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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.

Ask a specific question about this device

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 GU60A, GU60A-65 digital X-ray imaging systems are a stationary x-ray system designed for general radiography and 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 Postprocessing Engine (IPE) which is exclusively installed in S-station, and sent to the Picture Archiving, Communication System (PACS) sever for reading images.

The GU60A, GU60A-65 digital X-ray imaging systems consist of HVG (High Voltage Generator), U-arm positioner, X-ray tube, collimator, detector, ACE (Auto Exposure Control), DAP (Dose Area Product), CIB (Control Interface Box), remote controller, grid, barcode scanner, auto-stitching stand, weight distribution cap and workstation for Sstation including Image Post-processing Engine (IPE).

The difference between GU60A and GU60A-65 is that the option of their HVG is different. In detail, 50 kW and 68 kW are for GU60A and 65 KW is for GU60A-65.

The GU60A, GU60A-65 digital X-ray imaging systems were previously cleared under K180543, and some hardware options and three software features are added to the predicate device GU60A, GU60A-65. The changes are as follows:

• Two detectors
• 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 provided text describes a 510(k) premarket notification for the GU60A and GU60A-65 Digital X-ray Imaging Systems. It details the device, its intended use, and comparisons to predicate devices. However, the document does not contain any information about acceptance criteria or a study proving the device meets specific acceptance criteria based on performance metrics like accuracy, sensitivity, or specificity for a particular clinical task.

The document states:

• "Non-clinical data demonstrates that the proposed devices are as safe, as effective, and perform as well as the legally marketed predicate devices."
• "The application of detectors and software features, cleared with K181629, to the proposed device GU60A, GU60A-65 does not require clinical data."
• "The verification and validation for the software features added to the proposed device were also conducted and reviewed in accordance with internal design change procedure. As a result, requirement specifications were met and the proposed device shows no difference in non-clinical testing data such as MTF and DQE measurements from the predicate device."

This implies that the acceptance was primarily based on:

1. Substantial equivalence to predicate devices: The new features (S-Enhance, PEM, Remote View, and new detectors) were already cleared with previous predicate devices (K180543 and K181629).
2. Compliance with non-clinical performance and safety standards: Electrical, mechanical, environmental safety, EMC, and X-ray specific performance (MTF, DQE measurements) were conducted according to relevant IEC and FDA standards (e.g., ES 60601-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-2-28, IEC 60601-2-54, ISO14971, 21CFR1020.30, 21CFR1020.31).
3. Software verification and validation: Conducted according to internal design change procedures.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets clinical performance acceptance criteria because the provided text explicitly states that clinical data was not required for this 510(k) submission.

The document focuses on demonstrating substantial equivalence to pre-existing, cleared devices and adherence to engineering and non-clinical performance standards for X-ray imaging systems. It does not describe a study involving an AI component with specific performance metrics (like accuracy for a diagnostic task) and associated acceptance criteria that would typically involve human-in-the-loop studies, multi-reader multi-case studies, or expert ground truth adjudication.

If the question is implicitly asking about the "acceptance criteria" and "study" in the context of the entire X-ray system meeting regulatory clearance, then the answer is based on "substantial equivalence" and compliance with non-clinical performance and safety standards, as detailed in the document, rather than a clinical performance study for a specific diagnostic AI feature.

Based solely on the provided text, and understanding that it does not describe a clinical performance study for an AI component's diagnostic accuracy:

I cannot populate the requested table and answer many of the specific questions because the document does not contain the necessary information about a clinical performance study or diagnostic AI acceptance criteria. The submission is for a general radiographic imaging system and an enhancement software (S-Enhance) for clarity of foreign bodies/stones, but without specifying diagnostic performance metrics or a study to prove them.

Here's what can be inferred or stated based on the text's lack of this information:

1. A table of acceptance criteria and the reported device performance

The document's acceptance criteria related to safety and general performance are:

• Compliance with electrical, mechanical, environmental safety standards (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).
• Compliance with EMC testing (IEC 60601-1-2).
• Compliance with wireless function guidance.
• Conformity to FDA "Guidance for the Submission of 510(k)'s for Solid-State X-ray Imaging Devices" for non-clinical data (MTF and DQE measurements).
• Software verification and validation meeting "requirement specifications" in accordance with internal design change procedure.

The reported device performance in these areas is that "All test results were satisfying the standards" and "requirement specifications were met and the proposed device shows no difference in non-clinical testing data such as MTF and DQE measurements from the predicate device."

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

• Sample Size: Not applicable/Not specified, as no clinical test set for diagnostic performance was described. The non-clinical performance data (MTF, DQE) would use physical phantoms or test objects, not patient data in the typical sense of a test set for AI.
• Data Provenance: Not applicable/Not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable/Not specified, as no clinical test set or ground truth establishment process for diagnostic performance was described.

