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The PRORAD ATLAS ULTRAPORTABLE Digital X-ray system is intended to deliver high-quality, diagnostic radiographic images of the body extremities. It utilizes a portable X-ray unit, flat-panel detector and image acquisition software to produce clear digital images, enabling fast and accurate diagnosis. The portable X-ray unit is intended to be used only when stand/tripod mounted.

The PRORAD ATLAS ULTRAPORTABLE X-ray digital system is predominantly employed in various settings, including health-care centres, temporary and emergency health centres (established, especially in pandemic circumstances), outreach and field interventions (such as mobile clinics/vans, screening campaigns, and home care), and tele-radiology solutions in remote areas.

The primary users anticipated for the system include radiographers, radiological technologists, and medical professionals who are trained in safety, radiation protection, and image management.

The PRORAD ATLAS ULTRAPORTABLE PLUS Digital X-ray system is intended to deliver high-quality, diagnostic radiographic images of the body extremities. It utilizes a portable X-ray Unit, flat-panel detector and real-time image processing using software to produce clear digital images, enabling fast and accurate diagnosis. The portable X-ray unit is intended to be used only when stand/tripod mounted.

The PRORAD ATLAS ULTRAPORTABLE PLUS X-ray digital system is predominantly employed in various settings, including health-care centres, temporary and emergency health centres (established, especially in pandemic circumstances), outreach and field interventions (such as mobile clinics/vans, screening campaigns, and home care), and tele-radiology solutions in remote areas.

The primary users anticipated for the system include radiographers, radiological technologists, and medical professionals who are trained in safety, radiation protection, and image management.

The PRORAD ATLAS X-Ray system includes the ULTRAPORTABLE and ULTRAPORTABLE PLUS, which are portable diagnostic X-ray systems with fixed 70kV and 2mA tube current. These systems are intended to produce anatomical X-rays of the body extremities in both pediatric and adult patients. The PRORAD ATLAS X-Ray system was designed, developed, and manufactured by Prognosys Medical Systems Private Limited. The model numbers are listed below.

The PRORAD ATLAS X-ray system is a sophisticated, battery-powered X-ray generator offered in two versions: PRORAD ATLAS ULTRAPORTABLE and ULTRAPORTABLE PLUS. The main distinction between these models lies in their exposure time ranges and target anatomical areas. The ULTRAPORTABLE model provides exposure times ranging from 0.01 to 1.30 seconds, while the ULTRAPORTABLE PLUS model offers an extended exposure range of 0.01 to 2.5 seconds. Both models share identical internal components, software, algorithms, and operational features and are intended for imaging body extremities. The system includes a high-voltage tank with an X-ray tube mounted on an adjustable tripod stand, allowing users to adjust the height to the specific imaging area. Exposure parameters are configured through the X-ray generator's graphical user interface (GUI). After setting the parameters and positioning the patient on the detector, the X-ray is activated via an exposure switch. The detector captures the radiation, converts it into a digital signal, and transmits the data wirelessly to a computer equipped with compatible software. The images are processed and displayed on the computer for diagnostic review. The PRORAD ATLAS system is compatible with several 510(k)-cleared detectors and their associated software, listed below in Table 1. Prognosys includes one detector and its pre-configured software in the package, depending on availability. Fully battery-operated, the system does not support direct power connection but can seamlessly integrate with multiple detectors and compatible software as part of the package.

The provided FDA 510(k) clearance letter and supporting documentation for the PRORAD ATLAS ULTRAPORTABLE X-Ray Systems do not include acceptance criteria or a detailed study that proves the device meets specific performance criteria beyond general safety and effectiveness.

The document primarily focuses on demonstrating substantial equivalence to a predicate device (Remex KA6, K212144) rather than presenting a performance study with defined acceptance criteria. The "Summary of non-clinical testing" lists a series of international standards (IEC, ISO) and FDA guidance documents that were followed for design control, risk management, verification, and validation. The "Summary of clinical testing" mentions that clinical images were collected and reviewed by a qualified radiologist, confirming they are "clinically acceptable." However, specific quantitative acceptance criteria for image quality, diagnostic accuracy, or other performance metrics, along with the study design and results against those criteria, are not detailed in this document.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor can I provide information about sample size, expert details, adjudication methods, MRMC studies, standalone performance, or training set specifics, as this information is not present in the provided text.

Based on the available text, here's what can be extracted:

• Overall Conclusion: The device is deemed "safe and effective when the device is used as labelled and is substantially equivalent to the predicate device."

Here's a breakdown of why the requested information cannot be fully provided based on the input:

1. A table of acceptance criteria and the reported device performance: This information is not explicitly stated in the document. The document confirms that "Validation of PRORAD ATLAS X-Ray System has demonstrated that the system enables optimal and quality imaging of anatomical structures" and that clinical images are "clinically acceptable," but no specific quantitative criteria or performance metrics are given.

