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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 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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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.

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 and GM85 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, and sent to the Picture Archiving & Communication System (PACS) sever for reading images.

An 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 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, is substantially equivalent. It was cleared with K172229 that using the IPE is able to reduce dose of 50% for chest PA of average adult in GC85A.

This submission is purposed to get 510(k) clearance for expanding the scope of the claim, cleared with K172229, from GC85A to the proposed devices, Samsung x-ray systems.

The IPE, a software which has no relation with imaging chain, is applied to the proposed devices and it is evaluated that images acquired by a various imaging chain are substantially equivalent to GC85A in a non-clinical evaluation.

The proposed devices with the IPE employing an advanced noise reduction algorithm are able to reduce dose of 50% for chest PA of average adult for marketing purpose.

This claim is based on a limited study of an anthropomorphic phantom that simulates the x-ray properties of an average size adult, and on a small clinical study at one facility. Only routine PA chest radiography was studied, and results for larger-size adults (body mass index) greater than 30 was not studied to statistical significance. The pediatric patients was not studied and the clinical site is responsible for determining whether the particular radiographic imaging needs are not impacted by such x-ray dose reduction.

The provided text is a 510(k) Premarket Notification summary for several Samsung Digital X-ray Imaging Systems (GC70, GU60A&GU60A-65, GF50, GF50A, GR40CW, and GM85). The core of the submission is to expand the scope of a previously cleared Image Post-processing Engine (IPE) with an advanced noise reduction algorithm (from K172229 for GC85A) to these additional devices, claiming that the IPE can achieve a 50% dose reduction for chest PA of average adults while maintaining image quality.

However, the document explicitly states: "This submission does not required clinical data." This means that a clinical study proving the device meets specific acceptance criteria based on human reader performance with or without AI (MRMC study) was not conducted or submitted as part of this premarket notification. The evaluation relies heavily on non-clinical data and the substantial equivalence to a predicate device that previously demonstrated the dose reduction claim for a specific device (GC85A).

Given this, I cannot provide a table of acceptance criteria based on a clinical study or details about a MRMC study, as none were required or performed for this specific submission's scope expansion.

Here's what can be extracted and inferred from the document regarding the device and its testing, tailored to the questions where information is available:

Acceptance Criteria and Device Performance (Based on Non-Clinical Data)

Since no clinical study was required for this submission, the "acceptance criteria" and "reported device performance" are based on non-clinical evaluations comparing the image quality of the proposed devices with the IPE to the predicate device (GC85A) and to images produced with conventional settings. The primary claim revolves around the ability to maintain image quality at a 50% reduced dose.

Table of Acceptance Criteria and Reported Device Performance (Non-Clinical)

"Therefore, the IPE is capable of providing the same dose reduction in AP adult chest radiographs for the proposed devices as it does for the predicate GC85A." |
| Safety and EMC Standards Compliance: Electrical, mechanical, environmental safety, and EMC testing according to relevant standards. | "Electrical, mechanical, environmental safety and performance testing according to standard ES 60601-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-2-28, IEC 60601-2-54, ISO14971, 21CFR1020.30 and 21CFR1020.31 were performed, and EMC testing was conducted in accordance with standard IEC 60601-1-2. Wireless function was tested and verified followed by guidance, Radio frequency Wireless Technology in Medical Devices. All test results were satisfying the standards." |

Study Details (Based on Available Information)

1. Sample sized used for the test set and the data provenance:

   • Test Set (Non-clinical): The document mentions "a limited study of an anthropomorphic phantom that simulates the x-ray properties of an average size adult" and "a small clinical study at one facility." However, the quantitative assessment for this specific submission's purpose (expanding IPE scope) was non-clinical: "The quantitative assessment of image quality was conducted with the images of TOR CDR radiography phantom and TO20 contrast detail phantom taken at a various exposure condition with different Samsung X-ray imaging systems." No specific sample size (number of phantom images) is provided.
   • Data Provenance: The anthropomorphic phantom study and "small clinical study" mentioned for the initial GC85A clearance (K172229) are noted as having limitations: "Only routine PA chest radiography was studied, and results for larger-size adults (body mass index) greater than 30 was not studied to statistical significance. The pediatric patients was not studied..." The origin country of the data is not explicitly stated for these studies, but Samsung is a Republic of Korea company. The non-clinical test set for this submission involved "various Samsung X-ray imaging systems" which would likely be internally generated. The studies mentioned (phantom and small clinical) for the original IPE clearance (K172229) were likely a mix of retrospective/prospective, but this detail is not provided for those underlying studies, nor are they claimed as part of this current submission's direct evidence, only referenced as a basis.

