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This Digital Mobile Diagnostic X-Ray System is intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography.

These are modified versions of the predicate mobile digital diagnostic x-ray systems. They feature motorized movement and full battery operation. Various Canon digital X-ray panels are supplied with the system. The Mobile X-Ray Unit MOVIX DReamy has a Basic configuration or Advanced configuration. The Mobile X-Ray unit MOVIX DReamy is provided with touch screen to operate as a control console. The Digital Imaging System is composed by image receptors and application for image acquisition (control console & image processing controller). The Image acquisition software "CANON CXDI Control Software NE" runs on MOVIX DReamy and it is displayed on touch screen. The MOVIX DReamy Mobile X-Ray Unit is provided with separate battery packs for X-Ray generation and motorized movements of the unit can operate connected to mains or in stand-alone mode. New X-ray generator (model SHFM) is mounted on Battery Mobile X-Ray unit MOVIX DReamy. This X-Ray generator for MOVIX DReamy Mobile X-Ray Unit has a radiogenic unit mounted on head-assembly and comprising an X-ray tube with rotating anode and its circuit for high voltage. The electronic and associated software to control the X-ray generation are placed on mobile cart. The Battery Mobile X-Ray Unit MOVIX DReamy is provided with different output powers: 20 kW, 32 kW, 40 kW and 50 kW. There are available two X-ray tube inserts with rotating anode manufactured by CANON ELECTRON TUBES & DEVICES: XRR-3331 insert and E7886 insert. The Manual Beam Limiting Device is from Ralco, model: R108 F. External interface (controls) and covers are provided by Sedecal. There are two versions of collimator assembly, Basic and Advanced.

Based on the provided text, the MOVIX DReamy device is a mobile X-ray system. The document does not describe acceptance criteria for an AI/ML device or a study proving that the device meets such criteria. Instead, it is a 510(k) premarket notification for a mobile X-ray system, establishing substantial equivalence to a predicate device.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving an AI/ML device meets them based on the given document. The document describes the device, its intended use, comparison to a predicate device, and compliance with various international standards, but it explicitly states that no clinical testing was required to establish substantial equivalence.

The relevant sections for this request (AI/ML acceptance criteria and performance study) are not present in this document because it pertains to a different type of medical device clearance.

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Intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography.

This is a new generation of Ceiling Suspension Radiographic System. This system is characterized by its simple and functional design. Thanks to its vertical and horizontal displacements, the suspension can cover almost all the room positions in which it is installed allowing all radiographic procedures. The system is modular and supports different configurations, such as radiographic system without radiographic table or without Wall Stand. The X-ray image receptors used in this system are digital detectors. X-ray film and Computed Radiography (CR) image receptors can be used but they rarely are these days. The device software used is the CANON CXDI which is supplied unmodified by CANON (Clearance numbers above). It has a moderate level of concern. The Radiographic System ChallengeX AP is provided with Auto-positioning, Auto-centering and Auto-tracking functions and it is composed of: Ceiling Suspension (OTC), Radiographic Table, Wall Stand, High Voltage X-ray Generator and acquisition image software. Auto-tracking allows the X-ray Tube to follow the Receptor when it changes position or the other way around while the SID remains constant. The "Auto" features were present and validated in the predicate system.

The document provided is a 510(k) premarket notification for a medical device called "Radiographic System Challenge X." This notification aims to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving that the device meets specific acceptance criteria in a clinical study with an AI component.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for AI-based analysis is not present in the provided text.

The document discusses non-clinical testing for compliance with international standards and FDA guidance for traditional medical device aspects such as safety, electrical compatibility, radiation protection, and software validation. It explicitly states that clinical testing was not required to establish substantial equivalence because the digital x-ray receptor panels already had previous FDA clearance.

Key takeaway from the document regarding studies:

• No AI component or AI-specific acceptance criteria are documented.
• The device is a traditional X-ray system, not an AI-powered diagnostic tool.
• Clinical testing was not performed for this submission. The substantial equivalence was established through non-clinical bench testing and compliance with existing standards and previously cleared components (like the detectors and software).

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Intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography

The Soltus 500 Mobile Digital X-Ray System, Model 10501, ("Mobile X-Ray System") is the same as the predicate mobile PhoeniX with 2 additional features, (i) Distributed Antenna System (DAS), and (ii) Enhanced Work Flow (EWF). The Mobile X-Ray System has motorized movement and full battery operation. It contains a touch screen that operates as a control console. The Mobile X-Ray System supports various Canon flat panel detectors (Digital Radiography CXDI) supplied with the unit.

