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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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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 K230175), power supply system and software for acquiring and processing the clinical images.

The provided text is a 510(k) summary for the uDR 380i Pro mobile X-ray system. This document primarily focuses on establishing substantial equivalence to a predicate device (K222339) and does not contain detailed information about acceptance criteria or a comprehensive study demonstrating the device's performance against specific acceptance criteria.

The key change in this 510(k) submission is the addition of new flat panel detectors (CXDI-710C and CXDI-810C) and associated control software (CXDI Control Software NE). The document explicitly states: "The modifications performed on the uDR 380i Pro (K222339) in this submission are due to the addition of flat panel detectors, including CXDI-710C and CXDI-810C, and CXDI Control Software NE which were cleared in K230175." and "The device software is unchanged from the predicate device, except for the addition of CXDI Control Software NE."

Therefore, the performance data provided is primarily to demonstrate that these new components do not adversely affect the safety and effectiveness or alter the fundamental scientific technology of the device compared to the predicate.

Here's an analysis of the provided information concerning acceptance criteria and study details:

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

The document does not present a formal table of "acceptance criteria" for the device's overall performance. Instead, it compares the technological characteristics of the proposed device to the predicate device in Table 1: Comparison of Technology Characteristics. This table implicitly defines the acceptance (or "sameness") criteria based on the predicate device's specifications.

Acceptance is generally implied if the new device's specifications are "Same" or the differences are justified as not raising new safety/effectiveness concerns (as indicated by "Note 1" and "Note 2").

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

• Test Set Sample Size: The document 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." It does not specify the exact number of images or cases in this sample set. It's described as "Sample image," implying a representative, but not quantitatively defined, set.
• Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. Given that it's a 510(k) submission for a Chinese manufacturer (Shanghai United Imaging Healthcare Co.,Ltd.), the data could be from China, but this is not confirmed.

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

• Number of Experts: "a board certified radiologist" - This indicates one expert.
• Qualifications: "board certified radiologist"

4. Adjudication method for the test set:

• Adjudication Method: "Each image was reviewed with a statement indicating that image quality are sufficient for clinical diagnosis." This suggests a single-reader review without an explicit adjudication process involving multiple readers. It does not mention a 2+1, 3+1, or similar multi-reader adjudication.

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

• No MRMC Study: The document does not describe a multi-reader multi-case (MRMC) comparative effectiveness study. There is no mention of AI assistance or human readers improving with AI vs. without AI. The device is a mobile X-ray system, and the changes relate to its hardware (detectors) and basic control software, not an AI-powered diagnostic tool requiring such a study for a 510(k).

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

• Not Applicable in the traditional sense: This device is an X-ray imaging system, not an AI algorithm for diagnosis. The "performance data" provided ("Clinical Image Evaluation") is about the quality of the images produced, which are then interpreted by a human. It's not a standalone diagnostic algorithm.

7. The type of ground truth used:

• Expert Consensus (single expert, effectively): The "ground truth" for image quality assessment was established by a single "board certified radiologist" who determined if the "image quality [is] sufficient for clinical diagnosis." This is effectively expert opinion/assessment rather than a gold standard like pathology or long-term outcomes data.

8. The sample size for the training set:

• The document does not specify a sample size for a training set. This is generally because the submission is for a conventional imaging device with new detectors, rather than an AI/Machine Learning device that requires explicit training data and validation sets. The "software" mentioned (CXDI Control Software NE) is for detector control and image acquisition/processing, not a deep learning algorithm.

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

• Not applicable/Not provided: As no training set is mentioned in the context of AI/ML, there is no discussion of how ground truth for such a set was established. The "Clinical Image Evaluation" section focuses on verification of image quality for the new detectors.

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