Search Results

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.

The GM85 Digital Mobile X-ray Imaging 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 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 send to the Picture Archiving & Communication System (PACS) sever for reading images.

The GM85 Digital Mobile X-ray imaging System was previously cleared with K222353, and through this premarket notification, we would like to add more configurations in the previously cleared GM85 as a detector, accessories are newly added and software is updated for user convenience.

The new detector added in the proposed device is designed to achieve a higher IP rating of Dust and Water and reduce weight while maintaining durability, functionality and operation like the detector of the predicate device. The new detector and predicate device's detector are both an x-ray conversion device using an amorphous silicon flat panel and absorb incident x-rays, converts it to a digital signal, and then transmits it to the Samsung Digital X-ray System like that of the predicate device.

The provided text is a 510(k) Premarket Notification for the GM85 Digital Mobile X-ray Imaging System. It describes changes made to a previously cleared device (K222353) and argues for substantial equivalence.

Based on the provided text, the device is the GM85 Digital Mobile X-ray Imaging System. It is an X-ray imaging system, and the study focuses on the performance of a new detector (F4343-AW) and other accessories and software updates compared to the predicate device, also named GM85.

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

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state "acceptance criteria" in a quantitative format for specific imaging metrics. Instead, it focuses on demonstrating that the proposed device, with its new detector, accessories, and software, is substantially equivalent to the predicate device (GM85, K222353). The performance is assessed by comparing technical specifications and qualitative evaluation by experts.

The key performance characteristics and comparisons are as follows:

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

• Test Set Sample Size: The document refers to "Anthropomorphic phantom images" but does not specify the number of phantom images used for evaluation. It also notes that clinical data was not required.
• Data Provenance: The study is non-clinical. The "Anthropomorphic phantom images" would have been generated in a controlled testing environment, likely at the manufacturer's facility. The country of origin of the data is implicitly South Korea, where SAMSUNG ELECTRONICS Co., Ltd. is located. The study is a prospective evaluation of the new detector and modified system against the predicate.

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

• Number of Experts: The document states that phantom images "were evaluated by professional radiologists." It does not specify the number of radiologists who participated in this evaluation.
• Qualifications of Experts: The experts are described as "professional radiologists." No further details on their experience level (e.g., years of experience, subspecialty) are provided.

4. Adjudication Method for the Test Set

The document states that phantom images "were evaluated by professional radiologists and found to be equivalent to the predicate devices" and that there was "no significant difference in the average score of image quality evaluation." This suggests a comparative scoring or assessment. However, the specific adjudication method (e.g., consensus, majority vote, independent reads with statistical comparison) is not described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly done, nor was there a "human readers improve with AI vs without AI assistance" component. The study for substantial equivalence focused on comparing the image quality of the proposed device (with new detector) against the predicate device using phantom images, evaluated by radiologists. The purpose was to show equivalence of the device's output, not the improvement of human readers with AI assistance.

6. Standalone Performance Study (Algorithm Only)

The provided text describes the device as a "Digital Mobile X-ray Imaging System," which includes hardware (X-ray generator, detector) and software for image processing (IPE, S-Station). The evaluation primarily focuses on the entire system's ability to generate radiographic images with equivalent quality to the predicate, particularly with the new detector.

While software features are mentioned (S-Share, S-Enhance, SimGrid, PEM, QAP, Bone Suppression, Remote View, Mirror View, RFID, Value-up Package), and software was updated for user convenience, the study does not report a standalone algorithm-only performance (without human-in-the-loop performance) in terms of diagnostic accuracy or reader improvement for specific diagnostic tasks. The "phantom image evaluation" evaluates the quality of the images produced by the overall system, not an AI algorithm's diagnostic output.

7. Type of Ground Truth Used

The ground truth for the phantom image evaluation was established based on expert consensus/evaluation of image quality metrics. The "professional radiologists" evaluated the anthropomorphic phantom images. This is not pathology, nor outcomes data.

