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The Ziehm Solo is intended to provide contactless fluoroscopy Imaging, capturing, temporarily storing, and display of non-invasive x-ray imaging of the patient using pulsed and continuous fluoroscopy, during diagnostic, surgical and interventional procedures. Examples of clinical application may include cholangiography, endoscopic, urologic, orthopedic, neurologic, vascular, cardiac, critical care, and emergency room fluoroscopy procedures. Radiographic film examinations can be made with an accessory cassette device when attached to the Image Intensifier. This device does not support and is not intended for use in performing mammographic imaging.

The Ziehm Solo Mobile Stand incorporates a single arm monitor assembly providing a more adaptable positioning of the display monintors to the clinician and the C-arm in relation to the patient. The C-profile provides fixed distance mounting of the generator and Image Intensifier and manual rotation around a non iso-centric location. The mobile stand allows the manual rotational and linear movements of the C-arm with a motorized vertical movement for positioning the c-arm at various angles and distances for visualization of patient's anatomical structures. Optional 120kV and or 20mA Fluoro operations are available. The 2.02 kW high frequency generator incorporates a single focus fixed anode x-ray tube, and high voltage generator is a single mono-block generator tube housing assembly. The virtual collimator and x-ray control mount to the generator housing assemble and provides pulsed and continuous fluoroscopy operations including a special digital radiography (snapshot) mode. The SoloCenter is a centralized touch screen providing the user/operator with a graphical user Interface including the x-ray control panel. The Ziehm Solo does not have a conventional Monitor Cart, the workstation consists of a mechanical arm assembly supporting a single or dual high-resolution flat panel LCD display monitor(s). Ceiling or wall monitors can be added by means of two external monitor connectors. Other conventional external interfaces are provided on the mobile stand for preipherial devices such as video printers, and storage devices such as USB and DVD.

This document is a 510(k) Summary for the Ziehm Solo, a Digital Mobile C-Arm X-ray system. It outlines the device's description, indications for use, contraindications, technology, user characteristics, and the standards it meets. Importantly, it emphasizes substantial equivalence to a predicate device (ZIEHM VISION2 K073346) based on non-clinical performance test data.

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not specify quantitative acceptance criteria or detailed performance metrics. Instead, it relies on substantial equivalence to a predicate device and compliance with various international and federal standards. The reported "performance" is that the device meets these standards and is equivalent to the predicate.

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

The document does not specify any sample size for a test set in the context of clinical performance or diagnostic accuracy. The evaluation is based on "non-clinical performance test data" and a comparison to a predicate device. The data provenance is not explicitly stated beyond being "non-clinical performance test data" included in the submission. It does not refer to patient data or retrospective/prospective studies in the context of device performance.

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

This information is not applicable and not provided in this document. The submission is for a fluoroscopic X-ray system, and its evaluation relies on engineering and regulatory standards compliance, along with substantial equivalence to a predicate device. There is no mention of a diagnostic accuracy study requiring expert-established ground truth.

4. Adjudication Method for the Test Set:

This information is not applicable and not provided. As there is no diagnostic accuracy study described, no adjudication method would be required.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size:

No MRMC comparative effectiveness study is mentioned or implied. The document focuses on the device's technical specifications and substantial equivalence to a predicate, not on improvements in human reader performance with or without AI assistance. This device is an imaging system, not an AI-assisted diagnostic tool.

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

This information is not applicable and not provided. The Ziehm Solo is a hardware device for X-ray imaging, not a standalone algorithm.

7. The type of ground truth used:

This information is not applicable and not provided. Given the nature of the device and the submission, there is no diagnostic accuracy study described that would require a "ground truth" in the typical sense (e.g., pathology, clinical outcomes). The evaluation focuses on meeting engineering standards and being equivalent to a predicate.

8. The sample size for the training set:

This information is not applicable and not provided. This device is not an AI/ML algorithm that would undergo a training phase with a specific dataset.

