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1717FCC is indicated for digital imaging solution designed for general radiographic system for human anatomy. It is intended to replace film or screen based radiographic systems in all general purpose diagnostic procedures. Not to be used for mammography.

1717FCC is a digital solid state X-ray detector that is based on flat-panel technology. This radiographic image detector and processing unit consists of a scintillator coupled to amorphous silicon (a-Si) / Indium Gallium Zinc Oxide (IGZO) on TFT sensor. This device is connected to the user PC via wired LAN (ethernet cable) and it needs to be integrated with a radiographic imaging system. It does not operate as an X-ray generator controller but can be utilized to capture and digitalize X-ray images for radiographic diagnosis. The RAW files can be further processed as DICOM compatible image files by separate console SW(Xmaru RF) for a radiographic diagnosis and analysis.

The provided text describes a 510(k) summary for the Rayence 1717FCC Digital Flat Panel X-Ray Detector, claiming substantial equivalence to predicate devices (1717SCC, K171420) and a reference device (DRF 4343, K080859). The performance claims primarily revolve around demonstrating equivalent or better image quality and technical specifications compared to these predicate devices, rather than establishing acceptance criteria against a specific clinical performance threshold.

Therefore, the typical structure for answering questions about acceptance criteria and clinical study results for a new AI/CAD device (which usually involves specific metrics like sensitivity, specificity, AUC, human reader improvement, etc.) is not directly applicable to this document. This submission is for a hardware device (a digital X-ray detector), not an AI algorithm, and the primary method of demonstrating "acceptance" is through showing substantial equivalence to existing hardware rather than meeting specific clinical performance metrics.

However, I can interpret the request in the context of this 510(k) submission for a hardware device and extract relevant information to address the spirit of your questions as much as possible.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

For this hardware device, "acceptance criteria" are based on demonstrating equivalent or superior technical performance and image quality compared to a legally marketed predicate device, rather than diagnostic accuracy metrics.

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The Uroview FD is a solid state detector fluoroscopic X-ray system, primarily for urological applications (functional x-ray-diagnostics, endourology and minimal invasive urology/surgery). The system, which includes a radiologic/ urologic treatment table, may be used for urological treatment, planning and diagnostic procedures including but not limited to: · Querying and retrieving patient information and /or images from other modalities. · X-ray examination of the urogenital area (e.g. cyctoscopy, kidney, bladder, ureter, urethra) including KUB, IVP, vasovesiculography, reflux-cystogram, cystourethrogram, and micturation cystourethrogram combined with uroflow measurements. · Ultrasound examinations(in conjunction with a stand-alone ultrasound system) of the kidney, bladder, prostate, scrotum. · Endourological interventions (e.g. of the urethra, prostate, bladder, sphincter, ostium, kidney and ureter, catheter placement , penile implant placement, transurethral resection of prostate or bladder, alternative treatment of the BPH and brachytherapy). · Percutaneous interventions (e.g. PCN nephrolithotomy, resection, percutaneous nephrostomy). · Laparoscopy (e.g. cholecystectomy, lymph node dissection, abdominal testis detection/correction, varicocele). - · Application of fistula (kidney/bladder). - · Simple procedures (e.g. urethra, testis, phimonis). - · Introcorporeal shock wave lithotripsy. - Uroflow/urodynamics. - · Pediatric radiological and therapeutic applications.