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

   • For the non-clinical quantitative assessment in this submission (MTF, CNR, visibility of phantom images), human experts were not used to establish quantitative ground truth. These are objective measures.
   • For the original clearance of the IPE (K172229) where the "small clinical study" and "substantially equivalent" image quality claim was made with 50% dose reduction based on human perception, no details about expert readers, their number, or qualifications are provided in this summary.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Not applicable for the non-clinical quantitative assessment of phantom images.
   • Not provided for the underlying "small clinical study" that was part of the original IPE clearance.

4. 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. The document explicitly states: "This submission does not required clinical data." Therefore, no MRMC comparative effectiveness study was performed or submitted for this specific 510(k) notification. The evaluation relies on substantial equivalence to the predicate and non-clinical data.

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

   • The IPE is a software component (algorithm) that processes images. The "quantitative assessment of image quality was conducted with the images of TOR CDR radiography phantom and TO20 contrast detail phantom," which constitutes a standalone (algorithm only) performance evaluation based on objective image quality metrics (MTF, CNR, visibility). This confirms the algorithm's ability to process images in a way that, quantitatively, maintains image quality.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • For the non-clinical quantitative assessment (of image quality parameters like MTF, CNR, visibility), the "ground truth" is derived from physical phantoms with known properties and objective measurements. It is not based on expert consensus, pathology, or outcomes data.
   • The claim of "substantially equivalent" image quality at 50% dose reduction (from K172229) implicitly relies on human perception from a "small clinical study," but the ground truth establishment method for that is not detailed here.

7. The sample size for the training set:

   • Not mentioned in the document. The document describes the "proposed devices" (SAMSUNG X-ray systems) and the "IPE" (Image Post-processing Engine) as software. It asserts that the IPE "operates, from the input image, the roles of a region-of-interest extraction, tonescale mapping, noise reduction and texture restoration." It also notes the IPE "employing an advanced noise reduction algorithm." While algorithms require training data, the submission does not delve into the development or training of the IPE.

8. How the ground truth for the training set was established:

   • Not mentioned in the document, as details about the IPE's development and training process are outside the scope of this 510(k) summary, which focuses on demonstrating substantial equivalence for the application of an already cleared IPE to new devices.

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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 and Main cable. 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 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.

This document describes the premarket notification for the GR40CW Digital X-ray Imaging System (retrofit kit). The submission focuses on demonstrating substantial equivalence to predicate devices, particularly concerning the performance of a new detector, S4335-WV.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics in a pass/fail format. Instead, it relies on demonstrating equivalence or improvement compared to predicate devices for key technical specifications and imaging performance metrics.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document mentions "clinical images were obtained in accordance with FDA guidance for the submission of 510(k)'s for Solid State X-Ray Imaging Devices." However, it does not specify the sample size for the test set or the data provenance (country of origin, retrospective or prospective).

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

The clinical images were "evaluated by a professional radiologist." The document mentions "a professional radiologist," implying a single expert was used. Their specific qualifications (e.g., years of experience, subspecialty) are not provided.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

The document states the images were "evaluated by a professional radiologist." This suggests no formal adjudication method (like 2+1 or 3+1) was employed, as only one radiologist is mentioned as evaluating the images.

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 was done. The device GR40CW is described as a "Digital X-ray Imaging System" and a "retrofit kit" that generates digital images. It is not an AI-powered diagnostic tool, but rather a digital detector replacing analog film systems. Therefore, the question of human reader improvement with AI assistance is not applicable to this device.

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

Not Applicable. The GR40CW is a digital X-ray imaging system, not an algorithm, so a standalone performance evaluation of an "algorithm only" is not relevant. Its performance is tied to its image acquisition capabilities, which are then interpreted by human readers.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth for the clinical images was established by a professional radiologist's evaluation. It is not explicitly stated whether this involved objective measures like pathology or outcomes data, but rather the radiologist's interpretation of the images.

8. The sample size for the training set

The document does not specify any training set size. The context of the submission is a 510(k) for a device with a new detector, focusing on demonstrating equivalence to existing technology, not on training an AI algorithm.

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

Not Applicable. As no training set is mentioned in the context of an AI algorithm, the method for establishing ground truth for a training set is not discussed.

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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 and Main cable. 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.

This is a retrofit system consisting of Detector, Power supply box, Battery charger, Access point, CIB (Control Interface Box), Workstation, Barcode scanner and Main cable. This retrofit system is designed to generate a digital image while using the current analogue X-ray system by upgrading only the part of an analogue cassette film to the digital panel(detector), and does not get involved in controlling X-ray radiation related parameters, which is still controlled by the existing X-ray system.

