(28 days)
This device is a digital radiography/fluoroscopy system used in a diagnostic interventional angiography configuration. The system is indicated for use in diagnostic and anqioqraphic procedures for blood vessels in the heart, brain, abdomen and lower extremities.
INFX-8000V, V6.35, is an X-ray system that is capable of radiographic and fluoroscopic studies and is used in an interventional setting. The system consists of a C-arm, which is equipped with an X-ray tube, beam limiter and X-ray receptor, X-ray controller, computers with system and processing software, and a patient radiographic table.
This document describes a 510(k) premarket notification for the Toshiba Medical Systems Corporation's Infinix, INFX-8000V, V6.35 device. This submission is for a modification to a previously cleared device (INFX-8000V, V6.20, K152696). As such, the information provided focuses on the comparative performance of the modified device against its predicate rather than a comprehensive, standalone clinical study with human readers and ground truth established by experts.
Here's an analysis of the provided text in relation to your questions:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of "acceptance criteria" against "reported device performance" in the format typically seen for a new device's clinical validation. Instead, it states that the testing demonstrates the modified system's performance is "equal to or better than the predicate system." The performance metrics tested are listed, and the implicit acceptance criterion is that the new version performs at least as well as the predicate.
| Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Spatial Resolution | Equal to or better than predicate device (K152696) | Equal to or better than predicate |
| Low Contrast Resolution | Equal to or better than predicate device (K152696) | Equal to or better than predicate |
| Dynamic Range | Equal to or better than predicate device (K152696) | Equal to or better than predicate |
| DQE (Detective Quantum Efficiency) | Equal to or better than predicate device (K152696) | Equal to or better than predicate |
| MTF (Modulation Transfer Function) | Equal to or better than predicate device (K152696) | Equal to or better than predicate |
| Artifacts/Contrast/Dynamic Range of DSA | Equal to or better than predicate device (K152696) | Equal to or better than predicate |
| CNR (Contrast-to-Noise Ratio) | Equal to or better than predicate device (K152696) | Equal to or better than predicate |
| S/N Ratio (Signal-to-Noise Ratio) | Equal to or better than predicate device (K152696) | Equal to or better than predicate |
| Density Resolution | Equal to or better than predicate device (K152696) | Equal to or better than predicate |
| Virtual ROI function (Display of virtual X-ray field before exposure) | Functionality for displaying virtual X-ray field | Functionality added and tested |
| Pulse width modulation (Uniform brightness of projection data during LCI acquisition) | Functionality for uniform brightness during LCI acquisition | Functionality added and tested |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify a "test set" in terms of patient images or clinical data. The testing mentioned appears to be phantom or bench testing rather than clinical performance evaluation on human subjects. Therefore, information about data provenance (country, retrospective/prospective) and sample size for clinical test sets is not applicable or provided. The device is tested against applicable standards published by the International Electromechanical Commission (IEC) for Medical Devices and XR Systems.
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)
Since the testing primarily involved phantom/bench testing and not a clinical study with image interpretation, there is no mention of experts being used to establish a ground truth for a clinical test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as this was not a clinical study involving human interpretation of clinical images.
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
No MRMC study was performed or is mentioned. This device does not appear to be an AI-assisted diagnostic tool, but rather an imaging system with technical modifications to its acquisition capabilities and user interface (Virtual ROI, pulse width modulation). The focus is on the performance of the imaging system itself.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The testing described (spatial resolution, low contrast resolution, DQE, MTF, etc.) is standalone performance evaluation of the imaging system's technical capabilities, without human in the loop.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the technical performance metrics (spatial resolution, DQE, etc.), the "ground truth" would be established by the physical properties of the phantoms or test objects used and the measurement techniques defined by international standards (IEC). This is not related to expert consensus, pathology, or outcomes data from human patients.
8. 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" in the context of AI.
9. How the ground truth for the training set was established
Not applicable. As stated above, this device does not involve a machine learning training set.
§ 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.