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510(k) Data Aggregation
(170 days)
The SpectraWAVE X1-FFR Software features segmentation of coronary vessels, and measurement and reporting tools to facilitate the following use:
- Calculate the dimensions of coronary vessels;
- Quantify stenosis in coronary vessels;
- Quantify pressure drop in coronary vessels;
The SpectraWAVE X1-FFR Software is intended to be used by or under the supervision of a cardiologist.
The SpectraWAVE X1-FFR Software is a standalone medical device which is used in the catheterization lab as an angiography image assessment tool for assessing Fractional Flow Reserve using non-invasive quantitative and functional analysis of coronary vasculature.
The SpectraWAVE X1-FFR software comprises image processing and computational algorithms to perform functional coronary angiography, providing longitudinal estimations of coronary pressure drop and Fractional Flow Reserve (FFR) during angiogram and percutaneous coronary intervention (PCI) procedures.
The SpectraWAVE X1-FFR Software is a procedural aid intended to be used to support diagnosis by clinicians.
AI-derived algorithms are deployed on the device to support vessel segmentation and contouring. Analytical (non-AI) models are used for generating FFR values.
The SpectraWAVE X1-FFR Software:
- provides measurements of localized coronary pressure drops over the length of a coronary vessel, including the right and left coronary tree.
- provides dimensions of the coronary vessels and the amount of stenosis in coronary vessels;
- enables physiology assessment in a non-invasive manner, without the need for adenosine and without the need for additional radiation and contrast administration.
Here's an analysis of the provided FDA 510(k) clearance letter for the SpectraWAVE X1-FFR Software, extracting the requested information about acceptance criteria and the supporting study:
SpectraWAVE X1-FFR Software: Acceptance Criteria and Study Details
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state "acceptance criteria" for the X1-FFR's performance, but it does report on a key performance metric: the relationship between X1-FFR and invasive hyperemic pressure wire measurements.
| Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Bias between X1-FFR and invasive hyperemic pressure wire | A bias close to 0, indicating accuracy. | 0.00 |
| Agreement between X1-FFR and invasive hyperemic pressure wire | Narrow 95% limits of agreement, indicating precision and consistency. | [-0.12, 0.12] |
Note: The phrase "All testing passed the acceptance criteria" is mentioned, suggesting that internal acceptance criteria were defined and met, but these specific criteria are not detailed in the public 510(k) summary. The reported Bland-Altman analysis results serve as a key demonstration of performance.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: 306 vessels from 285 patients.
- Data Provenance: The study was a "retrospective clinical analysis." The country of origin is not specified in the provided document.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not explicitly state the number of experts or their qualifications for establishing the ground truth. However, the ground truth itself is defined by "invasive hyperemic pressure wire" measurements, which are considered the gold standard for FFR assessment and are performed by trained medical professionals (cardiologists).
4. Adjudication Method for the Test Set
The adjudication method for the test set is not explicitly described. Since the ground truth "invasive hyperemic pressure wire" is a direct physiological measurement, rather than a subjective interpretation, a formal adjudication of ground truth for the FFR values themselves is less common than for image-based diagnoses.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
There is no mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study or any effect size on how much human readers improve with AI vs. without AI assistance. The study focuses on the standalone performance of the X1-FFR software against a gold standard.
6. Standalone Performance Study (Algorithm Only)
Yes, a standalone performance study was done. The "retrospective clinical analysis" assessed the X1-FFR software's performance "relative to invasive hyperemic pressure wire." This implies the algorithm-only performance was evaluated without human-in-the-loop assistance for the FFR calculation itself. The software is described as a "procedural aid intended to be used to support diagnosis by clinicians," but the reported performance study specifically evaluates the software's calculation directly against the ground truth.
7. Type of Ground Truth Used
The ground truth used was invasive hyperemic pressure wire measurements. This is considered the current clinical gold standard (outcome/physiological measurement) for Fractional Flow Reserve (FFR).
8. Sample Size for the Training Set
The document does not specify the sample size used for the training set. It only describes the "retrospective clinical analysis" which served as the performance validation (test set).
9. How the Ground Truth for the Training Set Was Established
The document does not specify how the ground truth for the training set was established, as the training set details are not provided.
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