(140 days)
INNOVISION-DXII is a stationery X-ray system intended for obtaining radiographic images of various anatomical parts of the human body, both pediatrics and adults, in a clinical environment. INNOVISION-DXII is not intended for mammography, angiography, interventional, or fluoroscopy use.
INNOVISION-DXII is a stationary X-ray system using single and three phase power and consists of Tube, HVG(High voltage generator), Ceiling suspended X-ray tube support, Floor to Ceiling X-ray tube support, patient table, detector stand, and X-ray control console. The X-ray control console is a window-based software that can view X-ray images and a mobile console mounted on an Android-based board that only controls X-rays without viewer function.
After turning on the control unit, it irradiates the set X-ray on the exposure position properly generating X-ray in the inverter generator using IGBT. The compositions like supporters for X-ray tube and tables are used to supply power from the High Voltage generator. When inverter type of Generator creates X-ray irradiation by certain exposure conditions, and X-ray penetrates the patient's body. X-ray information is transferred to a visible ray by a sensor's scintillator, and it turns to an electric signal through A-Si after transmitting photodiode to a TFT Array. This X-ray system is used with FDA cleared X-ray detectors. The electric signal is magnified and turned into a digital signal to create image data. The image is transferred to the PC display by an Ethernet Interface, and it can be adjusted.
The FDA 510(k) clearance letter for INNOVISION-DXII explicitly states that clinical testing was not performed for this device. Therefore, there is no study described within this document that proves the device meets acceptance criteria related to clinical performance or human reader studies.
The provided document focuses on non-clinical performance tests to demonstrate substantial equivalence to the predicate device.
Here's an analysis based on the information provided, outlining what is and isn't available regarding acceptance criteria and studies:
Acceptance Criteria and Device Performance (Non-Clinical)
The acceptance criteria for the INNOVISION-DXII are implicitly the successful completion of the bench tests according to recognized international standards and demonstration that the differences from the predicate device do not raise new safety or effectiveness concerns. The "reported device performance" is the successful passing of these tests, indicating the device is safe and effective in its essential functions.
Table 1: Acceptance Criteria and Reported Device Performance (Non-Clinical Bench Testing)
| Test Category | Specific Test | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|---|
| X-ray Tube, Collimator, HVG | Tube Voltage accuracy | Meet specified accuracy standards (e.g., within a tolerance) | Passed |
| Accuracy of X-RAY TUBE CURRENT | Meet specified accuracy standards | Passed | |
| Reproducibility of the RADIATION output | Meet specified reproducibility standards | Passed | |
| Linearity and constancy in RADIOGRAPHY | Meet specified linearity and constancy standards | Passed | |
| Half Value Layer (HVL) / Total filtration | Meet specified HVL/filtration standards | Passed | |
| Accuracy of Loading Time | Meet specified loading time accuracy | Passed | |
| Detector | System Instability | No unacceptable system instability observed | Passed |
| Installation error | No unacceptable installation errors | Passed | |
| System Error | No unacceptable system errors | Passed | |
| Image Loss, Deletion, and Restoration | Proper handling of image loss, deletion, and restoration | Passed | |
| Image Save Error | No unacceptable image save errors | Passed | |
| Image Information Error | No unacceptable image information errors | Passed | |
| Image Transmission and Reception | Reliable image transmission and reception | Passed | |
| Header Verification | Correct header verification | Passed | |
| Security | Meet specified security requirements | Passed | |
| Image Acquisition Test | Successful image acquisition | Passed | |
| Search Function | Functional search capability | Passed | |
| Application Function (ELUI S/W) | Functional application software | Passed | |
| Resolution | Meet specified resolution standards | Passed | |
| Mechanical Components (Support, Table) | Moving distance | Accurate and controlled movement within specifications | Passed |
Study Details for Demonstrating Substantial Equivalence (Non-Clinical)
The study described is a series of bench tests (functional tests) conducted to ensure the safety and essential performance effectiveness of the INNOVISION-DXII X-ray system.
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Sample size used for the test set and data provenance:
- Sample Size: Not applicable. These are functional tests of the device itself rather than tests on a dataset. The "sample" refers to the physical device components and the system as a whole.
- Data Provenance: Not applicable in the context of image data. The tests are performed on the device in a laboratory setting. The standards referenced are international (IEC).
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Number of experts used to establish the ground truth for the test set and qualifications of those experts:
- Not applicable. Ground truth in this context refers to the expected functional performance of the device according to engineering specifications and regulatory standards (IEC 60601 series). These standards define the "ground truth" for electrical safety, mechanical performance, and radiation emission/accuracy. Experts are involved in conducting and interpreting these standardized tests, but there isn't a "ground truth" established by a panel of medical experts as there would be for image interpretation.
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Adjudication method for the test set:
- Not applicable. The tests are typically pass/fail based on objective measurements against predefined thresholds specified in the IEC standards. There is no subjective adjudication process mentioned.
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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, an MRMC comparative effectiveness study was explicitly NOT done. The document states: "Clinical testing is not performed for the subject device as the detectors were already 510(k) cleared and the imaging software (Elui) is the same as the predicate device. There were no significant changes." This device is a stationary X-ray system, not an AI-assisted diagnostic tool for image interpretation.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No, a standalone algorithm performance study was not done. This device is an X-ray imaging system; it does not feature a standalone diagnostic algorithm. While it includes an imaging software (Elui), its performance is assessed as part of the overall system's image acquisition and processing capabilities, not as an independent diagnostic algorithm.
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The type of ground truth used:
- For the non-clinical bench tests, the "ground truth" is defined by the engineering specifications and the requirements of the referenced international standards (IEC 60601-1-3, IEC 60601-2-28, IEC 60601-2-54). These standards specify acceptable ranges for parameters like tube voltage accuracy, radiation output linearity, image resolution, and system stability.
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The sample size for the training set:
- Not applicable. This device is an X-ray system, not a machine learning algorithm that requires a training set of data.
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How the ground truth for the training set was established:
- Not applicable, as there is no training set for this device.
Summary of Clinical/AI-related information:
The FDA 510(k) clearance for INNOVISION-DXII does not include any clinical studies or evaluations of AI performance, human reader performance, or diagnostic accuracy. The clearance is based purely on the non-clinical bench testing demonstrating that the device meets safety and essential performance standards and is substantially equivalent to its predicate device for obtaining radiographic images.
§ 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.