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The XGEO GC80 Digital X-ray Imaging System is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications.

The XGEO GC80 digital X-ray imaging system is to be used to take and store image for diagnosis of patients. It consists of the High voltage generator (HVG), Ceiling suspension, Detector, X-ray tube, Patient table, Wall stand, Collimator and etc.

The provided text describes the Samsung XGEO GC80, a digital X-ray imaging system, and its 510(k) premarket notification. However, the document does not contain specific acceptance criteria, a detailed study description, or performance data in the format requested.

It primarily focuses on establishing substantial equivalence to a predicate device (General Electric Company's Revolution XR/d) by comparing technical characteristics and outlining safety, EMC, and general performance testing against regulatory standards.

Therefore, I cannot fulfill all parts of your request with the input provided. Below is a summary of what can be extracted and what cannot.

Summary of Device Acceptance Information (Based on Provided Text):

The document largely focuses on demonstrating substantial equivalence to a predicate device and adherence to general safety and performance standards for an X-ray system. It does not present a detailed study with specific acceptance criteria and performance metrics for a novel algorithm or diagnostic aid in the way a clinical performance study would.

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: Not explicitly stated as specific performance targets (e.g., sensitivity, specificity, accuracy) for image interpretation. The "acceptance criteria" here implicitly refer to meeting established safety and performance standards relevant to X-ray systems and demonstrating substantial equivalence to a predicate device.
  • Implicit Acceptance Criteria:
    • Compliance with IEC 60601-1, IEC 60601-1-1, IEC 60601-1-3, IEC 60601-2-7, IEC 60601-2-28, IEC 60601-2-32 (Electrical, mechanical, environmental safety and performance).
    • Compliance with IEC 60601-1-2(2001) (EMC testing).
    • Demonstration that differences from the predicate device do not introduce new safety risks or negatively impact performance.
    • Resolution of detector being "higher than that of the predicate device" for high contrast, which is considered "more advantageous."
    • Image stitching functionality providing "more efficiency" for long areas of anatomy without affecting safety.
• Reported Device Performance:
  • "All test results were satisfactory" for the safety, EMC, and performance testing against the listed IEC standards.
  • The high contrast resolution of the XGEO GC80's detector is reported to be "higher than that of the predicate device," which is deemed "more advantageous."
  • The device is concluded to be "safe and effective and substantially equivalent to predicate devices."

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

• Not provided. The document does not describe a clinical test set or patient data used to evaluate a diagnostic algorithm's performance. The testing mentioned pertains to engineering, safety, and physical performance of the X-ray system itself.

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

• Not applicable/Not provided. This information would be relevant for evaluating a diagnostic AI algorithm's performance against expert-derived ground truth. The presented text describes a traditional X-ray system, not an AI-powered diagnostic device requiring such expert evaluation in this context.

4. Adjudication Method for the Test Set:

• Not applicable/Not provided. As no clinical test set or expert ground truth establishment is described, an adjudication method is not mentioned.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

• No. The document does not describe an MRMC study comparing human reader performance with and without AI assistance. This device is a diagnostic imaging system, not an AI-assisted interpretation tool.

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

• Not applicable/Not provided. The XGEO GC80 is an X-ray imaging system, not a standalone AI algorithm. It produces images for human interpretation.

7. The Type of Ground Truth Used:

• Not applicable/Not provided. For the system's performance, the "ground truth" corresponds to meeting engineering specifications and regulatory standards via physical tests, rather than a clinical ground truth like pathology or patient outcomes for a diagnostic algorithm.

8. The Sample Size for the Training Set:

• Not applicable/Not provided. This information is relevant for machine learning or AI models. This document describes an X-ray system, not an AI algorithm that requires a training set.

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

• Not applicable/Not provided. As no training set or AI algorithm is mentioned, this information is not relevant to the document.

In summary: The provided 510(k) summary focuses on demonstrating that the Samsung XGEO GC80 X-ray system is substantially equivalent to a legally marketed predicate device through engineering and regulatory compliance testing. It does not detail a clinical study with acceptance criteria and results related to diagnostic performance as would be expected for an AI-enabled medical device.

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