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

This information is not applicable and not provided. As there is no training set for an AI/ML algorithm, no ground truth establishment method is relevant.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

8. The sample size for the training set

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

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

This is not applicable to this type of device.

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The ZIEHM VISION product Family is intended to provide 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, anglographic, cholangiography, endoscopic, urologic, orthopedic, neurological, critical cate, and emergency room procedures. Radiographic film examinations can be made with an accessory cassette device when attached to the Image Intensifier. At the discretion of a physician the device may be used for other imaging applications.

ZIEHM VISION with option VARIO is intended to provide pulsed and continuous fluoroscopic imaging of patients during diagnostic, interventional and surgical procedures. It is intented for use in visualizing complex anatomical structures and procedures such as, vascular, cardiac, anglographic, cholangiography, endoscopic, urologic, orthopedic, neurological, critical care, and emergency room procedures and whenever the clinician benefits from variable Iso-centric positioning. Radiographic film examinations of a pharising than accessory cassette device when attached to the Image Intensifier. At the discretion of a physician the device may be used for other intaging applications.

ZIEHM VISION " with option FD is intended to provide pulsed and continuous fluoroscopic imaging of patients during diagnostic, interventional and surgical procedures. It is intended for use in isualizing complex anatomical structures and procedures such as, vascular, cardiac, angiographic, cholangiography, endoscopic, urologic, orthopedic, neurological, critical care, and emergency room procedures and where higher accuracy in image geometry is required in and around high magnetic fields. At the discretion of a physician the device may be used for other imaging applications.

ZIEHM VISION with option 3D is intended to provide 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, neurological, critical care, and emorgency room procedures and Whenever the clinician benefits from variable Iso-centric positioning and/or intraoperatively generated 3D imaging of high contrast objects (bones and joints), complex anatomical structures such as cervical, thoracic, and lumber regions of the spines and joint fractures of the upper and lower extremities, and where digital image and c-arm positioning data is required for computer aided surgery procedures. Radiographic film examinations can be made with an accessory cassete device when attached to the Image Intensifier. At the discretion of a physician the device may be used for other imaging applications.

The ZIEHM VISION product Family is a mobile C-am x-ray system intended for fluoroscopic imaging and is a modified version of our present ZIEHM VISION digital mobile c-arm K011292. The modified ZIEHM VISION incorporates additional new innovative technologies from two of our other legally marketed devices Ziehm Vision FD, and Ziehm Vario 3D. The base system includes highvoltage x-ray generator, and control, x-ray tube, image intensifier, touch control user interface and monitor cart/workstation with line power matching, Vision II 2D video image of seem with display, CAN bus control system, and internal and external image storage capabilities. The device includes, functional options such as Endoscopic monitor display interface, 3D imaging, NaviPort digital image exchange interface, SSXI/Flat Panel Detector, and Vario Iso-centric operation. There optigns will be identified by extensions to the product name ZIEHM VISION as Vario, FD, 3D, FD, 3D,

The ZIEHM VISION 2 product includes high-voltage x-ray generator and control, x-ray tube, image intensifier, and monitor cart/workstation with 2D image display and optional 3D digital image processing. Device provides internal and external image storage capability, and supports conventional spot-film capability with the Image intensifier option only. Optional monitor cart/workstation with NaviPort digital image exchange interface for Surgical Navigation Devices. Optional SSXI solid sate Varia ISO Contrio model in the imaging of critical anatomical structures. Optional Vario ISO-Centric mechanics work with the 3D maging or stand alone as a method for track anatomical structures in both LAT and AP projections.

The ZIEHM VISION has two main units, Mobile Stand and Monitor Cart workstation.

