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The DIGITAL RADIOGRAPHY CXDI-410C Wireless provides digital image capture for conventional film/screen radiographic examinations. This device is intended to capture for display radiographic images of human anatomy, and to replace radiographic film/screen systems in all general purpose diagnostic procedures. This device is not intended for mammography applications.

The CXDI-410C Wireless is a solid state x-ray imager with an approximate imaging area of 42.6 x 41.5 cm. The detector intercepts x-ray photons and the scintillator emits visible spectrum photons that illuminate an array of photo-detectors that create electrical signals. After the electrical signals are generated, the signals are converted to digital values and the images will be displayed on monitors. The digital value can be communicated to the operator console via wiring connection or wireless.

For the proposed model, temporary image storage is now possible and the detector weigh has been reduced from that of the predicate. The proposed model has increased protection against ingress, and continues to include the Standard Synchronization Mode, Non-Generator Connection Mode (detection of x-ray irradiation without direct electrical connection to the x-ray generator), and is compatible with the Scatter Correction feature. Testing has been conducted and has demonstrated that these changes have no impact on the safety or effectiveness of this flat panel detector.

The Standalone Mode allows for examinations using only the detector and a mobile X-ray system without a control computer by utilizing the temporary image storage on the FPD. The CXDI-410C Wireless can be used in emergency/trauma situations and other environments where equipment other than the detector and mobile X-ray system cannot be used and/or wireless communication is not possible.

The weight of the CXDI-410C (2.8kg) is effectively 25% less than the weight of the predicate CXDI-401C (3.8kg.) The weight reduction was accomplished through material changes, changes in the structure, and downsized components such as electrical boards and batteries.

The proposed device CXDI-410C offers an optional docking station. This option allows for a simplified method for charging the internal battery of the proposed CXDI-410C. The Docking Station connects to the PC with an Ethernet cable (cannot communicate wirelessly.) By placing a FPD into the docking station, that FPD is "registered" and available for use.

The provided text describes a 510(k) summary for the DIGITAL RADIOGRAPHY CXDI-410C Wireless device. This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and a standalone study proving performance against those criteria.

Therefore, many of the requested details about acceptance criteria, specific studies, ground truth establishment, expert involvement, and statistical analyses (like MRMC studies) are not available in the provided text. The document primarily relies on non-clinical image comparisons and compliance with relevant standards to assert substantial equivalence.

Here's the information that can be extracted or inferred from the text, along with details explicitly stated as not available:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics like sensitivity/specificity/accuracy goals. Instead, it focuses on demonstrating equivalency in key technical specifications and performance to a predicate device.

Key Differences/Improvements:

• Weight: Predicate: ≈ 3.8 kg; Proposed: ≈ 2.8 kg (25% reduction)
• External Dimensions: Predicate: 460 x 460 x 15.4 mm; Proposed: 460 x 460 x 15.7 mm
• Temporary Image Storage: Proposed device adds temporary image storage.
• Docking Station: Proposed device offers an optional docking station for charging and registration.

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

• Sample Size: Not specified. The document mentions "non-clinical image comparisons involving flat panel display static and dynamic images." The exact number of images or cases used for these comparisons is not provided.
• Data Provenance: Not specified (e.g., country of origin, specific institutions). The nature of the "non-clinical images" suggests they were likely test images generated under controlled conditions rather than patient data from a specific country.
• Retrospective or Prospective: Not specified, but "non-clinical image comparisons" typically refer to controlled test images rather than retrospective or prospective patient studies.

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.

The study referenced is "non-clinical image comparisons." This often implies technical evaluations rather than diagnostic interpretation requiring clinical experts to establish ground truth.

4. Adjudication Method for the Test Set

• Adjudication Method: Not specified. Given the nature of "non-clinical image comparisons" for technical equivalence, a formal clinical adjudication process as seen in diagnostic performance studies is unlikely to have been performed or necessary based on this summary.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance

• MRMC Study: No, an MRMC comparative effectiveness study was not performed or described.
• AI Improvement Effect Size: Not applicable, as this device is a digital radiography system (hardware), not an AI-powered diagnostic algorithm enhancing human reader performance. The document describes a flat panel detector, not software with AI capabilities for diagnostic assistance.

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

• Standalone Performance: The document refers to "Standalone function" for the device, which means the detector can operate and temporarily store images without a control computer. This is a functional feature of the device's hardware and firmware, not a measure of its diagnostic performance as a standalone algorithm (e.g., classifying disease) in the context of an AI device. The document does not describe a standalone diagnostic algorithm performance study.

7. The Type of Ground Truth Used

• Type of Ground Truth: Not explicitly stated but inferred to be technical benchmarks or quantitative image quality metrics for "non-clinical image comparisons." For instance, DQE and MTF values are listed, which are objective measures. There is no mention of expert consensus, pathology, or outcomes data being used as ground truth for these non-clinical comparisons, as these are typically for clinical diagnostic performance studies.

8. The Sample Size for the Training Set

• Sample Size: Not applicable and not specified. This device is a digital X-ray detector, not a machine learning or AI algorithm that requires a training set of data.

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

• Ground Truth for Training Set: Not applicable. As mentioned, this is a hardware device, not an AI algorithm requiring a training set with established ground truth.

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