8. Sample Size for the Training Set

The document does not provide information on the sample size for the training set. Training data would typically be applicable if this were an AI/CADe device with a specific machine learning model for diagnostic tasks, which is not the primary focus of this 510(k) for a basic X-ray imaging system with incremental changes. The "Image Post-processing Engine (IPE)" and features like "Bone Suppression" would have been developed using some form of training data previously, but details are absent here for this particular submission.

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

As no training set sample size is provided, the method for establishing ground truth for a training set is not mentioned in this document.

Ask a specific question about this device

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.

The GM85 Digital Mobile X-ray Imaging 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 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 send to the Picture Archiving & Communication System (PACS) sever for reading images.

The provided text describes a 510(k) premarket notification for the GM85 Digital Mobile X-ray Imaging System. The primary purpose of this notification is to add a new detector configuration to an already cleared device (K220175). As such, the study described focuses on demonstrating the substantial equivalence of the new detector and its integration, rather than establishing primary performance metrics from scratch for a completely new device.

Here's a breakdown of the acceptance criteria and the study conducted based on the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly tied to demonstrating equivalence to the predicate device's existing performance, particularly for the new detector. The non-clinical and clinical (phantom image evaluation) data serve to show that the new detector maintains similar performance characteristics.

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

• Sample Size for Test Set: The document mentions "Anthropomorphic phantom images were provided." It does not specify the exact number of phantom images or the number of distinct phantom cases used in the evaluation.
• Data Provenance: The nature of phantom images means the data is synthetic/simulated clinical data (using phantoms to mimic human anatomy) rather than human patient data. The country of origin for the data is not explicitly stated, but it would have been generated as part of the manufacturer's internal testing as advised by FDA guidance. The study is prospective in the sense that the evaluations were specifically conducted for this submission.

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

• Number of Experts: The document states that phantom images "were evaluated by professional radiologists." It does not specify the exact number of radiologists involved.
• Qualifications of Experts: They are described as "professional radiologists." Specific lengths of experience or subspecialties are not provided.

4. Adjudication Method for the Test Set

• The document implies a consensus or comparison approach: "They were evaluated by professional radiologists and found to be equivalent to the predicate devices. There is no significant difference in the average score of image quality evaluation between the proposed device and the predicate device." However, a specific adjudication method (e.g., 2+1, 3+1 decision rule) is not explicitly stated. It seems to be a comparative evaluation aiming for no significant performance degradation.

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. This submission focuses on hardware modification (new detector) to an existing device, not an AI-assisted diagnostic tool. Therefore, the concept of improving human readers with AI assistance is not applicable here.

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

• This is not an AI/algorithm-only device. The GM85 is an X-ray imaging system. The "standalone" performance here refers to the device's ability to produce images with acceptable quality on its own. Non-clinical data (MTF, DQE measurements) and phantom images contribute to demonstrating this standalone image performance. The evaluation by radiologists of the phantom images is more about confirming the quality of the "output" of the device in a clinical context, rather than evaluating an algorithm's diagnostic capability.

7. The Type of Ground Truth Used

• For the phantom image evaluation, the "ground truth" is established by the known characteristics of the anthropomorphic phantoms. The purpose of the radiologists' evaluation is to determine if the images produced by the new detector (compared to the predicate's detector) adequately represent these known phantom structures and maintain diagnostic quality. In essence, the ground truth is the known physical properties of the phantom, and the evaluation confirms the device's ability to render these properties accurately in images.

8. The Sample Size for the Training Set

• This submission describes a modification to an existing medical device's hardware (a detector), not an AI or machine learning algorithm. Therefore, there is no "training set" in the context of AI model development that would typically be described here. The device itself is "trained" or designed through engineering and validated through performance testing.

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

• As there is no AI training set as commonly understood in this context, the concept of establishing ground truth for a training set does not apply. The device's design and engineering would be based on established physics principles of X-ray imaging and medical imaging standards.

Ask a specific question about this device

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.

The GM85 Digital Mobile X-ray Imaging 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 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 send to the Picture Archiving & Communication System (PACS) sever for reading images.