The Mobile Stand C-arm consists of a High frequency generator and x-ray tube assembly with active VicionCantor uses to collination assembly, 9" or 12" image intensifier (image receptor), VisionCenter user touch control interface, and CCD camera, mechanical C-Profile supporting the generator, image receptor and integrated laser light localizers. The c-profile in conjunction with the other mechanics of the mobile stand allow manual rotational, linear and vertical movements for positioning the c-arm at various and distances for visualization of patient's anatomical structures.

Mobile stand optional functionality includes, VARIO ISO-Centric motorized movement, VARIO-3D recepted in available as a voluning for 3D imaging and Flat Panel Detector/SSXI (Image receptor) is available as a replacement for the trailer beechords on the mobile stand

Monitor Cart workstation consists of a mechanical assembly supporting dual flat panel LCD display monitors, line matching power supply, and Vision II digital image memory device. Optional functionality includes VisionCenter touch control, Vario 3D control and image processing, Ziehm NAVI PORT digital image exchange interface, Endoscopic monitor displays, external image storage and video connection for attachment of external monitor displays

The provided text is a 510(k) summary for the ZIEHM VISION2 product family, which is a mobile C-arm x-ray system. The document focuses on demonstrating substantial equivalence to previously marketed devices rather than presenting a de novo study with explicit acceptance criteria and performance data. Therefore, the information requested in the prompt regarding acceptance criteria, specific study details, and performance metrics in the format of a table cannot be fully extracted as such a study is not part of this 510(k) submission.

This 510(k) relies on showing that the new device does not raise new questions of safety or effectiveness compared to existing, legally marketed predicate devices.

Here's an analysis of the available information in relation to your request:

Acceptance Criteria and Reported Device Performance

The document does not provide a table of acceptance criteria and reported device performance in the context of a specific study for the ZIEHM VISION2 device. Instead, it states that the ZIEHM VISION2 product family does not raise new questions of safety or effectiveness and is substantially equivalent to the following current legally marketed devices:

• ZIEHM VISION (K011292)
• ZIEHM VISION FD (K061534)
• ZIEHM VARIO 3D (K061310)

The assertion of substantial equivalence implies that the device inherently meets the performance standards of these predicate devices, which would have undergone their own validation processes. The specific performance metrics of the new device are not explicitly detailed in a comparative table.

Detailed Study Information (Not Applicable for this 510(k) Summary)

The provided text does not describe a standalone study (like an MRMC or standalone AI performance study) with human readers, training sets, test sets, or ground truth establishment for the ZIEHM VISION2 device. This 510(k) submission is for an imaging device, not an AI/CADe system. Therefore, most of the requested points are not applicable.

Here's what can be inferred or explicitly stated based on the document:

1. Sample size used for the test set and the data provenance: Not applicable. No specific test set of images for performance evaluation is mentioned.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for image interpretation in a performance study is not discussed.
3. Adjudication method for the test set: Not applicable.
4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No. This is not an AI-assisted diagnostic device, so an MRMC study is not relevant to this submission.
5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: No. This device is an imaging system, not a standalone algorithm.
6. The type of ground truth used: Not applicable.
7. The sample size for the training set: Not applicable.
8. How the ground truth for the training set was established: Not applicable.

Standards Met

The document lists several standards that the ZIEHM VISION Family of mobile x-ray devices "will be tested and be shown to meet... prior to being marketed." These standards act as a form of acceptance criteria for the device's design and operation, ensuring safety and basic functionality. However, they do not quantify diagnostic performance in the way a clinical study might.

