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The X3C 1600 PLUS is intended for use by a qualified/trained doctor or technologist on both adult and pediatric patients for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts on both adult and pediatric patients. Applications can be performed with patient sitting, standing or lying in the prone or supine positions. The X3C 1600 Plus (510k submission device) is not intended for mammography.

The X3C 1600 Plus is a modification to Xplorer 1600 Plus where the Xplorer 1000 digital radiographic detector (a previously marketed device covered by 510k K992955) in Xplorer 1600 Plus system is replaced with X3C digital radiographic detector, previously marketed device under K070079. The X3C 1600 Plus system is manufactured by Imaging Dynamics.

The provided text describes a 510(k) submission for the X3C 1600 Plus Digital Radiographic System. However, it explicitly states that no clinical tests were conducted for this device, and its substantial equivalence was determined based on non-clinical tests comparing it to a predicate device. Therefore, it is not possible to provide information on acceptance criteria and a study proving the device meets them, as no such study focusing on clinical performance was performed or referenced in this document.

The document primarily focuses on demonstrating substantial equivalence to a predicate device (Xplorer 1600 Plus) by replacing a detector, and relies on non-clinical tests (performance, biocompatibility, safety) to support this claim.

To address the specific points of your request based on the absence of clinical data in this submission:

1. A table of acceptance criteria and the reported device performance

• Acceptance Criteria: Not specified for clinical performance as no clinical study was conducted. Non-clinical acceptance criteria would likely relate to technical specifications, safety standards, and performance against the predicate device in areas like image quality metrics (e.g., DQE, MTF), and electrical/mechanical safety (e.g., IEC 60601). These specific criteria and their reported performance are not detailed in the provided text.
• Reported Device Performance: In terms of clinical performance, none reported as no clinical tests were conducted. The submission states, "The device has been evaluated for performance, biocompatibility and effectiveness as well as thermal, electrical and mechanical safety and has been found to substantially equivalent to predicate device." However, specific quantitative performance metrics are not given.

2. Sample size used for the test set and the data provenance

• Sample Size: Not applicable for clinical tests as none were performed.
• Data Provenance: Not applicable for clinical tests.

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

• Not applicable as no clinical study with a test set requiring ground truth establishment by experts was conducted.

4. Adjudication method for the test set

• Not applicable as no clinical study with a test set requiring adjudication was conducted.

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 performed. This is a digital radiographic system, not an AI or CAD device. The submission explicitly states "No clinical tests conducted."

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

• Not applicable. This is a medical imaging hardware system, not an algorithm being tested for standalone performance.

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

• Not applicable as no clinical study requiring ground truth was conducted.

8. The sample size for the training set

• Not applicable as no clinical training set was used for an AI/CAD algorithm.

9. How the ground truth for the training set was established

• Not applicable as no clinical training set was used for an AI/CAD algorithm.

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