The provided text is a 510(k) Summary for the Soltus 500 mobile X-ray system. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove meeting specific acceptance criteria for performance metrics typically associated with AI/CADe devices.

Therefore, many of the requested elements for acceptance criteria and study details (like sample size for test/training sets, expert qualifications, adjudication methods, effect size of human readers with AI, ground truth details) are not applicable or findable in this type of submission.

Here's a breakdown based on the information available in the provided text:

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

The document doesn't present specific performance metrics or acceptance criteria in the typical sense of an AI/CADe device. Instead, the "acceptance criteria" are implied by demonstrating substantial equivalence to a predicate device and compliance with relevant safety and performance standards.

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

• Not applicable/Not provided. This device is a mobile X-ray system, not an AI/CADe device that performs diagnostic analysis on images. The evaluation primarily involved bench testing of the hardware and software components, and comparison to the predicate device. Clinical testing was explicitly stated as "not required."

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 clinical ground truth was established as clinical testing was not required.

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

• Not applicable/Not provided. No adjudication method was used as no clinical test set requiring ground truth was established.

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. This was not an AI/CADe device, and therefore no MRMC study was performed.

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

• Not applicable. This device is an X-ray imaging system, not a diagnostic algorithm.

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

• Not applicable/Not provided. No clinical ground truth was used for evaluation. The "ground truth" for the device's functionality was based on engineering specifications, performance standards, and comparison to the predicate device's established performance, verified through bench testing.

8. The sample size for the training set

• Not applicable/Not provided. This is a hardware system, not an AI/ML algorithm that requires a training set.

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

• Not applicable/Not provided. This is a hardware system; there is no training set or ground truth in this context.

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Intended for use by a qualified/trained doctor or technician on both adult and pediatic subjects for taking diagnostic radiographic exposures of the skull, spinal column, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography

These are redesigned versions of our predicate mobile digital diagnostic xray systems. They feature motorized movement and full battery operation. Various Canon digital Xray panels are supplied with the system. (See list above.) The Mobile X-Ray Unit PhoeniX has a Basic configuration or Advanced configuration. Advanced configurations include:

• Second screen on head assembly.
• Smooth movements of head assembly.
• Telescopic arm in four steps instead three steps for basic configuration.

The Mobile X-Ray unit is provided with touch screen to operate as a control console. The Digital Imaging System is composed by image receptors and application for image acquisition (control console & image processing controller). The Image acquisition software "CANON CXDI Control Software NE" runs on Mobile X-ray unit and it is displayed on touch screen. It is the user interface and compatible digital detectors are listed above. All have FDA Clearance. The Advanced configuration has a second Touch Screen Monitor located on head-assembly.

The PhoeniX Mobile X-Ray Unit is provided with separate battery packs for X-Ray generation and motorized movements of the unit can operate connected to mains or in stand-alone mode, that is, operating without mains being present or unplugged from mains. The unit is connected to mains to charge the batteries; New rating: the input voltage range goes from 100 V~ to 240 V~, 1 phase, 1.1 kVA. New X-ray generator (model SHFM) is mounted on Battery Mobile X-Ray unit PhoeniX. This new X-Ray generator for PhoeniX Mobile X-Ray Unit has a radiogenic unit mounted on headassembly and comprising an X-ray tube with rotating anode and its circuit for high voltage. The electronic and associated software to control the X-ray generation are placed on mobile cart. The Battery Mobile X-Ray Unit PhoeniX is provided with different output powers: 20 kW, 32 kW, 40 kW and 50 kW. There are available two X-ray tube inserts with rotating anode manufactured by CANON ELECTRON TUBES & DEVICES:

• New: XRR-3331 insert.
• New: E7886 insert.
  New: Manual Beam Limiting Device from Ralco, model: R108 F. External interface (controls) and covers are provided by Sedecal. There are two versions of collimator assembly, Basic and Advanced.

The provided text describes a 510(k) premarket notification for a mobile X-ray system named PhoeniX. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study for novel acceptance criteria.

Therefore, many of the requested items (acceptance criteria, specific study details with sample sizes, expert involvement, and ground truth information) are not directly addressed in the provided FDA submission as they would be for a de novo marketing authorization or a more extensive clinical study. The submission relies heavily on non-clinical testing and the prior clearance of its components and predicate devices.

However, I can extract information related to the device's technical specifications and the basis for its substantial equivalence, which implicitly acts as its "acceptance criteria" for regulatory clearance.

Here's an analysis based on the provided text, addressing the points where information is available:

1. Table of Acceptance Criteria (Implicit) and Reported Device Performance

The device is considered acceptable if its performance and specifications are substantially equivalent to the predicate device and meet relevant international standards. The "reported device performance" in this context refers to its technical specifications and compliance with safety standards, rather than clinical performance metrics like sensitivity or specificity.

