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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 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 GC70 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 GC70 digital X-ray imaging system consists of HVG (High Voltage Generator), ceiling suspension, X-ray tube, collimator, detector, wall stand, patient table, ACE (Auto Exposure Control), DAP (Dose Area Product), CIB (Control Interface Box), remote controller, grid, foot switch, barcode scanner, auto-stitching stand, weight distribution cap and workstation for S-station including Image Post-processing Engine (IPE).

The GC70 digital X-ray imaging system was previously cleared under K180543, and some hardware options and three software features are added to the predicate device GC70. The changes are as follows:

• Two High Voltage Generators
• . Two detectors
• . Slim wall stand
• . Software features called as S-Enhance, PEM (Pediatric Exposure Management) and Remote View
  • The S-Enhance is optional software to improve clarity of a foreign body (e.g. tube, line) and stone in chest, abdomen and L-spine images. With a single onscreen click, the companion image is created without additional settings or xray exposure, streamlining the process.
  • Pediatric Exposure Management is subdivided patient size and exposure conditions especially for pediatric patients based on weight and protocols. It follows same methodologies to define preset of patient size compare to preset of standard patient size from predicate device but specially optimized for pediatric patients.
  • The Remote view function provided images on another PC, not just on the device.

The Samsung GC70 Digital X-ray Imaging System, under K182647, is intended for generating radiographic images of human anatomy. This submission is a special 510(k) for changes to a previously cleared GC70 device (K180543), adding hardware options and three software features (S-Enhance, PEM, and Remote View) identical or similar to those cleared in predicate device GC85A (K181629).

1. Table of Acceptance Criteria and Reported Device Performance

No specific acceptance criteria or quantitative device performance metrics (e.g., sensitivity, specificity, accuracy) are provided in the document for the new features. The submission relies on the assertion that the new hardware and software features are identical or similar to previously cleared predicates and have undergone verification and validation testing to meet requirement specifications, functioning as safely and effectively.

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

The document does not specify a separate "test set" in the context of image data for evaluating the clinical performance of the software features. The verification and validation of the software features were conducted "in accordance with internal design change procedure." The non-clinical testing data, including MTF and DQE measurements, were provided in conformance to FDA guidance for solid-state X-ray imaging devices. However, no specific sample size of images or patients is reported, and there is no information on the country of origin or whether data was retrospective or prospective.

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

This information is not provided. The submission focuses on technical equivalence and verification/validation against internal specifications, rather than clinical performance studies requiring expert-adjudicated ground truth.

4. Adjudication method for the test set

This information is not provided. Given the nature of the submission (special 510(k) for hardware/software additions to an already cleared device, asserting equivalence), a formal adjudication process for a clinical test set is not described.

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

No MRMC comparative effectiveness study is mentioned or provided. The document explicitly states: "The application of these hardware options and software features, cleared with K181629, to the proposed device GC70 do not require clinical data." This indicates that no studies involving human readers or AI assistance were deemed necessary for this submission.

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

No standalone algorithm performance study is described in the provided text. The software features (S-Enhance, PEM, Remote View) are described as tools or enhancements to the imaging system, rather than standalone diagnostic algorithms requiring independent performance metrics like sensitivity or specificity. Their verification and validation were conducted against "internal design change procedure" and "requirement specifications."

7. The type of ground truth used

The document does not detail the type of ground truth used as it does not report clinical efficacy studies. The "ground truth" for the non-clinical tests (MTF, DQE) would be based on physical measurements and established phantom standards (e.g., IEC 62220-1). For the software features, the "ground truth" was likely defined by internal "requirement specifications" within Samsung's design change procedures, focusing on functional correctness and qualitative improvements as described (e.g., "improve clarity," "subdivided patient size").

8. The sample size for the training set

This information is not provided. Since the software features are described as "optional software to improve clarity" or "subdivided patient size and exposure conditions" and are stated to be "identical or similar" to features in a predicate device, it's possible they involve image processing or rule-based systems rather than deep learning models that require large training sets. Even if machine learning was used, the training data details are not disclosed.

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

This information is not provided. Similar to the training set sample size, the methodology for establishing ground truth for any potential training data is not detailed.