Relevant Standards (acting as indirect "acceptance criteria" for design/safety):

• Federal Performance Standard for Diagnostic X-ray Systems 21 CFR 1020.30, 21 CFR 1020.31 and 21 CFR 1020.30
• 93/42/EEC - Annex II of EC directive of the Medical Devices Directive (MDD)
• IEC 60601-1-3: Medical Electrical Equipment, Radiation Protection in Diagnostic Xray Equipment
• IEC 60601-1-4: General requirements for safety, Programmable electrical medical systems.
• IEC 60601-2-7: Medical Electrical Equipment, Safety of HV/X-ray Generators
• IEC 60601-2-28: Medical Electrical Equipment Part 2: Particular Requirements for the Safety of X-Ray Source Assemblies and X-Ray Tube Assemblies for Medical Diagnosis
• IEC 60601-2-32: Medical Electrical Equipment, Safety of Associated X-ray Equipment
• IEC60601-2-43: Particular requirements for the safety of X-Ray equipment for interventional procedures.
• IEC 60825-1: Safety of laser products, Equipment Safety, requirements, and user guide

Conclusion:

This 510(k) submission establishes substantial equivalence to predicate devices based on technological characteristics and intended use, rather than presenting a detailed clinical performance study with explicit acceptance criteria and corresponding performance data for the new device as an AI/CADe system would. The "study" here is the comparison to predicate devices and adherence to relevant safety and performance standards for x-ray equipment.

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The ZIEHM VARIO and ZIEHM VARIO 3-D C-arms provide fluoroscopic and spot film imaging of the patient during diagnostic, Interventional and surgical procedures. It is intended to be used whenever the Clinician benefits from Iso-centric positioning and/or intraoperatively generated 3D imaging of high contrast objects (bones and joints), complex anatomical structures such as cervical, thoracic, and lumber regions of the spine and joint fractures of the upper and lower extremities. The design includes features intended for performing vascular, angiographic, cholangiography, endoscopic, urologic, orthopedic, neurologic, and critical care and emergency room procedures. At the discretion of a physician the device may be used for other imaging applications. Radiographic film examinations can be made with an accessory cassette device attached to the Image Intensifier.

The ZIEHM VARIO 3D 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, image intensifier, and user. touch control interface, C-Profile supporting the generator and image intensifier 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 in addition the device has variable ISO Centric operation, and integrated Iso-centric operations for performing 3D imaging. The monitor cart workstation supports dual flat panel LCD display monitors, digital image memory device, imaging capture, image processing, and touch control user interface. External Video connection is provided with RS-170 video timing for domestic market, CCIR for International markets. The ZIEHM VARIO 3D also provides optional peripheral connections for such devices as video printers, DICOM 3, CAS connection for image guided surgery and external media storage devices.

The Ziehm VARIO and Ziehm VARIO 3D C-arms are fluoroscopic and spot film imaging devices. The provided text does not contain information about specific acceptance criteria or a study that evaluates the device's performance against such criteria. Instead, it focuses on substantial equivalence to predicate devices and compliance with general safety and performance standards for x-ray systems.

Therefore, I cannot populate the table or provide details for most of the requested points based on the given document.

Here's a summary of what can be inferred from the provided text, along with what cannot be answered:

1. Table of acceptance criteria and the reported device performance:

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

• Not provided. The document describes substantial equivalence to predicate devices and compliance with standards, not performance against specific clinical test data.

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

• Not applicable/Not provided. No specific test set or ground truth establishment is mentioned for performance evaluation.

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

• Not applicable/Not provided. No specific test set or adjudication method is mentioned for performance evaluation.

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

• No such study was mentioned. The device is an imaging system, not an AI-assisted diagnostic tool.

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

• Not applicable. The device described is an imaging system that requires human operation; it's not an algorithm for standalone performance.

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

• Not applicable/Not provided. No specific ground truth is mentioned for performance evaluation. The substantial equivalence relies on the predicate devices meeting regulatory standards.

8. The sample size for the training set:

• Not applicable/Not provided. This is an imaging device, not a machine learning algorithm requiring a "training set" in the conventional sense.

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

• Not applicable/Not provided.

