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This is a mobile diagnostic x-ray system 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.

This is a battery powered mobile diagnostic x-ray system which is provided without the digital x-ray acquisition systems used on our predicate model. The unit is provided with Lithium batteries to supply both X-ray generator for X-ray exposures and motors for movements instead of the Sealed Lead Acid batteries of the predicate model. This system has been made lighter and therefore more maneuverable. Lithium batteries provide a much lower charging time and more autonomy in standby. The indication for use remains the same as the predicate. The x-ray generator has been adapted to the new power supply based on Lithium batteries. The same. The main features of this equipment are:
a) A solid and ergonomic design. Easy operation, safety and precision of all positioning movements relative to the position of the patient.
b) Standard electrical outlet operation with single-phase lines at 100 -- 240 V*. Automatic line voltage compensation.
c) Head-Assembly rotation in relation to its transversal axis (±180°) and horizontal axis (120°). Collimator rotation in relation to its vertical axis (±90°).
d) Controls for lock release of Rotating Column and Telescopic Arm.
e) Column rotation in relation to its vertical axis (±317°), telescopic and vertical motion of the Arm.
f) X-ray Handswitch for X-ray exposures and Collimator Light.
Infrared Remote X-ray Handswitch (optional) for X-ray exposures and Collimator Light. g)
h) Dosimetry (optional):
i) DAP reading with an Ion Chamber. i)
ii) Calculated DAP (eDAP).
i) Manual Collimation.
Tube protection circuitry prolongs Tube life and increases system performance. i)
Equipped with closed loop control of X-ray Tube current, kVp and filaments, which minimize k) potential errors and the need for readjustments.

There is no imaging hardware or software supplied with the unit. That is the responsibility of the purchaser. The x-ray flat panel detectors (an integral part of a complete diagnostic system) are not part of the SM-IV device and must me provided separately by the user.

The provided text describes a 510(k) premarket notification for a mobile x-ray system (SM-IV) and focuses on demonstrating its substantial equivalence to a predicate device (PHOENIX, K212291). The assessment is primarily based on non-clinical testing and technical comparisons, and does not involve a study proving the device meets specific acceptance criteria related to diagnostic performance with human readers or AI.

Therefore, many of the requested details, such as those related to AI effectiveness, human reader studies, ground truth establishment for a test set, and sample sizes for diagnostic performance studies, are not applicable to this submission as it primarily concerns the safety and performance of the hardware itself, not its diagnostic accuracy in clinical use.

Here's a breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't present a formal table of "acceptance criteria" in the sense of predefined thresholds for diagnostic accuracy (e.g., sensitivity, specificity, AUC) for an AI or human-in-the-loop system. Instead, it focuses on demonstrating substantial equivalence to a predicate device based on technical specifications and compliance with safety standards.

The "performance" is largely described in terms of functional specifications and safety compliance, not diagnostic accuracy.

Study that Proves the Device Meets Acceptance Criteria:

The study described is a non-clinical bench testing and technical comparison to demonstrate substantial equivalence, rather than a clinical study of diagnostic performance.

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

• Sample Size for Test Set: Not applicable in the context of diagnostic performance. The "test set" here refers to the physical SM-IV unit which underwent bench testing. The document states, "A system was assembled and found to be operating properly." This implies testing of a single or a few manufactured units for functional and safety compliance.
• Data Provenance: Not applicable for diagnostic performance data. The device itself is manufactured by Sedecal SA in Madrid, Spain.

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

• Not applicable. This submission does not involve establishing ground truth for diagnostic images or AI performance. The assessment is based on engineering and manufacturing standards.

4. Adjudication Method for the Test Set:

• Not applicable. No diagnostic image interpretation requiring adjudication was performed.

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. An MRMC study was not conducted because the device is a mobile x-ray system (hardware), not an AI-powered diagnostic software or a system intended to assist human readers in image interpretation. The device itself does not include imaging software or digital detectors.

