria and statistical analysis.

The text explicitly states:

• "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 indicates that no new image quality performance study was conducted.
• The overall tone suggests a "substantial equivalence" argument primarily based on the software and hardware remaining fundamentally the same as the predicate, not on a new, explicit performance evaluation against novel acceptance criteria.

Therefore, based solely on the provided text, I cannot complete the request to describe the acceptance criteria and the study that proves the device meets them, nor can I fill in a table of acceptance criteria and reported device performance, or provide details on sample sizes, expert involvement, adjudication, or MRMC studies.

The document discusses:

• Device Name: Ziehm Solo FD
• Regulation Number: 21 CFR 892.1650
• Regulation Name: Image-Intensified Fluoroscopic X-Ray System
• Regulatory Class: Class II
• Product Codes: OWB, JAA, OXO
• Intended Use: Providing medical imaging for adults and pediatric populations using pulsed and continuous fluoroscopic imaging, for diagnostic, interventional, and surgical procedures (e.g., pediatric, cholangiography, endoscopic, urologic, lithotripsy, orthopedic, neurologic, vascular, cardiac, angiographic, critical care, and emergency room fluoroscopy procedures).
• Key Modification: Updated software release (Ubuntu 16.04 to Ubuntu 20.04).
• Compliance: States compliance with 21 CFR 1020.30-32 (Federal Performance Standards for X-Ray Fluoroscopic equipment), IEC 60601-1-3, and IEC 60601-2-54.

To reiterate, the information required for the detailed performance study aspects (acceptance criteria table, sample sizes, expert ground truth, MRMC, etc.) is absent from this FDA 510(k) letter and summary.

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The Ziehm Vision FD is intended for use in providing medical imaging for adults and pediatric populations, using pulsed and continuous fluoroscopic imaging. The device provides contactless fluoroscopic image capture, temporarily storing, and display of digital subtraction, and acquisition of cine loops during diagnostic, interventional and surgical procedures. Examples of clinical application may include pediatric, cholangiography, endoscopic, urologic, lithotripsy, orthopedic, neurologic, vascular, cardiac, angiographic, critical care, and emergency room fluoroscopy 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 FD mobile fluoroscopy system is comprised of a mobile stand with a C-Profile shaped support with both a mono-block high voltage generator assembly and Flat Panel image receptor. These attach to either end of a C-Profile providing a fixed SID. The device performs 2D medical imaging using 4 axes of manual movement and one vertical axes of motorized movement. A user touch screen provides for concise user selectable anatomical programs and Xray technique control. Integrated high-resolution flat panel display monitors directly mounted on the monitor cart providing the clinician with a precise angle for visualization of live fluoroscopic images of the patient's anatomy. This visualization helps to localize regions of pathology for surgical procedures. The mobile stand supports both a cable bound and optional wireless fluoroscopic footswitch. The Wireless footswitch operation allows for optimum positioning for the surgeon by removing the cable on the floor. The optional interface panel of the Ziehm Vision FD provides connection of peripheral devices such as external monitors, thermal video printers, and image storage devices (USB, DVD) and DICOM fixed wire and wireless network interfaces.

The provided document, a 510(k) Summary for the Ziehm Vision FD, describes a premarket notification for a modified fluoroscopic x-ray system. The study focuses on demonstrating substantial equivalence to a previously cleared predicate device (K193230), rather than establishing new acceptance criteria or proving clinical efficacy in a traditional sense. The changes primarily involve an additional 8-inch IGZO flat panel detector and updates to software and mechanical components.

Therefore, the acceptance criteria and study detailed below are framed within the context of a substantial equivalence submission, emphasizing performance comparison with a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a substantial equivalence submission, the "acceptance criteria" are implied by the performance of the predicate device and the new device's ability to demonstrate comparable safety and effectiveness. The "reported device performance" refers to how the modified Ziehm Vision FD performs relative to the predicate.

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

The document describes "non-clinical image comparison with sets of images" and "non-clinical image and dose Lab testing" using "anatomical phantoms."