The GM85 Digital Mobile X-ray imaging System was previously cleared with K181626, and through this premarket notification, we would like to add more configurations in the previously cleared GM85 as an optional collapsible column type with a manual collimator, a tube, four detectors, and exposure switches (two wired and one wireless types) are optionally added, and software including the Image Post-processing Engine (IPE) is changed in order to support new hardware and apply new software features.

The provided document is a 510(k) Premarket Notification for the Samsung GM85 Digital Mobile X-ray Imaging System. It describes the updated device and compares it to a legally marketed predicate device (K181626, also GM85). The document primarily focuses on demonstrating substantial equivalence rather than presenting detailed acceptance criteria and a comprehensive study for de novo device performance.

However, based on the information provided, here's an attempt to extract and synthesize what is available regarding acceptance criteria and the supporting study, focusing on the changes made to the device:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with numerical targets and corresponding device performance for the overall system in a typical format found in clinical studies. Instead, it describes differences and then asserts that these differences do not "contribute any adverse impact to the device's safety and effectiveness" or "do not impact safety and/or effectiveness."

The closest to acceptance criteria are the statements made about the new detectors and software features, aiming for equivalent or improved performance compared to the predicate device.

2. Sample Size for Test Set and Data Provenance

• Sample Size for Test Set: Not explicitly stated as a numerical sample size for "cases" in the traditional sense of a clinical study. The document mentions "Anthropomorphic phantom images were provided." The number of phantom images or specific phantom types isn't detailed. For software elements, "Software System Test Case for verification and validation" was performed, but no numerical count is given.
• Data Provenance: The study used "Anthropomorphic phantom images" and non-clinical data (MTF, DQE measurements, Software System Test Cases). This indicates testing in a controlled environment (laboratory/phantom studies). The country of origin for the data is not specified, but the manufacturer is based in the Republic of South Korea. The data is non-clinical/phantom-based, so it's not strictly "retrospective or prospective" in the human clinical trial sense.

3. Number of Experts and Qualifications for Ground Truth

• Number of Experts: "A professional radiologist" (singular)
• Qualifications of Experts: "professional radiologist" (no specific years of experience or subspecialty mentioned beyond being a radiologist).

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable or not specified. A single "professional radiologist" evaluated the phantom images, implying no consensus or multi-reader adjudication process as there was only one reviewer mentioned.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• MRMC Study: No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly stated or described. The evaluation involved a single radiologist reviewing phantom images.
• Effect Size: Not applicable, as no MRMC study was conducted.

6. Standalone (Algorithm only without human-in-the-loop performance) Study

• Standalone Study: Yes, performance data such as MTF and DQE measurements (IEC 62220-1) are inherent standalone technical performance metrics of the detectors. Software System Test Cases for verification and validation would also be considered standalone testing. The "anthropomorphic phantom images" evaluation by a single radiologist could be considered a form of standalone performance evaluation for the system's image quality output, as it assesses the device's generated images directly.

7. Type of Ground Truth Used

• Type of Ground Truth: The ground truth for the phantom image evaluation was implicitly the expected characteristics and quality of images of anthropomorphic phantoms, as assessed by a professional radiologist for equivalence to predicate devices. For technical metrics like MTF and DQE, the ground truth is against the measurement standards (IEC 62220-1). There was no pathology or outcomes data.

8. Sample Size for the Training Set

• Sample Size for Training Set: The document does not provide information regarding the sample size of a training set for any machine learning components. While the device includes an "Image Post-processing Engine (IPE)" and features like "SimGrid," if these involve learned algorithms, their training data is not discussed. This submission is for an X-ray system, and the focus is on hardware and general image processing functionality rather than an AI/CADe device where training data would typically be detailed.

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

• How Ground Truth for Training Set was Established: Not applicable or not provided, as training set details are absent.

Ask a specific question about this device

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 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 GM85 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 GM85 Digital Mobile X-ray imaging System is the equipment that captures 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 Bone Suppression Image (BSI) 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 BSI software option suppresses bone anatomy to enhance visualization of chest pathology in a companion image that is delivered in addition to the original diagnostic image.

