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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 GC70 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 GU60A & GU60A-65 Digital X-ray Imaging Systems are 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 GF50 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 GF50A 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 GR40CW Digital X-ray Imaging System is intended for use in general projection radiographic applications wherever conventional screen-film systems or CR systems may be used. This device is not intended for mammographic applications.

The GM85 Digital Mobile 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.

GC70, GU60&GU60A-65, GF50, GF50A, GR40CW, GM85 and GC85A are used to capture images by transmitting X-ray to a patient's body. The X-ray 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, SAMSUNG digital X-ray operation software, and sent to the Picture Archiving & Communication System (PACS) sever for reading images.

The IPE operates, from the input image, the roles of a region-of-interest extraction, tonescale mapping, noise reduction and texture restoration. The IPE employing an advanced noise reduction algorithm (hereinafter "new IPE") is shown that the image quality of PA radiograph for average adult chest, exposed at the condition of 50% lower dose at Entrance Skin Exposure (ESE) in comparison with the condition of the conventional noise reduction algorithm (hereinafter "old IPE"), is substantially equivalent.

The provided text describes the acceptance criteria and a study proving the device meets those criteria, specifically concerning dose reduction capabilities of the Image Post-processing Engine (IPE) with an advanced noise reduction algorithm in Samsung Digital X-ray Systems (GC70, GU60A, GU60A-65, GF50, GF50A, GR40CW, GM85, and GC85A).

Here is the requested information:

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

The core acceptance criterion is the ability of the new IPE to reduce X-ray dose while maintaining image quality comparable to the old IPE for diagnostic confidence. The specific dose reduction percentages are the performance metrics.

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

• Adult Abdominal Radiograph Test Set:

  • Anatomical phantom images: Number of images not specified, but taken at "various exposure condition." The study states, "the new IPE with an advanced noise reduction algorithm retained the quality of images captured at 47.5% reduced exposure in comparison with the old IPE."
  • Clinical images: Number of images not specified, but used to "confirm that it was possible to reduce the dose in clinical images as well."
  • Provenance: Not explicitly stated, but the submission is from Samsung Electronics Co., LTD. Republic of Korea. The clinical testing was conducted at "one medical site."
  • Retrospective or Prospective: Not specified.

• Pediatric Population Test Set (Chest, Abdomen, Skull):

  • Number of images: "Series of dose-simulated images" for each body part.
  • Number of patients: Not specified explicitly, but mentioned as "each patient."
  • Provenance: Not explicitly stated, but the submission is from Samsung Electronics Co., LTD. Republic of Korea. The clinical testing was conducted at "one medical site."
  • Retrospective or Prospective: Not specified.

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

• Adult Abdominal Radiograph Test Set:

  • Anatomical phantom images were reviewed by three professional radiologists.
  • Clinical images were reviewed by two professional radiologists.
  • Qualifications: "Professional radiologists" (no further details on experience given).

• Pediatric Population Test Set:

  • Three experienced pediatric radiologists.
  • Qualifications: "Experienced pediatric radiologists" (no further details on experience given).

4. Adjudication Method for the Test Set

The adjudication method is not explicitly detailed. However, for both adult and pediatric studies, images were "scored by the 5-point grading scale" for assessment of image quality. This implies individual scoring, and for the pediatric study, "Three experienced pediatric radiologists assessed the series of dose-simulated images to decide the optimal dose for each patient." The decision for the "optimal dose" for pediatric cases suggests a consensus or agreement among these experts, but the exact method (e.g., majority vote, discussion to reach consensus) is not specified.

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

No MRMC comparative effectiveness study was done to evaluate human readers' improvement with AI vs. without AI assistance. The study focused on the device's standalone performance in enabling dose reduction while maintaining image quality as assessed by human readers. The new IPE is a component within the imaging system, not an AI assistance tool for human readers.

6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, the studies evaluated the standalone performance of the new IPE algorithm in terms of enabling dose reduction while maintaining image quality. The performance was assessed by comparing images processed by the new IPE at reduced doses against images from the old IPE or a reference, with human experts providing the assessment of image quality and diagnostic appropriateness.

7. The Type of Ground Truth Used

The ground truth for both adult and pediatric studies was expert consensus/assessment of image quality and diagnostic appropriateness.

• For adult abdominal radiographs: Expert radiologists scored images based on a 5-point grading scale, considering anatomical regions, physical parameters, sharpness, and visualization.
• For pediatric populations: Experienced pediatric radiologists assessed dose-simulated images to determine the "optimal dose" at which image quality remained appropriate for diagnosis.

Additionally, phantom studies (TOR CDR radiography phantom and anthropomorphic phantom) were used to quantitatively assess image quality metrics like Contrast to Noise Ratio (CNR), Detail Compacted Contrast (DCC), and Modulation Transfer Functions (MTF).

8. The Sample Size for the Training Set

The document does not provide information about the training set size for the Image Post-processing Engine (IPE) algorithm. It focuses on the validation of the algorithm's dose reduction capabilities.

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

The document does not provide information on how the ground truth for the training set was established for the IPE algorithm.

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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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