2. Sample size used for the test set and the data provenance: The document states that "Clinical images of body extremities were collected from patients of varying ages, weights, and BMIs." However, the exact sample size and the provenance (e.g., country of origin, retrospective/prospective nature) of this clinical image test set are not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: The document mentions that images were "reviewed by a qualified radiologist." It does not specify the number of radiologists or their specific qualifications (e.g., years of experience, board certification).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: No adjudication method for the clinical image review is described.

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: An MRMC study is not mentioned. The device described is an X-ray system, not an AI software to assist human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This is not applicable as the device is an X-ray system, not an algorithm, and it's intended to be used by trained medical professionals.

7. The type of ground truth used: The ground truth for the clinical images appears to be "clinical acceptability" as determined by a "qualified radiologist." This aligns with "expert consensus" in a general sense, but no more objective ground truth (e.g., pathology, outcomes data) is mentioned for the image quality assessment.

8. The sample size for the training set: The document does not mention a training set, as it describes an X-ray hardware system, not an AI-driven software that requires a training set.

9. How the ground truth for the training set was established: Not applicable, as no training set is mentioned.

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GXR-Series Diagnostic X-Ray System, is a stationary X-ray imaging system, for the purpose of acquiring X-ray images of the desired parts of a patient's anatomy. This device is not intended for mammography or bone density applications.

GXR Series Diagnostic X-ray System is a digital radiographic system. There are 5 power output configurations which are reflected in the model's designation "GXR-XX". The models have 5 different output power ratings: 32kW, 40kW, 52kW, 68kW, 82kW. The subject device, GXR Series Diaqnostic X-ray System, is designed to diagnose the human body by providing radiographic x-ray image with anatomical structure. The subject device has the same x-ray hardware components and image management software as the predicate device. The subject device consists of a high voltage (HV) generator, a tube support unit, an X-ray beam limiting device, a patient table, wall Bucky stand, and an x-ray tube, that operates on a high-frequency inverter method. The operator control console is designed to be user-friendly, and the user can select or change x-ray parameters easily using a large graphic LCD panel display and a soft membrane switch. The GXR Series high frequency X-ray generator (manufactured by DRGEM) features accuracy, reproducibility and long-term stability with capacitor assisted general line power supply. The APR (Anatomical Programming) and the optional AEC (Automatic Exposure Control) features gives the user control of exposure factors, automatically optimized for the radiological study selected. The digital flat panel detectors provide spatial resolution, MTF, DQE and stability based on fine pixel pitch. Selection of an anatomical study on the imaging software automatically sets up the x-ray generator's pre-programmed exposure technique setting and post image processing for selected study. The subject device is able to use a total of 10 different digital detectors, (8 new plus 2 cleared in the predicate, which have been previously cleared by the 510(k) process. The GXR Series Diagnostic X-ray System consists of a combination of an x-ray generator. and associated equipment such as tube stand, patient table, and, digital imaging system. The main power cabinet contains the HT tank and control circuits, the filament drivers, the low speed starter, and interface connections to the room equipment. Tube stand and patient table allows the operator to position the patient. Full Featured Imaging Software & Digital Image Processing. Control console. The image manaqement software, RADMAX Digital Imaging Software (K182537) by DRGEM, is used in both the predicate and subject device to serve as a convenient interface to the hardware and images. Anatomical view-based digital image processing automatically optimizes and enhances the quality of the captured images. RADMAX (K182537) Digital Imaging Software is designed for acquiring images and processing the acquired images. The software can be used together with a digital X-ray detector and or an X-Ray generator. The main features of the RADMAX software are controlling and interfacing the detector, acquiring images after X-ray, storing acquired images, managing data, and image processing. It can also perform system control such as the collimation size, and filter selection.

The provided text describes a 510(k) premarket notification for the "GXR-Series Diagnostic X-Ray System." This submission aims to demonstrate substantial equivalence to a predicate device, not to evaluate the performance of an AI algorithm with specific acceptance criteria that are typically statistical (e.g., sensitivity, specificity, AUC).

Therefore, based on the provided document, I cannot fulfill your request for:

• A table of acceptance criteria and the reported device performance (related to AI algorithm statistical performance).
• Sample size used for the test set and data provenance.
• Number of experts used to establish the ground truth for the test set and their qualifications.
• Adjudication method.
• If a multi reader multi case (MRMC) comparative effectiveness study was done.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done.
• The type of ground truth used.
• The sample size for the training set.
• How the ground truth for the training set was established.