• Test set sample size: Not explicitly stated as a number of images or cases. It refers to "sets of images" and "anatomical phantoms."
• Data provenance: Non-clinical (phantom-based) lab testing. The country of origin for the data is not specified but the manufacturer is based in Germany. The testing appears to be retrospective in comparison to the predicate, as it's a verification and validation activity for a modified device.

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

• Number of experts: "A Radiologist performed an assessment of individual image sets." This implies one radiologist.
• Qualifications of experts: The document only states "A Radiologist." No specific experience level (e.g., "10 years of experience") is provided.

4. Adjudication Method for the Test Set

The document mentions that "A Radiologist performed an assessment of individual image sets" and provided a "conclusion." This suggests a single expert review rather than a formal adjudication method (like 2+1 or 3+1 consensus).

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

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. The study described is a non-clinical, phantom-based image comparison assessed by a single radiologist for substantial equivalence (comparability) in image quality and safety, not for an improvement in human reader performance with or without AI assistance. The device is an imaging system, not an AI-powered diagnostic aid meant to directly improve human reader effectiveness.

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

The device itself is a fluoroscopic x-ray system, not an AI algorithm. Therefore, the concept of "standalone performance" for an algorithm doesn't directly apply here. The performance tests described (image quality, dose, safety standards compliance) characterize the device's inherent capabilities without human interpretation as part of the core performance metric.

7. The Type of Ground Truth Used

For the non-clinical image comparison and dose testing, the "ground truth" was established using:

• Anatomical phantoms: These provide a known, controlled imaging target.
• Radiologist assessment: A radiologist's qualitative assessment of image quality and how it compares between the modified and predicate devices.

8. The Sample Size for the Training Set

This submission is for a medical imaging device (hardware and associated software), not a machine learning algorithm that requires a separate "training set." Therefore, the concept of a training set for an AI model is not applicable here. The software updates mentioned are optimizations and version changes, not a new AI model being trained.

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

As explained in point 8, a training set is not applicable to this device submission.

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The Ziehm Solo FD is intended for use in providing medical imaging for adults and pediatric populations, using pulsed and continuous fluoroscopic imaging.

The device provides contactless fluoroscopic image capture, temporarily storing, and display of digital subtraction, and acquisition of cine loops during diagnostic, interventional and surgical procedures. Examples of clinical application may include pediatric, cholangiography, endoscopic, urologic, lithotripsy, orthopedic, neurologic, vascular, cardiac, angiographic, critical care, and emergency room fluoroscopy 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 near MRI systems.

The Ziehm Solo FD uses X-ray imaging technology to visualize the human anatomy. The X-ray tube in the generator produces X-rays that penetrate the patient and then hit a special detector that converts them into digital images. This is done under the control of the user and at the direction of a physician who determines the specific clinical procedure. This visualization assists the physician in localizing pathological areas or during surgical procedures. The device enables real-time image acquisition as well as visualization of in vivo surgical procedures and post-operative results.
The Ziehm Solo FD consist of one mobile unit, the Mobile Stand. Optionally the device can be ordered with a Viewing Station (Monitor Cart). The Mobile Stand incorporates a small compact design making the positioning of the C-arm in relation to the patient easier for the operator. The generator with X-ray tube, advanced heat management system, X-ray control and collimators are assembled in one housing in a mono-block generator. The system control is handled via CAN BUS control system.
The mechanical C-Profile supports the generator, the flat panel detector and an integrated laser positioning device.
The optional available Viewing Station (Monitor Cart) provides a remote touch Solo Center that duplicates the touch Solo Center mounted on the Mobile Stand.
The proposed modified device Ziehm Solo FD employs the same fundamental control, and substantially equivalent scientific technology as that of our predicate device Ziehm Solo FD (K161976). Software architecture design is substantially equivalent to that of the predicate Ziehm Solo FD
The primary modification of the C-Arm includes an 8 inch IGZO (Indium gallium zinc oxide) flat panel detector (FPD The new 8 inch IGZO FPD is an addition to already introduced CMOS FPD. The flat panel detectors have the same outer product design of the housing, both devices use safety shielding for radiation suppression and use solid state x-ray image receptors (SSXI / FPD) 8 inch CMOS and the only difference to the predicate Ziehm Solo FD is the additional 8 inch IGZO panel.