The BSI option is designed to be exclusively installed in S-station, SAMSUNG digital Xray 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 text describes a 510(k) premarket notification for the GM85 Digital X-ray imaging System, specifically focusing on the integration of the Bone Suppression Image (BSI) feature. However, the document explicitly states that the application of BSI to the proposed device does not require clinical data and therefore, clinical studies to establish acceptance criteria or device performance are not detailed within this document.

The document primarily focuses on demonstrating substantial equivalence to predicate devices based on non-clinical data and technical characteristics, rather than presenting a performance study with acceptance criteria.

Therefore, many of the requested details about acceptance criteria and the study that proves the device meets them cannot be extracted from this particular submission.

Here's what can be inferred and what is explicitly stated as not applicable or not provided:

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

• Acceptance Criteria: Not explicitly stated in terms of clinical performance metrics (e.g., sensitivity, specificity, AUC). The acceptance criteria for this submission appear to be focused on substantial equivalence to predicate devices through technical comparisons and non-clinical testing.
• Reported Device Performance: No clinical performance metrics are reported because clinical data was deemed not required and thus not provided. The performance is assessed based on the device having the same detectors and therefore showing "no difference in non-clinical testing data such as MTF and DQE measurements from the predicate device #1 and #2."

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

• Sample Size: Not applicable/not provided. No clinical test set.
• Data Provenance: Not applicable/not provided. No clinical test data.

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

• Number of Experts: Not applicable/not provided. No clinical test set.
• Qualifications of Experts: Not applicable/not provided.

4. Adjudication method for the test set

• Adjudication method: Not applicable/not provided. No clinical test set.

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

• MRMC Study: No. The document explicitly states "The application of BSI... to the proposed device GM85 does not require clinical data." Therefore, an MRMC study was not performed for this submission.
• Effect Size: Not applicable/not provided.

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

• Standalone Performance: Not explicitly detailed as a performance study for the BSI feature itself. The BSI software option "provides companion images to assist diagnosis," implying it's an aid, not a standalone diagnostic tool without a human. However, its verification and validation were done through a "Software System Test Case" (non-clinical).

7. The type of ground truth used

• Type of Ground Truth: Not applicable for a clinical performance study. For the BSI software's non-clinical verification and validation, the ground truth would be against expected software output based on its design specifications, rather than clinical outcomes or expert consensus on patient data.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable/not provided. The document focuses on performance relative to predicate devices and non-clinical validation. Details regarding the training of the BSI algorithm itself are not included in this submission.

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

• Ground Truth for Training Set: Not applicable/not provided as training set details are not included.

Summary of what is provided regarding acceptance and study:

The acceptance for this 510(k) submission is based on demonstrating substantial equivalence to predicate devices. This is achieved through:

• Technical Characteristics Comparison: Showing that the proposed device (GM85 with BSI) is identical or equivalent to Predicate Device #1 (GM85 without BSI, K162278) in its core components (HVG, X-ray Tube Assembly, Detectors) and shares the BSI feature with Predicate Device #2 (GC70 with BSI, K163115).
• Safety, EMC, and Performance Data (Non-clinical):
  • Electrical, mechanical, environmental safety, and performance testing according to 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).
  • EMC testing according to IEC 60601-1-2.
  • Wireless function testing according to guidance on "Radio frequency Wireless Technology in Medical Devices."
  • All these tests "were satisfying the standards."
• Non-clinical Data for Imaging Performance:
  • Conformance to FDA "Guidance for the Submission of 510(k)'s for Solid-State X-ray Imaging Devices," including MTF and DQE measurements as tested by IEC 62220-1.
  • The proposed device uses the same detectors as the predicate devices, "so it shows no difference in non-clinical testing data such as MTF and DQE measurements from the predicate device #1 and #2."
• Software Verification and Validation: "BSI installed in S-Station of GM85 has been verified and validated through GM85 Software System Test Case." (This is a non-clinical, internal software validation).

Conclusion from the document: "The non-clinical demonstrates that the proposed device is as safe, as effective, and performs as well as the legally marketed predicate devices."

The critical point for this document is that the FDA determined, and the submission reflects, that for the integration of the already cleared BSI software into the GM85 mobile X-ray system, no new clinical data was required to demonstrate substantial equivalence.

Ask a specific question about this device