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

• No. This device is not an algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):

• Not applicable. Ground truth for diagnostic accuracy is not relevant to this submission. The "ground truth" for the device's performance is adherence to established engineering specifications and safety standards (e.g., IEC 60601 series).

8. The Sample Size for the Training Set:

• Not applicable. This device is a hardware system, not an AI algorithm requiring a training set.

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

• Not applicable.

In summary: The provided 510(k) summary focuses on demonstrating that the SM-IV mobile x-ray system is substantially equivalent to a legally marketed predicate device (PHOENIX) primarily through technical comparison and non-clinical bench testing to ensure safety and effectiveness of the hardware. It does not involve any studies on diagnostic performance, AI capabilities, or human reader accuracy, as these components (imaging software and digital detectors) are explicitly stated as not included with the SM-IV device.

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This is a mobile diagnostic x-ray system 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.

This is a capacitor assisted mobile diagnostic x-ray system which is provided without the digital x-ray acquisition systems used on our predicate model. The unit is provided with a battery to supply the internal PC up to 3 hours without mains connection. This system has been made lighter and more maneuverable, such that battery assisted motorized movement is no longer necessary. The removal of the movement motorization and the required rechargeable batteries resulted in a much lighter system. The generator is also smaller resulting in further weight reduction. The indication for use remains the same as the predicate. The system uses a different xray generator than the one used by the predicate but both are monoblock x-ray generators (same type of generator). The collimator has been changed from the Ralco R108F to the Varex Optica 10. They are functionally identical, having just two manual controls. Although the available generator options have lower peak outputs, the full range of examinations can still be made.

The provided text describes a 510(k) submission for a mobile x-ray system (SM-V) and its substantial equivalence to a predicate device (PHOENIX). It does not include information about clinical studies with acceptance criteria for device performance in the context of diagnostic accuracy, sensitivity, specificity, or reader studies typical for AI/CAD devices.

The "study" referenced in the document is a comparison of the characteristics of the new device (SM-V) against a predicate device (PHOENIX) and compliance with international standards, along with non-clinical testing. This comparison is to establish "substantial equivalence," not to prove diagnostic performance against specific acceptance criteria in a clinical setting.

Therefore, many of the requested sections about clinical study details, such as sample sizes, ground truth establishment, expert adjudication, and MRMC studies, are not applicable or cannot be extracted from this document, as clinical testing was explicitly not required.

Here's an attempt to answer the questions based only on the provided text, indicating when information is not present:

1. Table of acceptance criteria and the reported device performance

Based on the provided text, the acceptance criteria are related to the technical specifications and adherence to international standards, comparing the new device (SM-V) against a predicate device (PHOENIX). There are no "performance" metrics in terms of diagnostic accuracy (e.g., sensitivity, specificity) for a clinical study in this document.

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

• Sample Size for Test Set: Not applicable. The document explicitly states, "Clinical testing was not required to establish substantial equivalence." The testing performed was non-clinical (bench testing and compliance with standards).
• Data Provenance: Not applicable, as no clinical test set was used.

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

• Number of Experts: Not applicable.
• Qualifications of Experts: Not applicable.

4. Adjudication method for the test set

• Adjudication method: Not applicable.

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

• MRMC study: No, an MRMC study was not done. The device (SM-V) is a mobile diagnostic x-ray system, not an AI/CAD diagnostic aid. It explicitly states, "There is no imaging hardware or software supplied with the unit. That is the responsibility of the purchaser."

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

• Standalone performance: No, this is not an algorithm, but a hardware x-ray system. The document states, "There is no imaging hardware or software supplied with the unit."

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

• Type of Ground Truth: Not applicable, as no clinical study with a diagnostic ground truth was conducted. The "truth" in this context is adherence to technical specifications and safety standards.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. This document describes an x-ray hardware system, not a machine learning algorithm.

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

• Ground Truth Establishment for Training Set: Not applicable.

In summary: The provided 510(k) submission focuses on demonstrating substantial equivalence for a mobile x-ray hardware system by comparing its technical specifications and compliance with standards to a predicate device. It explicitly states that no clinical testing was required to establish this equivalence. Therefore, inquiries related to diagnostic performance studies, AI algorithms, human reader improvement, and associated methodologies for clinical data are not addressed in this document.

