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1. The MRH ALFA system is a radiographic system used for producing X-ray images of the human body, including all anatomical regions such as the head, thorax, column, abdomen, extremities and internal organs. The system is designed to be used with conventional film or CR systems and can be interfaced with a digital detector, but neither the X-Ray detector nor the image acquisition system are part of the MRH ALFA radiographic system. The acquisition system comes as a separate system.

The MRH ALFA system is not intended for use in mammography, fluoroscopy or angiography. The MRH ALFA system is intended for adults and pediatric patients. The pediation is as follow:

• · Child (3-12 yrs.), approximately 12 kg (26 lb.) to 51 kg (114 lb.)
• · Adolescent (12-21 yrs.), approximately 51 kg (114 lb.) to 80 kg (176 lb.)

2. The MRH II system is a radiographic system used for producing X-ray images of the human body, including all anatomical regions such as the head, thorax, column, abdomen, extremities and internal organs. The system is designed to be used with conventional film or CR systems and can be interfaced with a digital detector, but neither the X-Ray detector nor the image acquisition system are part of the MRH II radiographic system. The acquisition system comes as a separate system.

The MRH II system is not intended for use in mammography, fluoroscopy or angiography. The MRH II system is intended for adults and pediatric patients. The pediatric population is as follow:

• · Child (3-12 yrs.), approximately 12 kg (26 lb.) to 51 kg (114 lb.)
• · Adolescent (12-21 yrs.), approximately 51 kg (114 lb.) to 80 kg (176 lb.)

3. The MRH IIE system is a radiographic system used for producing X-ray images of the human body, including all anatomical regions such as the head, thorax, column, abdomen, extremities and internal organs. The system is designed to be used with conventional film or CR systems and can be interfaced with a digital detector, but neither the X-Ray detector nor the image acquisition system are part of the MRH IIE radiographic system. The acquisition system comes as a separate system.

The MRH IIE system is not intended for use in mammography, fluoroscopy or angiography. The MRH IIE system is intended for adults and pediatric patients. The pediatric population is as follow:

• · Child (3-12 yrs.), approximately 12 kg (26 lb.) to 51 kg (114 lb.)
• · Adolescent (12-21 yrs.), approximately 51 kg (114 lb.) to 80 kg (176 lb.)

The MRH ALFA, MRH II & MRH IIE Radiographic Systems designed and manufactured by CMR are general purpose, computed radiography (CR) X-ray systems used for diagnostic imaging (analog radiology) of adults and pediatric patients for taking 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. The devices are designed to meet the requirements of basic radiology procedures and produces a low radiation dose to the patient, while acquiring its images.

The provided text is a 510(k) Premarket Notification from the FDA for a new radiographic system. It does not describe a study proving a device meets acceptance criteria related to an AI/ML or diagnostic performance claim but rather demonstrates substantial equivalence to a predicate device.

Specifically, it focuses on the safety and performance of the X-ray system itself (MRH ALFA, MRH II & MRH IIE Radiographic Systems) compared to a previously cleared predicate device (ARiX RAD Radiographic System). The submission does not involve clinical testing or performance claims that would require acceptance criteria related to accuracy, sensitivity, or specificity of image interpretation, an AI algorithm, or human reader performance.

Therefore, I cannot extract the information required in your request bullet points (1-9) because this submission is about a conventional X-ray hardware system, not a diagnostic AI/ML device or a comparative effectiveness study involving human interpretation.

Here's why:

• No acceptance criteria for diagnostic performance: The document's "Summary of Safety and Performance Testing" (Section 11) lists standards related to electrical safety, electromagnetic compatibility, radiation safety, usability, and biocompatibility – all for the hardware itself. There are no performance metrics for diagnostic accuracy or image interpretation.
• No "device performance" in terms of diagnosis: The device's "performance" is demonstrated by passing the listed safety and electrical standards, not by its ability to detect or diagnose conditions in images.
• No test set data, ground truth, or experts for diagnostic interpretation: Since it's a hardware submission, there's no mention of a test set of medical images, ground truth establishment, or expert radiologists interpreting images for diagnostic accuracy.
• No AI/ML component: The devices are described as "general purpose, computed radiography (CR) X-ray systems used for diagnostic imaging (analog radiology)." There is no indication of an AI or machine learning component.
• No MRMC study: A Multi-Reader Multi-Case study would assess how human readers perform, usually with and without AI assistance. This is irrelevant for this hardware submission.
• No standalone algorithm performance: The device is the X-ray machine itself, not an algorithm.
• No training set data: Training sets are relevant for AI/ML models, which are not discussed here.

