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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 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 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 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 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 X-ray 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 is a 510(k) Summary for the Ziehm Vision FD, a mobile fluoroscopic C-arm system. It focuses on demonstrating substantial equivalence to a predicate device (Ziehm Vision FD K061534) rather than presenting a standalone study with specific acceptance criteria and detailed performance metrics of a novel AI device. Therefore, much of the requested information, particularly regarding AI-specific performance, sample sizes for test and training sets, number and qualifications of experts for ground truth, adjudication methods, and MRMC studies, is not available in this document as it pertains to a traditional medical device modification and not an AI/ML-based diagnostic system.

However, I can extract the relevant information regarding the non-clinical testing and the comparison to the predicate device to address the core of your request as much as possible from the provided text.

Here's a breakdown of the available information:

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

Since this is a submission for substantial equivalence of a modified conventional X-ray device, the "acceptance criteria" are not explicit performance metrics in the way one might expect for an AI/ML device. Instead, the acceptance criteria are largely implied by demonstrating compliance with various regulatory standards and showing equivalent performance to the predicate device.

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

• Test Set Sample Size: Not specified. The document mentions "sets of images" and "anthropomorphic phantoms" but does not give a number of images or cases.
• Data Provenance: The images were generated using "anthropomorphic (PMMA material) phantoms and anatomical simulation phantoms." This indicates that the data is synthetic/phantom-based rather than from human patients. Therefore, information on country of origin, retrospective, or prospective is not applicable in the traditional sense.

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

• Number of Experts: "A board-certified Radiologist." Implies one expert.
• Qualifications: "board-certified Radiologist." No specific years of experience are mentioned.

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

• Adjudication Method: "Evaluation of the individual images arranged in image sets was conducted by a board-certified Radiologist." This indicates a single reader assessment rather than an adjudication process involving multiple readers. Therefore, methods like 2+1 or 3+1 are not applicable.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not done. The submission explicitely states: "The modified Ziehm Vision FD mobile fluoroscopic C-arm system did not require live human clinical studies to support substantial equivalence." The evaluation was a comparison of image quality between the modified device and the predicate device, performed by a single radiologist using phantom images.
• Effect Size with AI: Not applicable, as this is a traditional medical imaging device modification, not an AI-based system.

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

• This is not an AI/ML algorithm; it is a fluoroscopic X-ray system. Therefore, the concept of "standalone algorithm performance" is not applicable. The device itself is the "standalone" system.

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

• Type of Ground Truth: For the image quality comparison, the "ground truth" was implicitly the assessment and conclusion of a single "board-certified Radiologist" based on images derived from "anthropomorphic (PMMA material) phantoms and anatomical simulation phantoms." This isn't pathology or outcomes data, but rather an expert's qualitative judgment of image quality and its suitability for patient care.

8. The sample size for the training set

• Training Set Sample Size: Not applicable. This is not an AI/ML device that requires a training set in that sense. The device's modifications are based on engineering design and validation processes, not machine learning model training.

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

• Ground Truth for Training Set: Not applicable, as there is no AI/ML training set mentioned in the document.

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The Ziehm Vision FD is intended to provide pulsed and continuous fluoroscopic imaging of patients during diagnostic, interventional and surgical procedures. 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. At the discretion of a physician the device may be used for other imaging applications.

The ZIEHM VISION FD has two main units; Mobile Stand and Monitor Cart workstation. The Mobile Stand C-arm consists of a high frequency generator, X-ray Tube assembly, Solid State X-Ray Imager / Flat Panel Detector, user touch control interface, C-Profile supporting the generator and Solid State X-ray Imager (SSXI), and Integrated Laser light localizers in the image receptor. The Mobile Stand C-profile provides fixed distance mounting of the generator and image receptor allowing the user rotational and linear movements for positioning the c-arm at various angles and distances for visualization of patient's anatomical structures.

The monitor cart workstation supports dual flat panel LCD display monitors, Vision II digital image memory device, imaging capture, image processing, and VisionCenter touch control user interface. External Video connection is provided with RS-170 video timing for domestic market, CCIR for International markets. The Vision FD also provides optional peripheral connections for such devices as video printers, DICOM 3 and external media storage devices.

This 510(k) summary does not contain the information requested regarding acceptance criteria and the study proving the device meets those criteria.

The document is a submission for a 510(k) premarket notification for the "Zichm Vision FD Digital Mobile Imaging System." It focuses on establishing substantial equivalence to a predicate device (Ziehm Vision), providing device descriptions, indications for use, and compliance with applicable standards.

Specifically, the following information is missing from the provided text:

• A table of acceptance criteria and the reported device performance: This document does not include any specific performance metrics or acceptance criteria related to image quality, accuracy, sensitivity, specificity, or any other quantifiable measure beyond stating the device's intended use for "higher accuracy in image geometry."
• Sample size used for the test set and the data provenance: There is no mention of any test set, patient data, or its provenance.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: As no test set is described, there's no information about ground truth establishment or experts.
• Adjudication method for the test set: Not applicable since no test set is described.
• 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: This is not an AI-assisted device; it's a mobile imaging system. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this device's submission and is not mentioned.
• If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable for a fluoroscopic imaging system.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.): No ground truth is described.
• The sample size for the training set: There is no mention of a training set as this is not an AI/machine learning device.
• How the ground truth for the training set was established: Not applicable.

The document primarily focuses on regulatory compliance, product description, and claiming substantial equivalence to an existing device (K011292) based on its intended use and general performance characteristics rather than providing a detailed performance study with specific acceptance criteria.

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