Search Results

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

The GR40CW digital X-ray imaging system consists of Detector, Power supply box, Battery pack, Battery charger, Access point, CIB(Control Interface Box), Workstation, Barcode scanner, Main cable and software for image acquisition and image processing and does not include the X-ray generator. This system is used to capture images by transmitting X-ray to a patient's body. The X-ray passing through a patient's body is sent to the detector and then converted into electrical signals. These signals go through the process of amplification and digital data conversion in the signal process device before being sent to the S-Station (Operation Software) and saved in DICOM file, a standard for medical imaging. The captured images are sent to the Picture Archiving & Communication System (PACS) server, and can be used for reading images. The GR40CW digital X-ray imaging system was previously cleared with K180543, and through this premarket notification, we would like to add more configurations in the previously cleared GR40CW as three detectors are newly added, and some software features called as SimGrid, S-Enhance, BSI (Bone Suppression Image), Remote View and manual Stitching are newly added as stated below. SimGrid software option, cleared with K171119. is able to compensate the contrast loss due to scatter radiations, primarily acquisitions without a physical anti-scatter grid. BSI software option suppresses bone anatomy and S-Enhance is renamed from Tube & Line Enhancement (TLE), which was cleared before with the predicate device GM85 at K171119, to enhance visibility of tubes and lines and provide enhanced images separately from original images. In this submission, the scope of S-Enhance is expanded from tubes and lines on chest images to foreign body (e.g. tubes, lines and needles) and urinary stones on chest, abdomen, and L-spine. And Manual Stitching to capture a body part that is larger than the detector's by capturing multiple images and Remote View function to remote access to view the current image on the workstation through a web browser. It was determined that the level of concern for the software contained in the GR40CW digital X-ray imaging system was Moderate in accordance with the FDA guidance for the Content of Premarket Submissions for Software Contained in Medical Device".

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

1. Table of Acceptance Criteria and Reported Device Performance

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

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

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

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

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

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

4. Adjudication Method for the Test Set

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

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

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

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

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

7. The Type of Ground Truth Used

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

8. The Sample Size for the Training Set

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

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

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

Ask a specific question about this device

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

The GR40CW digital X-ray imaging system consists of Detector, Power supply box, Battery pack, Battery charger, Access point, CIB(Control Interface Box), Workstation, Barcode scanner and Main cable. This system is used to capture images by transmitting X-ray to a patient's body. The X-ray passing through a patient's body is sent to the detector and then converted into electrical signals. These signals go through the process of amplification and digital data conversion in the signal process device being sent to the S-Station (Operation Software) and saved in DICOM file, a standard for medical imaging. The captured images are sent to the Picture Archiving & Communication System (PACS) server, and can be used for reading images.

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

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

1. Table of Acceptance Criteria and Reported Device Performance

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

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

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

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

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

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

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

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No MRMC comparative effectiveness study was done. The device GR40CW is described as a "Digital X-ray Imaging System" and a "retrofit kit" that generates digital images. It is not an AI-powered diagnostic tool, but rather a digital detector replacing analog film systems. Therefore, the question of human reader improvement with AI assistance is not applicable to this device.

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

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

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

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

8. The sample size for the training set

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

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

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

Ask a specific question about this device

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

The GR40CW digital X-ray imaging system consists of Detector, Power supply box, Battery pack, Battery charger, Access point, CIB(Control Interface Box), Workstation, Barcode scanner and Main cable. This system is used to capture images by transmitting X-ray to a patient's body.

The X-ray passing through a patient's body is sent to the detector and then converted into electrical signals. These signals go through the process of amplification and digital data conversion in the signal process device before being sent to the S-Station (Operation Software) and saved in DICOM file, a standard for medical imaging. The captured images are sent to the Picture Archiving & Communication System (PACS) server, and can be used for reading images.

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

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

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

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

1. Table of Acceptance Criteria and Reported Device Performance

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

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

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

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

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

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

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

4. Adjudication Method for the Test Set

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

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

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

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

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

7. The Type of Ground Truth Used

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

8. The Sample Size for the Training Set

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

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

Not applicable.

Ask a specific question about this device