In summary, the provided document is a regulatory submission for X-ray hardware, demonstrating substantial equivalence to a predicate device based on manufacturing, safety, and physical performance standards, not on diagnostic performance or AI algorithm validation.

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The ARIX RAD system is a radiographic system used for producing X-ray images of the human body, including all anatomical regions such as the head, thorax, column, abdomen, extremities and internal organs. The system is design to be used with conventional film or CR systems and can be interfaced with a digital detector, but neither the X-Ray detector nor the image acquisition system are part of the ARIX RAD radiographic system. The acquisition system comes as a separate system.

The ARiX RAD system is not intended for use in mammography, fluoroscopy or angiography.

The ARiX RAD system is intended for adults and pediatric patients. The pediation is as follows:

• · Child (3-12 yrs.), approximately 12 kg (26 lb.) to 51 kg (114 lb.)
• · Adolescent (12-21 yrs.), approximately 51 kg (114 lb.) to 80 kg (176 lb.)

The ARiX RAD Radiographic System designed and manufactured by Compañía Mexicana de Radiología (CMR) is a general purpose, computed radiography (CR) X-ray system used for diagnostic imaging (analog radiology) of adults and pediatric patients for taking 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. The device is designed to meet the requirements of basic radiology procedures.

The ARIX RAD Radiographic system is capable of interfacing with AeroDR, PaxScan 4336W, Venu1717 detector in trigger mode. However, it is also capable of operating with external triggering devices providing the Hand-switch activation signals and the X-Ray Enable signal of the digital system as an external authorization for the X-Ray emission.

The provided text describes the ARiX RAD Radiographic System and its substantial equivalence to a predicate device (Sedecal Millennium Plus). It outlines technical specifications and conformity to various standards but does not contain information on acceptance criteria for a device's performance based on diagnostic accuracy, sensitivity, or specificity, nor does it present a study proving the device meets such criteria.

The document focuses on demonstrating that the ARiX RAD Radiographic System is substantially equivalent to a legally marketed predicate device (Sedecal Millennium Plus) through comparisons of intended use, technological characteristics, and conformance to recognized safety and performance standards for X-ray systems. It explicitly states that clinical investigations were not required as the indications for use are equivalent to the predicate device, which has a proven safety and effectiveness record.

Therefore, many of the requested items (acceptance criteria, reported device performance figures, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance, and effect sizes) are not available in the provided text, as the regulatory submission did not mandate such studies for this type of device and its specific pathway to market.

Below, I will extract and summarize the information that is available in the provided text, and explicitly note when requested information is absent.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily based on compliance with harmonized standards for X-ray equipment, electrical safety, EMC, and radiation safety. The "reported device performance" refers to the device successfully passing the required tests for these standards. There are no diagnostic performance metrics (e.g., sensitivity, specificity, accuracy) provided as this was not a clinical performance study.

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

• Sample size for test set: Not applicable (N/A). The document describes non-clinical performance data (testing against various standards) rather than clinical testing with a "test set" of patients or data. The testing involved a final finished device unit.
• Data provenance: N/A. The testing was non-clinical, performed on the device itself for compliance with engineering and safety standards.

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

• Number of experts: N/A. This information is not relevant to the non-clinical testing performed.
• Qualifications of experts: N/A.

4. Adjudication method for the test set

• Adjudication method: N/A. Not a clinical study requiring ground truth 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

• MRMC study done: No.
• Effect size: Not applicable.

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

• Standalone study done: No. This device is an X-ray radiographic system, not an AI algorithm.

7. The type of ground truth used

• Type of ground truth: N/A. The "ground truth" for the non-clinical tests was successful adherence to the quantitative and qualitative requirements of the listed international and national standards (e.g., electrical safety, radiation output, EMC, usability, biocompatibility).

8. The sample size for the training set

• Sample size for training set: N/A. This is not an AI/machine learning device. The document describes a traditional medical device (radiographic system) for which no "training set" in the machine learning sense would be used. The device's design, development, and manufacturing stages included internal quality assurance and quality control measures.

