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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 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.

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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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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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, extremities, 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 2.0 system is a motorized mobile radiographic system consisting of a mobile base unit, and a user interface (computer, keyboard, display, mouse), combined with a flat solid state X-ray detector. It is used by the operator to generate, process and handle digital X-ray images. The MobileDiagnost wDR 2.0 integrates a new generation of wireless portable x-ray detectors (SkyPlate) to replace the former detector WPD FD-W17 cleared under the predicate submission (K111725).

Unfortunately, based solely on the provided text, I cannot provide a detailed table of acceptance criteria and reported device performance with the specific metrics you requested (e.g., sample sizes, number of experts, adjudication methods, MRMC study details, ground truth types for test and training sets).

The document is a 510(k) summary for the MobileDiagnost wDR 2.0, which focuses on demonstrating substantial equivalence to a predicate device rather than providing a comprehensive report of a standalone clinical study with detailed performance metrics against predefined acceptance criteria.

However, I can extract and infer some information that partially addresses your request, particularly concerning the non-clinical and "clinical image concurrence" studies mentioned.

Here's an attempt to answer your questions based on the available text:

1. Table of Acceptance Criteria and Reported Device Performance

The document primarily states that the device's non-clinical performance values are "basically equal or better than the predicate device." Specific acceptance criteria or targets are not explicitly listed in a table format in the provided text. The performance is reported in comparison to the predicate device.

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

• Non-Clinical Tests: Sample sizes are not specified for the non-clinical tests (DQE, MTF, Aliasing, etc.). The provenance is not explicitly stated but is implicitly from laboratory testing of the device itself.
• Clinical Image Concurrence Study: Sample size for the test set is not specified. The data provenance is not explicitly stated, but it involved "clinical images were collected and analyzed." It is a retrospective study ("clinical images were collected"). No country of origin is specified.

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

• Non-Clinical Tests: Not applicable, as these are objective physical measurements of device characteristics.
• Clinical Image Concurrence Study: The text mentions a "single blinded, concurrence study" to ensure images meet "user needs" and provide "equivalent diagnostic capability" to the predicate. The number of experts is not specified, nor are their specific qualifications (e.g., "radiologist with 10 years of experience"). It implies expert readers assessed the images.

4. Adjudication Method for the Test Set

• Non-Clinical Tests: Not applicable.
• Clinical Image Concurrence Study: The term "concurrence study" is used, implying agreement among readers or against a standard. However, the specific adjudication method (e.g., 2+1, 3+1, none) is not detailed in the provided text.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

• The document describes a "single blinded, concurrence study" for clinical image analysis. While it compares the new device's images to the predicate, it doesn't explicitly state it was an MRMC comparative effectiveness study in the typical sense of measuring human reader improvement with AI vs. without AI assistance. This device is an X-ray system, not an AI diagnostic tool. Therefore, the concept of "human readers improve with AI vs without AI assistance" does not apply directly to this device's evaluation as presented. No effect size is mentioned.

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

• This question is not directly applicable as the MobileDiagnost wDR 2.0 is an X-ray imaging system, not an AI algorithm. The performance evaluation focuses on the image quality and physical characteristics of the imaging system itself, not an algorithm's diagnostic capabilities in isolation. The non-clinical performance data represents the standalone performance of the device's imaging capabilities.

7. The Type of Ground Truth Used

• Non-Clinical Tests: The "ground truth" for these tests are objective physical standards and measurements (e.g., how a detector should perform according to physics principles and consensus standards).
• Clinical Image Concurrence Study: The "ground truth" was established by expert assessment for "equivalent diagnostic capability" and meeting "user needs." This is a form of expert consensus on image quality and diagnostic utility, comparing images from the new device to those from the predicate.

8. The Sample Size for the Training Set

• Not applicable / Not specified. The document describes performance testing of an imaging device, not a machine learning algorithm that requires a training set. The "clinical images" mentioned were for validation, not training.

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

• Not applicable. As above, there is no mention of a training set for an algorithm in this context.

In summary: The provided 510(k) summary focuses on demonstrating that the MobileDiagnost wDR 2.0 is substantially equivalent to its predicate device through non-clinical (technical) performance criteria and a clinical image concurrence study. It highlights compliance with recognized standards and claims that the new device's technical performance is "equal or better" than the predicate and that its images provide "equivalent diagnostic capability." However, it lacks the fine-grained details about sample sizes, expert qualifications, and specific adjudication methods for the clinical image study that would be typical for evaluating a new diagnostic AI algorithm.

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Sedecal "NOVA FA DR System" 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. Not for mammography.

"NOVA FA DR System" refers to a full Digital Radiography system consisting of: NOVA: Automatic Ceiling Suspension NBS: Tilting Vertical Wall Stand system with CXDI Canon Detectors 401C / 401C Compact / 55C / 501C (Option 1) NET: Elevating Table with CXDI Canon Detector (same detectors as Wall Stand) (Option 2) Flexi DT: Mobile Elevating Table SEDECAL SHF Generator Series, output powers: 50 kW / 65 kW / 80 kW Toshiba Tube: maximum heat dissipation: 300 kHU / 400 kHU Ralco Collimator: Manual / Motorized

Here's a breakdown of the acceptance criteria and study information for the Sedecal "NOVA FA DR System" based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes a modification to an existing X-ray system (K090279). The acceptance criterion for this modification is implicitly to demonstrate that the modified device is as safe and effective as the predicate device, with images of at least comparable quality.

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

• Sample Size for Test Set: Not explicitly stated. The document mentions "various human body structures (chest, skull, abdomen, extremities)" were acquired, but no number of cases or patients is provided.
• Data Provenance: Not explicitly stated (e.g., country of origin). The study used "clinical images," implying prospective acquisition for the purpose of the study, but this is not explicitly confirmed. Given Sedecal is based in Spain, it's plausible the images were acquired there, but this is speculation.

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

• Number of Experts: One.
• Qualifications of Experts: "Board Certified Radiologist." No specific years of experience are mentioned.

4. Adjudication Method for the Test Set:

• Adjudication Method: None explicitly mentioned. With only one radiologist, there was no need for adjudication for consensus.

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 or AI comparative effectiveness study was performed or mentioned. This submission is for a modification to a digital X-ray system, not an AI-powered diagnostic tool. The focus is on the imaging system itself, not on reader performance improvement with or without AI.

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

• This is not applicable as the device is a digital X-ray system, not an algorithm, and its performance inherently involves human operation and interpretation.

7. The Type of Ground Truth Used:

• Ground Truth Type: Expert opinion/evaluation by a Board Certified Radiologist. The "good quality, high resolution, and clinically acceptable" assessment served as the ground truth for image quality.

8. The Sample Size for the Training Set:

• Not applicable/Not mentioned. This document describes a 510(k) for a hardware modification and new detectors, not an AI/machine learning algorithm that requires a training set. The "testing" refers to verification and validation of the hardware performance, software integration, and image quality.

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

• Not applicable/Not mentioned. As above, there is no training set for an AI algorithm.

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