Search Results

uDR 380i Pro is a mobile digital radiography device intended to acquire X-ray images of the human anatomy for medical diagnosis. uDR 380i Pro can be used on both adult and pediatric patient by a qualified and trained operator. This device is not intended for mammography.

uDR 380i Pro is a diagnostic mobile x-ray system utilizing digital radiography (DR) technology. It can be moved to different environments for an examination, like emergency room. ICU and ward. It mainly consists of a lifting column - telescopic cantilever frame system, system motion assembly, X-ray System (high voltage generator, x-ray tube, collimator and wireless flat panel detectors which have been cleared in K170332 and K192632), power supply system and software for acquiring and processing the clinical images.

uDR 380i Pro is intended to acquire X-ray images for both adult and pediatric, especially for person who may not be able to be moved to a traditional RAD room. The system offers:

• A 14"×17" or 14"×14" flat panel detector
• . A high-power, 32 kW or 50kW generator
• A maneuverable drive system
• X-ray tube-collimator assembly with flexible movement
• Storage for detectors and supplies
• Image Acquisition Workstation with touchscreen user interface

I am sorry, but the provided text does not contain detailed information about the acceptance criteria or a study that proves the device meets specific acceptance criteria in the way you've outlined with performance metrics, sample sizes, expert qualifications, and adjudication methods.

The document is a 510(k) premarket notification for a medical device (uDR 380i Pro) and focuses on demonstrating substantial equivalence to a predicate device (Carestream DRX-Revolution). While it lists some technical specifications and claims that these differences do not raise new safety and effectiveness concerns, it does not present a formal study with acceptance criteria and reported device performance in the format you requested.

Here's a breakdown of what is available in the provided text in relation to your request:

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

• The document provides a "Comparison of Technological Characteristics with the Predicate Devices" table (pages 4-7) which lists various specifications for both the proposed device (uDR 380i Pro) and the predicate device (DRX-Revolution).
• Instead of acceptance criteria, it provides the specifications of both devices and uses "Remark" notes (Note 1 to Note 13) to discuss any differences and justify why these differences do not raise new safety and effectiveness concerns.
• For example, for "Maximum Output Power," the proposed device lists "32kW/ 50kW" compared to the predicate's "32kW." The remark states that the larger output power represents better capability and does not raise new safety and effectiveness concerns.
• For "DQE" (Detective Quantum Efficiency), it states "Typical: 58% @3uGy,0.5lp/mm" for the proposed device and "Typical: 63% @2.5uGy,0.5lp/mm" for the predicate, noting that "Performance is similar" and "it did not raise new safety and effectiveness concerns."
• This is a comparison for substantial equivalence, not a standalone performance study against pre-defined acceptance criteria.

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

• The document mentions a "Clinical Image Evaluation" on page 10. It states: "Sample image of Head, chest, abdomen, spine, pelvis, upper extremity and lower extremity were provided with a board certified radiologist to evaluate the image quality in this submission."
• However, it does not specify the sample size (number of images or cases) used for this evaluation.
• The data provenance is not explicitly stated (e.g., country of origin, retrospective or prospective).

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

• It states that "a board certified radiologist" was used.
• It refers to "a board certified radiologist" (singular), implying one expert.
• No specific experience level (e.g., 10 years of experience) is mentioned beyond "board certified."

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

• The document states that "Each image was reviewed with a statement indicating that image quality are sufficient for clinical diagnosis."
• This description points to a subjective review rather than a formal adjudication process (like 2+1 or 3+1 consensus). It sounds like a single radiologist's assessment.

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 is mentioned. The device is a mobile X-ray system, not an AI-based diagnostic tool that assists human readers.

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

• The device is a hardware system (mobile X-ray) with accompanying software for image acquisition and processing. It is not an algorithm for standalone diagnostic performance. Therefore, this question is not directly applicable in the context of this device. The "Clinical Image Evaluation" was about the image quality produced by the system for visual assessment by a radiologist.

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

• For the "Clinical Image Evaluation," the "ground truth" was the assessment of image quality by "a board certified radiologist" who determined if the images were "sufficient for clinical diagnosis." This falls under expert opinion/assessment of image quality rather than a definitive diagnosis established by other means like pathology or outcomes data.

8. The sample size for the training set:

• The document does not mention any training set size because the submission is for a medical imaging device (hardware and software for image acquisition), not a machine learning or AI algorithm that requires a training set for its core function of interpretation or diagnosis.

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

• As no training set is discussed or implied for the device's primary function, this information is not available.

In summary, the provided FDA 510(k) summary focuses on demonstrating substantial equivalence based on technical specifications and a general assessment of clinical image quality by a radiologist, rather than a detailed performance study against specific acceptance criteria for an AI-enabled diagnostic device.

Ask a specific question about this device

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

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

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

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

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

Ask a specific question about this device

Intended for digital image capture use in general radiographic examinations, wherever conventional screen-film systems may be used, excluding fluoroscopy, angiography and mammography. The kit allows imaging of the skull, chest, shoulders, spine, abdomen, pelvis, and extremities.

