(232 days)
The Angio Workstation (XIDF-AWS801) is used in combination with an interventional angiography system (Alphenix series systems, Infinix-i series systems and INFX series systems) to provide 2D and 3D imaging of selective catheter angiography procedures for the whole body (includes heart, chest, abdomen, brain and extremity).
When XIDF-AWS801 is combined with Dose Tracking System (DTS), DTS is used with selective catheter anglography procedures for the heart, chest abdomen, pelvis and brain.
The XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.3 is used for images input from Diagnostic Imaging System and Workstation, image processing and display. The processed images can be outputted to Diagnostic Imaging System, Workstation and/or other PACS devices. The XIDF-AWS801 provides the image information and measurement results that are required when performing Angiography procedures.
Here's a breakdown of the acceptance criteria and study information for the XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.3, based on the provided FDA 510(k) summary:
The provided document is a 510(k) summary for a software update to an existing device. As such, it primarily focuses on demonstrating substantial equivalence to the predicate device rather than presenting a de novo study with explicit acceptance criteria for entirely new performance claims. The "acceptance criteria" in this context refer to demonstrating that the updated device performs at least as well as, or better than, the predicate device across various aspects, including safety and effectiveness.
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a submission for a modification to a cleared device (software change from V8.0 to V9.3), the acceptance criteria are implicitly tied to demonstrating that the new version is substantially equivalent to the predicate device (XIDF-AWS801, V8.0, K181415) and does not raise new questions of safety or effectiveness. Explicit numerical performance metrics as "acceptance criteria" are not detailed in this summary for the updated software. Instead, the "performance" demonstrated is that the modifications maintain existing performance and potentially offer improvements without compromising safety.
| Aspect of Performance/Criteria | Reported Device Performance (XIDF-AWS801, V9.3) |
|---|---|
| Overall Performance | "Performance that is equal to or better than the predicate system." (Implies meeting or exceeding predicate's imaging capabilities, processing speed, accuracy etc. where applicable) |
| Safety | "Designed and manufactured under the Quality System Regulations (21 CFR § 820 and ISO 13485). Conforms to applicable parts of IEC60601-1 standards. Meets all requirements of the Federal Diagnostic Equipment Standard (21 CFR §1020)." |
| Software Validation/Integration | "Software modules were subject to verification and/or validation testing to ensure that they were properly integrated into the existing software platform." |
| Risk Mitigation | "Design controls used for this device included risk management and all known risks were mitigated to an acceptable level." |
| Intended Use | "Performs in a manner similar to and is intended for the same use as the predicate device, as indicated in product labeling." |
2. Sample Size Used for the Test Set and Data Provenance
The summary does not explicitly state a specific sample size used for a test set (e.g., number of images or cases) for clinical performance evaluation. The "testing" mentioned refers to verification and validation of software modules and the system's overall performance against the predicate.
The data provenance is not specified regarding country of origin or retrospective/prospective nature. Given the type of device (angiography workstation software), testing would likely involve technical performance and potentially review of existing clinical data/images for validation of new features or ensuring consistency with previous versions.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The summary does not mention the use of experts to establish ground truth for a test set. This type of evaluation is not typically required for a software update to an angiography workstation that primarily processes and displays images, unless new diagnostic functions were introduced that required clinical validation against expert opinion.
4. Adjudication Method for the Test Set
As there's no mention of a clinical test set with expert ground truth, an adjudication method is not applicable or mentioned in this summary.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
No MRMC comparative effectiveness study was mentioned or performed. The device is an angiography workstation with various imaging and processing functionalities, not an AI-assisted diagnostic tool that directly impacts human reader interpretation in the context of an MRMC study. While it has improved "Dynamic Device Stabilization" and "Embolization Planning software," these are functional enhancements, not AI-driven diagnostic aids requiring MRMC studies to measure reader improvement.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The device itself is a workstation used to process and display images for clinical interpretation, inherently involving a "human-in-the-loop." Therefore, a standalone (algorithm only) performance evaluation in a purely diagnostic sense is not applicable or mentioned in this context for this type of device and submission. The "standalone" aspect applies more to specific AI algorithms making diagnostic predictions.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
Given the nature of the software update to an angiography workstation, the "ground truth" for its validation would primarily involve:
- Technical Specifications: Ensuring algorithms produce images and measurements according to predefined technical and mathematical standards.
- Predicate Device Performance: Comparing processed images and functionalities against the established performance of the cleared predicate device.
- Risk Analysis: Ensuring that the software changes do not introduce new, unmitigated risks.
Clinical ground truth from experts, pathology, or outcomes data is not mentioned as being used directly for this software update.
8. The Sample Size for the Training Set
The document does not refer to a "training set" in the context of machine learning. The improvements, such as "Dynamic Device Stabilization (DDS) software has been improved" or "Embolization Planning software has been migrated," indicate software engineering enhancements rather than a system trained on a specific dataset.
9. How the Ground Truth for the Training Set Was Established
Since no training set is mentioned in the context of machine learning, the method for establishing ground truth for a training set is not applicable or mentioned.
§ 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.