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Agfa's DX-D 100 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 100 is not indicated for use in mammography.

The new device is a combination of a conventional mobile x-ray system with digital image capture equipment. The new device is essentially a modification of the predicate mobile x-ray system, Sedecal Easy Moving Plus (K090322). In this case, the digital detector available with the predicate has been replaced with Agfa's system, its previously cleared DX-D Imaging Package (K092669). The DX-D 100 uses Agfa's familiar NX workstation with MUSICA2TM image processing and flat panel detectors of the scintillator-photodetector type (Cesium Iodide or Gadolinium Oxysulfide).

The provided document is a 510(k) summary for the Agfa DX-D 100 mobile x-ray system. The information provided focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and conformity to product and management standards. It explicitly states, "No clinical testing was performed in the development of the DX-D 100." Therefore, the document does not contain the information requested regarding acceptance criteria and performance studies of the device meeting those criteria through a clinical validation or similar study involving ground truth and expert readers.

It only describes the device and its equivalence to legally marketed predicate devices, with testing limited to product standards and management standards (e.g., electrical safety, DICOM compliance, risk management, quality management).

Thus, I cannot populate the table or answer the specific questions about the study that proves the device meets acceptance criteria derived from a clinical performance evaluation.

Reason for Not Providing Information on Acceptance Criteria and Performance Study:

The document states:

• "Performance of the complete system has been validated. Sample images have been provided." (This refers to technical validation, not clinical performance against acceptance criteria in humans)
• "No clinical testing was performed in the development of the DX-D 100."

This explicitly indicates that the type of study detailed in the request (involving ground truth, human readers, sample sizes, and expert adjudication) was not conducted or, at least, not submitted as part of this 510(k) premarket notification. The 510(k) relied on demonstrating substantial equivalence through technological comparison and adherence to safety and performance standards for an x-ray system, rather than clinical performance data.

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