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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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Allengers Wireless/ Wired X-Ray Flat Panel Detectors used with AWS (Acquisition Workstation Software) Synergy DR FDX/Synergy DR is used to acquire/Process/Display/Store/Export radiographic images of all body parts using Radiographic techniques. It is intended for use in general radiographic applications wherever a conventional film/screener CR system is used.

Allengers Wireless/Wired X-ray Flat Panel Detectors are not intended for mammography applications.

The Wireless/ Wired X-Ray Flat Panel Detectors are designed to be used in any environment that would typically use a radiographic cassette for examinations. Detectors can be placed in a wall bucky for upright exams, a table bucky for recumbent exams, or removed from the bucky for non-grid or free cassette exams. These medical devices have memory exposure mode, and extended image readout feature. Additionally, rounded-edge design for easy handling, image compression algorithm for faster image transfer, LED design for easy detector identification, extra protection against ingress of water. This Device is currently indicated for general projection radiographic applications and the scintillator material is using cesium iodide (CsI). The Wireless/ Wired X-Ray Flat Panel Detectors sensor can automatically collect x-ray from an x-ray source. It collects the x-ray and converts it into digital image and transfers it to Desktop computer / Laptop/ Tablet for image display. The x-ray generator (an integral part of a complete x-ray system), is not part of the submission. The sensor includes a flat panel for x-ray acquisition and digitization and a computer (including proprietary processing software) for processing, annotating and storing x-ray images, the personal computer is not part of this submission.

Wireless/ Wired X-Ray Flat Panel Detectors used with Accessory: "AWS (Acquisition Workstation Software) Synergy DR FDX/ Synergy DR", runs on a Windows based Desktop computer/ Laptop/ Tablet as a user interface for radiologist to perform a general radiography exam. The function includes:

1. User Login
2. Display Connectivity status of hardware devices like detector
3. Patient entry (Manual, Emergency and Worklist)
4. Exam entry
5. Image processing
6. Search patient Data
7. Print DICOM Image
8. Exit

This document describes the 510(k) clearance for Allengers Wireless/Wired X-Ray Flat Panel Detectors (K243734). The core of the submission revolves around demonstrating substantial equivalence to a predicate device (K223009) and several reference devices (K201528, K210988, K220510). The key modification in the subject device compared to the predicate is an increased scintillator thickness from 400µm to 600µm, which consequently impacts the Modulating Transfer Function (MTF) and Detective Quantum Efficiency (DQE) of the device.

Based on the provided text, the 510(k) relies on non-clinical performance data (bench testing and adherence to voluntary standards) to demonstrate substantial equivalence, rather than extensive clinical studies involving human subjects or AI-assisted human reading.

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

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the comparison to the predicate device's performance, particularly for image quality metrics (MTF and DQE). The goal is to demonstrate that despite changes, the device maintains diagnostic image quality and does not raise new safety or effectiveness concerns.

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

The document explicitly states that the submission relies on "Non-clinical Performance Data" and "Bench testing". There is no mention of a clinical test set involving human subjects or patient imaging data with a specified sample size. The data provenance would be laboratory bench testing results. The country of origin of the data is not explicitly stated beyond the company being in India, but it's performance data, not patient data. The testing is described as functional testing to evaluate the impact of different scintillator thicknesses.

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

This information is not applicable as the clearance is based on non-clinical, bench testing data (physical performance characteristics like MTF and DQE) rather than clinical image interpretation or diagnostic performance that would require human expert ground truth.

4. Adjudication Method for the Test Set

Not applicable, as there is no mention of a human-read test set or ground truth adjudication process.

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

No. The document does not mention an MRMC study or any study involving human readers, with or without AI assistance. The device is an X-ray detector, not an AI software.

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

Not applicable in the context of an AI algorithm, as this device is an X-ray detector and associated acquisition software. However, the "standalone" performance of the detector itself (MTF, DQE, sensitivity) was assessed through bench testing and measurements, which can be considered its "standalone" performance.