Summary of available information:

• Device Name: Ziehm Vario 3D Mobile Imaging System
• Intended Use: Fluoroscopic and spot film imaging during diagnostic, interventional, and surgical procedures; for iso-centric positioning and intraoperatively generated 3D imaging of high contrast objects (bones and joints), complex anatomical structures, and joint fractures. Also for vascular, angiographic, cholangiography, endoscopic, urologic, orthopedic, neurologic, and critical care and emergency room procedures.
• Predicate Devices:
  • SIEMENS Medical Systems AG ISO-C 3D Mobile Surgical C-arm System (K003266)
  • SIEMENS Medical Solutions USA, ISO-C 3D Mobile C-arm System (K032280)
• Compliance: The device was designed to comply with applicable portions of various standards and regulations for product safety requirements, including Federal Performance Standard for Diagnostic X-ray Systems (21 CFR 1020.30, 21 CFR 1020.31, 21 CFR 1020.30 - Note: there's a typo in the provided text with 1020.30 listed twice), UL 60601-1, IEC 60601 series, IEC 60825-1, 93/42/EEC Annex 1, and DIN ISO 14971.
• Conclusion: The FDA determined the device is substantially equivalent to the predicate devices and does not raise new questions of safety or effectiveness.

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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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The Ziehm Vision R is designed to provide pulsed and continuous fluoroscopic imaging, and spot film imaging of the patient during diagnostic, Interventional and surgical procedures. The design includes features for diagnostic and interventional cardiac imaging procedures, and is also intended for use in visualizing complex anatomical structures and procedures for vascular, angiographic, cholangiography, endoscopic, urologic, orthopedic, neurologic, and critical care and emergency room procedures. At the physician's discretion the device may be used for other imaging applications.

Radiographic film examinations can be made with an accessory cassette device attached to the Image Intensifier.

The Ziehm Vision R has two mobile units: a mobile C-arm stand and a monitor cart/ workstation. The C-arm stand contains the x-ray control, high voltage generator, VisionCenter touch controlusion interface, power subs-systems, and control system. The "C profile" or C-shaped mechanical assembly supports at one end the image intensifier and the other the high voltage generator and lubes hassion assembly. The C-Profile is designed to perform rotational and linear movements that allow the user to position the imaging components at various angles and distances with respect to the prieve

The monitor cart/workstation supports dual flat panel LCD display monitors, integrated Ziehm Vision digital image system, imaging capture, image processing, DICOM 3, and VisionCenter touch vontol user interface. External Video connection is provided with RS-170 video timing for domestic market, CCIR for International markets.

The Ziehm Vision R also provides optional peripheral connections for such devices as video printers, thermal printers, network connections, DICOM 3, and external media storage such as USB, DVD devices. A single auxiliary connection is provided for connection to angiographic injoctor systems with the aim of synchronizing image acquisition of angiographic images during controst media injections.

This 510(k) submission for the Ziehm Vision R Digital Mobile Imaging System is for an X-ray system, not an AI/ML powered device. Typically, 510(k) submissions for such traditional medical devices do not include the detailed performance study information requested for AI/ML devices. Therefore, a direct answer to the prompt's specific requirements (acceptance criteria of an AI model, sample sizes, ground truth establishment, MRMC studies, etc.) cannot be provided from the given text.

The provided text focuses on:

• Substantial Equivalence: Comparing the Ziehm Vision R to previously cleared predicate devices (Ziehm Vision K011292, OEC 9800 Plus K021049, OEC 9800 E/CV K024012). This is the primary method of demonstrating safety and effectiveness for traditional devices in 510(k) submissions.
• Device Description and Intended Use: Outlining what the device is, how it functions, and for what medical purposes it is intended.
• Compliance with Standards: Listing various electrical, radiation safety, and medical device standards the device adheres to.

Therefore, many of the requested fields cannot be filled based on the provided document because they pertain to performance testing protocols specific to AI/ML software, which is not applicable here.

However, to address the prompt as best as possible with the available information, here's a summary of what can be extracted and an explanation of why other requested information is not present:

1. Acceptance Criteria and Reported Device Performance:

For a traditional X-ray system, "acceptance criteria" and "reported device performance" are typically defined by compliance with manufacturing specifications, safety standards, and functional equivalence to predicate devices, rather than AI-specific metrics like AUC or F1 score.

