(30 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 angiographic procedures for blood vessels in the heart, brain, abdomen and lower extremities.
The Alphenix, INFX-8000V/B, V8.0, 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/Ω-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.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Alphenix, INFX-8000V/B, V8.0.
It's important to note that the document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than on establishing new performance criteria or conducting elaborate clinical trials. Therefore, much of the information typically found in a comprehensive study report is either not present or is addressed through indirect means like conformance to standards and bench testing.
1. Table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria or a dedicated performance table for the new Alphenix V8.0 against a specific set of metrics. Instead, the primary criterion for acceptance in a 510(k) submission is Substantial Equivalence to the predicate device.
The reported "performance" is that the modifications (V8.0 software, Tablet Console, New Examination Menu, Programming Restructuring, Spot ROI Fluoroscopy for 8" FPD, Multi-phase CBCT, Sleep Mode, UPS Connection Kit, System Input Power Change, TFP-1200C Image Quality Improvement, Space Improvement, HSBP, and Fluoroscopy Roadmapping) result in performance that is equal to or better than the predicate system.
| Acceptance Criteria (Implicit from 510(k) Process) | Reported Device Performance (Alphenix, INFX-8000V/B, V8.0) |
|---|---|
| Substantial Equivalence to Predicate Device | "Performs in a manner similar to and is intended for the same use as the predicate device." |
| No new Indications for Use or Intended Use | "No new indications for use or intended use of the device." |
| Safety and Effectiveness comparable to Predicate | "Substantially equivalent in safety and effectiveness to the predicate device." |
| Meets Applicable Standards | Conforms to IEC 60601-1, -1-2, -1-3, -1-6, -2-28, -2-43, IEC 62304, IEC 62366, and 21 CFR §1020. |
| Risks mitigated to acceptable level | "All known risks were mitigated to an acceptable level." |
| Image Quality (for specific changes) | Improved image quality for Hybrid (aSi/CMOS) FPD, TFP-1200C (noise reduction, pixel area/FOV change). |
2. Sample size used for the test set and the data provenance
The document explicitly states that "Clinical images were deemed not necessary" for the improvements made. Therefore, there is no human-readable test set in the traditional sense, and thus no sample size for such a set.
The testing primarily involved:
- Bench testing: This refers to laboratory-based evaluations.
- Phantom testing: Used to verify image metrics related to improvements in image quality. The sample size for these phantom tests is not specified, nor is the specific data provenance (e.g., country of origin, retrospective/prospective). This type of testing is generally performed in a controlled laboratory environment by the manufacturer.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Since clinical images were not used and ground truth was not established through expert review of patient data, this information is not applicable and not provided in the document. The "ground truth" for the phantom testing would be based on the known physical properties and settings of the phantoms themselves.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no human expert review or clinical test set adjudication was performed or reported for the modifications.
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
A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or reported for this device. The device is an X-ray system, and the modifications described are internal system improvements (software, hardware components, workflow enhancements) rather than an AI-driven interpretive tool that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This refers to the performance of the core diagnostic algorithms without human intervention. While the device contains various algorithms for image processing and system control (e.g., Alphenix V8.0 software), the document does not describe a "standalone" performance evaluation in the context of a diagnostic product (e.g., an AI for disease detection). The assessment was against the performance of the predicate system through bench and phantom testing, demonstrating that the system's output (images) is "equal to or better" than the previous version.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the testing described (bench and phantom testing) would be based on:
- Known physical properties and settings of phantoms: For image quality metrics.
- Engineering specifications and design requirements: For functional tests of the new software features, console, and other modifications.
- International standards (IEC): Conformance to these standards serves as a "ground truth" for safety and basic performance.
No expert consensus, pathology, or outcomes data was used for establishing ground truth for the modifications evaluated in this submission, as clinical images were not deemed necessary.
8. The sample size for the training set
The document does not mention any "training set" in the context of machine learning or AI model development. The described modifications primarily involve software updates for usability, system features, and image quality improvements, not the development of a new AI algorithm requiring a training set.
9. How the ground truth for the training set was established
Not applicable, as no training set for an AI algorithm is mentioned or implied.
§ 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.