Search Results

Agfa's DX-D Imaging Package is indicated for use in providing diagnostic quality images to aid the physician with diagnosis. Systems can be used with MUSICA2 image processing to create radiographic images of the skeleton (including skull, spinal column and extremities) chest, abdomen and other body parts. Agfa's DX-D Imaging Package is not indicated for use in mammography.

The new device is a direct radiography imaging system of similar design and construction to the predicates. Agfa's DX-D Imaging Package uses Agfa's familiar NX workstation with MUSICA2TM image processing and flat panel detectors of the scintillator-photodetector type. Flat panel detectors with scintillators of both Cesium Iodide (Csl) and Gadolinium Oxysulfide (GOS) are available. The device is used to capture and digitize x-ray images without a separate digitizer common to computed radiography systems.

Please note: The provided text is a 510(k) summary for a radiographic imaging system. It primarily focuses on demonstrating substantial equivalence to predicate devices and does not contain detailed information about specific acceptance criteria, a dedicated study proving performance against those criteria, or the methodology typically associated with AI/CAD device evaluation (e.g., sample sizes for test/training sets, ground truth establishment, expert adjudication, or MRMC studies).

Therefore, many of the requested sections will be marked as "Not provided in the document."

Here's the breakdown of the information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Not provided in the document. The 510(k) summary focuses on substantial equivalence to predicate devices based on similar technology and intended use, rather than presenting specific quantitative acceptance criteria and device performance metrics against them. It mentions "laboratory testing and an image comparison study" but does not detail their results or acceptance thresholds.

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

Not provided in the document. The document refers to "laboratory testing and an image comparison study," but no details are given regarding the sample size of images/cases used in these studies, nor their provenance (e.g., country of origin, retrospective/prospective nature).

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

Not provided in the document. The document does not describe the establishment of a ground truth for a test set, nor the involvement or qualifications of experts for such a purpose.

4. Adjudication Method for the Test Set

Not provided in the document. No information on adjudication methods for a test set is present.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

Not provided in the document. The text does not mention an MRMC comparative effectiveness study or any effect size related to human readers improving with AI assistance. The device described is a direct radiography imaging system, not an AI/CAD system.

6. If a Standalone (Algorithm Only) Performance Study Was Done

Not applicable. The device is an imaging system (hardware and associated software for image processing), not a standalone algorithm or AI. The document refers to "image processing" (MUSICA2™) but not as an AI-driven diagnostic algorithm that would require standalone performance evaluation.

7. The Type of Ground Truth Used

Not provided in the document. No information on the type of ground truth used is present. The document focuses on demonstrating that the new imaging package produces "diagnostic quality images," implying clinical interpretability, but does not detail how this was quantitatively assessed with a ground truth.

8. The Sample Size for the Training Set

Not applicable/Not provided. The device is a direct radiography imaging system. While its image processing (MUSICA2™) would have been developed and "trained" in a broader sense, the document does not describe it as an AI/machine learning model with a distinct "training set" in the context of device approval. The 510(k) relies on substantial equivalence to existing technology, not on novel AI performance evaluation.

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

Not applicable/Not provided. As above, the device's nature and the content of the 510(k) summary do not include details about ground truth establishment for a training set in the context of AI approval.

Ask a specific question about this device