The GR40CW retrofit system can be applied to the existing analogue X-ray system by two ways (CIB and AED modes). 1) In CIB mode, CIB is only connected to a signal line of a hand switch for passively detecting the signal, as On or Off, coming out from the hand switch to the X-ray Generator Console, to make the digital detector ready to active or inactive to receive X-ray radiation. 2) In AED (Automatic Exposure Detection) mode, without CIB, the detector is sensing of radiation exposure. Once it recognizes the exposure, it become active right away to receive X-ray radiation. This whole process is independently operated from the existing analogue X-ray system.

This document describes the 510(k) Pre-market Notification for the SAMSUNG ELECTRONICS Co., Ltd. GR40CW Digital X-ray Imaging System (K152094), which is seeking substantial equivalence to the predicate device XGEO GR40CW (K140235).

Here's an analysis of the acceptance criteria and the study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The submission focuses on demonstrating substantial equivalence by analyzing technological characteristics and non-clinical performance data, rather than defining specific acceptance criteria for diagnostic accuracy metrics (e.g., sensitivity, specificity) for a particular clinical task. The "acceptance criteria" here are implicitly tied to demonstrating that the proposed device performs "as well as" or is "substantially equivalent" to the predicate device in terms of image quality and safety.

The document states: "In non-clinical data, the proposed detector shows curves and measurements of MTF and DQE that improved from the predicate device, and the proposed GR40CW has been shown a substantially equivalent or improved to the predicate device." And elsewhere: "The proposed device shows no difference in non-clinical testing data such as MTF and DQE measurements from the predicate device." These statements appear somewhat contradictory or at least imprecise. Good practice would involve specific numerical targets for MTF and DQE or clearly defined thresholds for "improvement" or "no difference."

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

The document explicitly states: "12.Clinical data: Not required since the different detector area, CPU and Memory specification, and a new CIB do not have relation to and affect the clinical images of the detector which was cleared with the predicate device."

Therefore, no clinical test set (i.e., for evaluating diagnostic performance on patient data) was used. The focus was on non-clinical engineering and image quality performance data to establish substantial equivalence.

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

Not applicable, as no clinical test set requiring expert ground truth establishment was used.

4. Adjudication Method for the Test Set

Not applicable, as no clinical test set requiring adjudication was used.

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

Not applicable. This submission is for a digital X-ray imaging system, not an AI-powered CAD (Computer-Aided Detection) or diagnostic assistance device. Therefore, no MRMC study assessing human reader improvement with AI was conducted.

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

Not applicable, as this is an imaging acquisition device, not an algorithm for diagnosis or detection.

7. The Type of Ground Truth Used

For the non-clinical performance data (MTF, DQE), the "ground truth" would be established by the physical and technical specifications of the detectors and measurement protocols (e.g., JEC 62220-1). It's not a clinical ground truth like pathology or expert consensus.

8. The Sample Size for the Training Set

Not applicable, as this is an imaging acquisition device. The submission does not describe a machine learning algorithm that requires a training set of data.

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

Not applicable.

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The XGEO GR40CW Digital X-ray Imaging System is intended for use in general projection radiographic applications wherever conventional screen-film systems may be used. This device is not intended for mammographic applications.

Not Found

This document is a 510(k) premarket notification for the SAMSUNG ELECTRONICS Co., Ltd. XGEO GR40CW, a stationary x-ray system. The document states that the device is substantially equivalent to the predicate device XGEO GC80 (K123098). However, it does not contain the detailed study information required to fill out all the requested fields about acceptance criteria and study proving device meets the acceptance criteria.

The provided text focuses on the administrative aspects of the 510(k) submission and the FDA's regulatory response, rather than providing technical details of performance studies or acceptance criteria.

Therefore, I cannot provide a complete answer based on the provided text.

Specifically, the following information is not present in the provided document:

• A table of acceptance criteria and the reported device performance: This information is typically found in the performance testing section of a 510(k) submission, which is not included here.
• Sample sized used for the test set and the data provenance: Not provided.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided.
• Adjudication method for the test set: Not provided.
• 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: This is a traditional X-ray system, not an AI device, so this type of study would not be applicable or expected.
• If a standalone (i.e., algorithm only without human-in-the loop performance) was done: As above, this is not an AI device.
• The type of ground truth used: Not provided.
• The sample size for the training set: Not provided (and likely not applicable as it's not an AI/ML device).
• How the ground truth for the training set was established: Not provided (and likely not applicable).

The document is primarily a 510(k) summary and the FDA's clearance letter, which includes the device name, manufacturer, contact information, classification, predicate device, and the intended use statement. It confirms the FDA's determination of substantial equivalence but does not delve into the specifics of the performance studies conducted to support that determination.

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