(107 days)
The XGEO GU60A 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 XGEO GU60A digital X-ray imaging system is to be used to take and store image for diagnosis of patients. It consists of the High voltage generator (HVG), U-arm positioner, Detector, X-ray tube, Collimator and etc.
The provided text does not contain detailed information about the acceptance criteria or a study that proves the device meets specific performance criteria beyond general safety and effectiveness.
Here's an analysis of what is and isn't present in the document based on your request:
1. A table of acceptance criteria and the reported device performance
- The document states that "Non-clinical testing and Clinical Testing were conducted in accordance with Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices" and that "All test results are satisfied."
- It also mentions differences from the predicate device in "pixel pitch, high contrast limiting resolution, DQE, MTF and communication," noting that the proposed device has higher DQE and MTF values. These are performance metrics, but no specific acceptance criteria or quantitative performance results are provided in a table.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- This information is not provided in the document.
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)
- This information is not provided in the document.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- This information is not provided in the document.
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
- The text describes a digital X-ray imaging system, not an AI-assisted diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable and not mentioned.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- As the device is an X-ray imaging system and not an algorithm for diagnosis, standalone algorithm performance is not applicable and not mentioned. The device produces images for a qualified/trained doctor or technician to interpret.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- This information is not provided in the document.
8. The sample size for the training set
- This information is not provided in the document. The device is a hardware imaging system, not a machine learning algorithm that requires a training set in the typical sense.
9. How the ground truth for the training set was established
- This information is not provided as it's not an AI/ML device in the context of requiring ground truth for a training set.
Summary of available information related to acceptance criteria and device performance:
The document primarily focuses on demonstrating substantial equivalence to a predicate device (XGEO GU60A, K123106) by highlighting that observed differences in technical specifications (pixel pitch, high contrast limiting resolution, DQE, MTF, communication) do not negatively impact safety or effectiveness.
-
Acceptance Criteria (Implicit/General):
- Compliance with various electrical, mechanical, environmental safety, and performance standards (ES 60601-1:2012, IEC 60601-1-3:2008, IEC 60601-2-28:2010, IEC 60601-2-54:2009, 21CFR1020.30, 21CFR1020.31, IEC 60601-1-2:2007).
- Compliance with "Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices" for non-clinical and clinical testing.
- No new potential safety risks compared to the predicate device.
- Performance "as well as" the predicate device despite differences in certain technical specifications.
- The proposed device has "higher DQE value" and "higher MTF value" compared to the predicate, implying improvement in image quality.
-
Reported Device Performance:
- "All test results are satisfied" (in reference to the listed standards and guidance documents).
- The device has a different (likely smaller, leading to higher resolution) pixel pitch.
- Higher high contrast limiting resolution (due to pixel pitch).
- Higher DQE value (affects image quality).
- Higher MTF value (affects image quality).
- Supports both wired and wireless communication (predicate only wired).
No specific quantitative acceptance criteria or detailed results of performance studies are presented in this 510(k) summary beyond the general statement that all tests were satisfied and the device performs at least as well as the predicate, with some technical improvements.
§ 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.