The document focuses on the device itself (an X-ray system), not an AI algorithm for image analysis. The "Performance Data" section describes nonclinical testing for general safety and effectiveness of the X-ray system as a whole, ensuring it meets standards for medical electrical equipment, radiation protection, and software lifecycle, and performs comparably to the predicate device. The only "difference" highlighted is the ability to interface with additional previously cleared digital flat panel detectors.

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The MasteRad MX30 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, 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 device represents a new combination of already cleared solid state digital x-ray acquisition panels (plus one NEW panel) and software with the diagnostic x-ray compnents required to make a complete system. The purchaser may select their digital panel from this list: Varex PaxScan 2530Wv4, Varex PaxScan 4336Wv4, Varex PaxScan 4343R, Varex PaxScan 4343RC, Varex XRpad 4343F, Varex XRpad 3025, Varex XRpad 4336, Toshiba* FDXA4343R. As compared to our predicate system, the tube stand is floor mounted instead of ceiling mounted. The collimator is different. Instead of the Ralco collimator, a Collimare model is supplied. The purchaser selects one of the following FDA certified models: CML-150-0001-C; CTL-150-0001-C; CML-125-0001-C. The x-ray tube and the high voltage generator remains the same as our predicate. The x-ray tube is a Toshiba model and the generator is the CPI CMP 200DR. The image acquisition software is a newer version of our Voyance software originally cleared in K130377.

The MasteRad MX30 is an X-ray system, and the provided text describes its substantial equivalence to a predicate device (K143257). The acceptance criteria and supporting studies are based on demonstrating that the new device, particularly a new digital X-ray receptor panel, maintains diagnostic quality and safety.

Here's a breakdown of the requested information:

1. Table of acceptance criteria and the reported device performance

The acceptance criteria are implicitly tied to demonstrating that the new Toshiba FDXA4343R digital panel (and the overall MasteRad MX30 system) performs at least as well as, or equivalently to, the predicate device and the previously cleared Toshiba FDX4343R panel. The primary performance criterion is diagnostic quality of images.

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

• Sample Size: The document does not specify a numerical sample size for the clinical images beyond stating "Clinical images were acquired from the new Toshiba panel." It implies a sufficient number were obtained for review, but no specific count is given.
• Data Provenance: The document does not explicitly state the country of origin. It indicates the images were "acquired from the new Toshiba panel" for the purpose of this submission, which suggests a prospective acquisition for evaluation, specifically for a new panel not previously cleared by the FDA.

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

• Number of Experts: One expert.
• Qualifications: "A board certified radiologist." No specific years of experience are mentioned.

4. Adjudication method for the test set

• Adjudication Method: Not applicable/None explicitly stated as an adjudication method. The evaluation was performed by a single board-certified radiologist who "reviewed" the images and "found them to be of excellent diagnostic quality." There is no mention of multiple reviewers or a consensus process.

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

• MRMC Study: No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed.
• AI Improvement Effect Size: Not applicable. This submission is for an X-ray system and its digital detector, not an AI-powered diagnostic tool for interpretation.

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

• Standalone Performance: Not applicable. This device is an X-ray acquisition system, not a standalone algorithm. The "performance" described relates to the imaging capabilities of the hardware component (the digital detector) rather than an interpretive algorithm.

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

• Ground Truth Type: Expert opinion/evaluation. The ground truth for image quality was established by a single board-certified radiologist's assessment of "diagnostic quality." This is based on the expert's interpretation of whether the images are suitable for clinical diagnosis.

8. The sample size for the training set

• Training Set Sample Size: Not applicable. The document describes the validation of a hardware system and its updated software, not a machine learning model that requires a training set.

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

• Training Set Ground Truth Establishment: Not applicable, as there was no training set for a machine learning model.

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The RADMAX Digital Imaging Software, used together with a digital X-ray image processing system designed for acquiring images and processing acquired images. The main features of the software are controlling and interfacing the detector, acquiring images after X-ray, storing acquired images, managing data, and image processing. The RADMAX Digital Imaging Software, is not intended for the acquisition of mammographic image data.

The X-ray generator is not part of the RADMAX Digital Imaging Software, device.

If the X-ray generator does not allow interfacing with external software the RADMAX Digital Imaging Software device cannot be interfaced with X-ray Generator.

However, when using third-party generator, use the AED function to acquire the image by sensing the X-ray photon. When using the DRGEM Corporation, generator (models GXR, GXR-U), the RADMAX Digital Imaging Software can only select or change values of X-ray exposure parameters (kVP, mAs or kVP, mA or density).

The RADMAX Digital Imaging Software from DRGEM Corporation, is a digital Xray image processing system designed for acquiring images and processing acquired images. The software can be used together with a digital X-ray detector and or an X-Ray generator. The main features of the software are controlling and interfacing the detector, acquiring images after X-ray, storing acquired images, managing data, and image processing.

