(92 days)
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 SimGrid is a technology that enhances the visibility of major clinical equipment by compensating for the decrease in contrast that is caused by scatter radiation of all kinds of anatomical regions.
The Tube & Line Enhancement enhances the visibility of tube and line to support radiologists or ICU clinicians who may need to find tubes and line on chest radiographs by trained professionals, such as physician, radiologists, and technicians.
The Pediatric Exposure Management support radiologists to select suitable patient's size or take steps to serve an optimal exposure conditions to the lowest possible levels especially for the pediatric patients.
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 SimGrid is an additional image processing software option which is able to compensate the contrast loss due to scatter radiations, primarily acquisitions without a physical anti-scatter grid of all kinds of anatomical regions.
The SimGrid is available as options to be exclusively installed in S-station, which is a Samsung Digital X-ray operation S/W, while this post-image processing software does not depend on how the image is acquired, or with what acquisition device.
The Tube & Line Enhancement (TLE) is that after generating a normal post processing image, pressing the TLE button will create a companion view. For making a better tube & line look in chest radiography, input raw image is processed by using stronger contrast and detail enhancement algorithm. This supports clearer visibility of tube & lines than normal post processing image.
TLE is available as options to be exclusively installed in S-station, which is a Samsung Digital X-ray operation S/W, while this post-image processing software does not depend on how the image is acquired, or with what acquisition device.
The Pediatric Exposure Management provides subdivided patient size and exposure conditions of chest and abdomen radiographs specially optimized for pediatric patients. It helps an optimal dose for radiographic procedures of pediatric patients by providing guidance of optimized exposure conditions according to patient's weight and procedures.
The provided text describes the safety and effectiveness information for the Samsung GM85 Digital X-ray imaging System, including its optional features SimGrid and Tube & Line Enhancement (TLE).
1. Table of acceptance criteria and the reported device performance:
The document does not explicitly state pre-defined acceptance criteria with numerical thresholds. Instead, the "acceptance" is implicitly based on demonstrating substantial equivalence to predicate devices through a combination of non-clinical and clinical data, as required by FDA 510(k) submission guidelines. The performance is reported in terms of comparative benefits over baseline or predicate devices.
| Feature | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| GM85 System | Safe, effective, and performs as well as legally marketed predicate devices #1 (GM60A) and #2 (GC85A) regarding image characteristics, gantry movement, and overall radiographic image acquisition. | - Has same detectors and image processing as predicate devices, showing no significant changes in image characteristics compared to GM60A and GC85A. |
- Gantry (Newly designed for enhanced coverage and usability) has same structures (battery powered, wheel-based, built-in console, rotational collapsible column, extractable arm, rotational tube head) as predicate GM60A, thus no significant changes in acquiring radiographic images.
- Extended coverage of GM85's moving range is more helpful for positioning than GM60A.
- Tube target angle of 14° does not have significant changes in image characteristics compared to GM60A's 12°-16°.
- Collimator has same design as predicate GC85A but with mechanical changes to mount sub-display unit, no significant changes in performance.
- S-Align has same design but operates only manually (compared to GC85A), with no adverse impacts on safety/performance.
- Conclusion: "The non-clinical and clinical data demonstrate that the proposed device is as safe, as effective, and performs as well as the legally marketed predicate devices #1, #2 and #3." |
| SimGrid Software| Demonstrates better local contrast than images acquired without a physical anti-scatter grid, extending to additional anatomical regions as compared to the predicate device's description. | - Evaluated with various phantoms at various exposure conditions. - Demonstrates that SimGrid processing gives better local contrast than images acquired without a grid at expanded anatomical regions. (Previously 510(k) cleared with predicate device #2). |
| Tube & Line Enhancement (TLE) Software| Enhances the visibility of tubes and lines on chest radiographs to support radiologists or ICU clinicians, functioning as an assistant tool without being a substitute for the original image. Performance should be comparable or superior to the predicate device ClearRead +Confirm (K123526) in enhancing tube and line visibility. It should also be applicable to all patients, including pediatric patients, without compromise. | - "After generating a normal post processing image, pressing the TLE button will create a companion view." - Uses stronger contrast and detail enhancement algorithm for clearer visibility of tubes & lines than normal post processing image.
- Evaluated with a chest phantom (with an inserted tube line). Comparison between normal post image and TLE image proved TLE processing gives better tube and line visibility than original post processing.
- The intended use specifies it "generates a companion image which can provide clear visibility of tubes and lines in addition to the original chest radiograph."
- "TLE software amplify specific frequencies suitable for tubes and lines partially, it does not depend on the size of patients. Therefore TLE software can be used for all patients including the pediatric patient."
- No significant changes in performance compared to predicate device #3. |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: "Evaluated 30 case of phantom image includes eight parts of the body."
- Data Provenance: Not explicitly stated, but given it's a 510(k) submission from SAMSUNG ELECTRONICS Co., Ltd. (Republic of Korea), it's highly likely the testing was conducted in Korea, or by a contract research organization. The study used non-clinical phantom images, not human patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: "Evaluated by a professional radiologist." (Implies one professional radiologist was used).
- Qualifications: "professional radiologist." No further details on years of experience or sub-specialty are provided.
4. Adjudication method for the test set:
- The document states the phantom images were "evaluated by a professional radiologist." There is no mention of an adjudication method (like 2+1 or 3+1) or multiple readers.
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 study mentioned. The clinical data section only refers to phantom image evaluations reviewed by one radiologist for equivalence. The TLE and SimGrid features are described as enhancing images or providing better contrast/visibility, but without a formal MRMC study to quantify human reader improvement.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, in essence. The evaluations for SimGrid and TLE were primarily focused on the algorithm's output performance (e.g., "better local contrast," "better tube and line visibility") when applied to phantom images. While a radiologist reviewed the outputs, the assessment was about the visual quality of the processed image rather than a diagnostic performance study of the radiologist using the device. The GM85 system itself, including its basic image acquisition and processing, also undergoes standalone performance testing (e.g., MTF, DQE).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the phantom images, the "ground truth" is based on the known physical properties of the phantom and the expert assessment of image quality (e.g., contrast, visibility of structures) by a professional radiologist. This is a form of expert assessment of image features rather than a clinical ground truth like pathology or patient outcomes.
8. The sample size for the training set:
- The document does not specify the sample size for the training set for any of the software features (SimGrid, TLE, PEM). It implies that SimGrid was cleared previously, and TLE/PEM are new additions with their own evaluations.
9. How the ground truth for the training set was established:
- The document does not provide details on how ground truth was established for the training sets of SimGrid, TLE, or PEM. It generally states that SimGrid was previously cleared and TLE/PEM are based on algorithms designed for specific enhancements. For TLE, it mentions "input raw image is processed by using stronger contrast and detail enhancement algorithm," suggesting expert knowledge of what constitutes "better contrast" for tubes and lines likely informed the algorithm's development.
§ 892.1720 Mobile x-ray system.
(a)
Identification. A mobile x-ray system is a transportable device system intended to be used to generate and control x-ray for diagnostic procedures. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.