Regarding the Study Proving Acceptance Criteria:

The "study" in this submission is primarily a non-clinical bench testing and comparative analysis to establish substantial equivalence to a legally marketed predicate device (K161345 RadPRO® Mobile 40kW; RadPRO® Mobile 40kW FLEXPLUS).

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

• Sample Size: Not specified in terms of number of images or patients. The non-clinical testing involved "Systems covering all generator/panel combinations were assembled and tested." This suggests testing of device configurations rather than a "test set" of medical images or patient data in the typical sense of an AI/CAD device.
• Data Provenance: Not applicable in the context of clinical data for a "test set." The testing是在实验室环境中，使用设备进行物理和功能验证。

3. Number of Experts and Qualifications to Establish Ground Truth:

• Not applicable as this was a non-clinical submission for substantial equivalence based on technical specifications and functionality. Clinical trials requiring expert reads for ground truth were not performed.

4. Adjudication Method:

• Not applicable as there was no clinical reading study or consensus required for ground truth determination.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No, an MRMC comparative effectiveness study was not done. The document states: "Summary of clinical testing: Clinical testing was not required to establish substantial equivalence because all digital x-ray receptor panels have had previous FDA clearance." This device is a mobile X-ray system, not an AI or CAD software that assists human readers.

6. Standalone (Algorithm Only Without Human-in-the-loop) Performance:

• Not applicable. This device is an X-ray imaging system, not an algorithm that performs a diagnostic task independently. Its performance is related to image quality, radiation output, mechanical safety, and electrical safety.

7. Type of Ground Truth Used:

• Technical Specifications and Compliance with Standards: The "ground truth" for this submission are the established performance characteristics of the predicate device and the specified requirements of relevant international safety and performance standards (e.g., IEC 60601 series, 21 CFR 1020.30). The "truth" is that the device meets these engineering and regulatory benchmarks.
• The document mentions that the modified combination of components "produced diagnostic quality images as good as our predicate generator/panel combination," implying an internal assessment of image quality, but no explicit detailed ground truth generation method is described for clinical image interpretation.

8. Sample Size for the Training Set:

• Not applicable. This is not an AI/ML device that requires a training set of data. The device's components (X-ray generator, panels, software) are either updates to existing technology or previously cleared devices.

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

• Not applicable, as there is no training set for an AI/ML algorithm.

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The uDR 592h, uDR596i Radiographic system is intended to use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, limbs and trunk .Not for mammography.

The uDR 592h, uDR 596i is a digital medical X-ray imaging system that the X-ray generated by the X-ray tube assembly is converted into digital signal through flat panel detector, finally image data using TCP/IP protocol transfers to image process software.

The system consists of Bucky Wall Stand, Tube Stand, Table, High-voltage Generator, X-ray Tube Assembly, Collimator, Flat Panel Detector, Power Distribute Unit, Control Console, Pluggable Grid, Ionization Chamber, Stitching Stand, Image Processing System and Monitor. The system software is a program used for patient administration, acquisition and post processing, image transmission and filming.

The system software provides functions such as import/export images, image viewing, image annotation, patient and study administration, store/delete/rec-over rejected images, exposure index monitoring, image documentation and achieving, automatic exposure control (AEC), stitching.

For automatic exposure control function, high voltage generator can terminate exposure automatically and the stitching provided in uDR 596i can stitch 2-4 single frame images into a full image.

Based on the provided text, here's a detailed breakdown of the acceptance criteria and the study information for the uDR 592h and uDR 596i devices:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria alongside reported device performance for a specific clinical endpoint. Instead, the "acceptance criteria" are implied by adherence to various electrical, safety, and performance standards, and the "reported device performance" is a general statement about meeting these standards and specifications.

However, a specific "Note 12" under "Comparison of Technological Characteristics" mentions acceptance criteria for the stitching function:

Other "performance data" are described in terms of conformance to various standards:

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

The document explicitly states: "No Clinical Study is included in this submission."

Therefore, there is no information on a sample size for a clinical test set or its data provenance in the provided text. The only mention of "clinical images" for evaluation is in the context of the stitching feature and "sample clinical images evaluation" under performance verification, but no details on size or origin are given.

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

For the specific "stitching feature" evaluation, it states: "The clinical images of stitching feature have been reviewed by a board-certified radiologist". This implies one expert.

The qualification provided is: "board-certified radiologist". No information on years of experience is given.

For any other "sample clinical images evaluation," no details regarding experts or their qualifications are provided.

