(103 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 angiography procedures for the heart, chest abdomen, pelvis and brain.
The XIDF-AWS801, Angio Workstation (Alphenix Workstation), V8.0 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.
The provided text describes a 510(k) submission for a medical device called XIDF-AWS801, Angio Workstation (Alphenix Workstation), V8.0. However, it does not contain a specific study that directly proves the device meets acceptance criteria in the way a clinical trial or performance study would typically be presented.
Instead, the submission outlines changes made to an existing cleared device (XIDF-AWS801, Angio Workstation, V7.0 - K172646) and asserts substantial equivalence to that predicate device. The "acceptance criteria" are implicitly tied to the safety and performance standards of the predicate device and the new modifications meeting those same standards, or better.
Here's an analysis based on the information provided:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly define "acceptance criteria" in a quantitative table with corresponding performance metrics as would be typical for a new device's efficacy study. Instead, the "acceptance" is based on demonstrating that the modified device's performance is equal to or better than the predicate system and that all requirements for the modifications have been met.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Conformance to IEC60601-1-2:2014 & IEC62304:2006 + A1:2015 | Testing of modified system conducted in accordance with applicable standards. |
| Compliance with IEC62366:2007 + A1:2014 (Usability) | Not explicitly detailed for modifications, but assumed as part of overall system design and safety. |
| Compliance with ISO 14971:2007 (Risk Management) | Risk analysis and verification/validation testing conducted; all known risks mitigated to an acceptable level. |
| Software Documentation (Moderate Level of Concern) | Included in submission, software modules subject to verification/validation. |
| Image Quality of AlphaCT (3D acquisition) Artifact Reduction | Phantom image evaluations employed in bench testing, demonstrating requirements met. Modifications implemented to reduce artifacts. |
| Stent visualization in AlphaCT Device acquisition | Application of a spatial filter (11x11 pixels) to reconstructed slice images in the axial direction to improve stent visualization. |
| Functionality of new features (BP Auto Angle Support, Needle Guidance Function Oblique View, CAA Vessel Track) | Verification/validation testing conducted, demonstrates requirements met. |
| Overall safety and effectiveness compared to predicate | Performs in a manner similar to and intended for the same use as the predicate device. Substantially equivalent in safety and effectiveness. |
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: Not explicitly stated. The testing appears to involve bench testing using phantom images and software verification/validation. This suggests the "test set" would primarily comprise simulated scenarios, phantom data, and potentially internal system testing data rather than a large clinical dataset.
- Data Provenance: The testing describes "bench testing" and "phantom image evaluations." This implies prospective data generated specifically for the verification of the modifications. There is no mention of country of origin for this specific test data, but the manufacturer is Canon Medical Systems Corporation in Japan, implying testing would likely occur there or at associated facilities.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified. Given the nature of the device (angiography workstation software), "experts" would likely be clinical users (e.g., interventional radiologists) or biomedical engineers with expertise in image processing and medical imaging, but this is not mentioned.
4. Adjudication Method for the Test Set:
- Adjudication Method: Not specified. Since the testing primarily involved bench testing and phantom evaluations, formal adjudication by a panel of experts for clinical endpoints is unlikely to have occurred in the context described. Adjudication might have been integrated into the internal verification and validation processes by design engineers and subject matter experts.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- Was an MRMC study done? No. The document does not mention an MRMC comparative effectiveness study where human readers' performance with and without AI assistance was evaluated. The device is an angiography workstation with advanced image processing and viewing features, not explicitly an "AI" device as typically evaluated in MRMC studies for diagnostic accuracy improvement.
- Effect Size: Not applicable, as no such study was reported.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
- Was a standalone study done? Yes, implicitly. The "bench testing" and "phantom image evaluations" are forms of standalone performance assessment for the modifications (e.g., artifact reduction, stent visualization improvement, functionality of new features like angle support). The software modules were also subjected to verification and validation testing to ensure proper integration and performance.
7. Type of Ground Truth Used:
- Ground Truth Type: For the image quality evaluations (e.g., artifact reduction, stent visualization), the ground truth would likely be based on physical phantom measurements, known image characteristics, and engineering specifications. For the functional aspects of the software modifications, the ground truth would be adherence to the design requirements and expected output. There is no mention of pathology, expert consensus on clinical cases, or outcomes data being used as ground truth for this submission's testing.
8. Sample Size for the Training Set:
- Training Set Sample Size: Not specified. The document does not explicitly state that the device uses machine learning or AI that requires a "training set" in the conventional sense. The "AlphaCT (3D acquisition) Artifact Reduction" and "application of the spatial filter" are described as modifications to existing algorithms, rather than newly trained AI models. If there were any learning components, the training data details are not provided.
9. How the Ground Truth for the Training Set Was Established:
- Ground Truth for Training Set: Not applicable, as the document does not describe the device as having a "training set" for AI or machine learning models. The modifications appear to be software updates/enhancements based on algorithmic refinement and engineering design.
§ 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.