(14 days)
CardIQ Analysis II is a post processing software option for Advantage Windows Workstation (AW) Platform. This product can be used for the analysis of CT angiography images and for the assessment of plaque densities with the coronary arteries. It provides a number of display, measurement and batch filming features. The product can be used to aid trained physicians for visualizing and assessing cardiac anatomy, and coronary vessels.
CardIQ Analysis II is a post processing software option that can be used in the analysis of CT angiography images to display structures of the heart in a MIP, reformat or volume rendering view. The software has the ability to measure the diameter of the vessel, Hounsfield Units within connay arteries, or plaque density within a vessel. Measurements, densities and images can all be priced to reports or saved to the AW workstation.
The provided text does not contain detailed information about specific acceptance criteria or a dedicated study proving the device meets those criteria. The document is a 510(k) summary for CardIQ Analysis II, focusing on substantial equivalence to a predicate device rather than performance metrics against set acceptance criteria.
However, based on the available information, we can infer some aspects related to the "study" context, particularly regarding validation and verification.
Here's an attempt to answer your questions based on the limited information:
1. Table of Acceptance Criteria and Reported Device Performance
Not explicitly stated in the document. The submission focuses on substantial equivalence to an existing predicate device (CardIQ Option 1.0, K003408) rather than specific quantitative performance metrics against novel acceptance criteria.
2. Sample size used for the test set and the data provenance
Not explicitly stated. The document mentions "Software Development, Validation and Verification Process to ensure performance to specifications, Federal Regulations and user requirements." This implies testing was performed, but details on the sample size of test cases or the origin of the data (e.g., country of origin, retrospective/prospective) are not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not explicitly stated. The document indicates the product is "to aid trained physicians." However, there is no mention of experts involved in establishing ground truth for any formal validation study described here.
4. Adjudication method for the test set
Not explicitly stated.
5. 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
Not explicitly stated. The document describes a "post processing software option" to aid physicians, but it does not present a comparative effectiveness study with human readers, nor an effect size for improvement.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not explicitly stated. Given the description as a "post processing software option that can be used in the analysis of CT angiography images to display structures... [and] measure the diameter of the vessel, Hounsfield Units, or plaque density," it implies a standalone functional assessment of the software's capabilities to perform these tasks. However, a formal standalone performance study with specific metrics is not detailed in this summary.
7. The type of ground truth used
Not explicitly stated. For a device that measures vessel diameter, Hounsfield Units, and plaque density, the ground truth would likely involve physical phantom measurements, expert manual measurements on images, or potentially correlation with other imaging modalities or pathology reports (if applicable to plaque density assessment). However, the document does not specify.
8. The sample size for the training set
Not applicable/Not stated. The document refers to a "Software Development, Validation and Verification Process." This is not a machine learning model, so there is no "training set" in the sense of AI/ML.
9. How the ground truth for the training set was established
Not applicable/Not stated. As it's not described as an AI/ML device, the concept of a "training set" for ground truth establishment is not relevant in the context presented.
Summary of Inferred Information from the Document:
The document focuses on establishing substantial equivalence to a predicate device, CardIQ Option 1.0 (K003408). The primary "proof" of meeting criteria appears to be:
- Software Development, Validation, and Verification Process: This general statement implies that internal testing was conducted to ensure the software performs to specifications and user requirements, and adheres to federal regulations and industry standards.
- Absence of new safety risks: The conclusion states, "CardIQ Analysis II does not result in any new potential safety risks and performs as well as devices currently on the market." This suggests a risk analysis was performed.
- Functional Description: The device's capabilities (displaying structures, measuring diameter, Hounsfield Units, plaque density) are described. The implied "acceptance criteria" here would be that the software successfully performs these described functions.
Missing Information:
Crucially, this 510(k) summary does not provide the specific, granular details about acceptance criteria and a dedicated study with quantitative performance metrics that you would typically expect for a device proving its performance against established criteria. It mainly relies on validating that the new version (CardIQ Analysis II) is functionally similar and equally safe to its predicate, CardIQ Option 1.0.
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.