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This is a digital mobile diagnostic x-ray system 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 modified version of our previous predicate mobile PHOENIX. The predicate PHOENIX mobile is interfaced with Konica – Minolta Digital X-ray panels and CS-7 or Ultra software image acquisition. PHOENIX mobile systems will be marketed in the USA by KONICA MINOLTA. Models with the CS-7 Software will be marketed as AeroDR TX m01. Models with the Ultra software will be marketed as mKDR Xpress. The modification adds two new models of compatible Konica-Minolta digital panels, the AeroDR P-65 and AeroDR P-75, cleared in K210619. These newly compatible models are capable of a mode called DDR, Dynamic Digital Radiography wherein a series of radiographic exposures can be rapidly acquired, up to 15 frames per seconds maximum (300 frames).

The provided text describes a 510(k) premarket notification for a mobile x-ray system. The document focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a study to prove the device meets specific performance-based acceptance criteria for an AI/algorithm.

Therefore, many of the requested details, such as specific acceptance criteria for algorithm performance, sample sizes for test sets, expert ground truth establishment, MRMC studies, or standalone algorithm performance, are not applicable or not present in this type of submission.

The essence of this submission is that the entire mobile x-ray system, including its components (generator, panels, software), is deemed safe and effective because it is substantially equivalent to a previously cleared device, with only minor modifications (adding two new compatible digital panels and enabling a DDR function in the software, which is stated to be "unchanged firmware" and "moderate level of concern").

Here's an attempt to address your questions based on the provided text, while acknowledging that many of them pertain to AI/algorithm performance studies, which are not the focus of this 510(k):

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

The document does not specify performance-based acceptance criteria for an AI/algorithm. Instead, it demonstrates substantial equivalence to a predicate device by comparing technical specifications. The "acceptance criteria" in this context are implicitly met if the new device's specifications (kW rating, kV range, mA range, collimator, power source, panel interface, image area sizes, pixel sizes, resolutions, MTF, DQE) are equivalent to or improve upon the predicate, and it remains compliant with relevant international standards.

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

No specific test set or data provenance (country, retrospective/prospective) is mentioned for AI/algorithm performance. The "testing" involved "bench and non-clinical tests" to verify proper system operation and safety, and that the modified combination of components produced diagnostic quality images "as good as our predicate generator/panel combination." This implies physical testing of the device rather than a dataset for algorithm evaluation.

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

Not applicable. There was no specific test set requiring expert-established ground truth for an AI/algorithm evaluation. The determination of "diagnostic quality images" likely involved internal assessment by qualified personnel within the manufacturer's testing process.

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

Not applicable. No adjudication method is described as there was no formal expert-read test set for algorithm performance.

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. An MRMC study was not conducted as this submission is not about an AI-assisted diagnostic tool designed to improve human reader performance. It is for a mobile x-ray system.

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

No. This submission is for a medical device (mobile x-ray system), not a standalone AI algorithm. The software components (CS-7 and Ultra) are part of the image acquisition process, and the only software "modification" mentioned is enabling the DDR function, which is a feature of the new panels, not an AI for diagnosis.

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

Not applicable. The substantial equivalence argument relies on comparing technical specifications and demonstrating that the physical device produces images of "diagnostic quality" equivalent to the predicate, rather than an AI producing diagnostic outputs against a specific ground truth.

8. The sample size for the training set

Not applicable. This is not an AI/ML algorithm submission requiring a training set. The software components are for image acquisition and processing, not for AI model training.

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

Not applicable, as no training set for an AI/ML algorithm was used or mentioned.

