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The PLX5200A is intended for use by a qualified/trained doctor or technologist on both adult and pediatric patients for taking diagnostic radiographic exposures of the skull, spinal column, extremities, and other body parts. Applications can be performed with patient sitting, standing or lying in the prone or supine positions. It is not intended for mammography.

The proposed device is a mobile x-ray system, it uses digital techniques for image capture, display and manipulation and the mobile design allows it to operate on mains or battery power and to be driven or pushed by an operator to various locations within a building or facility. It is commonly used for bedside imaging. This system consists of a mobile base unit, combined X-ray tube assembly, collimator, frame, X-ray flat panel detector, and image processing system.

This device is a Diagnostic X-ray System, which is a hardware device. The provided text indicates that no clinical study was included in this submission. Therefore, there is no acceptance criteria or study data for device performance as requested for AI/software devices.

However, the submission does mention various performance data related to the hardware itself, which are not based on clinical efficacy or diagnostic accuracy. These include:

• Electrical safety and electromagnetic compatibility (EMC): The system complies with IEC 60601-1:2005+A1:2012 / ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, IEC 60601-1-3:2008+A1:2013, IEC 60601-2-54:2009, IEC 62471 standard for safety, and IEC 60601-1-2: 2014 standard for EMC. Radio frequency (RF) wireless coexistence of equipment testing was performed according to IEEE ANSI C63.27-2017.
• Software Verification and Validation: The Embedded software and the workstation software were considered a "Moderate" level of concern and were verified and validated according to FDA's "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." They comply with FDA recognized standard IEC 62304.
• Cybersecurity: Documentation was provided according to "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices."
• DICOM: DICOM declaration was provided according to FDA recognized standard NEMA PS 3.1 - 3.20 (2016).
• Usability Testing: Usability validation was performed and complies with FDA recognized standard IEC 60601-1-6 Edition 3.1 and EC 62366-1 Edition 1.0.
• Risk Management: Activities were performed and documented according to FDA recognized standard ISO 14971 Second edition 2007-03-01.
• Biocompatibility Testing: Conducted in accordance with ISO 10993-1, including Cytotoxicity, Skin Sensitization, and Skin Irritation for the x-ray flat panel detector.

Since this is a hardware device clearance, and not an AI/software as a medical device (SaMD) or an AI-powered diagnostic device, the typical acceptance criteria and study design elements requested (like sample size for test/training sets, expert ground truth, MRMC studies, standalone performance) are not applicable or provided in this 510(k) summary.

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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.

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Mars 1417X wireless digital flat panel detector is indicated for digital imaging solutions designed to provide general radiographic diagnosis for human anatomy including both adult and pediatric patients. It is intended to replace film/screen systems in all general-purpose diagnostic procedures. The device is not intended for mammography or dental applications.

Mars1417X Wireless Digital Flat Panel Detector is a wireless digital flat panel detector that supports single frame mode. Its key component is a TFT/PD image sensor flat panel with an active area of 35cm×43cm. The sensor plate has a direct-deposited CsI scintillator to convert X-ray to visible photon. These visible photons are transformed to electron signals by a diode capacitor array within the TFT panel, which are composed and processed by connecting to scanning and readout electronics, forming a panel image transmitted to a PC through the user interface. The main function is to convert X-ray to digital image for high resolution X-ray imaging. It is a key component of a DR system, enabling the digitalization of medical X-ray imaging with DR system software. iRay SDK (including iDetector) provides an API interface for DR system manufacturers to control the detector.

The provided text describes a 510(k) premarket notification for the Mars 1417X Wireless Digital Flat Panel Detector. This document primarily focuses on demonstrating substantial equivalence to a predicate device (Mars1417V-TSI) rather than presenting a standalone clinical study with detailed acceptance criteria and performance data.

Therefore, the information required to answer most of your questions (especially those related to a clinical study, reader performance, and ground truth establishment) is not present in the provided text. The document states that "clinical consideration may not necessary for changes in the dimensions of the image receptor with otherwise identical materials if non-clinical information is sufficient to support the substantial equivalence." This implies that a formal clinical study, as you've outlined, was likely not conducted or required for this 510(k) clearance.

However, I can extract the acceptance criteria and performance related to the device's technical specifications and non-clinical testing as presented in the document, comparing the proposed device (Mars1417X) to its predicate (Mars1417V-TSI).

Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by demonstrating equivalence or improvement over the predicate device's technical specifications. The "reported device performance" refers to the specifications of the proposed device, Mars1417X.

As for the other points, based on the provided text:

2. Sample size used for the test set and the data provenance: Not applicable in the context of clinical reads for performance testing. The "test set" here refers to the physical device's specifications being evaluated against the predicate. Data provenance is not described for any clinical study. The device manufacturer is iRay Technology Taicang Ltd. in China. The submission is for a 510(k) Pre-Market Notification, which relies on demonstrating substantial equivalence, often through non-clinical performance data and comparison to an existing device, rather than new clinical trials.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for clinical diagnostic performance using expert consensus or pathology is not mentioned, as a clinical performance study of this nature was likely not performed.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. There is no mention of adjudication for a clinical test set.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: No, an MRMC study was not done, and this device is a digital flat panel detector, not an AI diagnostic algorithm. Its primary function is to convert X-rays to digital images, not to provide AI assistance to human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm but a hardware device. Its performance is measured by its raw imaging capabilities (e.g., spatial resolution, DQE).

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the specified improvements (e.g., spatial resolution, DQE), the ground truth is established through physical measurements and standardized imaging tests as per industry standards (e.g., lp/mm, ISO standards for DQE measurement). For safety aspects, compliance with standards like IEC/ES 60601-1 and ISO 10993-1 establishes "ground truth" for electrical safety, EMC, and biological evaluation.

8. The sample size for the training set: Not applicable. This is a hardware device, not an AI algorithm requiring a training set.

9. How the ground truth for the training set was established: Not applicable.

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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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