7. The Type of Ground Truth Used

The "ground truth" for the performance claims (MTF, DQE, sensitivity) is based on physical phantom measurements and engineering specifications obtained through controlled bench testing following recognized industry standards (e.g., IEC 62220-1-1). It is not based on expert consensus, pathology, or outcomes data from patient studies.

8. The Sample Size for the Training Set

Not applicable. This submission is for an X-ray flat panel detector, not an AI/ML model that would require a "training set" of data.

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

Not applicable. As stated above, this device does not involve an AI/ML model with a training set.

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The Wireless(V14 CLARITY, V14 HC, V17 CLARITY, V17 HC, F14 CLARITY, F14 HC)/Wired(V14 CLARITY, V14 HC, V17 CLARITY, V17 HC, F14 CLARITY, F14 HC, W17 Clarity, W17 HC) PRORAD X-Ray Flat Panel Detector with DROC is intended to capture for display radiographic images of human anatomy. It is intended for use in general projection radiographic applications wherever conventional film/screen or CR systems may be used. The PRORAD X-Ray Flat Panel Detector with DROC is not intended for mammography, tomography, and angiography applications. The use of this product is not recommended for pregnant women and the risk of radioactivity must be evaluated by a physician.

PRORAD X-Ray Flat Panel Detector with DROC is the similar product to the predicate, Yushan X-Ray Flat Panel Detector with DROC, K201528, K210988, K220510. There are 8 models in this submission, V14 Clarity, V14 HC, V17 Clarity, V17 HC, W17 HC, F14 Clarity, F14 HC, W17 Clarity are a portable(wireless)/nonportable(wired) digital detector. The PRORAD X-Ray Flat Panel Detector with DROC is designed to be used in any environment that would typically use a radiographic cassette for examinations. Detectors can be placed in a wall bucky for upright exams, a table bucky for recumbent exams, or removed from the bucky for non-grid or free cassette exams. These medical devices have memory exposure mode, and extended image readout feature. Additionally, rounded-edge design for easy handling, image compression algorithm for faster image transfer, LED design for easy detector identification, extra protection against ingress of water.

The PRORAD X-Ray Flat Panel Detector with DROC sensor can automatically collects x-ray images from an x-ray source. It collects x-rays and digitizes the images for their transfer and display to a computer. The x-ray generator (an integral part of a complete x-ray system), is not part of the submission. The sensor includes a flat panel for x-ray acquisition and digitization and a computer (including proprietary processing software) for processing, annotating and storing x-ray images. The personal computer is not part of this submission.

PRORAD series is working by using DROC. This is a software running on a Windows PC as an user interface for radiologist to perform a general radiography exam. The function include:

1. Detector status update
2. Xray exposure workflow
3. Image viewer and measurement.
4. Post image process and DICOM file I/O
5. Image database: DROC support the necessary DICOM Services to allow a smooth integration into the clinical network

This submission for the PRORAD X-Ray Flat Panel Detector with DROC (K240771) indicates that no new performance data was generated to demonstrate substantial equivalence. Instead, the device is deemed substantially equivalent to its predicate devices (Yushan X-Ray Flat Panel Detector with DROC, K201528, K210988, K220510) due to minimal changes in product name, appearance, and labeling, implying that the performance of the device is identical to the predicates. Therefore, the acceptance criteria and study details would be those established for the predicate devices.

However, based solely on the provided document, which states "no clinical study has been performed" and that "the performance data is the same and need no extra validation," it explicitly does not include a study directly proving the device meets new acceptance criteria. It relies on the substantial equivalence argument, meaning the predicate devices' performance data is referenced implicitly.

Since the document explicitly states "No clinical study has been performed" and "Therefore the performance data is the same and need no extra validation", there isn't a direct study described in this document that proves the device meets (new) acceptance criteria. Instead, the device is deemed substantially equivalent to the predicate devices and thus relies on the predicate devices' performance data. The document does not provide details of any specific acceptance criteria or performance study results for the PRORAD device itself.

However, based on the non-clinical performance data section, it states that "the image quality evaluation confirmed that the image quality of the PRORAD X-Ray Flat Panel Detector with DROC is substantially equivalent to that of the predicate device." While this isn't a detailed study, it implies a comparison.