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

• Not applicable/Not specified, as no clinical test set or adjudication process was 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

• Was an MRMC study done? No. The document states "The application of detectors and software features... does not require clinical data."
• Effect size: Not applicable.

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

• Not applicable/Not specified, as no standalone diagnostic performance study for an AI algorithm was described. The S-Enhance is described as "optional software to improve clarity," which suggests image processing, not a standalone diagnostic AI.

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

• Not applicable/Not specified, as no clinical ground truth for diagnostic performance was described. For non-clinical validation (MTF, DQE), the "ground truth" would be the known physical properties of the test phantoms.

8. The sample size for the training set

• Not applicable/Not specified, as no information about an AI training set is provided.

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

• Not applicable/Not specified, as no information about an AI training set or its ground truth establishment is provided.

Ask a specific question about this device

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.

Ask a specific question about this device

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 GU60A & GU60A-65 digital X-ray imaging systems are to be used to take and store image for diagnosis of patients. It consists of HVG(High voltage generator), U-arm positioner, Detector, X-ray tube, Collimator, AEC(Auto Exposure Control), DAP(Dose Area Product), CIB(Control Interface Box), Remote controller, Grid, Barcode scanner and Autostitching stand.

These systems 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 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.

The GU60A & GU60A-65 digital X-ray imaging systems is stationary, and it was previously cleared under K151685. The software features cleared with K171119, SimGrid, BSI (Bone Suppression Image) and TLE (Tube & Line Enhancement), is added to the predicate x-ray system (K151685).

The software features called as SimGrid, BSI (Bone Suppression Image) and TLE (Tube & Line Enhancement) is a post-image processing software option which provides companion images to assist diagnosis in addition to the images obtained from normal diagnosis protocol.

The SimGrid software option is able to compensate the contrast loss due to scatter radiations, primarily acquisitions without a physical anti-scatter grid.

The BSI software option suppresses bone anatomy and the TLE software option enhances visibility of tube and catheter features in a companion image that is delivered in addition to the original diagnostic image.

These software features are designed to be exclusively installed in S-station, SAMSUNG digital X-ray operation software, while it uses the radiological image as an input and do not depend on how the image is acquired or which radiology device is used.

The provided document does not contain details about specific acceptance criteria, a study proving the device meets those criteria, or reported device performance metrics in the format requested. The document is a 510(k) premarket notification summary for an X-ray imaging system, focusing on demonstrating substantial equivalence to predicate devices rather than providing detailed performance study results against specific acceptance criteria.

Therefore, many of the requested fields cannot be filled from the provided text.

Here's an analysis of what can be extracted:

1. A table of acceptance criteria and the reported device performance

• Acceptance Criteria: Not explicitly stated in the provided text. The document refers to conformance with various standards (ES 60601-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-2-28, IEC 60601-2-54, ISO14971, 21CFR1020.30, 21CFR1020.31, IEC 62220-1) and a guidance document for wireless technology. It also states that all test results were "satisfying the standards." However, specific numerical acceptance criteria for performance (e.g., sensitivity, specificity, accuracy) for the software features are not detailed.
• Reported Device Performance: No specific performance metrics (e.g., sensitivity, specificity, accuracy) are reported for the device, or its software features (SimGrid, BSI, TLE). It only mentions that MTF and DQE measurements "show no difference in non-clinical testing data... from the predicate device."

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

• Not specified. The document states "The application of SimGrid, TLE, S-DAP and BSI, cleared with K171119, to the proposed device GU60A & GU60A-65 does not require clinical data." This implies no clinical test set was used for the substantial equivalence demonstration of these specific software features. Non-clinical testing data (MTF and DQE) likely used phantoms, but the sample size or provenance of that data is not provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable as no clinical data or specific test set adjudicated by experts is described in the document.

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

• Not applicable as no clinical data or specific test set with expert adjudication is described in the document.

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. The document explicitly states that clinical data was not required for the software features in question.

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

• The document implies that the software features (SimGrid, BSI, TLE) provide "companion images to assist diagnosis." This suggests an assistive role rather than a standalone diagnostic role, but no specific performance metrics for this assistance are provided. The fact that clinical data was not required for these features further supports that a standalone performance study was not conducted for this submission.

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

• Not applicable, as no clinical studies with established ground truth are described for the performance of the features. For non-clinical MTF and DQE measurements, the ground truth would be determined by the phantom properties and measurement protocols per IEC 62220-1.

8. The sample size for the training set

• Not specified. The document describes the device as a hardware system with added post-processing software features. There is no mention of an "AI" or "machine learning" algorithm in the modern sense that would require a distinct training set. The software features (SimGrid, BSI, TLE) are described as "post-image processing software option" rather than adaptive learning algorithms.

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

• Not applicable, as a training set for an AI/ML algorithm is not described.

