(90 days)
The Angio Workstation (XIDF-AWS801) is used in combination with an interventional angiography system (Infinix-i series systems and INFX series systems) to provide 2D and 3D imaging in 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 in selective catheter angrography procedures for the heart, chest, abdomen, pelvis and brain.
The XIDF-AWS801 Angio Workstation is used for images input from Diagnostic lmaging System and Workstation, image processing and display. The processed images can be outputted to Diagnostic Imaging System and Workstation.
Here's a breakdown of the acceptance criteria and study information for the XIDF-AWS801, Angio Workstation, v5.31, based on the provided FDA 510(k) summary:
This device (XIDF-AWS801, Angio Workstation, v5.31) is a modification of a previously cleared device (XIDF-AWS801, Angio Workstation w/Dose Tracking System, K132106). The changes are specifically related to the Dose Tracking Software, expanding it to provide estimated skin dose for the head and improving simultaneous tracking of dual tubes.
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly present a table of specific numerical acceptance criteria (e.g., accuracy percentages, error margins) for the Dose Tracking System's performance in K141541. Instead, it states:
| Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Dose Tracking Performance | "Testing was performed to verify the estimated dose displayed by the software with the actual measured dose on the phantom within the gantry field of exposure." | "Testing has verified that the changes perform as intended." |
| Safety and Effectiveness | "The modifications incorporated into the XIDF-AWS801, v5.31, do not change the indications for use or the intended use of the device." | "Safety and effectiveness have been verified via risk management and application of design controls to the modifications." |
| Conformance | "The device is designed and manufactured under the Quality System Regulations as outlined in 21 CFR § 820 and ISO 13485 Standards." "This device is in conformance with the applicable parts of the IEC standards." | (Implied through continued manufacturing and design controls to these standards) |
Key Observation: The summary focuses on verifying that the changes (expansion to head dose estimation and dual-tube tracking) perform as intended and do not negatively impact the established safety and effectiveness of the predicate device. There are no specific quantifiable performance metrics provided for the estimated dose compared to actual measured dose.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. The document mentions "commercially available phantom and measurement tools" but does not quantify the number of phantoms, tests, or data points used in the testing.
- Data Provenance: The testing was "performed using commercially available phantom and measurement tools." This indicates that the data is prospective (generated specifically for this testing) and likely collected in a controlled laboratory or testing environment, rather than from patient data. The country of origin for the data is not specified, but the manufacturing site is in Japan (Toshiba Medical Systems Corporation).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not applicable/Not stated. The ground truth for the dose estimation was established by "actual measured dose on the phantom within the gantry field of exposure," implying physical measurement rather than expert interpretation.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. The ground truth was based on physical measurements, not expert consensus requiring 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
- MRMC Study: No. This device is a dose tracking system, not an AI-assisted diagnostic tool that would typically involve human readers interpreting images. The primary function is to provide an estimated skin dose for dose management.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Standalone Performance: Yes, in essence, the testing described appears to be a standalone performance evaluation of the algorithm's ability to estimate dose against physical measurements. The "estimated dose displayed by the software" was compared against "actual measured dose on the phantom."
7. The Type of Ground Truth Used
- Type of Ground Truth: Physical measurement/reference standard. Specifically, the "actual measured dose on the phantom within the gantry field of exposure."
8. The Sample Size for the Training Set
- Sample Size: Not stated. The document describes a "modification of a cleared device" and implies that the dose tracking software is based on physical models and algorithms rather than machine learning that requires a "training set" in the traditional sense of AI. If machine learning was involved, this information is not provided. The testing focused on validating the modified software behavior.
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth for Training Set Was Established: Not applicable/Not stated. Given the nature of a dose tracking system, it's more likely based on established physics and calibration models than a "training set" with ground truth in the context of image recognition. If the original development of the dose tracking algorithms involved data-driven training, this information is not present in the provided summary focusing on the modification of an already cleared device.
§ 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.