PRIMO S is an image acquisition and processing software application, in radiography mode for Flat Panel detectors. The software is specifically designed for integration with production equipment of the SEDECAL group. The PRIMO S application will be used on different types of Sedecal equipment / systems:

• mobile units
• fixed installations.

The PRIMO S VP application provides the following functions:

• User login: the device is usable only by authenticated users
• Management of the operator interface GUIs and setup of the application itself
• The operator interface GUI must reserve a space on the monitor for the Sedecal equipment/system GUI (choice of examination (APR), X-ray generator commands, collimator, stand, etc.)
• Management of patient data through manual entry and reception from the DICOM WORKLIST service
• Management of image processing algorithms for each type of examination
• Management of the automatic advancement procedures of the operations during the study.
• Image acquisition and processing
• Saving in Hard Disk of the acquired images
• Automatic and manual image stitching procedure
• Off-line image editing and optimization using process and graphic functions
• Documentation of images and study data using DICOM services of STORE, PRINT, CDROM, MPPS, RDSR, STORAGE COMMITMENT
• Application configuration setup
• Export and automatic saving of images on external support (USB key)

The application communicates with the Sedecal equipment through software modules (DLL) for:

• The choice of the examination, made by the operator through a GUI defined by Sedecal (APR)
• Send the exposure parameters foreseen by the selected exam (kV, mA, mAs, ms, collimator aperture, stand position, ...)
• Receive the system status parameters and the exposure result

While the provided text describes the PRIMO S device and its 510(k) submission, it explicitly states:

"6. Clinical testing. Not required for a determination of substantial equivalence."

This indicates that a clinical study with detailed acceptance criteria and performance metrics, as requested in your prompt, was not performed or required for the FDA clearance of this specific device. The clearance was based on substantial equivalence to a predicate device, supported by non-clinical testing and adherence to various standards.

Therefore, I cannot provide the specific information you requested regarding validation studies, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, or ground truth establishment for a clinical test set, as such a study was not conducted or reported in this document.

The document primarily focuses on:

• Device Description: What PRIMO S is and what it does.
• Indications for Use: The medical conditions and body parts it's intended for.
• Technological Characteristics Comparison: How it compares to its predicate device (Sedecal SA K130883) in terms of X-ray generator, digital detectors, panel sizes, operating system, etc.
• Non-Clinical Testing: A list of standards (IEC 62304, EN/IEC 62366-1, ISO 14971, NEMA DICOM, ISO 15223-1) that were employed in development, and mention of software validation based on FDA guidance and cybersecurity considerations.

Since there's no clinical trial data, I cannot populate the table or answer the specific questions about the study design that would prove the device meets acceptance criteria based on clinical performance.

Ask a specific question about this device

The DIGITAL RADIOGRAPHY CXDI-CS01 provides digital image capture for conventional film/screen radiographic examinations. This device is intended to capture, for display, radiographic images of human anatomy, and to replace radiographic film/screen systems in all general purpose diagnostic procedures. This device is not intended for mammography applications.

The DIGITAL RADIOGRAPHY CXDI-CS01 is a series of solid-state x-ray detectors. The detector intercepts x-ray photons, and the scintillator emits visible spectrum photons that illuminate an array of photodetectors that create electrical signals. After the electrical signals are generated, the digital values are sent to the PC via wired or wireless connection, converted to images with the CXDI Control Software (CCS), then displayed on monitors. The digital value can be communicated to the operator console via wired or wireless connection.

The subject of this Special 510(k) submission is a change to the DIGITAL RADIOGRAPHY CXDI-702C Wireless and CXDI-402C Wireless to make a series of detectors including the DIGITAL RADIOGRAPHY CXDI-702C Wireless (K192632), CXDI-402C Wireless (K192632), CXDI-710C Wireless (K170332), CXDI-810C Wireless (K170332), and CXDI-410C Wireless (K171270), under the proposed device the DIGITAL RADIOGRAPHY CXDI-CS01. This change will change the Multi Box to be a Standard Component from an optional component for the detectors. The Multi Box has the functions of connecting to the X-ray generator to synchronize the X-ray exposure and photographing, supplying power to the FPD (front panel detector), communicating between the FPD and the image capture computer, connecting the status indicator to the Multi Box to turn the FPD on and off and switch to a ready state, connecting to the WLAN access point to communicate to the FPD wirelessly, and connecting to the docking station to charge the FPD and communicate between the FPD and image capture computer. These functions of the Multi Box have not changed since its clearance under the predicate device (K192632). The X-ray I/F (Interface) Unit has been removed as an optional component for the DIGITAL RADIOGRAPHY CXDI-702C Wireless and CXDI-402C Wireless as the Multi Box performs the function of the X-ray I/F Unit (connecting to the X-ray generator to synchronize the x-ray exposure and photographing). In addition, the detectors will all use the version software cleared under the DIGITAL RADIOGRAPHY CXDI-702C Wireless and CXDI-402C Wireless (K192632). Together, these changes make up the DIGITAL RADIOGRAPHY CXDI-CS01.

