Search Results

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