(108 days)
The XGEO GF50 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.
This system is 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 device being sent to the XGEO 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 XGEO GF50 is intended to be used for capturing digital X-ray images of various parts of the body including the head, chest, spine, abdomen, joints, hands, feet and other organs.
The XGEO GF50 is a Digital X-ray Imaging System.
Here's an analysis of its acceptance criteria and the study that proves its performance:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document describes the XGEO GF50 as being "Substantially Equivalent" to a predicate device (XGEO GC80) rather than setting specific numeric acceptance criteria for diagnostic performance. Therefore, the "acceptance criteria" here refer to the demonstration of substantial equivalence.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Imaging Performance Equivalence | Images provide equivalent diagnostic capability to predicate device. |
| Non-clinical: Resolution (MTF) | Proposed detector performs better than predicate. |
| Non-clinical: Detective Quantum Efficiency (DQE) | Proposed device has better DQE performance. |
| Safety and Effectiveness | All test results for electrical, mechanical, environmental, EMC, and wireless function were satisfied; device is safe and effective. |
| Intended Use Equivalence | Same as predicate device (generating radiographic images, not mammographic). |
| Technological Characteristics Equivalence | No significant change in materials, energy source, or technological characteristics compared to predicate device. Differences explained and deemed equivalent. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. The clinical study is referred to as a "concurrence study" but does not detail the number of images or patients used.
- Data Provenance: Not explicitly stated regarding country of origin or specific institutions. It is a "clinical data" study. The document refers to "radiologists in the study" evaluating images of the XGEO GF50 against the predicate device. It is a prospective evaluation comparing the new device's images to a known, established device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not explicitly stated. The document mentions "qualified radiologists" without specifying their number.
- Qualifications of Experts: "Qualified radiologists." Specific experience (e.g., "10 years of experience") is not provided.
4. Adjudication Method for the Test Set
- Adjudication Method: Not explicitly stated. The term "concurrence study" suggests that the radiologists evaluated the images to confirm they were diagnostically equivalent, likely reaching a consensus or agreement among themselves. However, the specific method (e.g., 2+1, 3+1, none) is not detailed.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
- MRMC Study: The document describes a "concurrence study" where "qualified radiologists" evaluated images for "equivalent diagnostic capability." This implies a comparison against the predicate device, which is a form of comparative effectiveness. However, it's not explicitly labeled as a formal MRMC study, nor does it provide details on the statistical methodology (e.g., comparing reader performance with/without AI assistance, as the device itself is an X-ray system, not primarily an AI diagnostic tool in this context).
- Effect Size: Not applicable/not provided. This device is a digital X-ray system, not an AI-powered diagnostic tool intended to assist or replace human readers. The study aims to show equivalence of the image quality and diagnostic capability produced by the new X-ray system compared to an existing one. Therefore, "how much human readers improve with AI vs. without AI assistance" is not a relevant metric for this type of device.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Standalone Performance: Not applicable. The XGEO GF50 is a digital X-ray system that produces images for human interpretation, not an algorithm that provides a standalone diagnostic output. The "performance" being evaluated is the diagnostic quality of the images produced by the system. Non-clinical data (MTF, DQE) does provide a form of "standalone" (system-only) technical performance metrics.
7. The Type of Ground Truth Used
- Type of Ground Truth: The clinical study relies on expert consensus/radiologist interpretation for the diagnostic capability of the images. The radiologists "evaluate the image of XGEO GF50 is substantially equivalent to predicate device." This means their clinical assessment of the images from the new device, likely compared to images from the predicate device (or possibly compared to a reference standard diagnosis if provided, though not explicitly stated), formed the "clinical ground truth" for equivalence.
8. The Sample Size for the Training Set
- Sample Size: Not applicable. As an X-ray imaging system, the device does not employ a "training set" in the context of machine learning algorithms for diagnostic output. The system is designed to acquire images, and its performance is evaluated based on the quality of those images as assessed by human experts, and technical specifications.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth Establishment: Not applicable, as there is no "training set" for a diagnostic algorithm in this context. The "ground truth" for the device's technical specifications and image quality is established through engineering standards, non-clinical tests (MTF, DQE), and clinical evaluation by radiologists on test 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.