The provided text describes a Special 510(k) submission (K203849) for a device called "DIGITAL RADIOGRAPHY CXDI-CS01". This submission is for modifications to previously cleared devices rather than a new standalone device. Therefore, the document focuses on demonstrating that the changes do not negatively impact the device's compliance with established standards and do not raise new questions of safety or effectiveness compared to the predicate device.

The acceptance criteria are therefore related to maintaining compliance with existing performance standards and regulations rather than establishing new performance metrics. The study described is a verification/validation activity to confirm that the modifications do not affect compliance.

Here's the information extracted from the document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not detail specific quantitative acceptance criteria or performance metrics for the device's diagnostic capabilities (e.g., sensitivity, specificity for detecting a disease). Instead, it focuses on demonstrating continued compliance with established standards after modifications. The "performance" section primarily shows that key technical characteristics related to image acquisition are identical to the predicate and reference devices.

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

The document does not specify a "test set" in terms of imaging data or patient cases. The study described is a design verification and validation process focused on the engineering and regulatory impact of changes (making the Multi Box a standard component, removing the X-ray I/F Interface as an option, and updating software). This typically involves testing the modified device against specified technical requirements and standards, not a clinical study with a patient image dataset.

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

Not applicable. As described above, this was not a clinical study involving image interpretation with expert ground truth.

4. Adjudication method for the test set

Not applicable.

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

No MRMC study was performed or described. The device is a digital radiography detector and associated software, not an AI-assisted diagnostic tool.

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

Not applicable. This is not an algorithm for autonomous interpretation. It's an imaging capture device.

7. The type of ground truth used

Not applicable in the context of clinical diagnostic accuracy. The "ground truth" for this submission is adherence to existing regulatory requirements and technical standards.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI-based device requiring a training set.

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

Not applicable.

Ask a specific question about this device

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).

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device

ProRad Series Stationary Radiographic System is intended for use by a qualified, trained doctor or technician on both adult and paediatric 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.

The ProRad series Stationary Radiographic System is a diagnostic x-ray system intended for general purpose radiographic imaging of the human body. There are two types of configurations (2FC and 3NC) for ProRad; the difference is in the mounting of the X-ray tube. For X-ray tube mounting the configuration is either the floor mounted (2FC) or ceiling suspension (3NC) assembly.

The devices are a new combination of a previously cleared solid state digital x-ray acquisition panel and software with the diagnostic x-ray components (including Xray tube, high frequency X-ray generator, a tilting vertical bucky, X-ray table and collimator) required to make a complete system. The purchaser may select any of the digital panels and software based on the user's requirements. The other components are also available in different configurations to meet specific customer needs. The X-ray panel and imaging software have been previously cleared by the FDA, and most of the other components are used in previously cleared 510(k) devices.

Here's an analysis of the acceptance criteria and study information for the ProRad 2FC and ProRad 3NC Digital Stationary Radiographic Systems, based on the provided text:

Acceptance Criteria and Device Performance Table:

The document primarily focuses on demonstrating substantial equivalence to predicate devices rather than setting and reporting specific performance metrics with acceptance criteria in a comparative table for novel device features. The "Comparable Properties" table (pages 6-8) is used to show alignment with predicate devices.

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

• Sample Size: Not explicitly stated as a separate "test set" for a dedicated algorithm performance study. Instead, compliance is demonstrated through testing of the integrated system and reliance on previous FDA clearances for individual components.
• Data Provenance: Not applicable in the context of an algorithm performance test set. The clinical images reviewed by a radiologist were "acquired by the device," but the origin (e.g., country, prospective/retrospective status) is not specified.

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

• Number of Experts: One radiologist.
• Qualifications of Experts: Only "a radiologist" is mentioned. Specific qualifications (e.g., years of experience, board certification) are not detailed.

3. Adjudication method for the test set:

• Adjudication method: Not applicable. The radiologist's review was a single assessment, not a consensus or adjudication process among multiple readers.

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:

• MRMC Study: No. The document explicitly states: "Since the digital x-ray panels and software have previously received FDA clearance, a clinical study was not required as per the FDA guidance document." The clinical image review was supplementary.
• Effect size of human reader improvement with AI: Not applicable, as no MRMC study or AI assistance evaluation was conducted. The device is an imaging system, not an AI diagnostic tool.

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

• Standalone Performance Study: No. This device is a diagnostic X-ray system, which intrinsically requires a human (a qualified doctor or technician) in the loop for operation and interpretation. The performance of individual cleared components (digital panels, software) was relied upon.

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

• Type of Ground Truth: For the supplementary review, the "ground truth" was the radiologist's assessment that the images were "acceptable and allowed the radiologist to make an accurate diagnosis." This is a form of expert opinion on image quality and diagnostic utility, rather than an objective "truth" like pathology or outcomes.

7. The sample size for the training set:

• Sample Size for Training Set: Not applicable. This document does not describe a machine learning algorithm that requires a training set. The device is a conventional X-ray system composed of cleared components.

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

• Ground Truth for Training Set: Not applicable, as there is no machine learning algorithm described.

Ask a specific question about this device