Ask a specific question about this device

This is a digital mobile diagnostic x-ray system 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 type of our previous predicate mobile PhoeniX. The predicate PhoeniX mobile is interfaced with Canon Digital X-ray panels and Canon control software CXDI-NE. The new PhoeniX mobile is interfaced with Konica – Minolta Digital X-ray panels and CS-7 or Ultra software image acquisition. Phoenix mobile systems will be marketed in the USA by KONICA MINOLTA. Models with the CS-7 Software will be marketed as AeroDR Tran-X Models with the Ultra Software will be marketed as mKDR II. The compatible digital receptor panels are the same for either model. The CS-7 software was cleared under K151465/K172793, while the Ultra software is new. The CS-7 is a DIRECT DIGITIZER used with an image diagnosis device, medical imaging device and image storage device connected via the network. This device digitally processes patient images collected by the medical imaging device to provide image and patient information. By contrast the Ultra-DR software is designed as an exam-based modality image acquisition tool. Ultra-DR software and its accompanying Universal Acquisition Interface (UAI) were developed to be acquisition device independent. Basic Features of the software include Modality Worklist Management (MWM) / Modality Worklist (MWL) support, DICOM Send, CD Burn, DICOM Print, and Exam Procedure Mapping. Ultra Software is designed to increase patient throughput while minimizing data input errors. Ultra is made up of multiple components that increase efficiency while minimizing errors. The main components of Ultra are the Worklist, Acquisition Interface and Configuration Utility. These components combine to create a Stable, Powerful, and Customizable Image capture system. The intuitive graphical user interface is designed to improve Radiology, Technologist accuracy, and image quality. Worklist and Exam screens were developed to allow site specific customizations to seamlessly integrate into existing practice workflows.

Here's an analysis of the acceptance criteria and study information for the PHOENIX Digital Mobile Diagnostic X-Ray System, based on the provided text.

Based on the provided document, the PHOENIX device is a digital mobile diagnostic x-ray system, and the submission is for a modification to an existing cleared device (K192011 PHOENIX). The "study" described is primarily non-clinical bench testing to demonstrate that the modified system, with new digital flat-panel detectors (AeroDR series) and new acquisition software (Ultra), is as safe and effective as the predicate device. No clinical study information is provided in this document.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a quantitative, measurable sense for the overall device performance. Instead, it focuses on demonstrating substantial equivalence to a predicate device. The comparison is primarily in the form of feature similarity and compliance with international standards for safety and electrical performance.

Summary of the "Study" Proving Acceptance Criteria

The study described is a non-clinical, bench testing-based assessment for demonstrating substantial equivalence rather than a clinical study measuring diagnostic performance outcomes.

The core argument for substantial equivalence is based on:

1. Identical Indications for Use.
2. Identical platform (mobile system, generator, collimator, power source).
3. Replacement of components (detectors and acquisition software) with components that are either:
   • Previously FDA cleared (AeroDR detectors, CS-7 software).
   • Validated according to FDA guidance (Ultra software).
4. Compliance with recognized international standards for medical electrical equipment.

Here are the specific details requested:

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

• Sample Size for Test Set: Not applicable. No patient-level test set data is mentioned for testing diagnostic performance. The "test set" consisted of physical devices (systems covering all generator/panel combinations) for bench testing and software for validation.
• Data Provenance: Not applicable for a clinical test set. The testing was non-clinical bench testing. The detectors themselves (AeroDR) are stated to have been "previously cleared" by the FDA, implying their performance was established via other submissions, likely including data from various countries consistent with regulatory submissions.

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

• Not applicable. There was no clinical test set requiring expert ground truth establishment for diagnostic accuracy.

4. Adjudication Method for the Test Set

• Not applicable. There was no clinical test set requiring adjudication.

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

• No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical testing was not required to establish substantial equivalence because all digital x-ray receptor panels have had previous FDA clearance."
• Effect size of human readers improvement: Not applicable, as no such study was performed.

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

• Yes, in spirit, for the software component. The new image acquisition software (Ultra) was validated according to the "FDA Guidance: Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." This validation assesses the software's functionality and performance as a standalone component within the system, ensuring it correctly manages workflow, acquires images, and processes them. However, this is software validation, not a standalone diagnostic performance study in the context of an AI algorithm producing diagnostic outputs.

