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Agfa's DX-Si system is indicated for use in providing diagnostic quality images to aid the physician with diagnosis. The DX-Si can be used to column radiographic exposures of the skeleton (including skull, spinal column and extremities) chest, abdomen and other body parts. The DS-Xi is not indicated for use in mammography.

Use with separately cleared accessories allows the DX-Si to be conveniently used in generating urological, tomographic, pediatio and dental images.

The predicate and new devices are nearly identical computed radiography imaging systems. The DX-Si (new device) is a combination of previously cleared systems combined and marketed as a single system. The devices are the DX-S Digitizer with NX workstation and Siemens OEM version of its Multix Top x-ray system.

The new device includes an interface that allows users to select initial xray exposure settings and review exposure parameters from the digitizer workstation.

The basic principles of operation are unchanged.

The provided text describes the Agfa DX-Si integrated digital imaging system, which is a combination of existing cleared devices. The submission focuses on demonstrating substantial equivalence to its predicate devices rather than presenting novel performance studies for a new device. Therefore, much of the requested information about acceptance criteria and detailed study results is not present in the document.

Here's a breakdown of what can be extracted and what is not available due to the nature of the 510(k) submission for substantial equivalence:

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

This information is not explicitly provided in the document. The submission states: "The DX-Si integrated digital imaging system has been tested for proper performance to specifications through various in-house and imaging performance tests." However, the specific acceptance criteria (e.g., image quality metrics, dose limits, diagnostic accuracy thresholds) and the quantified performance results against these criteria are not detailed.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

This information is not provided. The document does not describe a clinical study with a test set of images.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This information is not provided. As no clinical study with a test set is described, there's no mention of experts establishing ground truth.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

This information is not provided. Similarly, without a described test set and ground truth establishment, no adjudication method is mentioned.

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

This information is not provided. The document makes no mention of an MRMC study or AI assistance. The DX-Si system is described as a conventional digital imaging system, not an AI-powered diagnostic tool.

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

This information is not provided. The DX-Si is a medical imaging system, not an algorithm being tested in a standalone capacity.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This information is not provided.

8. The sample size for the training set

This information is not applicable/not provided. The DX-Si is a hardware and software system for image acquisition and viewing. It's not an AI model that requires a "training set" in the machine learning sense. The testing referred to ("in-house and imaging performance tests") would likely involve engineering and image quality assessments rather than training data for an algorithm.

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

This information is not applicable/not provided.

Summary of available information regarding the "study" and acceptance criteria:

The "study" in this context refers to the technological comparison and performance testing against specifications, not a clinical trial.

• Acceptance Criteria: While not explicitly listed in a table, the document implies that the device was deemed acceptable because it demonstrated "proper performance to specifications" and "met the requirements of EN 60601-1-1 and EN 60601-1-2" (electrical safety and electromagnetic compatibility standards). The primary acceptance criterion for 510(k) purposes was demonstrating substantial equivalence to the predicate devices.
• Reported Device Performance: The document states that the device "has been tested... and shown to meet the requirements." No specific quantitative performance metrics (e.g., spatial resolution, DQE, MTF) are provided. The "performance" is implicitly tied to being substantially equivalent to the cleared predicate devices, which are already accepted as providing "diagnostic quality images."

In essence, the 510(k) for K063421 for the DX-Si system relies on demonstrating that the new combined system has "the same technological characteristics" and "the same indications for use" as its previously cleared predicate devices. This type of premarket notification often focuses on engineering testing and comparison to established components rather than de novo clinical trials or detailed performance studies against specific diagnostic acceptance criteria.

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The Digital Fluoroscopic Imaging System is indicated for use in generating fluoroscopic images of human anatomy for diagnostic and intervention angiography procedures. It is intended to replace fluoroscopic images obtained through the image intensifier technology. This device is not intended for mammography applications.

The Digital Fluoroscopic Imaging System is indicated for use in diagnostic and interventional angiographic procedures of human anatomy. It is intended to replace image intensifier fluoroscopic systems in all diagnostic or interventionnal procedures. This device is not intended for mammography applications.

The Digital Fluoroscopic Imaging System is designed to perform fluoroscopic x-ray examinations. The detector is comprised of amorphous silicon with a cesium iodide scintillator. The resulting digital image can be sent through a Fiber Channel link to an acquisition equipment then to network (in using DICOM) for applications such as post-processing, printing, viewing and archiving. Digital Fluoroscopic Imaging System consists of an angiographic monoplane positioner, a vascular table, an X-RAY system and a digital detector.

The GE Medical Systems Digital Fluoroscopic Imaging System (Innova 4100) was studied for its diagnostic capabilities compared to a predicate device, the Innova 2000. The primary goal was to demonstrate equivalent image diagnostic capability.

Here's a breakdown of the acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance

• Test Set Sample Size: 11 pairs of patient sequences. This relatively small number suggests a comparative efficacy study.
• Data Provenance: The study was conducted at three hospitals:
  • Saint-Luke's Hospital (Bethlehem, Pennsylvania - US)
  • Saint-Francis Hospital (Peoria, Illinois - US)
  • Centre Paris Nord (Sarcelles - France)
    This indicates a mix of retrospective and prospective data, given the comparison of existing Innova 2000 images with new Innova 4100 images. The involvement of different hospitals across different countries suggests a more diverse dataset than if it were confined to a single institution or country.

3. Number of Experts and Qualifications

• Number of Experts: 6 radiologists.
• Qualifications: Not explicitly stated beyond "radiologists." It's implied they are qualified to interpret angiographic images for diagnostic purposes.

4. Adjudication Method

• The document describes the radiologists "compared digital images" and "found that the digital images from the Innova 4100 had equivalent image diagnostic capability." This phrasing suggests a consensus or majority opinion among the radiologists, but a specific adjudication method (e.g., 2+1, 3+1) is not detailed.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• Yes, a clinical comparison study was done with 6 radiologists evaluating images.
• Effect Size of Human Readers with vs. without AI: Not applicable. This study does not involve AI assistance to human readers. It's a comparison of two different fluoroscopic imaging systems (Innova 2000 vs. Innova 4100) and their inherent diagnostic image quality.

6. Standalone Performance (Algorithm Only)

• Not applicable. This is a medical device clearance for an imaging system, not an artificial intelligence algorithm. The device itself is the entire system outputting images.

7. Type of Ground Truth Used

• Expert Consensus/Clinical Agreement: The "gold standard" for determining equivalent diagnostic capability was the collective evaluation and agreement of the 6 radiologists. There's no mention of pathology or long-term outcomes data being used as ground truth for this particular comparison.

8. Sample Size for the Training Set

• Not applicable. This device is a digital fluoroscopic imaging system, not an AI algorithm that requires a distinct training set. The "training" for the device would be its engineering and design, informed by established medical imaging principles and prior device iterations (like the Innova 2000).

9. How Ground Truth for the Training Set was Established

• Not applicable, as there is no specific "training set" in the context of an AI algorithm. The device's fundamental design is based on known physics, engineering principles, and clinical requirements for fluoroscopic imaging.

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