(29 days)
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 GU60A, GU60A-65 digital X-ray imaging systems are a stationary x-ray system designed for general radiography and 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 Postprocessing Engine (IPE) which is exclusively installed in S-station, and sent to the Picture Archiving, Communication System (PACS) sever for reading images.
The GU60A, GU60A-65 digital X-ray imaging systems consist of HVG (High Voltage Generator), U-arm positioner, X-ray tube, collimator, detector, ACE (Auto Exposure Control), DAP (Dose Area Product), CIB (Control Interface Box), remote controller, grid, barcode scanner, auto-stitching stand, weight distribution cap and workstation for Sstation including Image Post-processing Engine (IPE).
The difference between GU60A and GU60A-65 is that the option of their HVG is different. In detail, 50 kW and 68 kW are for GU60A and 65 KW is for GU60A-65.
The GU60A, GU60A-65 digital X-ray imaging systems were previously cleared under K180543, and some hardware options and three software features are added to the predicate device GU60A, GU60A-65. The changes are as follows:
- Two detectors
- Software features called as S-Enhance, PEM (Pediatric Exposure Management) and Remote View
- The S-Enhance is optional software to improve clarity of a foreign body (e.g. tube, line) and stone in chest, abdomen and L-spine images. With a single onscreen click, the companion image is created without additional settings or xray exposure, streamlining the process.
- Pediatric Exposure Management is subdivided patient size and exposure conditions especially for pediatric patients based on weight and protocols. It follows same methodologies to define preset of patient size compare to preset of standard patient size from predicate device but specially optimized for pediatric patients.
- The Remote view function provided images on another PC, not just on the device.
The provided text describes a 510(k) premarket notification for the GU60A and GU60A-65 Digital X-ray Imaging Systems. It details the device, its intended use, and comparisons to predicate devices. However, the document does not contain any information about acceptance criteria or a study proving the device meets specific acceptance criteria based on performance metrics like accuracy, sensitivity, or specificity for a particular clinical task.
The document states:
- "Non-clinical data demonstrates that the proposed devices are as safe, as effective, and perform as well as the legally marketed predicate devices."
- "The application of detectors and software features, cleared with K181629, to the proposed device GU60A, GU60A-65 does not require clinical data."
- "The verification and validation for the software features added to the proposed device were also conducted and reviewed in accordance with internal design change procedure. As a result, requirement specifications were met and the proposed device shows no difference in non-clinical testing data such as MTF and DQE measurements from the predicate device."
This implies that the acceptance was primarily based on:
- Substantial equivalence to predicate devices: The new features (S-Enhance, PEM, Remote View, and new detectors) were already cleared with previous predicate devices (K180543 and K181629).
- Compliance with non-clinical performance and safety standards: Electrical, mechanical, environmental safety, EMC, and X-ray specific performance (MTF, DQE measurements) were conducted according to relevant IEC and FDA standards (e.g., ES 60601-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-2-28, IEC 60601-2-54, ISO14971, 21CFR1020.30, 21CFR1020.31).
- Software verification and validation: Conducted according to internal design change procedures.
Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets clinical performance acceptance criteria because the provided text explicitly states that clinical data was not required for this 510(k) submission.
The document focuses on demonstrating substantial equivalence to pre-existing, cleared devices and adherence to engineering and non-clinical performance standards for X-ray imaging systems. It does not describe a study involving an AI component with specific performance metrics (like accuracy for a diagnostic task) and associated acceptance criteria that would typically involve human-in-the-loop studies, multi-reader multi-case studies, or expert ground truth adjudication.
If the question is implicitly asking about the "acceptance criteria" and "study" in the context of the entire X-ray system meeting regulatory clearance, then the answer is based on "substantial equivalence" and compliance with non-clinical performance and safety standards, as detailed in the document, rather than a clinical performance study for a specific diagnostic AI feature.
Based solely on the provided text, and understanding that it does not describe a clinical performance study for an AI component's diagnostic accuracy:
I cannot populate the requested table and answer many of the specific questions because the document does not contain the necessary information about a clinical performance study or diagnostic AI acceptance criteria. The submission is for a general radiographic imaging system and an enhancement software (S-Enhance) for clarity of foreign bodies/stones, but without specifying diagnostic performance metrics or a study to prove them.
Here's what can be inferred or stated based on the text's lack of this information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Diagnostic Performance) | Reported Device Performance (Diagnostic Performance) |
|---|---|
| Not specified in the document | Not specified in the document |
| (No clinical performance acceptance criteria or results are provided) | (The document states "does not require clinical data" for the changes) |
The document's acceptance criteria related to safety and general performance are:
- Compliance with electrical, mechanical, environmental safety standards (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).
- Compliance with EMC testing (IEC 60601-1-2).
- Compliance with wireless function guidance.
- Conformity to FDA "Guidance for the Submission of 510(k)'s for Solid-State X-ray Imaging Devices" for non-clinical data (MTF and DQE measurements).
- Software verification and validation meeting "requirement specifications" in accordance with internal design change procedure.
The reported device performance in these areas is that "All test results were satisfying the standards" and "requirement specifications were met and the proposed device shows no difference in non-clinical testing data such as MTF and DQE measurements from the predicate device."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not applicable/Not specified, as no clinical test set for diagnostic performance was described. The non-clinical performance data (MTF, DQE) would use physical phantoms or test objects, not patient data in the typical sense of a test set for AI.
- Data Provenance: Not applicable/Not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable/Not specified, as no clinical test set or ground truth establishment process for diagnostic performance was described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not specified, as no clinical test set or adjudication process was described.
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
- Was an MRMC study done? No. The document states "The application of detectors and software features... does not require clinical data."
- Effect size: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable/Not specified, as no standalone diagnostic performance study for an AI algorithm was described. The S-Enhance is described as "optional software to improve clarity," which suggests image processing, not a standalone diagnostic AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable/Not specified, as no clinical ground truth for diagnostic performance was described. For non-clinical validation (MTF, DQE), the "ground truth" would be the known physical properties of the test phantoms.
8. The sample size for the training set
- Not applicable/Not specified, as no information about an AI training set is provided.
9. How the ground truth for the training set was established
- Not applicable/Not specified, as no information about an AI training set or its ground truth establishment is provided.
§ 892.1680 Stationary x-ray system.
(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.