The provided text describes the 510(k) premarket notification for the Ziehm Solo FD, a mobile fluoroscopic C-Arm. The submission asserts substantial equivalence to a predicate device (Ziehm Solo FD K161976) and references a comparative reference device (Ziehm Vision FD K193230) for specific comparisons related to flat panel detector technology (IGZO vs. a-Si).

However, the document does not contain the detailed information necessary to fully answer all aspects of your request regarding specific acceptance criteria for AI/algorithm performance and a comparative effectiveness study (MRMC) demonstrating human reader improvement with AI assistance. This is likely because the device described is an X-ray system, not an AI-powered diagnostic algorithm. The testing described focuses on the device's fundamental imaging capabilities, electrical safety, electromagnetic compatibility, and compliance with X-ray performance standards, rather than the diagnostic performance of an AI algorithm.

The closest relevant information relates to image quality assessment and dose reduction.

Here's a breakdown of the available and missing information based on your request:

Acceptance Criteria and Device Performance (Based on available information)

The document does not explicitly state "acceptance criteria" in the format of specific quantitative metrics for a diagnostic AI algorithm. Instead, it details that the device's safety and performance are confirmed by:

1. Compliance with applicable CDRH 21 CFR subchapter J performance requirements.
2. Adherence to recognized and general consensus standards.
3. Designing and manufacturing under Ziehm Imaging GmbH Quality System (21 CFR 820).
4. System verification and validation testing to ensure the device performs to product specifications and its intended use.
5. Bench testing, including non-clinical imaging and dose testing, demonstrating the device's ability to provide reduced dose while maintaining image quality.

The performance is reported qualitatively through statements of compliance and equivalence.

Study Details (Based on available information)

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

   • Sample Size: Not explicitly stated as a numerical count of images or patients. The document mentions "sets of images" and "anatomical phantoms" representing "both the adult and pediatric populations."
   • Data Provenance: The study used "non-clinical imaging and dose testing methods," implying the use of phantoms rather than real patient data. There is no mention of country of origin or whether it was retrospective/prospective clinical data, as it was a phantom-based bench study.

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

   • Number of experts: Singular. "A Radiologist performed an assessment of individual image sets."
   • Qualifications of experts: "A Radiologist." No further details on years of experience or specialization are provided.

3. Adjudication method for the test set:

   • No explicit adjudication method (like 2+1, 3+1) is mentioned. The assessment was performed by "A Radiologist."

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 comparative effectiveness study was not done. The document describes a technical performance validation of an X-ray imaging system, not a study assessing an AI algorithm's impact on human diagnostic performance. The statement "Radiologist conclusion, the image quality of the Ziehm Solo FD results in a comparable patient care to the reference device Ziehm Vision FD (K193230)" indicates an expert's qualitative judgment on image quality itself, not a measure of improved human reader performance with AI assistance.

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

   • This question is not applicable in the context of the provided document, as the device is an X-ray system, and there's no mention of a standalone AI algorithm for diagnostic inference. The "software" updates mentioned are for system control and image processing, not for AI-driven diagnostic tasks.

6. The type of ground truth used:

   • Expert Consensus/Assessment based on Phantoms: For image quality assessment, the "ground truth" was established through the "Radiologist's conclusion" on "anatomical phantoms" and "image comparison sets." This is a form of expert assessment of image quality, not clinical ground truth derived from pathology or patient outcomes.

7. The sample size for the training set:

   • Not applicable/Not provided. This document does not describe the development or training of an AI algorithm in the sense of machine learning, so there is no "training set." The software mentioned is traditional device control and image processing software.

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

   • Not applicable/Not provided. As there is no AI algorithm training set discussed, this information is not relevant to the content of the provided document.

Summary of what's provided vs. what's missing for an AI-focused request:

The document details the substantial equivalence of an X-ray imaging system based on hardware modifications and compliance with electrical, mechanical, and X-ray performance standards. It provides limited information regarding formal clinical study design, especially concerning human reader performance or the training/validation of an AI-driven diagnostic algorithm. The "software" sections refer to system operating software, not typically advanced AI for image interpretation that would require MRMC or standalone AI performance metrics.

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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.

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