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 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