The X-ray generator or digital detector is not part of the RADMAX Digital lmaging Software, device. The RADMAX Digital Imaging Software does not control exposure or electrical charge and X-ray calibration. If the X-ray generator does not allow interfacing with external software like the RADMAX Digital Imaging Software device, then the software cannot be interfaced with X-ray Generator. The RADMAX Digital Imaging Software can only select or change values of X-ray exposure parameters (KVp. mA second or kVp. mAs) according to the defined value determined by each X-ray company.

The RADMAX Digital Imaging Software, is not intended for the acquisition of mammographic image data.

The RADMAX Digital Imaging Software device is not intended for the acquisition of mammographic image data and is meant to be used by qualified medical personnel only. The Users must be qualified to create and diagnose radiological image data.

The main functions of the RADMAX Imaging Software are as follows:

• . Acquisition and storage of digital X-ray images from a digital X-ray Detector.
• Input Study information (patient information, exam information). .
• . Management of stored (archived) images.
• Image processing for enhancement of archived images. ●
• Review of stored images. ●
• Editing of images. ●
• DICOM conformance (e.g. DICOM Storage, DICOM Work list, DICOM Print, etc.) ●
• For a DR system (X-ray machine and generator and Digital X-rav detector, etc.) or a need to interface with installed X-ray system, the:
  • Ability to configure X-ray exposure condition (kVp, mA, Sec etc) for various body parts and positions.
  • -Communication between the Generator Console and the RADMAX device.

The X-ray generator control function depends on the X-ray Generator company. The X-ray generator is not part of the RADMAX Digital Imaging Software device since the RADMAX device can only interface and control the Generator by the algorithm provided by the X-ray Company. The RADMAX device can only select or change values of X-ray exposure parameters (kVp, mA second or kVp; mAs) according to the defined value determined by each X-ray company.

The RADMAX Digital Imaging Software, device does not control exposure or electrical charge and or calibration of the X-ray equipment. If the X-ray generator does not allow interfacing with an external software like the RADMAX Imaging Software, then RADMAX, cannot be interfaced with the X-rav Generator.

The provided text describes the RADMAX Digital Imaging Software, focusing on its substantial equivalence to a predicate device (K123650: ARIX RAD ACQUISITION CONSOLE). Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't present a formal table of quantitative acceptance criteria with reported numerical performance values in the way a diagnostic AI would. Instead, it uses a comparative table to demonstrate "substantial equivalence" to a predicate device (K123650: ARIX RAD ACQUISITION CONSOLE) across various functionalities. The "acceptance criteria" here are essentially that the new device's functionality must be "Same" or, if "different," must have "No impact on safety or efficacy" and "no new potential or increased safety risks."

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

The document mentions "nonclinical testing results are provided in the 510(k)" and that "The Validation Test Plan was designed to evaluate all input functions, output functions, and actions performed by the RADMAX Digital Imaging Software and followed the process documented in the System Validation Test Plan." However, it does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective) for any testing.

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

The document does not provide information on the number of experts used or their qualifications for establishing ground truth. The device functionality is primarily compared against a predicate device based on technical specifications rather than diagnostic performance against clinical ground truth.

4. Adjudication Method for the Test Set:

The document does not describe any adjudication method like 2+1 or 3+1. The testing appears to be focused on system validation and functionality comparison, not on inter-rater agreement for diagnostic interpretations.

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

No MRMC comparative effectiveness study was mentioned in the provided text. The document focuses on demonstrating substantial equivalence in features and functionality, not on how the software improves human reader performance or diagnostic accuracy.

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

The document explicitly states: "Diagnosis is not performed by the software but by Radiologists, Clinicians and or referring Physicians." This indicates the device is not a standalone diagnostic algorithm; it's an imaging software for acquisition, processing, and management. Therefore, a standalone performance study as typically understood for an AI diagnostic algorithm was not performed or applicable in this context.

7. The Type of Ground Truth Used:

Given that the device is primarily a software for image acquisition, processing, and management, the "ground truth" for its validation appears to be functional correctness and adherence to technical specifications rather than clinical ground truth (like pathology results or physician consensus on a diagnosis). The "predetermined acceptance criteria" mentioned in the nonclinical testing section would likely relate to whether the software performs its intended functions as designed (e.g., correct image acquisition, storage, processing, display of controls).

8. The Sample Size for the Training Set:

The document does not mention any training set size. This is consistent with the device being a general imaging software rather than a machine learning or AI-driven diagnostic tool that requires a training set.

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

Since there's no mention of a training set, there's no information on how its ground truth would have been established.

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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.

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