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Agfa HealthCare's DX-D Imaging Package is indicated for use in general projection radiographic applications to capture for display diagnostic quality radiographic images of human anatomy for adult, pediatic and neonatal examinations. The DX-D Imaging Package may be used wherever conventional screen-film systems, CR or DR systems may be used.

Agfa HealthCare's DX-D Imaging Package is not indicated for use in mammography.

Agfa HealthCare's DX-D Imaging Package is a solid state x-ray system, a direct radiography (DR) system (product code MQB) intended to capture images of the human body. It is a combination of Agfa HealthCare's NX Workstation, one or more flat-panel detectors, needlephosphor detectors for direct radiography (DR) applications.

DX-D Imaging Package uses the NX Workstation to process data utilizing Agfa HealthCare's MUSICA image processing software, which includes optional image processing algorithms for adult, pediatric and neonatal images that were previously cleared for use in Agfa HealthCare's DX-D Imaging Package (K122736). The acronym MUSICA stands for Multi-Scale-Image-Contrast-Amplification. MUSICA acts on the acquired images to preferentially enhance the diagnostically relevant, moderate and subtle contrasts.

This submission is to obtain clearance for Agfa HealthCare to market the DX-D Imaging Package using a minimum of 50% dose reduction marketing claims.

Principles of operation and technological characteristics of the DX-D Imaging Package and predicate devices are the same. The DX-D Imaging Package is physically and electronically identical to the predicate K122736 since it is the same device; however, Agfa HealthCare would like to include a minimum of 50% dose reduction claims for marketing purposes. It uses the same workstation and same scintillator-photodetector flat panel detectors, needle-phosphor detectors and cassettes, or photo-stimulable imaging plates to capture and digitize the image.

The provided text describes the acceptance criteria and the study conducted for the Agfa HealthCare DX-D Imaging Package, focusing on its dose reduction claims.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size:
  • Images: 195 images (13 exposures for each of 5 phantoms using 3 detector types).
  • Phantoms: 5 different anatomical phantoms (skull, chest, abdomen, hand, neonatal).
• Data Provenance: The study was a laboratory evaluation using phantoms, not human patient data. Therefore, country of origin or retrospective/prospective classification isn't directly applicable in the conventional sense for patient data. It's an experimental study conducted by the sponsor.

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

• Number of Experts: Five (5)
• Qualifications of Experts: Board-certified radiologists.

4. Adjudication Method for the Test Set

The radiologists were asked to match test images to a reference image by scrolling through a series of test images until the closest match was found. There was a consistency check where image positions were reversed and a second reading session was done with a different reference image. However, the text does not describe an adjudication method for reconciling disagreements among multiple readers; rather, it implies individual assessment and an average calculation of dose reduction.

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

This was not a MRMC comparative effectiveness study in the typical sense of evaluating human reader performance with and without AI assistance on diagnostic tasks. Instead, it was an image quality equivalency study where radiologists evaluated the visual equivalence of images generated at reduced doses compared to standard doses.

• Effect Size: Not applicable as it was not a human-in-the-loop diagnostic study with AI assistance. The study focused on whether images produced with reduced dose were deemed visually equivalent to standard dose images by radiologists.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, a standalone technical evaluation of image quality was performed using Detective Quantum Efficiency (DQE). This is a measure of the imaging device's ability to preserve the signal-to-noise ratio. The DQE for the CsBr CR and CsI DR was found to be more than double that of the predicate device (CR MD4.0), indicating superior dose efficiency.

7. The Type of Ground Truth Used

• For the image quality evaluation by radiologists, the ground truth was expert consensus (visual equivalence) against a reference image exposed at a fixed condition. The "ground truth" for the dose reduction claim was established by the radiologists determining when a reduced-dose image was visually equivalent to a reference image, and then calculating the dose difference.

8. The Sample Size for the Training Set

The document does not specify a training set sample size. The study described is a performance evaluation of the imaging system and its dose reduction capability, not an AI algorithm that requires a separate training set. The "MUSICA image processing software" is mentioned as having "optional image processing algorithms" that were "previously cleared," but no details about their training are provided in this document.

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

As no training set is described for the dose reduction study, this information is not provided in the document. If referring to the MUSICA image processing software, the document states these algorithms were "previously cleared," implying their ground truth and development were established in prior submissions, but details are not given here.

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