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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 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 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 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 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. 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 Ziehm Solo 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. Additionally the device has the option of additional motorized axes of rotational movement for the (A-Axes C-profile motorization of the single A-axes provides the user an alternative for visualizing anatomical structures when performing certain procedures such as but not limited to working with lithotripsy procedures. A user touch screen provides for concise user selectable anatomical programs and X-ray technique control. Integrated highresolution flat panel display monitors directly mounted on the horizontal arm of the mobile stand 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 surqical 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 Solo 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 Solo FD" mobile fluoroscopic X-ray system. It describes the device, its intended use, and a comparison to predicate devices, focusing on the substantial equivalence argument.

However, the document does not contain information about acceptance criteria for device performance, nor details of a study that proves the device meets specific performance criteria through a rigorous clinical or non-clinical evaluation with a defined test set, expert involvement, or adjudication methods.

The document discusses:

• Non-Clinical Test Data Summary: It states that verification/validation testing was successfully conducted on the Ziehm Solo FD, including internal functional specifications (software) and nonclinical image comparisons involving flat panel display images from the new device and the predicate Ziehm Vision² FD (K073346). It also mentions compliance with FDA requirements for diagnostic X-ray systems (e.g., leakage radiation, peak tube potential, fluoroscopic entrance exposure rates, beam-limiting alignment) and voluntary safety standards (IEC standards).
• Image Quality Metrics: It lists several physical characteristics of the X-ray image receptor and system performance, such as DQE (70%), resolution (4 lp/mm), dynamic range (68 dB), and grayscale (16 bit). These are technical specifications rather than acceptance criteria for a study.

Therefore, based solely on the provided text, I cannot answer the questions regarding acceptance criteria and the study that proves the device meets them because such detailed information is not present in this 510(k) summary.

The summary indicates that the device's substantial equivalence is based on:

1. Direct modifications to cleared predicate devices.
2. Compliance with engineering design controls and quality management systems.
3. Verification and Validation testing to internal functional specifications (including software).
4. Nonclinical image comparisons between the new device and a predicate device.
5. Compliance with relevant FDA guidance documents and federal performance standards for X-ray fluoroscopic equipment, as well as voluntary safety standards (e.g., IEC standards).

The document is primarily focused on demonstrating substantial equivalence to predicates for regulatory approval, rather than reporting a clinical performance study with detailed acceptance criteria and ground truth establishment methods for a specific indication leveraging AI or advanced image analysis algorithms that would typically require such a study.

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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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