Here's an attempt to answer the questions based on the limited information regarding this specific device's performance, highlighting the reliance on predicate device information:

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

Based on the provided document, no specific acceptance criteria for the PRORAD X-Ray Flat Panel Detector with DROC itself are listed, nor is new device performance data reported. The document states that the device's technical characteristics, design, functional, and performance characteristics are similar to the predicate devices. The assumption is that the new device meets the same performance characteristics as the predicate. The comparison table of technical characteristics (from page 8-14 of the original document) contains performance-related metrics that are presented as identical or nearly identical between the subject device and the predicates.

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

The document states, "No clinical study has been performed." For non-clinical tests (e.g., electrical safety, EMC, mechanical, biocompatibility), sample sizes are not specified. The "image quality evaluation" also does not mention a sample size or data provenance. The assessment relies on the inherent similarity of the new device to the previously cleared predicate devices.

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, as no new clinical study was performed for this 510(k) submission. The document relies on "image quality evaluation" that confirmed substantial equivalence, but details on experts or ground truth establishment for this comparison are not provided.

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

Not applicable, as no new clinical study involving adjudication was performed for this 510(k) submission.

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

Not applicable. This device is a digital X-ray flat panel detector, 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 device is an imaging hardware component, not an algorithm for standalone diagnostic performance.

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

Not applicable, as no new clinical study requiring ground truth was performed for this 510(k) submission. The "image quality evaluation" for substantial equivalence would likely rely on quantitative technical metrics rather than clinical ground truth for diagnostic accuracy.

8. The sample size for the training set

Not applicable, as no machine learning algorithm development (which would require a training set) is described for this device in the document.

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

Not applicable, as no machine learning algorithm development is described.

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The MasterX 800 Series is intended for use by a qualified/trained doctor or technologist. As part of a radiographic system, the MasterX 800 Series is intended to acquire digital radiographic images on adult and pediatric patients. It is suitable for all routine radiography exams, including specialist areas like intensive care or trauma work, excluding fluoroscopy, angiography and mammography.

This device represents a new combination of already cleared solid state digital x-ray acquisition panels and already cleared software. It is suitable for use with adult and pediatric populations. This is an upgrade kit for existing or new systems.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the MasterX 800 Series, structured according to your request:

Based on the provided FDA 510(k) Summary, the MasterX 800 Series device is primarily an upgrade kit consisting of a new combination of already cleared digital X-ray acquisition panels and existing software. The submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a de novo study with strict acceptance criteria for novel performance claims.

Therefore, the "acceptance criteria" here are implicitly tied to demonstrating safety and effectiveness compared to the predicate, and the "study" is primarily non-clinical validation and integration testing.

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

Since this is a 510(k) submission for an existing technology combination, explicit quantitative acceptance criteria for new clinical performance aren't stated as they would be for a novel AI device with specific performance metrics. Instead, the "performance" shown is its equivalence to the predicate device and the compliance of its components with relevant standards.

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

• The document states: "Summary of clinical testing: Not required."
• Therefore, there is no clinical test set, sample size, or data provenance from a clinical study. The evaluation relies on non-clinical testing.

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 as no clinical test set or ground truth established by experts was used for performance evaluation in a clinical context. The evaluation was primarily engineering and regulatory in nature, comparing an assembled system to a predicate device.

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

• Not applicable as no clinical test set requiring adjudication was used.

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 an X-ray acquisition system, not an AI-powered diagnostic or assistive tool.

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

• Not applicable as this is an X-ray acquisition system, not an algorithm being evaluated for standalone performance. The "software" referred to is image acquisition software, which is part of the system operation, not an AI for interpretation.

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

• No clinical ground truth (expert consensus, pathology, outcomes data) was used, as no clinical study was performed. The "ground truth" for the non-clinical testing was defined by engineering specifications, regulatory standards compliance, and comparison to the predicate device's established performance parameters (e.g., DQE, MTF).

8. The sample size for the training set

• No training set is mentioned or applicable, as this device is an X-ray acquisition system and not an AI/machine learning algorithm that requires training data.

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

• Not applicable, as there is no training set mentioned or used.

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