Ask a specific question about this device

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 GU60A & GU60A-65 digital X-ray imaging systems are to be used to take and store image for diagnosis of patients. It consists of HVG(High voltage generator), U-arm positioner, Detector, X-ray tube, Collimator, AEC(Auto Exposure Control), DAP(Dose Area Product), CIB(Control Interface Box), Remote controller, Grid, Barcode scanner and Auto-stitching stand. These systems 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 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.

The provided text is a 510(k) Premarket Notification for the SAMSUNG ELECTRONICS Co., Ltd. GU60A & GU60A-65 Digital X-ray Imaging Systems. This document primarily focuses on establishing substantial equivalence to a predicate device (XGEO GU60A, K140332) rather than providing detailed acceptance criteria and a comprehensive study report for the device's performance.

Therefore, the requested information cannot be fully extracted. Here's a breakdown of what can and cannot be provided based on the given text:

Information that can be extracted, partially or fully:

• Acceptance Criteria and Reported Device Performance: This information is not explicitly presented in a table format with specific quantitative acceptance criteria or detailed device performance metrics. The document states that "All test results were satisfying the standards" for safety, EMC, and performance, and "The proposed devices show no difference in non-clinical testing data such as MTF and DQE measurements from the predicate device." It also mentions "A Clinical images review report...which shows the equivalent diagnostic capability to the predicate device." However, no specific numerical or statistical acceptance criteria for diagnostic capability are provided.
• Data Provenance (country of origin, retrospective/prospective): Not specified for the clinical images review.
• Ground Truth (type of): The "Clinical images review report" implies expert consensus from a qualified reviewer for diagnostic capability, but specific details about how ground truth was established are not provided.
• Standalone Performance: The "Non-clinical data" section describes testing such as MTF and DQE measurements (IEC 62220-1), which are measures of a device's standalone performance. The document states "The proposed devices show no difference in non-clinical testing data such as MTF and DQE measurements from the predicate device."

Information that cannot be extracted from the provided text:

• Sample size for the test set: Not mentioned.
• Number of experts used to establish the ground truth for the test set and their qualifications: Not mentioned.
• Adjudication method for the test set: Not mentioned.
• Multi-Reader Multi-Case (MRMC) comparative effectiveness study: Not mentioned.
• Effect size of human readers with vs without AI assistance: Not applicable as no AI component is described.
• Sample size for the training set: Not mentioned. This device does not appear to utilize AI/ML, so a "training set" in that context would not be relevant.
• How the ground truth for the training set was established: Not applicable.

Based on the available text, here's what can be reported:

1. A table of acceptance criteria and the reported device performance

Since specific quantitative acceptance criteria and detailed device performance for diagnostic capability are not provided, this table will reflect the general statements made in the document regarding equivalence and compliance.

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

• Sample Size for Test Set: Not specified.
• Data Provenance: Not specified. The company is based in the Republic of Korea, but the origin of the clinical images for review is not stated, nor is whether the 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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified, although a "qualified/trained doctor or technician" is mentioned in the Indications for Use for operating the system. The "clinical images review report" implies a qualified reviewer, but details are not provided.

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

• Adjudication Method: Not specified.

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, nor is any AI component described for the device. The device is a digital X-ray imaging system, not an AI-assisted diagnostic tool.

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

• Yes, standalone performance testing was done for the physical imaging components.
  • "Non-clinical testing data was provided in conformance to the FDA "Guidance for the Submission of 510(k)'s for Solid-State X-ray Imaging Devices", which includes MTF and DQE measurements as tested by IEC 62220-1."
  • The results indicated that "The proposed devices show no difference in non-clinical testing data such as MTF and DQE measurements from the predicate device."

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

• The "Clinical images review report" implies expert consensus or review by qualified individuals for assessing "equivalent diagnostic capability." However, the exact nature (e.g., specific clinical endpoints, pathology correlation) used to establish ground truth for this review is not detailed.

8. The sample size for the training set

• Not applicable/Not mentioned, as the document describes a hardware device (X-ray system) and not an algorithm requiring a "training set" in the context of AI/ML.

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

• Not applicable/Not mentioned, for the same reason as above.

Ask a specific question about this device

The XGEO GU60A 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 GU60A 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), U-arm positioner, Detector, X-ray tube, Collimator and etc.

The provided text does not contain detailed information about the acceptance criteria or a study that proves the device meets specific performance criteria beyond general safety and effectiveness.

Here's an analysis of what is and isn't present in the document based on your request:

1. A table of acceptance criteria and the reported device performance

• The document states that "Non-clinical testing and Clinical Testing were conducted in accordance with Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices" and that "All test results are satisfied."
• It also mentions differences from the predicate device in "pixel pitch, high contrast limiting resolution, DQE, MTF and communication," noting that the proposed device has higher DQE and MTF values. These are performance metrics, but no specific acceptance criteria or quantitative performance results are provided in a table.

