(247 days)
This device is a digital radiography/fluoroscopy system use in a diagnostic interventional angiography configuration. The system is indicated for use in diagnostic and angiographic procedures for the heart, brain, abdomen and lower extremities.
This device in 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 that 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.
The provided text describes modifications to an existing X-ray system, the INFX-8000V, and outlines safety and testing procedures to demonstrate substantial equivalence to its predicate device. This document is a 510(k) summary, which typically focuses on demonstrating equivalence rather than establishing new acceptance criteria or conducting extensive clinical trials for new device performance claims.
Based on the provided information, the device is an X-ray system, not an AI/ML-driven diagnostic algorithm. Therefore, many of the requested criteria (e.g., sample sizes for test sets, ground truth establishment for training/test sets, number of experts, MRMC studies, standalone algorithm performance) are not applicable or described in this type of submission for this particular device.
Here's an analysis of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly define acceptance criteria in a quantitative table format for specific performance metrics. Instead, it states that the modified device's performance is "equal to or better than" the predicate system. The performance characteristics tested include:
| Acceptance Criteria (Implicit) | Reported Device Performance (Summary) |
|---|---|
| Spatial Resolution | Equal to or better than predicate |
| Low Contrast Resolution | Equal to or better than predicate |
| Dynamic Range | Equal to or better than predicate |
| DQE (Detective Quantum Efficiency) | Performance enhancement from predicate |
| MTF (Modulation Transfer Function) | Equal to or better than predicate |
| NOS (Noise Overtone Spectrum) | Equal to or better than predicate |
| Conversion Function | Equal to or better than predicate |
| Fluoroscopic Still Image Resolution | Equal to or better than predicate |
| Fluoroscopic Still Image Dynamic Range | Equal to or better than predicate |
| Fluoroscopic Still Image After Image Resolution | Equal to or better than predicate |
| DSA (Digital Subtraction Angiography) Artifacts | Equal to or better than predicate |
| DSA Contrast | Equal to or better than predicate |
| DSA Dynamic Range | Equal to or better than predicate |
| Horizontal Streak Noise | Equal to or better than predicate |
| Focal Spot Resolution | Changes (.3/.6/1 to .4/.6/.9) but evaluated to be equal or better |
Study Proving Acceptance Criteria:
The study involved nonclinical testing using "commercially available phantoms and test objects." This testing was conducted "as prescribed in published and FDA recognized equipment standards" where applicable. The conclusion was that "Based upon the results of the verification testing the performance of the modified device is equal to or better than the predicate device."
2. Sample size(s) used for the test set and the data provenance:
- Sample size: Not applicable/not explicitly stated in terms of patient data. The testing involved "commercially available phantoms and test objects." Since this is a hardware and software modification for an X-ray system, the "test set" refers to the measurements taken from these phantoms and objects.
- Data provenance: The data is generated from controlled laboratory testing using specified phantoms and test objects. It is not patient data from a specific country, nor is it retrospective or prospective in a clinical sense.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable as the "ground truth" for evaluating an X-ray system's physical performance (resolution, DQE, etc.) is established by the known properties of the phantoms and test objects and measured against established engineering and physics standards. There is no mention of human expert interpretation for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This is not applicable as the "test set" is composed of phantom and test object measurements, not cases requiring human interpretation and adjudication.
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:
This is not applicable. The device is an X-ray imaging system, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This is not applicable. The device is an integrated X-ray system, not a standalone AI algorithm. The performance testing was for the overall system's imaging capabilities.
7. The type of ground truth used:
The "ground truth" for the performance testing of the X-ray system was based on known physical properties of commercially available phantoms and test objects, measured according to established engineering and physics standards, and compared against the performance of the predicate device.
8. The sample size for the training set:
This is not applicable. The device is an X-ray imaging system, not an AI/ML system that requires a "training set" in the context of machine learning. The software updates mentioned are system software (v5.30) and do not imply an AI learning model.
9. How the ground truth for the training set was established:
This is not applicable for the reasons stated in point 8.
§ 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.