(86 days)
The XEPHILIO MC-1100 mobile fluoroscopy system is designed to provide fluoroscopic and spot-film radiographic images of the patient during diagnostic, surgical and interventional procedures. Examples of clinical application may include cholangiography, endoscopy, urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures. The system may be used for other imaging applications at the physician's discretion.
The XEPHILIO MC-1100 mobile fluoroscopy system consists of two mobile units: a Mainframe (C-Arm) and a Workstation. The Mainframe (C-Arm) is comprised of a high voltage generator, x-ray control, and a "C" shaped apparatus, which supports an X-ray tube and a flat panel detector [Canon CSX-10]. The Mainframe is designed to perform linear and rotational motions that allow the user to position the x-ray imaging components at various angles and distances with respect to the patient. The Mainframe can be used to acquire both still and moving images. The Workstation is a mobile platform that supports image display monitors and image processing. Interfaces are provided for optional peripherals such as recording and printing devices.
The provided document, K121303, a 510(k) summary for the XEPHILIO MC-1100 mobile fluoroscopy system, primarily focuses on demonstrating substantial equivalence to predicate devices through comparisons of technological characteristics, non-clinical test data, and compliance with safety standards. It does not contain detailed information about specific acceptance criteria, a study proving those criteria, or the specific performance metrics typically associated with AI/algorithm-based medical devices.
Therefore, many of the requested sections about acceptance criteria, detailed study design, ground truth establishment, expert involvement, and AI performance metrics cannot be directly extracted from this document.
Here's the information that can be extracted or inferred:
1. Table of Acceptance Criteria and Reported Device Performance:
Based on the provided text, specific quantitative acceptance criteria and their corresponding reported device performance values in a comparative study are not detailed. The document generally states that "Tests were performed on the XEPHILIO MC-1100 which demonstrated that the device is safe and effective, performs comparably to the predicate device(s), and is substantially equivalent to the predicate device(s)." This indicates qualitative acceptance of comparable performance rather than specific numerical thresholds.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety | Device demonstrated to be safe. |
| Effectiveness | Device demonstrated to be effective. |
| Comparability to predicate devices | Device performs comparably to predicate devices. |
| Substantial Equivalence | Device is substantially equivalent to predicate devices. |
| Compliance with FDA Software Guidance | Documentation provided demonstrating compliance. |
| Compliance with U.S. Performance Standard for radiographic equipment | Testing confirmed compliance. |
| Compliance with relevant voluntary safety standards (IEC 60601 series) | Testing confirmed compliance. |
2. Sample Size Used for the Test Set and Data Provenance:
The document mentions "non-clinical image comparisons involving flat panel display images taken with the new device and the predicate device(s)." However, it does not specify the sample size (number of images or cases) used in these comparisons for the test set, nor does it provide any information on the data provenance (e.g., country of origin, retrospective or prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
The document does not mention using experts to establish ground truth for image comparisons. The "non-clinical image comparisons" likely refer to technical image quality assessments rather than clinical interpretation.
4. Adjudication Method for the Test Set:
No information about an adjudication method is provided, as no expert review process is described for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
The document does not indicate that an MRMC comparative effectiveness study was conducted to evaluate human reader improvement with or without AI assistance. The device is a mobile C-Arm system, and the evaluation focuses on its performance against predicate hardware, not on AI-assisted diagnostic effectiveness.
6. Standalone (Algorithm Only) Performance Study:
The document does not describe a standalone (algorithm only) performance study. The device is a hardware system, and the evaluations are about its overall safety and effectiveness as a medical imaging system.
7. Type of Ground Truth Used:
For the "non-clinical image comparisons," the "ground truth" would likely be based on technical image quality metrics and specifications, compared against the predicate devices. It is not based on expert consensus, pathology, or outcomes data in a clinical diagnostic sense, as this is a hardware device submission.
8. Sample Size for the Training Set:
The document does not mention or imply the existence of a "training set" in the context of an AI/algorithm. The device is a hardware imaging system, and its development and testing are described in terms of engineering validation and verification, not machine learning model training.
9. How the Ground Truth for the Training Set Was Established:
As there is no mention of a "training set" or an AI/algorithm being developed, there is no information on how ground truth for a training set would have been established.
§ 892.1650 Image-intensified fluoroscopic x-ray system.
(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. 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). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic 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. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.