2. Sample size used for the test set and the data provenance: Not applicable. This device is not an AI/ML algorithm requiring a distinct test set for performance evaluation in the context of this 510(k) summary. Its "performance" is primarily demonstrated through engineering verification and validation against established standards and comparison to predicate devices, not through a clinical test set for an AI model.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth establishment for an AI model's test set is not relevant for this traditional hardware device 510(k) summary.

4. Adjudication method for the test set: 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: Not applicable. This device is an X-ray imaging system, not an AI-powered diagnostic aid that would be compared for its impact on human reader performance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not a standalone AI algorithm.

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

8. The sample size for the training set: Not applicable. The device does not "learn" from a training set in the way an AI/ML model does.

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

Summary of what the document does provide regarding "proof of meeting acceptance criteria":

The document argues for substantial equivalence primarily based on:

• Identical Intended Use: The Ziehm Vision R has the same intended use as the predicate devices (K011292, K021049, K024012) for fluoroscopic and spot film imaging during various medical procedures.
• Similar Technological Characteristics: It is a mobile C-arm type X-ray system, including a high-voltage generator, X-ray tubes, image intensifier, monitor cart/workstation with digital imaging capabilities, similar to the predicates.
• Compliance with Recognized Standards: The device was designed to comply with a comprehensive list of national and international standards for medical electrical equipment, radiation safety, electromagnetic compatibility, and software safety (listed in Section 2). These standards themselves embody a set of "acceptance criteria" for safe and effective operation.

The "study" that "proves" the device meets acceptance criteria, in this context, is the demonstration of adherence to these standards and the comparison of its technical specifications and performance to the legally marketed predicate devices, which the FDA found acceptable in their previous clearances. This is the standard pathway for traditional medical device 510(k) clearance, rather than a clinical trial or performance study on an algorithm's output.

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The ZIEHM QUANTUM series Mobile C-Arm is intended for use in both Radiographic and Fluoroscopic applications. It is suitable for a wide variety of surgical intervention or guidance procedures requiring X-ray imaging - both inside and outside the operating room. These procedures include Cerebral, Thoracic, Vascular, Biliary, Abdominal, Orthopaedic, Peripheral, Embolization, Stent Placement, Urological Special Vascular-I flow Procedures, and other related fluoroscopic examinations requiring interventional procedures.

The ZIEHM QUANTUM Mobile C-arms are also suitable as a back up for fixed-based X-ray Vascular and Intervention Procedures.

Radiographic film examinations can be made with an accessory cassette device attached to the Image Intensifier.

ZIEHM QUANTUM (Mobile x-ray system)

The provided document is a 510(k) premarket notification approval letter from the FDA for a mobile x-ray system (ZIEHM QUANTUM). This type of document generally approves a device based on its substantial equivalence to a predicate device and does not typically contain detailed information about specific acceptance criteria or comprehensive study designs with the level of detail requested in the prompt (e.g., sample sizes for training/test sets, expert qualifications, adjudication methods for ground truth, MRMC studies, standalone performance).

Therefore, based only on the provided text, it's not possible to describe the acceptance criteria and the study that proves the device meets those criteria with the requested level of detail. The document confirms the device's substantial equivalence to a predicate device for its stated indications for use, but it doesn't elaborate on the specific acceptance criteria or the specifics of studies conducted to demonstrate that equivalence.

The document only states the "Indications for Use" for the ZIEHM QUANTUM, which is a description of how the device is intended to be used, not a set of performance acceptance criteria. It also mentions "Radiographic film examinations can be made with an accessory cassette device attached to the Image Intensifier," which is a functional description, not a performance metric.

Without more detailed study reports, an answer to your prompt cannot be fully generated from this document.

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