(59 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 angiography procedures for the heart, chest, abdomen, pelvis and brain.
The XIDF-AWS801, Angio Workstation, V7.0 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 and Workstation.
This document is a 510(k) summary for the Toshiba Medical Systems Corporation's XIDF-AWS801, Angio Workstation, V7.0. It is a modification of a previously cleared device (XIDF-AWS801, Angio Workstation, V6.20, K152785). The submission primarily focuses on establishing substantial equivalence to the predicate device and does not provide detailed acceptance criteria or a specific study demonstrating performance against such criteria.
However, based on the provided text, we can infer some information relevant to the request:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria or detailed reported device performance in a table format. It focuses on the substantial equivalence argument, asserting that "system modifications result in performance that is equal to or better than the predicate system." The key performance aspects implicitly covered by the modifications and safety assessment are:
| Acceptance Criteria (Inferred from device changes and safety statement) | Reported Device Performance (Summary from text) |
|---|---|
| Image Quality (oLCI image quality improvement, 3D Calibration improvement, 3D Road Map and 3D Viewer renewal, 3D/CBCT artifact provisions) | "o LCI image quality improvement: Implementation of pulse width modulation during 3D reconstruction." This function was migrated from a previously cleared device (K162614). "Renewal of 3D Road Map and 3D Viewer." "Provisions of 3D 3D/CBCT artifact (RFC [Ring free correction] / BHC [Beam hardening correction])". These changes are intended to maintain or improve image quality compared to the predicate. |
| Computed Data Accuracy (Cerebral Aneurysm Analysis, IV-LINQ integration) | "Cerebral Aneurysm Analysis...intended to facilitate the extraction and segmentation of user identified aneurysms on the cerebral arteries. The software can be used as an adjunct to diagnosis for the purposes of measurement of size and aspect ratio." (Main software introduced from K151091). "Clinical analysis application IV-LINQ (OCT/IVUS integration module): Images from IVUS or OCT can be imported and used under the supervision of a cardiologist or radiologist to facilitate enhanced stent visualization and measure stent dimensions." (Module added from K151780). These indicate the system's ability to provide accurate measurements and visualizations. |
| System Reliability (Dynamic Device Stabilizer improvement, Serviceability improvement, DTS improvement) | "Dynamic Device Stabilizer improvement." "DTS (Dose Tracking System) improvement." "Serviceability improvement." These imply enhancements to the system's robust operation. |
| Safety | "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 IEC60601-1 standards." "All requirements of the Federal Diagnostic Equipment Standard, as outlined in 21 CFR §1020, that apply to this device, will be met and reported via product report." Risks were mitigated to an acceptable level. |
| Functionality (Workflow Improvements, communication with other systems, 2D data input for 3D reconstruction) | "Workflow Improvements: Measurement and segmentation may be performed on 3D-WS; Multiple data (volume, object) and analysis results provided by clinical applications are available on 3D-RM application; Ease to define working angles." "Communication with Angio Workstation 3D viewer (image data, image storage condition, etc.)" and "Communication with Infinix-i Interventional Angiography systems (3D image angle, etc.)" for Cerebral Aneurysm Analysis. "Two dimensional data (512 x 512 x 12/16 bits) inputs are available for 3D reconstruction." |
| Security | "Security Kit for DoD: the Security Kit for DoD (software) is available for XIDF-AWS801/B1. This kit is to meet the security requirement of the U.S. Department of Defense." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a distinct "test set" for performance evaluation in terms of number of cases or data provenance. The assessment relies on the modifications made to the predicate device and the validation of those changes.
The text mentions "test data that demonstrates that the system modifications result in performance that is equal to or better than the predicate system." However, no details on the size or characteristics of this test data are provided. It does not mention retrospective or prospective studies or the country of origin for any data used in this specific submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not detail a specific "test set" with ground truth established by experts for this submission.
For the "Cerebral Aneurysm Analysis" and "IV-LINQ (OCT/IVUS integration module)" applications, it mentions that the IV-LINQ module is "[imported] and used under the supervision of a cardiologist or radiologist." For the Cerebral Aneurysm Analysis, it states "[the software] can be used as an adjunct to diagnosis for the purposes of measurement of size and aspect ratio." This implies that the ground truth for these features would typically be clinical assessment by qualified specialists (cardiologists or radiologists), but the number of experts or their years of experience for any specific validation data is not provided in this document.
4. Adjudication Method for the Test Set
No details on an adjudication method (e.g., 2+1, 3+1, none) are provided as there is no explicitly defined external "test set" with expert review mentioned for this submission. The internal testing refers to "software verification and validation testing."
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The document does not indicate that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done. There is no mention of human readers improving with or without AI assistance, nor any effect size. This submission focuses on modifications to an existing workstation and demonstrating substantial equivalence, not a comparative efficacy study of AI assistance.
6. Standalone (Algorithm Only) Performance Study
The document does not explicitly describe a standalone (algorithm only) performance study. The device, XIDF-AWS801, Angio Workstation, V7.0, is an "Angio Workstation" and includes "Angio Workstation 3D viewer" and is "used in combination with an interventional angiography system." While it contains sophisticated software modules (e.g., Cerebral Aneurysm Analysis, IV-LINQ), the submission positions them as part of an integrated workstation and does not report on their isolated algorithmic performance. The focus is on the integrated system's equivalence.
7. Type of Ground Truth Used
The document does not explicitly state the type of ground truth used for performance validation. However, given the nature of the applications (Cerebral Aneurysm Analysis, IV-LINQ for stent visualization and measurement), it can be inferred that:
- For the Cerebral Aneurysm Analysis, ground truth for aneurysm detection and measurement would ideally come from definitive clinical diagnosis and potentially other validated imaging modalities or surgical findings.
- For IV-LINQ, the ground truth for stent visualization and measurement would likely be based on expert clinical assessment by cardiologists or radiologists using intravascular ultrasound (IVUS) or optical coherence tomography (OCT) images, potentially compared with angiographic or other invasive measurements.
- For general image quality improvements, the ground truth would be based on qualitative and quantitative assessments against established imaging standards and clinical expectations.
8. Sample Size for the Training Set
The document does not specify the sample size used for any training set. It describes software modifications and the integration of modules "migrated" or "introduced" from previously cleared devices (K162614, K151780, K151091). These previously cleared devices or modules may have undergone their own training and validation, but details are not included in this K172646 submission.
9. How the Ground Truth for the Training Set Was Established
As no training set is described, the document does not provide information on how ground truth was established for any 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.