(27 days)
AccuFFRangio Plus is indicated for use in clinical settings where validated and reproducible quantified results are needed to support the assessment of coronary vessels in X-ray angiographic images, for use on individual patients with coronary artery disease.
When the quantified results provided by AccuFFRangio Plus are used in a clinical setting on X-ray images of an individual patient, the results are only intended for use by the responsible clinicians.
AccuFFRangio Plus is a system that is used to perform calculations in X-ray angiographic images of the coronary arteries. It includes hardware and software (AccuFFRangio) and the hardware of the device which mainly has a display function and provide the software an operation environment. AccuFFRangio Plus is changed from our own legally marketed predicate device AccuFFRangio that is a stand-alone software package. Therefore, the significant change lies in equipping a computer system to the software on a particular mobile cart.
The provided text is a 510(k) summary for the device AccuFFRangio Plus. It primarily focuses on demonstrating substantial equivalence to a predicate device (AccuFFRangio) by highlighting that the core software is unchanged and the modifications are primarily hardware-related. As such, the document does not detail specific acceptance criteria or performance studies for the AI/algorithm itself for several reasons:
- The 510(k) is for a hardware modification of an already cleared device. The "significant change" lies in integrating the existing software into a new hardware system (a mobile cart with computer, monitor, etc.). Therefore, the performance data presented primarily addresses the new hardware aspects (electrical safety, EMC, etc.) and leverages the software's previous clearance.
- The software (AccuFFRangio) was likely cleared previously. The document states, "The software installed in the subject device is the same as the predicate device." This suggests that the clinical performance and acceptance criteria for the software were established and validated during the predicate device's (AccuFFRangio, K210093) original 510(k) clearance process. This document is not resubmitting that, but relies on it.
- The device calculates "quantified results" and "quantification of the pressure drop," not necessarily an AI-driven diagnosis or classification. While the term "AI" or "deep learning" is not explicitly used, the description of "quantified results" and "pressure drop" calculations suggests an analytical tool rather than a traditional diagnostic AI that might have sensitivity/specificity metrics.
Therefore, based solely on the provided text, I cannot provide a detailed response to your request regarding AI acceptance criteria and study proving the device meets them because this information is not present in this specific 510(k) summary. The summary explicitly states: "No clinical testing was necessary to support the device modifications described in this Special 510(k)." and "The following testing was leveraged from the predicate device. The results from the predicate were used to support the subject device the software contained in the AccuFFRangio Plus is the same as the predicate device."
To answer your request, one would need to refer to the original 510(k) submission for the predicate device, AccuFFRangio (K210093), as that is where the software's performance and validation data would have been submitted. This document focuses on the safety and efficacy of the hardware integration and the overall system's continued substantial equivalence.
However, I can extract information related to the general "performance data" presented for the current 510(k), which focuses on the hardware and usability aspects:*
Acceptance Criteria and Study for AccuFFRangio Plus (Hardware-Focused)
As established above, this 510(k) focuses on the hardware modifications. The "acceptance criteria" and "performance" are therefore related to the safety and functionality of the integrated system, not the clinical performance of the underlying software's calculations, as that was established during the predicate device's clearance (K210093).