7. The Type of Ground Truth Used

• For the overall device: Substantial equivalence to a legally marketed predicate device (K192011 PHOENIX), which itself would have demonstrated safety and effectiveness.
• For the components (detectors): Prior FDA clearance of the Konica-Minolta AeroDR panels served as the "ground truth" for their imaging characteristics (MTF, DQE, pixel size, etc.) being diagnostically acceptable.
• For the software (Ultra): Validation against specified functional and performance requirements outlined in the FDA software guidance, which serves as the ground truth for software quality and safety.
• For the PHOENIX system itself: Compliance with international safety and performance standards (IEC series) served as the ground truth for its electrical, mechanical, and radiation safety.

8. The Sample Size for the Training Set

• Not applicable. This device is not an AI/ML algorithm that requires a training set in the conventional sense of image analysis. It is an imaging acquisition device. The software validation is based on engineering principles and testing, not statistical training on a dataset.

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

• Not applicable. As above, no training set for an AI/ML algorithm was used.

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These radiographic systems are 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.

Proteus Radiographic System, Models XR/f ST and XR/f ET; MULTIRAD and MULTIRAD NET. These radiographic systems are designed for general radiography in hospitals, clinics, radiology imaging centers and medical practices. It is 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. Patients may be physically abled, disabled, immobilized or in state of a shock. The Radiographic Systems are not intended for mammography applications. If children are to be examined, they should always be accompanied by an adult.

Radiographic System Proteus XR/f has been interfaced with the Digital Imaging System of Konica Minolta Inc consisting of the image receptor and application for image acquisition (control console & image processing controller).

Here's an analysis of the provided text regarding the acceptance criteria and study information for the Proteus XR/f, Models ST and ET, Multirad, and Multirad NET Radiographic Systems:

Acceptance Criteria and Device Performance:

The document describes the device as being "substantially equivalent" to a legally marketed predicate device (K090279: Sedecal "Millennium Plus Digital Diagnostic X-Ray System") and references a reference device (K182688: Konica Minolta Wireless Detector SKR3000) without modification. The performance comparison is primarily qualitative, focusing on similar specifications and compliance with standards rather than explicit quantitative acceptance criteria with reported numerical performance.

Here's a table summarizing the implicit acceptance criteria based on the comparison to the predicate devices and the reported device characteristics:

Study Information:

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

   • The document states: "Clinical testing was not required to establish substantial equivalence because all digital x-ray receptor panels have had previous FDA clearance."
   • Therefore, there is no explicit test set of patient images or data described for the Proteus XR/f system itself. The substantial equivalence relies on non-clinical (bench) testing and the prior clearance of its components (particularly the digital x-ray detector panel).

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

   • Not applicable, as no clinical test set requiring expert ground truth establishment for the Proteus XR/f was conducted. The clearance is based on substantial equivalence to predicate devices and component (digital x-ray receptor panel) clearances.

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

   • Not applicable, as no clinical test set was conducted.

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 MRMC comparative effectiveness study was mentioned or performed. This device is an X-ray system, not an AI-powered diagnostic tool, so such a study would not be relevant for its primary clearance.

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

   • Not applicable, as this is an X-ray imaging system, not an AI algorithm. Its performance is related to image quality and system functionality, not diagnostic algorithmic output.

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

   • For the X-ray system itself, the "ground truth" for its performance is assessed through bench testing against established engineering and safety standards (e.g., IEC 60601 series, 21 CFR 1020.30, 1020.31) and comparison of technical specifications (kVp, mA, mAs accuracy, MTF/DQE values) to the predicate devices. The image quality, for instance, is implicitly compared to "diagnostic quality images as good as our predicate generator/panel combination."
   • For the digital X-ray receptor panels used within the system (Konica Minolta Wireless Detector SKR3000), their prior FDA clearances would have involved their own ground truth evaluations, but those details are not provided in this document.

7. The sample size for the training set:

   • Not applicable, as this is an X-ray imaging system, not an AI algorithm that requires a training set.

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

   • Not applicable, as this device does not utilize a training set.

