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The VALORY system is a General Radiography X-ray imaging system used in hospitals, clinics and medical practices by radiographers, radiologists and physicists to make, process and view static X-ray radiographic images of the skeleton (including skull, spinal column and extremities), chest, abdomen and other body parts on adults and pediatric patients.

Applications can be performed with the patient in sitting, standing or lying position.

The system is not intended for use in Mammography applications

VALORY is a solid state x-ray system, a direct radiography (DR) system (product code MQB) intended to capture general radiographic images of the human body. VALORY is a ceiling mounted stationary X-Ray system with digital image capture that consists of a tube and operator console with a patient table and/or wall stand. VALORY uses Agfa's NX workstation with MUSICA2 TM image processing and flat-panel detectors of the scintillator-photodetector type (Cesium Iodide - CsI) to capture and process the digital image.

The provided text describes the VALORY system, a general radiography X-ray imaging system, and its substantial equivalence to a predicate device (DR 600, K152639). However, it does not detail specific acceptance criteria for performance metrics (e.g., sensitivity, specificity, accuracy) or a study proving the device meets these criteria in the way a clinical performance study would.

Instead, the submission focuses on demonstrating substantial equivalence through:

• Comparison of technological characteristics.
• Bench testing for image quality and usability.
• Software verification and validation.
• Compliance with electrical safety, EMC, and radiation protection standards.
• Adherence to quality management systems and guidance documents.

Here's an attempt to extract and organize the requested information, noting where specific details are not provided in the text:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not specify quantitative acceptance criteria for image quality or clinical performance metrics (like sensitivity, specificity, or accuracy) in a traditional sense. The performance is assessed relative to the predicate device.

"Additional image quality validation testing for NX 23 was completed in scope of the DX-D Imaging Package with XD Detectors and included a full range of GenRad image processing applications compared to MUSICA 2 image processing using anonymized adult and pediatric phantoms and read by eight internal experts." |
| Usability: Meets safety and workflow requirements. | "Usability evaluations for VALORY were conducted with external radiographers. The usability studies evaluated overall product safety, including workflow functionality for adults and pediatric patients, system movements, information and support for components. The results of the usability tests, fulfillment of the validation acceptance criteria, and assessment of remaining defects support VALORY passing usability validation testing." |
| Software Safety: Acceptable risk profile. | "Software verification testing for NX 23 was completed... For the NX 23 (NX Orion) software there are a total of 535 risks in the broadly acceptable region and 37 risks in the ALARP region with only four of these risks identified. Zero risks were identified in the Not Acceptable Region. Therefore, the device is assumed to be safe, the benefits of the device are assumed to outweigh the residual risk." |
| Compliance: Meets relevant electrical, EMC, and radiation standards. | VALORY is compliant to FDA Subchapter J mandated performance standards 21 CFR 1020.30 and 1020.31. Also compliant with IEC 60601 series, ISO 13485, ISO 14971, DICOM, IEC 62366-1, and IEC 62304. |
| Functional Equivalence: Same intended use as predicate. | The VALORY system has indications for use that is consistent with and substantially equivalent to the legally marketed predicate device (K152639). |

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

The "test set" consisted of:

• Anthropomorphic adult and pediatric phantoms.
• No information on the exact number of phantoms or images used in these tests.
• The data provenance is not specified as country of origin, but it is implied to be laboratory-generated phantom data as "No clinical trials were performed in the development of the device. No animal or clinical studies were performed in the development of the new device."
• The studies were retrospective in the sense that they were conducted for submission, but not using existing clinical patient data.

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

• Image Quality Evaluation: "qualified internal experts and external radiographers" evaluated images from phantoms compared to the predicate device. For NX 23 testing, "eight internal experts" read images. Specific qualifications (e.g., years of experience) for these experts are not provided.
• Usability Evaluation: "external radiographers." Specific numbers and qualifications are not provided.

4. Adjudication Method for the Test Set

The document does not explicitly describe an adjudication method for the expert evaluations, such as 2+1 or 3+1. It states experts "evaluated" and "read" the images, implying their findings were used as the basis for comparison.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

• No MRMC comparative effectiveness study was done.
• The device is a general radiography X-ray imaging system, not explicitly an AI-assisted diagnostic device for specific disease detection. Its image processing (MUSICA/MUSICA2/MUSICA3) is an established technology from the predicate device and other Agfa systems. The study focuses on demonstrating image quality equivalence, not on reader performance improvement with AI assistance.

6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done

• The VALORY system itself is an imaging system, not a standalone diagnostic algorithm.
• The software risk assessment for NX 23 (the workstation software) involved evaluating risks without explicit human interaction for every risk listed, focusing on software failure modes. However, this is not a diagnostic "algorithm only without human-in-the-loop performance" in the sense of an AI CAD system. The image processing algorithms within MUSICA are an integral part of the system's image generation, not a separate diagnostic interpretation.

7. The Type of Ground Truth Used

• Image Quality: The ground truth for image quality evaluation was based on the performance of the predicate device (DR 600) and other marketed flat-panel detectors, combined with expert evaluation of images from anthropomorphic phantoms. It's a comparative assessment rather than a definitive "ground truth" of a disease state.
• Usability: Ground truth for usability was established through the feedback and performance of external radiographers during usability studies, ensuring the system met workflow and safety requirements.
• Software/Safety: Ground truth for software safety and compliance was against established standards (IEC, ISO, FDA regulations) and internal risk analyses.

8. The Sample Size for the Training Set

The document makes no mention of a "training set" in the context of machine learning or AI models. The device is being cleared based on substantial equivalence to an existing X-ray system, not as a novel AI diagnostic algorithm that requires a distinct training dataset. The "image processing algorithms" mentioned are presented as existing, cleared technologies from previous Agfa devices.

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

Since there is no mention of a distinct training set for an AI model, this information is not applicable and not provided in the document.

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