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

• Ground truth for training set: N/A.

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PACS CORE/ENCORE™ is a software device that receives digital images and data from various sources (such as, CT scanners, MR scanners, ultrasound systems, R/F units, computer and direct radiographic devices, secondary capture devices, scanners, imaging gateways, or other imaging sources). Images and data can be communicated, processed, manipulated, enhanced, stored, and displayed within the system and/or across computer networks at distributed locations. Post-processing of the images can be performed using Multi Planar Reconstruction (MPR). Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretation. Mammographic images may only be interpreted using a monitor that meets technical specifications identified by FDA. Typical users of this system are trained professionals, physicians, nurses, and technicians.

The PACS CORE/ENCORE™ system is a PACS workstation capable of receiving DICOM 3.1 medical images. The System allows displaying studies that are not in the same place where the system is placed. With its Web features, it is possible to review, modify, and approve studies located in a server. General features are as follows:

• Integration to PACS systems and inter-connectivity with DICOM stations.
• Performing queries to storage systems in other workstations and/or servers to retrieve DICOM studies or images.
• Image printing in Windows and DICOM printers.
• Selecting and ordering patient lists by date, study, name, gender or ID number.
• Importing and exporting images to DVD or CDROM in the following modes: DICOM DIR, DICOM files, JPEG or BMP.
• Importing NON-DICOM images to DICOM 3.0 format.
• Transfer of studies, images and reports via e-mail.
• Study Visualization by series.
• Cine feature.
• 3D reconstruction allowing: MPR (Multiplane Reconstruction) .
• Integrated report feature with transcription through pre-set templates, digital dictation, and voice recognition.
• Possibility to integrate with a Radiology Information System (RIS).
• Work list follow-up; dictated study, transcribed study, and authorized study.
• Due to its Web features, it is possible to review, change and approve studies remotely.
• Complete Web Windows Presentation Foundation (XBAP) technology application.
• Windows Presentation Foundation desk application.

This document pertains to the FDA 510(k) premarket notification K161518 for the PACS CORE/ENCORE™ system, a Picture Archiving Communications System. Based on the provided text, the device is a PACS workstation for receiving, processing, manipulating, enhancing, storing, and displaying digital medical images and data.

The FDA 510(k) submission for PACS CORE/ENCORE™ focuses on demonstrating substantial equivalence to an existing predicate device rather than presenting a novel clinical study with specific acceptance criteria related to diagnostic performance metrics (e.g., sensitivity, specificity for disease detection). The core of the evaluation revolves around the software's functionality and safety as a medical image management system.

Therefore, the requested information needs to be interpreted within the context of a PACS system's validation for substantial equivalence, which primarily involves functional testing and safety assessments.

Here's an attempt to extract and infer the information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a PACS system and the submission is focused on substantial equivalence based on functional and safety requirements, the acceptance criteria are related to the system's ability to perform its stated functions without significant failures, rather than clinical performance metrics.

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

The document states, "The complete system configuration has been tested at the factory and the device has passed all in-house pre-determined testing criteria without significant failures."

• Sample Size: The text does not specify a numerical sample size for the test set (e.g., number of images, number of cases). The testing appears to be functional and system-level validation rather than a clinical study evaluating diagnostic accuracy on a specific number of patient cases.
• Data Provenance: The text does not explicitly state the country of origin or whether the data was retrospective or prospective. Given it's "in-house pre-determined testing criteria," it likely involves a combination of simulated data, test data, and potentially a limited set of real patient images for functional verification within a controlled environment, rather than a large-scale clinical dataset.

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

This type of information is typically not applicable to the validation of a PACS system for substantial equivalence by the FDA. PACS systems are image management tools, and their "ground truth" during testing is typically whether they correctly display, process, store, and transmit images according to technical specifications. It does not involve expert readers establishing a diagnostic ground truth for disease states. Therefore, the document does not mention experts establishing ground truth for a test set.

4. Adjudication Method for the Test Set

Not applicable for this type of system validation. Adjudication methods (like 2+1, 3+1) are used in clinical studies where there's disagreement among human readers interpreting medical images to establish a consensus ground truth. This is not described for the PACS CORE/ENCORE™ testing.