1. Table of Acceptance Criteria and Reported Device Performance (Hardware & Usability)
| Test Category | Acceptance Criteria (Pre-defined) | Reported Device Performance |
|---|---|---|
| Electrical Safety | Compliance with IEC 60601-1:2012 | All applicable requirements met. |
| Electromagnetic Compatibility | Compliance with IEC 60601-1-2:2014 (4th ed.) | All emissions and immunity tests passed. |
| Hardware Verification | Meet internal specifications, incoming inspections of raw materials, and final inspections of finished devices. | All hardware requirements evaluated/tested and found to meet pre-defined acceptance criteria. |
| Transportation Testing | Compliance with ASTM D4169-16 | All tests passed. |
| Human Factors (Usability) | Safe and effective use by the intended user population, no use errors for critical tasks. | Fifteen qualified participants performed all critical tasks without any use errors. No residual use-related risks identified. Conclusion: can be used safely and effectively. |
| Accelerated Aging Testing | Meet pre-defined acceptance criteria for service life. | All pre-defined acceptance criteria met. Service life validated to be 5 years. |
| Labeling Inspection | Compliance with company's quality management system documentation. | All inspections passed. |
| Software Verification & Validation | Software requirements met, device meets user needs and performs as intended (leveraged from predicate). | Software verification testing in accordance with design requirements. Software validation to ensure user needs are met and performs as intended. |
| Cybersecurity | Verification of Cybersecurity control and management (leveraged from predicate). | Testing to verify Cybersecurity control and management. |
2. Sample Size and Data Provenance
- Test Set Sample Size:
- Human Factors Testing: 15 qualified participants.
- For other tests (Electrical Safety, EMC, Hardware Verification, Transportation, Accelerated Aging, Labeling), the sample size typically refers to the number of units tested, which isn't explicitly stated but is implicitly "sufficient" to meet the standard requirements.
- Data Provenance: Retrospective (leveraging data and conclusions from the predicate device's software clearance). No new clinical data was generated for this specific 510(k). Country of origin is not specified for the original data, but the submitter is from Hangzhou, China.
3. Number of Experts and Qualifications for Ground Truth
- Not applicable to the hardware/usability tests described in this document.
- For the Human Factors testing, "15 qualified participants" were used. Their specific qualifications (e.g., medical professionals, years of experience) are not detailed here, but they would be representative of the intended users.
- For the original software's ground truth establishment (from the predicate device's 510(k)), this information would be detailed in K210093.
4. Adjudication Method for the Test Set
- Not applicable for the hardware/usability tests.
- For the Human Factors testing, success was determined by the absence of "use errors" during "critical tasks," rather than a formal adjudication process.
5. MRMC Comparative Effectiveness Study
- No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted for this 510(k). The document explicitly states "No clinical testing was necessary to support the device modifications described in this Special 510(k)."
6. Standalone Performance (Algorithm Only without Human-in-the-Loop)
- The software aspect of the device ("AccuFFRangio") is described as a "stand-alone software package" in the predicate description. Therefore, standalone software performance was likely evaluated during the predicate device's (K210093) clearance. This 510(k) document does not provide those details, but leverages that previous data. The "AccuFFRangio Plus" is now an integrated hardware/software system.
7. Type of Ground Truth Used
- For the hardware studies, ground truth is based on engineering standards (e.g., IEC, ASTM) and internal quality control specifications.
- For the software's calculations (leveraged from the predicate), the type of ground truth (e.g., another device, invasive measurements, expert consensus on imaging) would have been established during K210093. This document describes the device as providing "quantified results of coronary vessel segments based on a 3D reconstructed model" and "Quantification of the pressure drop in coronary vessels," implying quantitative ground truth rather than subjective diagnostic labels.
8. Sample Size for the Training Set
- Not applicable to this 510(k) which covers hardware modifications and re-uses existing software.
- For the original software development (from the predicate device's 510(k)), this information would be detailed in K210093.
9. How the Ground Truth for the Training Set was Established
- Not applicable to this 510(k).
- For the original software (from the predicate device's 510(k)), this information would be detailed in K210093.
In summary, this 510(k) submission is a "special 510(k)" for a hardware modification, explicitly relying on the prior clearance of its predicate software. Therefore, the detailed AI/algorithm specific performance data and acceptance criteria you requested are not contained within this document but would be found in the original submission for the predicate device, AccuFFRangio (K210093).
§ 892.1600 Angiographic x-ray system.
(a)
Identification. An angiographic x-ray system is a device intended for radiologic visualization of the heart, blood vessels, or lymphatic system during or after injection of a contrast medium. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.