4. Adjudication Method for the Test Set

There is no mention of a formal adjudication method (like 2+1 or 3+1) for any test set. For the stitching feature, it appears to be a single "board-certified radiologist" review, not a consensus or adjudication process.

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 MRMC comparative effectiveness study was done as "No Clinical Study is included in this submission." The devices are referred to as "digital medical X-ray imaging system" and there is no indication of AI assistance in the available text.

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

The device is described as a "digital medical X-ray imaging system," not an AI algorithm. Therefore, no standalone algorithm performance study would be relevant in this context. The "software" section details verification and validation of the software components as part of the system.

7. The Type of Ground Truth Used

For the stitching feature, the ground truth was based on expert opinion/consensus by a board-certified radiologist who "indicated that the provided images are of sufficient diagnostic quality."

For the broader "Performance Verification" and "Non-Clinical Testing," the ground truth is indirectly established by adherence to recognized international standards for electrical safety, EMC, radiation protection, and imaging performance parameters (e.g., dosimetry, image performance tests like DQE, MTF).

8. The Sample Size for the Training Set

The document states, "No Clinical Study is included in this submission." Therefore, there is no information on a training set or its sample size. The device is a traditional X-ray system, not an AI-driven image analysis tool requiring a training set in the typical sense.

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

As no training set is mentioned (since it's not an AI device relying on one), there is no information on how ground truth for a training set was established.

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The device is designed to perform general radiography x-ray examinations on all pediatric and all adult patients, in all patient treatment areas.

Treatment areas are defined as professional health care facility environments where operators with medical training are continually present during patients' examinations.

The ModelOne mobile X-ray system is a diagnostic mobile x-ray system utilizing digital radiography technology. The device consists of a self-contained x-ray generator, image receptor(s), imaging display and software for acquiring medical diagnostic images both inside and outside of a standard stationary x-ray room. The ModelOne system incorporates a flat-panel(s) detector that can be used wirelessly for exams as in-bed projections. The system is intended to be marketed with two options with flat-panel digital images from Canon and Konica Minolta.

Based on the provided text, the device is an X-ray system, and the "study" described is a non-clinical performance evaluation rather than a traditional clinical study with human patients. The information provided is for regulatory clearance (510(k) summary) rather than a comprehensive research paper on AI performance.

Therefore, many of the typical acceptance criteria and study details for an AI/ML device (e.g., ground truth establishment for a test set, MRMC studies, standalone AI performance) are not applicable or not provided in this document. The device is a mobile X-ray system, not an AI-powered diagnostic tool. The focus is on the safety and performance of the hardware and integrated previously-cleared digital imagers, demonstrating substantial equivalence to a predicate device.

Here's an attempt to answer the questions based only on the provided text, noting where information is absent or not relevant for this type of device:

Acceptance Criteria and Device Performance (Non-AI X-ray System)

The document describes performance tests for a mobile X-ray system, NOT an AI/ML device. The acceptance criteria are implicit in the performance tests verifying the functionality and safety of the hardware. The "reported device performance" refers to the successful completion of these non-clinical tests.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for the Test Set and Data Provenance

• Sample Size for Test Set: Not explicitly stated in terms of number of "cases" or "patients" as this is a device performance test, not a clinical study on diagnostic accuracy. The tests involve the device itself and its components.
• Data Provenance: The tests are "non-clinical testing" and performed on the device hardware. Usability tests involved "professional personal" at a "hospital," but this is for evaluating the device's operation in a real-world setting, not an evaluation of diagnostic output. It's a "retrospective" view of testing results provided to the FDA.

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

• Not Applicable / Not Provided. This document describes a mobile X-ray system, not an AI/ML diagnostic algorithm that requires expert-established ground truth for image interpretation. The "ground truth" here is the device's functional performance against its design specifications and compared to a predicate, not clinical diagnostic accuracy.

4. Adjudication Method for the Test Set

• Not Applicable / None. No adjudication method is mentioned as this is not a study assessing human or AI diagnostic performance based on image interpretation.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No. "No clinical testing was performed on the subject device." Therefore, no MRMC study was conducted to evaluate human readers with or without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance

• Not Applicable / No. The device itself is an X-ray imaging system. It produces images, but the document does not describe a new AI algorithm for interpreting those images. The "software" mentioned is for acquiring and displaying images, and its risk is classified. The post-processing is defined by protocols from previously cleared Canon and Konica Minolta image software.

7. Type of Ground Truth Used

• Functional Performance Specifications and Predicate Comparison. The "ground truth" for this regulatory submission is that the device functions according to its design specifications (e.g., battery life, driving distance, exposure time) and performs "as well as or better than the predicate device" in non-clinical settings.

