(48 days)
The UNIEXPERT 2 PLUS is a stationary general-purpose radiographic imaging system indicated for use in acquiring diagnostic X-Ray images of osseous structures and soft tissues of the human body to aid physicians with patient diagnosis. The system has analogue, computed radiography (CR) as well as digital radiography (DR) imaging capabilities. The UNIEXPERT 2 PLUS is not indicated for use in mammography.
The UNIEXPERT 2 PLUS is a diagnostic X-Ray system intended for radiographic imaging of osseous structures and soft tissues of the human body. The system may be used for analogue film imaging as well as digital image acquisition.
The UNIEXPERT 2 PLUS is comprised of an X-Ray generator with user interface, X-Ray tube, beam limiting device, vertical column tube stand, radiographic table, vertical wall stand, digital X-Ray image detector.
The provided text describes a 510(k) premarket notification for the Adani UNIEXPERT 2 PLUS, a stationary general-purpose radiographic imaging system. The submission aims to demonstrate substantial equivalence to a predicate device, the Q-Rad Radiographic System (K011486).
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of quantitative acceptance criteria alongside specific device performance metrics for the UNIEXPERT 2 PLUS. Instead, it states that:
| Acceptance Criteria Category | Description of Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Functional & Mechanical | All mechanical and electrical functions as intended. | "Results confirmed all performance criteria were met satisfactorily and fell within predetermined acceptance criteria." |
| Imaging Performance | Appropriate image quality and capabilities for diagnostic X-Ray images of osseous structures and soft tissues. | "Sample clinical images covering a range of anatomical areas were provided to demonstrate the overall imaging capabilities of the device." "Results confirmed all performance criteria were met satisfactorily and fell within predetermined acceptance criteria." |
| Safety | Compliance with relevant safety standards (IEC 60601-1-2:2014, IEC 60601-1:2012, IEC 60601-1-3:2013, IEC 60601-1-6:2013, IEC 6234:2006, IEC 60601-2-54:2015). | "System performance testing including functional testing of all mechanical and electrical functions, imaging performance, safety and EMC testing of the UNIEXPERT 2 PLUS system was conducted in accordance with [listed IEC standards]." "The output of the verification and validation process confirmed functionality and safety to be within acceptable limits." |
| EMC Testing | Compliance with Electromagnetic Compatibility standards. | "System performance testing including functional testing of all mechanical and electrical functions, imaging performance, safety and EMC testing of the UNIEXPERT 2 PLUS system was conducted in accordance with IEC 60601-1-2:2014." |
| Software Functionality | StudyWorks Software Complex enables operation, controls components, manages image acquisition, and communicates via DICOM effectively. | "Software/Firmware verification and validation, as well as acceptance testing were conducted to verify that all features of the StudyWorks Software Complex functioned as intended and that results fell within pre-determined acceptance criteria." |
| Risk Analysis | Identification of hazards, mitigation of risks, and evaluation of acceptance criteria for residual risks. | "Risk analysis was performed on the entire system." "Risk analysis was performed to identify potential hazards, mitigate risks and evaluate acceptance criteria for residual risks." "The level of concern for this software has been determined to be 'moderate'." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document mentions "Sample clinical images covering a range of anatomical areas were provided to demonstrate the overall imaging capabilities of the device." However, it does not specify the sample size (number of images or patients) used for this clinical image evaluation.
- Data Provenance: The document does not explicitly state the country of origin for the clinical images used for testing. It also does not specify whether the data was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document mentions that "Sample clinical images covering a range of anatomical areas were provided to demonstrate the overall imaging capabilities of the device." However, it does not specify the number of experts used, nor their qualifications, for establishing ground truth for these clinical images.
4. Adjudication Method for the Test Set
The document does not describe any adjudication method used for establishing ground truth for the test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance was not done. This submission is for an imaging system, not an AI-powered diagnostic aid. The purpose is to demonstrate substantial equivalence to a predicate X-ray system, not to prove clinical effectiveness or improvement over human readers.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
N/A. This device is a radiographic imaging system, which is intended for human operation and interpretation. It is not an AI algorithm that would operate in a standalone manner without human involvement. The "software" (StudyWorks Software Complex) mentioned performs operational control and image management, not autonomous diagnostic analysis.
7. The Type of Ground Truth Used
Based on the context of an imaging system intended for acquiring diagnostic X-ray images, the "ground truth" for evaluating image quality and diagnostic capability would implicitly be based on expert interpretation of the acquired images to confirm they allow for accurate diagnosis as intended (e.g., clear visualization of osseous structures and soft tissues). However, the document does not explicitly detail how this "ground truth" was established or what specific modalities (e.g., pathology, outcomes) were used to confirm it for the provided clinical images.
8. The Sample Size for the Training Set
The document does not mention a training set sample size. This is expected as the UNIEXPERT 2 PLUS is a general X-ray imaging system, not an AI-powered diagnostic algorithm that typically undergoes machine learning training. Its performance is evaluated based on its ability to produce diagnostic quality images, not on its ability to learn from a dataset to perform a specific task.
9. How the Ground Truth for the Training Set Was Established
Since there is no mention of a training set, the document does not describe how ground truth for a training set was established.
§ 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.