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

The MobileDiagnost wDR 2.2 is a motorized mobile radiographic system consisting of a mobile base unit, a user interface consisting of Eleva Workspot combined with flat solid state X-ray detectors used to operate, generate, process and handle digital X- ray images. The MobileDiagnost wDR 2.2 integrates a new wireless portable detector (SkyPlate E). The family of SkyPlate detectors (Large and Small) have already been integrated into the MobileDiagnost wDR 2.0 based on the K141736 pre-market submission.

The provided text describes a 510(k) premarket notification for the MobileDiagnost wDR 2.2, a mobile X-ray system. The focus of the submission is to demonstrate substantial equivalence to a predicate device, the MobileDiagnost wDR 2.0 (K141895), with several modifications. The document does not contain a clinical study to prove the device meets acceptance criteria in terms of diagnostic effectiveness or a "performance study" in the typical sense of evaluating a new diagnostic algorithm's accuracy. Instead, the submission relies on demonstrating substantial equivalence through non-clinical verification and validation tests against established standards.

Therefore, the requested information needs to be framed within this context of demonstrating substantial equivalence, rather than a traditional diagnostic performance study.

Here's the breakdown of the information based on the provided text:

Acceptance Criteria and Device Performance (within the context of Substantial Equivalence)

The acceptance criteria are implicitly defined by the compliance with recognized international and FDA consensus standards and the outcome of the comparison to the predicate device, showing that modifications do not raise new questions of safety or effectiveness. The device performance is assessed against these standards and through direct comparison of technical characteristics to the predicate.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a substantial equivalence submission relying on technical changes and compliance with standards, the "acceptance criteria" are compliance with these standards and the "reported device performance" is the verification that these standards are met, and that the technical characteristics of the modified device are acceptably equivalent to the predicate.