8. Sample Size for the Training Set

• Not Applicable. This is not an AI/ML algorithm that requires a training set of data.

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

• Not Applicable. As above, no AI/ML training set is mentioned or implied.

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Intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography.

RadPRO® Mobile 40kW and RadPRO® Mobile 40kW FLEXPLUS, Model SM-40HF-B-D-VIR are mobile x-ray units that covers all the specific needs of any radiographic examination at the patient's bed, first aid, and emergency, orthopedics, pediatric, and operating theater. These battery or line operated units combine stand-alone for exposures with battery assisted motor drive for the greatest ease in imaging. Five different models of digital image acquisition panels are offered: Canon CXDI 401C Wireless, Canon CXDI 701C Wireless, Canon CXDI 801C Wireless. All of the Canon panels and the associated software have been cleared by FDA, (K131106 and K133693) so integration with the mobile system was straightforward. The device complies with the US Federal Safety Performance Standard and is UL listed.

This document is a 510(k) premarket notification for the RadPRO® Mobile 40kW and RadPRO® Mobile 40kW FLEXPLUS, Model SM-40HF-B-D-VIR, a mobile X-ray system. The submission aims to demonstrate substantial equivalence to legally marketed predicate devices.

Here's an analysis of the provided text in response to your request:

Acceptance Criteria and Device Performance

The document does not explicitly state "acceptance criteria" in the traditional sense of numerical targets for performance metrics (e.g., sensitivity, specificity, accuracy). Instead, it focuses on demonstrating substantial equivalence to a predicate device (Sedecal Mobile Digital Diagnostic X-Ray Systems, K101517) through technical and safety comparisons, and by showing that the device is as safe and effective. The performance is assessed through compliance with relevant standards and successful integration of previously cleared components.

The table below summarizes the comparison between the new device and the predicate, highlighting the "performance" implicitly defined by these comparisons:

Study Proving Acceptance Criteria (Substantial Equivalence):

The study proving the device meets the acceptance criteria (i.e., is substantially equivalent to the predicate) is primarily a non-clinical bench and laboratory testing study, complemented by the fact that core components (digital panels) were previously FDA cleared.

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

2. Sample size used for the test set and the data provenance:

• Test Set Sample Size: The document does not specify a "sample size" in terms of number of patient cases or images for testing the entire device system's imaging performance beyond general statements about "test images." However, the digital panels themselves (Canon CXDI series) were previously cleared by the FDA (K131106 and K133693), implying their performance was assessed in their respective submissions.
• Data Provenance: Not explicitly stated for specific images. The testing was conducted by SEDECAL SA in Algete, Madrid, España (Spain). The nature of the testing described (laboratory, bench, test images, clinical image comparisons) suggests some data would be internally generated or acquired during testing. Given it's a 510(k) for an X-ray system, the "data" is primarily technical specifications, compliance with standards, and image quality demonstrations rather than a large clinical dataset for a diagnostic algorithm.

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

• Number of Experts: "Sample images were verified by a Board Certified Radiologist." This indicates at least one expert.
• Qualifications: "Board Certified Radiologist." No details on years of experience.

4. Adjudication method for the test set:

• Not specified. Given only one expert is mentioned for image verification, a formal adjudication method (like 2+1 or 3+1) is unlikely to have been employed for the specific "sample images." The primary method appears to be comparison against accepted standards and the predicate device's performance.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

• No, an MRMC comparative effectiveness study was not done. The submission focuses on demonstrating substantial equivalence of the hardware system, not on evaluating human reader performance with or without AI assistance. The device is a mobile X-ray system, not an AI-powered diagnostic algorithm in the typical sense of needing MRMC studies to assess reader improvement.

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

• This question is not directly applicable to this device in the context of a diagnostic AI algorithm. The device itself is a standalone X-ray imaging system. The submission details its performance, safety, and effectiveness without reliance on a human-in-the-loop performance for its core function of image acquisition. The "Enhanced Work Flow" is a separate software capability for facilitating client software, not an AI algorithm for interpreting images.

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

• For the "sample images" mentioned, the ground truth was expert verification by a Board Certified Radiologist. The overall "ground truth" for the device's main function comes from compliance with established technical standards (e.g., electrical safety, radiation performance, image acquisition parameters) and the performance of the legally marketed predicate device.

8. The sample size for the training set:

• This device is a hardware X-ray system, not an AI algorithm trained on a dataset of images. Therefore, there is no "training set" in the context of machine learning.

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

• N/A, as there is no training set for an AI algorithm.

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