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

• This information is not provided in the document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

• This information is not provided in the document.

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

• This information is not provided in the document.

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

• The text describes a digital X-ray imaging system, not an AI-assisted diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable and not mentioned.

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

• As the device is an X-ray imaging system and not an algorithm for diagnosis, standalone algorithm performance is not applicable and not mentioned. The device produces images for a qualified/trained doctor or technician to interpret.

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

• This information is not provided in the document.

8. The sample size for the training set

• This information is not provided in the document. The device is a hardware imaging system, not a machine learning algorithm that requires a training set in the typical sense.

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

• This information is not provided as it's not an AI/ML device in the context of requiring ground truth for a training set.

Summary of available information related to acceptance criteria and device performance:

The document primarily focuses on demonstrating substantial equivalence to a predicate device (XGEO GU60A, K123106) by highlighting that observed differences in technical specifications (pixel pitch, high contrast limiting resolution, DQE, MTF, communication) do not negatively impact safety or effectiveness.

• Acceptance Criteria (Implicit/General):

  • Compliance with various electrical, mechanical, environmental safety, and performance standards (ES 60601-1:2012, IEC 60601-1-3:2008, IEC 60601-2-28:2010, IEC 60601-2-54:2009, 21CFR1020.30, 21CFR1020.31, IEC 60601-1-2:2007).
  • Compliance with "Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices" for non-clinical and clinical testing.
  • No new potential safety risks compared to the predicate device.
  • Performance "as well as" the predicate device despite differences in certain technical specifications.
  • The proposed device has "higher DQE value" and "higher MTF value" compared to the predicate, implying improvement in image quality.

• Reported Device Performance:

  • "All test results are satisfied" (in reference to the listed standards and guidance documents).
  • The device has a different (likely smaller, leading to higher resolution) pixel pitch.
  • Higher high contrast limiting resolution (due to pixel pitch).
  • Higher DQE value (affects image quality).
  • Higher MTF value (affects image quality).
  • Supports both wired and wireless communication (predicate only wired).

No specific quantitative acceptance criteria or detailed results of performance studies are presented in this 510(k) summary beyond the general statement that all tests were satisfied and the device performs at least as well as the predicate, with some technical improvements.

Ask a specific question about this device

The XGEO GU60A 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 GU60A 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), U-arm positioner, Detector, X-ray tube, Collimator and etc.

The provided text describes a 510(k) premarket notification for the "XGEO GU60A Digital Diagnostic X-ray System." It outlines the device's intended use and compares it to a predicate device, but it does not contain acceptance criteria or a study proving the device meets those criteria in the format requested.

The document primarily focuses on demonstrating substantial equivalence to a predicate device (Revolution XR/d of General Electric Company) for regulatory purposes. It mentions various tests conducted for safety, EMC, and performance according to established standards (e.g., IEC 60601 series, 21 CFR 1020.30, 21 CFR 1020.31, and FDA guidance for 510(k)s for Solid State X-ray Imaging Devices). It states, "All test results were satisfied," which implies the device passed, but it does not specify what those acceptance criteria were or present the detailed results of those tests.

Therefore, most of the requested information cannot be extracted from this document, specifically:

1. A table of acceptance criteria and the reported device performance: Not provided. The document states "All test results were satisfied" for safety, EMC, and performance tests, but does not list specific criteria or 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): Not provided. The document mentions "Non-clinical testing and Clinical Testing were conducted," but gives no details about sample size, provenance, or study design.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience): Not provided.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not provided.

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 explicitly stated. The device is a "Digital Diagnostic X-ray System" for generating images, not an AI-powered diagnostic aid that assists human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is unlikely for this type of device as described.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. The device is a hardware system for image acquisition, not a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not provided, as detailed clinical study results are absent.

8. The sample size for the training set: Not provided. This device is an X-ray imaging system, not an AI model that typically requires a training set in the same context.

9. How the ground truth for the training set was established: Not provided. (See point 8).

Summary of what is present:

• Device Name: XGEO GU60A Digital Diagnostic X-ray System (K123106)
• Intended Use: Generating radiographic images of human anatomy by a qualified/trained doctor or technician. Not for mammographic applications.
• Predicate Device: Revolution XR/d of General Electric Company.
• Studies Conducted (mentioned, not detailed): Electrical, mechanical, environmental safety and performance testing according to IEC 60601 series, 21CFR1020.30, 21CFR1020.31; EMC testing according to IEC 60601-1-2(2001); Non-clinical testing and Clinical Testing in accordance with FDA guidance for 510(k)s for Solid State X-ray Imaging Devices.
• Conclusion: The device is safe and effective and substantially equivalent to the predicate device, with all test results reported as "satisfied."

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