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The SanteView-3001C provides digital image capture for conventional film/screen radiographic examinations. The device is intended to replace radiographic film/screen systems in all general purpose diagnostic procedures. This device is not intended for mammography applications.

The SanteView-3001C is a solid state x-ray imager which has 440x440mm imaging area. The SanteView-3001C intercepts x-ray photons and the scintillator emits visible spectrum photons that illuminate an array of photo-detectors that create an electrical signals. After the electrical signals are generated, it is converted to digital value, and the images will be displayed on monitors.

The provided text describes a 510(k) summary for the SanteView-3001C, a digital flat panel X-ray detector, to demonstrate its substantial equivalence to predicate devices. However, the document does not contain specific acceptance criteria, detailed study designs, or comprehensive performance data as typically found in a clinical study report for a new AI-powered diagnostic device.

It mainly focuses on declaring the device's technical specifications, indications for use, and a general statement about safety and effectiveness.

Therefore, many of the requested sections below cannot be populated from the provided text.

Acceptance Criteria and Device Performance

The document does not explicitly state specific quantitative acceptance criteria or detailed performance metrics. It makes a general statement about "concurrence study" but provides no details of what was measured or what the targets were.

Study Details

The provided text mentions a "concurrence study," but it lacks sufficient detail to answer most of the questions about its methodology.

1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

   • Sample Size: Not specified.
   • Data Provenance: Not specified.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

   • Not specified.

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

   • Not specified.

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 MRMC comparative effectiveness study is mentioned, nor is any AI component indicated in the device description. The device is a "Digital Flat Panel X-ray Detector" which captures digital images for conventional radiographic examinations.

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

   • The SanteView-3001C is a hardware device (X-ray detector). The concept of "standalone algorithm performance" as typically applied to AI/software is not relevant here. The device's performance is likely evaluated in terms of image quality metrics compared to predicate devices, but these details are not provided.

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

   • Not specified. The "concurrence study" likely involved comparing images from the SanteView-3001C to images from predicate devices, potentially using image quality assessment, but the specific ground truth method is not described.

7. The sample size for the training set:

   • Not applicable, as this is a hardware device (X-ray detector) and not an AI algorithm that undergoes training in the conventional sense.

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

   • Not applicable.

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