• IEC 60601-1 (Edition 3.1)
• IEC 60601-1-2 (Edition 4.0)
• IEC 60601-1-3 (Edition 2.1)
• IEC 60601-1-6 (Edition 3.1)
• IEC 60601-2-54 (Edition 1.1)
• IEC 62304 (Edition 1.0:2006)
• IEC 62366 (Edition 1.0 2015)
• ISO 14971 (Edition 2.0, 2007)
• ISO 10993-1 (Edition 4.0 2009)
• IEC 60601-2-28 (Edition 2.0 2010-03)
• IEC 62220-1 (Edition 1.0 2015-03)
• NEMA PS 3.1 - 3.20 (DICOM)
• "Guidance for the Submission of 510(k)s for Solid State X-Ray Imaging Devices" (Sept 1, 2016)
• "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (May 11, 2005)
• "Pediatric Information for X-ray Imaging Device Premarket Notifications" (Nov 28, 2017) | Meets acceptance criteria and is adequate for its intended use, demonstrating substantial equivalence. Non-clinical information deemed sufficient to support substantial equivalence. |
  | II. Technical Characteristics Equivalence (MobileDiagnost wDR 2.2 vs. MobileDiagnost wDR 2.0) | | |
  | Base Unit Type, X-ray Tube rotational capabilities, Mains Supply, Mode of Exposure, Available Exposure Methods, X-ray Absorber, Installation type, Readout Mechanism, Maximum X-ray Dose for Linear Response, Maximum Usable Dose, Maximum Lifetime Dose, Image Processing (Eleva Workstation), ADC Digitisation, Signal to Electronic Noise Ratio (SENR), Data Interface to Workstation, X-ray Tube type, material, maximum voltage, nominal focal spot, anode type, nominal anode input power, Generator configurations, Collimator operation mode, beam shape, External Connectivity (DICOM), Software Platform (Eleva WorkSpot with SkyFlow). | Same/Identical to predicate. | Identical; thus, demonstrating Substantial Equivalence (SE). |
  | Dimensions (overall, transport, source-floor distance) | Minor differences in mm measurements. | Differences do not impact safety or effectiveness. Thus, demonstrating SE. |
  | Detector Models | Addition of SkyPlate E Large (Trixell 3543DR). Previously cleared SkyPlate Large/Small retained. | Addition of SkyPlate E detector does not impact safety or effectiveness. Thus, demonstrating SE. All technical detector characteristics influencing image quality assessed per FDA guidance. |
  | Detector Weight | Max 3.1 kg (vs. Max 3 kg for predicate). | Difference has no impact on clinical workflow, safety, or effectiveness. Thus, demonstrating SE. |
  | Image Size (X-ray field) | 345.0 mm x 426.0 mm (vs. 344.8 mm x 421.2 mm for predicate). | Difference does not impact clinical Image Quality, safety, or effectiveness. Thus, demonstrating SE. |
  | Pixel Size | 160 µm (vs. 148 µm for predicate). | Difference of 12 µm pixel size does not impact image resolution "to an extent that can impact the clinical image quality," safety or effectiveness. Thus, demonstrating SE. |
  | Image matrix size (Number of pixels) | 2156 x 2662 pixels (vs. 2330 x 2846 pixels for predicate). | "Infinitesimal change" and reduction in number of pixels due to 160 µm pixel size does not impact clinical Image Quality, safety, or effectiveness. Thus, demonstrating SE. |
  | Nyquist Frequency | 3.125 lp/mm (vs. 3.38 lp/mm for predicate). | Difference does not impact clinical Image Quality, safety, or effectiveness. Thus, demonstrating SE. |
  | Modulation Transfer Function (MTF) & Detective Quantum Efficiency (DQE) | Slightly different typical values reported (e.g., MTF at 1 lp/mm: 62% vs. 61%; DQE at 3 lp/mm: 22% vs. 29%). | Differences do not impact clinical Image Quality, safety, or effectiveness. Thus, demonstrating SE. |
  | Grids | Addition of new large grids for SkyPlate E. Previously cleared grids retained. | Addition of new grids has no impact on clinical workflow, safety, or effectiveness. Thus, demonstrating SE. |
  | Column Configuration | Sliding Column (vs. Standard/Short Column for predicate). | Sliding Column provides better viewing; its introduction does not impact safety or effectiveness. Thus, demonstrating SE. |
  | System Power ON/OFF | Keyless user access (vs. Physical Key for predicate). | Keyless user access provides authenticated access; its introduction does not impact safety or effectiveness. Thus, demonstrating SE. |
  | Exposure @ zero degree column position | Exposures allowed (vs. No Exposure allowed for predicate). | Allows examinations in space-constrained situations; difference does not impact safety or effectiveness. Thus, demonstrating SE. |
  | Exposure during Charging | Exposures allowed (vs. Not allowed for predicate). | Allows charging during exam preparation; exposure energy still drawn from generator batteries, not mains. Does not impact safety or effectiveness. Thus, demonstrating SE. |
  | Handles on Collimator | Handles can be used to move both Tube head and Collimator (vs. only Tube head for predicate). | Provides ease of use; difference does not impact safety or effectiveness. Thus, demonstrating SE. |
  | Image Processing Algorithm | UNIQUE 2 (vs. UNIQUE for predicate). | UNIQUE 2 provides improved image processing (reduced noise, improved contrast) and was already cleared under K182973. Upgrading does not alter clinical workflow, safety, or effectiveness. Thus, demonstrating SE. |

Study Details (as applicable for a Substantial Equivalence submission based on non-clinical data)

The provided text clearly states: "The MobileDiagnost wDR 2.2 does not require clinical study since substantial equivalence to the primary currently marketed and predicate device MobileDiagnost wDR 2.0 (K141895- September 18, 2014) was demonstrated with the following attributes: Indication for use; Technological characteristics; Non-clinical performance testing; and Safety and effectiveness."

This means there was no "study" in the sense of a clinical trial or a diagnostic performance study to evaluate accuracy, sensitivity, specificity, etc., with human or AI readers. The "study" here refers to the comprehensive non-clinical verification and validation process against relevant standards.