The "Uroview FD" is a solid state detector fluoroscopic, X-ray system, primarily for urological applications (functional x-ray diagnostics, endourology and minimal invasive urology/surgery). The basic unit is a cantilevered, continuously adjustable, isocentric tilting patient table called the "Uroview FD Skeleton", which can be raised and tilted to provide convenient access for the patient as well as optimum and ergonomic operating conditions for the user. The Uroview FD X-ray system is a completely mounted system and is equipped with a digital imaging system with a dynamic flat detector, designed to replace traditional spot film devices using screen-film cassettes or "CR" plates and fluoroscopy with image intensifier CCD cameras. The system is also equipped with a generator and automatic, multilayer, square field collimation system intended for installation on stationary X-ray equipment. A rotating anode X-ray tube is mounted. The measuring chamber is placed between the patient and the detector in order to detect the actual dose value for the automatic exposure control (AEC), to provide consistent x-ray film appearance and to guarantee error-free images even at low kV values. Attenuation factor is low and X-ray scattering is reduced to minimum by using a moveable grid. The Uroview FD X-ray system includes the following major components: - . Uroview FD skeleton (urological table incl. tilting table) - . High Frequency RF X-ray generator - X-ray tube incl. housing - . Collimator - . Measuring chamber - . Grid - . Dynamic flat panel detector (Pixium RF4343 FL, originally cleared under K080859) - . Digital imaging workstation - Video monitors - . Accessories The Uroview FD X-ray System includes the following two software programs: HIRIS RF43 and Uroview FD software; these are explained briefly. The Hiris RF43 software controls the digital imaging system in fluoroscopy and radiography modes using the flat panel detector. The software is specifically designed for remote controlled fluoroscopy and radiography and emergency equipment and performs real-time X-ray diagnostics of the gastro-intestinal tract and the urogenital system. The Uroview FD software controls the patient table Uroview FD (Skeleton) and does not interact with the HIRIS RF43 software. It allows the user comprehensive control of the patient table via hand control and foot switch allowing operator to activate movement of the Uroview FD. The Uroview FD system is designed to meet the requirements in accordance with relevant sections of 21CFR 1020.30-1020.33.

It appears there's a misunderstanding in the prompt's request for acceptance criteria and study details for an AI/Software as a Medical Device (SaMD). The provided text is a 510(k) summary for a physical medical device, the Uroview FD, which is an X-ray fluoroscopic system.

This document does not describe an AI/SaMD product or a clinical study evaluating its performance with respect to specific acceptance criteria in the way typically required for AI/SaMD. Instead, it focuses on demonstrating substantial equivalence of the Uroview FD X-ray system to a predicate physical device (UROSKOP Omnia) based on technological characteristics and non-clinical performance data.

Therefore, most of the requested information regarding AI/SaMD acceptance criteria, test sets, ground truth establishment, expert adjudication, MRMC studies, and standalone performance for an AI model cannot be extracted from this document, as it pertains to a different type of device and different regulatory pathway.

The document explicitly states:

• "There was no human clinical testing required to support the medical device as the indications for use is equivalent to the predicate device." (Section 10. Clinical Performance Data)
• The software mentioned (HIRIS RF43 and Uroview FD software) controls the digital imaging system and patient table, respectively, and is verified at a "Moderate Level of Concern" for functionality, compatibility, risk analysis, and user interface. This is standard software validation for a hardware device, not an AI algorithm performing diagnosis or detection.

Given this, I cannot provide the requested table and study details as they are framed for an AI/SaMD. I can, however, summarize the non-clinical performance acceptance criteria and proof of adherence as outlined in the document for the physical Uroview FD X-ray system:

Summary of Acceptance Criteria and Performance for the Uroview FD X-ray System (Non-AI/SaMD)

The Uroview FD is a physical X-ray fluoroscopic system, not an AI/SaMD. Its acceptance criteria and performance demonstration are based on non-clinical testing to prove substantial equivalence to a legally marketed predicate device (UROSKOP Omnia).

1. Table of Acceptance Criteria and Reported Device Performance

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

Not applicable in the context of AI/SaMD performance evaluation. The data for these tests are derived from laboratory and engineering tests of the physical device and its components, not from patient data or clinical imaging test sets.

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

Not applicable. Ground truth as typically understood for AI models (e.g., diagnostic labels on medical images) is not relevant here. The "ground truth" for these tests refers to the engineering specifications and performance standards.

4. Adjudication Method for the Test Set

Not applicable. There is no adjudication process involving multiple human reviewers for these non-clinical engineering and electrical tests.

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

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "There was no human clinical testing required to support the medical device as the indications for use is equivalent to the predicate device." This study type is for evaluating the impact of AI on human reader performance, which isn't relevant for this physical X-ray system.

6. If a Standalone (Algorithm Only) Performance was done

No, a standalone algorithm performance study was not done. The software components are for controlling the hardware and imaging process, not for performing diagnostic tasks independently.

7. The Type of Ground Truth Used

The ground truth for this device's performance demonstration is based on engineering specifications, recognized national and international standards (e.g., IEC, ISO), and validated internal test procedures. This is typical for a hardware medical device seeking substantial equivalence.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device, so there is no "training set" for an algorithm.

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

Not applicable, as there is no training set for an AI algorithm.

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