Search Results

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)

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).

Ask a specific question about this device

AccuFFRangio 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 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.

ArteryFlow® AccuFFRangio is designed as a stand-alone software package to run on a PC. This software can read traditional x-ray angiographic images with DICOM format from the local file directory.

The AccuFFRangio is composed of the following analysis workflows: Image Loading, Frame Selection, Vessel Reconstruction, QCA Vessel Quantification, and AccuFFRangio Calculation for visualization of the target coronary segment, quantification of the stenosis and pressure drop of the coronary seqment. The AccuFFRangio parameter is only for quantitative imaging output but not for diagnosis and the AccuFFRanigo product has a moderate level of concern.

The user can calculate the pressure drop and AccuFFRangio (FFR) value for the coronary vessel. To obtain these values for a specific lesion in a coronary vessel, the user has to start with Frame Selection using two angiographic images from different views. In each of these images, a classic 2D coronary contour detection is performed, after which a reconstruction of the coronary segment is obtained in 3D space. Based on the 3D reconstruction and user input of the aortic pressure, the pressure drop and AccuFFRangio value can be calculated.

AccuFFRangio enables interventional cardiologists to obtain accurate anatomical quantifications of one or more lesions in the analyzed coronary segment, and to assess the best viewing angles which can be helpful for optimal visualization of the lesion during percutaneous coronary intervention (PCI) treatment.

Results can be displayed and generated by the software, which contains patient information, imaging of actual and reference vessel boundaries, dimensions of the vessel sizing, pressure drop, and AccuFFRangio value. The results can be export in PDF format. This functionality is independent of the type of vendor acquisition equipment.

Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:

Acceptance Criteria and Device Performance

Study Details for Acceptance Criteria Proof:

1. Sample size used for the test set and the data provenance:

   • 3D Vessel Reconstruction: "A phantom study had been implemented by using three different types stenosis of brass model." The specific number of images or cases analyzed in this phantom study is not provided.
   • AccuFFRangio calculation: "a series of X-ray angiographic dataset with known pressure drops were analyzed." The specific number of cases or images in this dataset is not provided.
   • Data Provenance: Not explicitly stated for either study (e.g., country of origin, retrospective/prospective). The phantom study suggests a controlled laboratory environment rather than patient data. The AccuFFRangio Calculation refers to an "X-ray angiographic dataset," implying patient data, but details are missing.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • The document does not mention the use of human experts to establish ground truth for the test sets in either the 3D vessel reconstruction or AccuFFRangio calculation studies.
   • For the 3D vessel reconstruction, the ground truth was based on "three different types stenosis of brass model," implying a physical model with known dimensions.
   • For the AccuFFRangio calculation, the ground truth was established by "X-ray angiographic dataset with known pressure drops." The method by which these "known pressure drops" were determined (e.g., invasive FFR measurements, expert consensus using other clinical data) is not specified, and therefore, the involvement or qualifications of experts are not described.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Not applicable/Not mentioned. The studies described do not involve human review for ground truth with an adjudication process.

4. 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:

   • No MRMC comparative effectiveness study is described in the provided text. The studies focus on the standalone performance of the device compared to a predicate device or known physical/physiological values.

5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

   • Yes, the studies described are standalone performance evaluations of the AccuFFRangio software. The text explicitly states that "AccuFFRangio is designed as a stand-alone software package." The performance data section describes evaluating the software's output directly against phantom measurements or known physiological values.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

   • 3D Vessel Reconstruction: Physical phantom measurements (brass models).
   • AccuFFRangio calculation: "Known pressure drops" from an X-ray angiographic dataset. The origin or method of determining these "known pressure drops" is not detailed, so it's not explicitly stated as expert consensus, invasive FFR, or outcomes data.

7. The sample size for the training set:

   • The document does not provide information about the sample size used for the training set of the AccuFFRangio device. The performance data section focuses solely on validation/testing.

8. How the ground truth for the training set was established:

   • As training set details are not provided, how its ground truth was established is also not described in the document.

Ask a specific question about this device