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The CR30-X is indicated for use to provide diagnostic quality images to aid in physician diagnosis. The CR30-X is intended to be used mainly in chest, skeletal and gastro-intestinal x-ray imaging applications.

The predicate and newly modified devices are computed radiography imaging systems. Instead of traditional screens and photographic film for producing the diagnostic image, these systems utilize an "imaging plate," a plate coated with photo-stimulatable storage phosphors that are sensitive to X-rays and capable of retaining a latent image. After exposure, this imaging plate is inserted into a digitizer that scans it with a laser and releases the latent image in the form of light that is converted into a digital image file. The image can then be previewed on a computer workstation, adjusted if necessary then stored locally, sent to an archive, printed or sent to a softcopy capable display such as a PACS system.

The CR30-X and the CR25.0 are similar. The CR30-X utilizes an improved light collector to obtain maximum light efficiency. However, the basic principles of operation are unchanged.

The provided text describes a Special 510(k) for a device modification of the Agfa CR30-X Computed Radiography system, not a study performing a traditional comparative effectiveness or standalone performance evaluation against distinct acceptance criteria in the manner often seen for AI/ML devices.

The premise of a Special 510(k) is that the device modification is minor and does not significantly alter the safety or effectiveness of the device, thus requiring less extensive performance data than a traditional 510(k). The core argument is substantial equivalence to a predicate device (Agfa CR25.0) which has already been cleared.

Therefore, many of the requested categories for acceptance criteria and study details are not applicable to this type of submission. The 'acceptance criteria' in this context are primarily related to maintaining the performance characteristics of the predicate device and meeting general electrical and safety standards.

Here's a breakdown based on the provided document:

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 a Special 510(k) for a device modification. The submission relies on demonstrating that the modified device (CR30-X), which primarily features an "improved light collector," maintains substantial equivalence to an already cleared predicate device (CR25.0). No independent "test set" for diagnostic performance is described. The performance data mentioned are "in-house reliability and imaging performance demonstration tests," but details are not provided.

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

Not applicable. This type of submission does not involve external expert adjudication for a ground truth test set in the way an AI/ML diagnostic device submission would.

4. Adjudication Method for the Test Set

Not applicable.

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

Not applicable. This is not an AI-assisted diagnostic device, but a Computed Radiography imaging system.

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

Not applicable. This is a hardware/system modification, not a standalone algorithm.

7. The Type of Ground Truth Used

The concept of a "ground truth" as typically applied to diagnostic AI models (e.g., pathology, outcomes data) is not relevant to this submission. The "truth" in this context refers to the device's ability to produce diagnostic quality images consistently and safely, equivalent to the predicate device. This is assessed via internal technical and performance testing.

8. The Sample Size for the Training Set

Not applicable. This device does not involve a "training set" in the context of AI/ML.

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

Not applicable.

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