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

• Sample Size: Not applicable. No clinical test set of patient data was used for a diagnostic performance evaluation. The "tests" were non-clinical verification and validation tests on the device itself (e.g., electrical safety, electromagnetic compatibility, radiation protection, software validation, usability, risk management).
• Data Provenance: Not applicable. No patient data (retrospective or prospective, from any country) was used for evaluating the device's diagnostic performance for the purpose of this 510(k) submission.

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. There was no diagnostic test set requiring ground truth established by experts.

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

• Not applicable. There was no diagnostic test set requiring adjudication.

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. This device is not an AI-assisted diagnostic product but rather an X-ray imaging system with updated components and software functionalities.

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

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

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

• Not applicable. There was no diagnostic performance study requiring ground truth. Ground truth for the non-clinical tests would be the established scientific/engineering principles, specifications, and regulatory standards.

8. The sample size for the training set

• Not applicable. This device is an X-ray system, not a machine learning model that requires a "training set" in the context of AI. The software (UNIQUE 2) was previously cleared (K182973), indicating its own development and validation, but details of its training are not provided here.

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

• Not applicable, as there was no training set for the device itself. For the incorporated UNIQUE 2 image processing algorithm, its ground truth establishment (if it involved machine learning) would have been part of its original 510(k) (K182973), but those details are not in this document.

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These Portable Diagnostic Radiographic Systems are 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).

DRAGON X SPSL4HC and DRAGON X SPSL8HC are mobile x-ray units that cover all the specific needs of any radiographic examination at the patient's bed, first aid, and emergency, orthopedics, pediatric, and operating theater. These line operated units combine stand-alone feature for exposures for ease in imaging. Two different models of digital image acquisition panels are offered: FDX3543RP and FDX3543RPW. Both of the Toshiba panels and the associated software have been previously cleared by FDA (K130883). Integration with the portable system was straightforward. The device complies with the US Federal Safety Performance Standard and is UL listed.

This document describes the Predicate Device Summary and not a study to prove that the device meets acceptance criteria. The requested information cannot be extracted from the provided text.

Here is a breakdown of why this information cannot be extracted from the provided text:

• No Acceptance Criteria or Performance Data: The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. It does not contain a pre-defined set of acceptance criteria for the new device's performance, nor does it present data showing the new device's performance against such criteria.
• No Clinical Study Design Details: The document explicitly states "Summary of Clinical Testing: Not required because the proposed digital panels have prior FDA clearance." This means no new clinical study was conducted for this 510(k) submission to assess the device's clinical performance. Therefore, details like sample size, data provenance, expert qualifications, ground truth establishment, MRMC study results, or standalone performance are not present.
• Focus on Substantial Equivalence: The primary objective of this 510(k) is to demonstrate that the DRAGON X SPSL4HC and DRAGON X SPSL8HC are substantially equivalent to the predicate device (Sedecal Digital Portable X-ray Units: SPSLW4 and SPSLW8). This is achieved by comparing characteristics like intended use, configuration, performance standards, generator, collimator, and power source, and noting that the only key difference is the manufacturer of the digital panel and accompanying software, which themselves have prior FDA clearance (K130883).
• Bench and Lab Testing Summary: While Section 7 mentions "Laboratory testing included performance testing to the DHHS Radiation Safety Performance Standard, Electrical Safety per IEC-60601. EMC per IEC-60601-1-2; IEC 60601-1-3 Radiation protection in diagnostic X-ray equipment, IEC 60601-2-54 Particular Requirements For The Basic Safety And Essential Performance Of X-Ray Equipment for Radiography and Radioscopy, and FCC Parts 15 and 18. A risk analysis was performed. Test images were obtained to confirm total system functionality. Every unit manufactured undergoes thorough performance testing which includes visual and configuration testing, hipot testing, generator testing, including generator controls (voltage, current, timing), and image acquisition," these are general statements about compliance with regulatory standards and functional checks, not a detailed study with specific acceptance criteria and quantitative results for clinical or algorithmic performance as requested.

In summary, this document is a regulatory submission demonstrating substantial equivalence, not a research paper detailing a study of acceptance criteria and device performance.

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