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The FDR SE Lite flat panel detector system is intended to capture for display radiographic images of human anatomy. It is intended for use in general projection radiographic applications wherever conventional film/screen or CR systems may be used. The FDR SE Lite is not intended for mammography, fluoroscopy, and angiography applications, as well as pediatric and neonatal exams.

Fujifilm's FDR SE Lite (DR-ID 330), is a portable digital detector system that interfaces with, and acquires and digitizes X-ray exposures from, standard radiographic systems. DR-ID 330 is designed to be used in any environment that would typically use a radiographic cassette for examinations of adults, not for pediatrics and neonates. The detector models support only wireless data communication between the detector and the console. Detectors can be placed in a wall bucky for upright exams, a table bucky for recumbent exams, or removed from the bucky for non-grid or free cassette exams.

The provided text is a 510(k) summary for the Fujifilm FDR SE Lite Flat Panel Detector System (DR-ID 330). It is a regulatory filing for a medical device and thus focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study proving the device meets specific acceptance criteria for AI or diagnostic performance in the way clinical trials typically would.

Based on the provided document, the FDR SE Lite Flat Panel Detector System is a hardware device (a digital X-ray detector), not an AI-powered diagnostic tool. Therefore, the questions related to AI-specific acceptance criteria, ground truth, expert readers, MRMC studies, and training sets are not applicable to this device's submission.

The document explicitly states: "Clinical Performance Data: No clinical study has been performed. The substantial equivalence has been demonstrated by non-clinical studies." This means the device's performance was evaluated through technical tests and comparisons to the predicate device's specifications, not through studies involving human readers or AI algorithms.

Here's a breakdown of what can be answered based on the provided text, and where the information is not present or not applicable:

Acceptance Criteria and Device Performance:

Since this is a hardware device (FDR SE Lite Flat Panel Detector System) and not an AI algorithm, the acceptance criteria relate to technical performance, safety standards, and equivalence to a predicate device. The document does not provide a table of quantitative acceptance criteria and specific reported performance values in the way one would expect for an AI algorithm's diagnostic accuracy (e.g., sensitivity, specificity, AUC). Instead, it states that the device conforms to voluntary standards and that image quality was confirmed to be substantially equivalent.

Study Details (as applicable to a hardware device 510(k) submission):

1. Sample size used for the test set and the data provenance:

   • Sample Size: Not specified in terms of patient images. The "test set" here refers to the non-clinical performance evaluations of the device hardware.
   • Data Provenance: Not applicable in the context of patient data. The non-clinical tests would have been performed in a laboratory or engineering setting. The document only mentions "Fujifilm Corporation" (Japan) as the submitter and "Fujifilm Medical Systems U.S.A., Inc." as the US representative.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable. No ground truth established by experts in a diagnostic sense, as no clinical study was performed. The "ground truth" for hardware performance would be defined by engineering specifications and objective measurements against validated reference standards.

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

   • Not applicable. No expert readers or adjudication for diagnostic performance. Adjudication methods are relevant for clinical studies involving reader interpretations of images.

4. 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:

   • No. The document explicitly states: "No clinical study has been performed." Therefore, no MRMC study, and no human reader improvement (as this is a hardware device, not an AI algorithm assisting human readers).

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

   • Not applicable. This device is a flat panel detector, not an algorithm.

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

   • Not applicable. For a hardware device, "ground truth" for performance would relate to physical measurements (e.g., DQE, MTF, SNR, dose efficiency), adherence to engineering specifications, and compliance with national/international standards. It's not diagnostic "ground truth" in the clinical sense.

7. The sample size for the training set:

   • Not applicable. This is a hardware device, not an AI algorithm that requires a training set.

8. How the ground truth for the training set was established:

   • Not applicable. As above, no training set for an algorithm.

In summary: The provided document is a regulatory filing for a medical imaging hardware device (an X-ray detector). It demonstrates substantial equivalence for market clearance based on non-clinical performance and adherence to standards, not complex clinical studies, AI performance metrics, or human reader studies. The questions posed are primarily relevant to AI/CADe/CADx devices, which is not what the FDR SE Lite Flat Panel Detector System is.

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