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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 GR40CW digital X-ray imaging system consists of Detector, Power supply box, Battery pack, Battery charger, Access point, CIB(Control Interface Box), Workstation, Barcode scanner, Main cable and software for image acquisition and image processing and does not include the X-ray generator. This system is 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 device before being sent to the S-Station (Operation Software) and saved in DICOM file, a standard for medical imaging. The captured images are sent to the Picture Archiving & Communication System (PACS) server, and can be used for reading images. The GR40CW digital X-ray imaging system was previously cleared with K180543, and through this premarket notification, we would like to add more configurations in the previously cleared GR40CW as three detectors are newly added, and some software features called as SimGrid, S-Enhance, BSI (Bone Suppression Image), Remote View and manual Stitching are newly added as stated below. SimGrid software option, cleared with K171119. is able to compensate the contrast loss due to scatter radiations, primarily acquisitions without a physical anti-scatter grid. BSI software option suppresses bone anatomy and 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 Manual Stitching to capture a body part that is larger than the detector's by capturing multiple images and Remote View function to remote access to view the current image on the workstation through a web browser. It was determined that the level of concern for the software contained in the GR40CW digital X-ray imaging system was Moderate in accordance with the FDA guidance for the Content of Premarket Submissions for Software Contained in Medical Device".

Here's a breakdown of the acceptance criteria and study information for the GR40CW device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly list a table of "acceptance criteria" with pass/fail thresholds in the typical sense for product validation. Instead, it focuses on demonstrating substantial equivalence to predicate devices. The performance evaluation is primarily comparative.

However, based on the non-clinical and clinical data descriptions, we can infer the key performance areas evaluated and the general finding of equivalence.

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

• Test Set for New Detector and S-Enhance (Clinical Data):
  • Sample Size: Not explicitly stated as a number of images or patients. It mentions "Anthropomorphic phantom images were provided"; and "these images were not necessary to establish substantial equivalence... but they provide further evidence...".
  • Data Provenance: Not explicitly stated (e.g., country of origin). The study used "Anthropomorphic phantom images," which are specialized phantoms designed to mimic human anatomy for imaging studies. This is a controlled, laboratory-based setup rather than real patient data. It is a prospective study design as the images were "provided" for evaluation.

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

• Number of Experts: Not explicitly stated. The document mentions "They were evaluated by professional radiologists." The exact number (e.g., 3, 5, 10) is not provided.
• Qualifications: "Professional radiologists." No specific years of experience or subspecialty are listed.

4. Adjudication Method for the Test Set

• Adjudication Method: Not explicitly stated. The text only says "They were evaluated by professional radiologists." This implies individual evaluation, but it doesn't describe a consensus or majority rule method if multiple radiologists were involved, nor does it specify if a single radiologist was the sole evaluator.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

• MRMC Study: No, a formal MRMC comparative effectiveness study, comparing human readers with AI assistance versus without AI assistance, was not explicitly detailed or performed as part of this submission. The clinical data section focuses on "Anthropomorphic phantom images" evaluated by radiologists to demonstrate equivalence of the device (including the S-Enhance feature) to predicate devices, not on the improvement of human performance using the AI feature.
• Effect Size: Not applicable, as an MRMC study demonstrating human reader improvement with AI assistance was not described.

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

• Standalone Performance: The non-clinical data provides standalone performance metrics for the device components like MTF and DQE (measured by IEC 62220-1), which characterize the imaging chain's inherent physical performance.
• For the software features like S-Enhance, the clinical data describes evaluations by radiologists of images generated by the software. While radiologists evaluate the output, the core performance of the S-Enhance algorithm in creating the companion images is assessed based on their ability to "provide clear visibility for foreign bodies such as lines, and needles, and urinary stones." This suggests a form of standalone performance evaluation of the algorithm's output, even if human experts are interpreting that output. The submission aims to show the complete system works as intended and that S-Enhance produces images with desired characteristics.

7. The Type of Ground Truth Used

• Ground Truth Type: For the clinical evaluation regarding the new detector and S-Enhance, the ground truth was expert consensus/opinion (professional radiologists) on the "image quality evaluation" and the "clear visibility for foreign bodies... and urinary stones" in images generated from anthropomorphic phantoms. Phantoms provide a known truth in terms of implanted objects.

8. The Sample Size for the Training Set

• Training Set Sample Size: Not provided or discussed in this document. This submission pertains to modifications to an already cleared device, and the focus is on the performance of the new detectors and expanded software features (S-Enhance). Details about the training data for the S-Enhance or other software algorithms are not included.

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

• Training Set Ground Truth Establishment: Not provided or discussed, as the training set sample size was not mentioned.

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