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

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. Such studies compare the diagnostic performance of human readers with and without AI assistance or different devices. This FDA submission is for a PACS system, which is a foundational imaging infrastructure tool, not a diagnostic AI algorithm.

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

No, an algorithm-only (standalone) performance study was not done. The PACS CORE/ENCORE™ is a system for managing and displaying images, not a standalone diagnostic algorithm. The indications for use explicitly state that "A physician, providing ample opportunity for competent human intervention interprets images and information being displayed and printed," confirming a human-in-the-loop approach for image interpretation.

7. The Type of Ground Truth Used

The "ground truth" for the PACS CORE/ENCORE™ system's testing would be:

• Functional Specifications: Whether the system correctly performs each function as defined in its Software Requirements Specification (SRS) and User Manual (e.g., Does it display the image correctly? Does MPR work as expected? Can it query the archive?).
• Technical Compliance: Adherence to standards like DICOM 3.1 for image handling and communication.
• Safety Requirements: Absence of errors that compromise patient safety or data integrity.

It is not a clinical ground truth like pathology, expert consensus on disease, or patient outcomes data.

8. The Sample Size for the Training Set

The document does not mention a "training set" because PACS CORE/ENCORE™ is not an AI/Machine Learning diagnostic device that requires a training set. The system is validated based on its adherence to functional and safety requirements, not by learning from a dataset.

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

Not applicable, as there is no training set for this type of device.

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The ARiX RAD Acquisition Console™ software, used together with a digital X-ray detector is 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, optimizing window level and width of acquired images, rotating images, zooming images, measuring images and other features used for imaging processing. The ARiX RAD Acquisition Console™ system is compatible with the DICOM 3.x communications standard. It can transfer images processed in PACS and print images with a film printer compatible with DICOM 3.0 by using DICOM and network systems.

The ARIX RAD Acquisition Console™ system is not intended for the acquisition of mammographic image data and is meant to be used by qualified medical personnel only and users must be qualified to create and diagnose radiological image data.

The main functions of the ARiX RAD Acquisition Console™ system are as follows:

a) Acquisition and storage of digital X-ray images from a digital X-ray Detector.
b) Input Study information (patient information, exam information).
c) Management of stored (archived) images.
d) Image processing for enhancement of archived images.
e) Review of stored images.
Editing of images.
g) DICOM conformance (e.g. DICOM Storage, DICOM Work list, DICOM Print, etc.)
h) For a DR system (X-ray machine and generator and Digital X-ray 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 Generator Console and ARIX RAD Acquisition Console™ . system.

The ARiX RAD Acquisition Console™ is software used together with a digital . X-ray image acquisition system that uses a digital detector and a Compact GMX RAD X ray generator.
The system allows the user to acquire, review, process, and store high . resolution images, up to 43 cm x 35 cm (17 in x 13.8 in), at 2880 x 2400 pixel resolution and 14 bits depth.
The ARiX RAD Acquisition Console™ provides digital images in compliance . with the DICOM 3.0 standard.

The provided text describes the ARiX RAD Acquisition Console™ as medical imaging software but does not contain information regarding specific acceptance criteria or a study proving its performance against such criteria in the context of diagnostic accuracy.

The nonclinical testing section states: "The complete system configuration has been assessed and tested at the factory and has passed all predetermined in-house testing criteria. The Validation Test Plan was designed to evaluate all input functions, output functions, and actions performed by the ARiX RAD Acquisition Console™ software in each operational mode and followed the process documented in the System Validation Test Plan. Nonclinical testing results are provided in the 510(k). Validation testing indicated that as required by the risk analysis, designated individuals performed all verification and validation activities and that the results demonstrated that the predetermined acceptance criteria were met."

This statement confirms that internal acceptance criteria were met through nonclinical testing (factory assessment, validation test plan), but it does not detail those criteria or the results in a way that would allow for a table of acceptance criteria and reported device performance related to diagnostic efficacy. It focuses on the software's functional performance (input/output, actions, DICOM compatibility, etc.) rather than its performance in detecting or characterizing disease.

Therefore, I cannot fulfill your request for the detailed table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth details related to diagnostic performance, as this information is not present in the provided 510(k) summary. The document focuses on establishing substantial equivalence based on technical characteristics and intended use, rather than on a clinical performance study with defined diagnostic endpoints.

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