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The GC85A 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 GC85A digital X-ray imaging system is a stationary x-ray system designed for general radiography and used to capture images by transmitting X-ray to a patient's body. The Xray passing through a patient's body is sent to the detector and then converted into electrical signals. These signals go through the process of amplification and digital data conversion in the signal process on the S-station, which is the Operation Software (OS) of Samsung Digital Diagnostic X-ray System, and save in DICOM file, a standard for medical imaging. The captured images are tuned up by an Image Post-processing Engine (IPE) which is exclusively installed in S-station, and sent to the Picture Archiving & Communication System (PACS) sever for reading images.

The GC85A digital X-ray imaging system was previously cleared with K172229, and through this premarket notification, we would like to add more configurations in the previously cleared GC85A as three High Voltage Generators and two detectors are newly added, and three software features are newly added as stated below.

S-Enhance is renamed from Tube & Line Enhancement (TLE), which was cleared before with the predicate device GM85 at K171119, to enhance visibility of tubes and lines and provide enhanced images separately from original images. In this submission, the scope of S-Enhance is expanded from tubes and lines on chest images to foreign body (e.g. tubes, lines and needles) and urinary stones on chest, abdomen, and L-spine. And Pediatric Exposure Management (PEM), which was cleared before with the predicate device GM85 at K171119, is subdivided patient size and exposure conditions especially for pediatric patients based on weight and protocols, and Remote View to enable the images on the device is being displayed on the remote monitor. It was determined that the level of concern for the software contained in the GC85A digital X-ray imaging system was Moderate in accordance with the FDA guidance, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Device".

The provided document, a 510(k) Premarket Notification for the Samsung GC85A digital X-ray imaging system, primarily focuses on demonstrating substantial equivalence to predicate devices rather than establishing novel acceptance criteria or presenting an in-depth study proving a device meets specific performance criteria for new features. The document describes additions and changes to an already cleared device (GC85A, K172229) and incorporates features from another predicate device (GM85, K171119).

However, based on the Clinical data section (page 8), we can infer the following about acceptance criteria and the study conducted for S-Enhance and the new detectors:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria in a table format for new features. Instead, it relies on a qualitative assessment of "equivalence" to predicate devices. For S-Enhance and the new detectors, the acceptance criteria are implicitly based on achieving equivalent image quality to the predicate devices and ensuring S-Enhance provides "clear visibility" for foreign bodies.

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

• Test Set Sample Size: Not explicitly stated. The document mentions "Anthropomorphic phantom images were provided." This indicates that the images used in the evaluation were of phantoms (physical models representing human anatomy), not actual patient data. The exact number of phantom images is not specified.
• Data Provenance: The data is from "Anthropomorphic phantom images." This implies a controlled, laboratory-based study. No information about country of origin is provided, but Samsung Electronics Co., Ltd. is based in the Republic of Korea. It is a prospective study as these images were generated specifically for this evaluation.

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

• Number of Experts: Not explicitly stated. The document mentions "professional radiologists."
• Qualifications of Experts: "professional radiologists." Specific experience (e.g., "10 years of experience") is not provided.

4. Adjudication Method for the Test Set

• Adjudication Method: Not explicitly stated. The phrasing "evaluated by professional radiologists and found to be equivalent" suggests a consensus or majority opinion approach, but the specific method (e.g., 2+1, 3+1) is not detailed. The mention of "average score considering the standard deviation of image quality evaluation" suggests a quantitative assessment that might have been averaged across multiple readers, but the method of handling disagreements is not described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size

• A formal MRMC comparative effectiveness study to quantify human reader improvement with vs. without AI assistance was not described in the provided text. The study described focuses on whether the device's image quality (including S-Enhance) is equivalent to predicate devices, and whether S-Enhance provides clear visibility. It does not measure the impact of AI assistance on human reader performance.

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

• The document implies that the S-Enhance feature (an algorithm) was evaluated in terms of its ability to "generate a companion image which provide clear visibility for foreign bodies." This is a form of standalone evaluation of the algorithm's output. However, it's not a standalone diagnostic performance study (e.g., sensitivity/specificity of an AI model to detect foreign bodies). The evaluation relies on human radiologists assessing the quality and visibility provided by the algorithm's output.

7. The Type of Ground Truth Used

• For the phantom images, the "ground truth" for the new detectors and S-Enhance would be the inherent properties and known structures within the anthropomorphic phantoms. The "equivalence" assessment by radiologists serves as the validation of how well the device's images represent this known ground truth. It's essentially an expert consensus on image quality and perceptibility of structures in controlled phantom images.

8. The Sample Size for the Training Set

• Details about the training set for S-Enhance (or any other software feature) are not provided in this document. Given that S-Enhance was "renamed from Tube & Line Enhancement (TLE), which was cleared before with the predicate device GM85 at K171119," it's likely that any training for the core functionality occurred prior to this submission and was part of the K171119 clearance. This submission expands the scope of S-Enhance.

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

• As the training set details are not provided, information on how its ground truth was established is also not available in the document.

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