(31 days)
The Plaque Analysis option is a non-invasive diagnostic reading software intended for use by cardiologists and radiologists as an interactive tool for viewing and analyzing cardiac CT data for determining the presence and extent of coronary plaques.
Philips' Comprehensive Cardiac Analysis (CCA) Plaque Assessment tool is a noninvasive diagnostic reading software intended to provide cardiologists and radiologists with an optimized non-invasive application to provide accurate quantification and characterization of coronary plaque. It is an interactive post-processing tool for viewing and analyzing cardiac CT image data for determining the presence and extent of coronary plaques.
The Plaque Analysis option was added to the Comprehensive Cardiac Analysis option (a.k.a. CCA) predicate device. It provides analysis of the vessel lumen and wall and makes it easier to detect findings in the coronary vessels.
The Plaque Analysis application calculates lumen and vessels contours, detects findings along the vessel wall by a single click algorithm and provides a set of measurements for all the detected findings. The option includes visualization and manual correction tools.
Outputs of the application include coronary findings segmentation and quantification.
1. Table of acceptance criteria and reported device performance:
The provided 510(k) summary (K092742) for Philips' Comprehensive Cardiac Analysis (CCA) Plaque Assessment Tool does not explicitly state specific quantitative acceptance criteria or the numerical performance results of a study designed to meet such criteria. The document focuses on demonstrating substantial equivalence to predicate devices based on safety and effectiveness considerations, rather than reporting on a specific performance study with defined metrics.
However, based on the description of the device's function, we can infer the intent of performance from the device description and indications for use. The device "provides analysis of the vessel lumen and wall and makes it easier to detect findings in the coronary vessels," and its intended use is to "provide accurate quantification and characterization of coronary plaque."
Therefore, for the purpose of this exercise, we will conceptualize the implied performance and how it might be assessed, even though the specific metrics and results are not present in the provided text.
| Acceptance Criteria (Implied from Device Description) | Reported Device Performance (Not explicitly stated with quantitative values in the 510(k)) |
|---|---|
| Accurate detection of coronary plaques | Device "detects findings along the vessel wall by a single click algorithm" |
| Accurate quantification of coronary plaques | Device "provides a set of measurements for all the detected findings" |
| Accurate characterization of coronary plaques | Device intended to "provide accurate quantification and characterization of coronary plaque" |
| Facilitates analysis of vessel lumen and wall | "provides analysis of the vessel lumen and wall and makes it easier to detect findings" |
| Non-invasive diagnostic reading software for cardiologists and radiologists | Intended for use by "cardiologists and radiologists as an interactive tool" |
| Substantially equivalent to predicate devices for safety and effectiveness | "is substantially equivalent in safety and effectiveness to the predicate devices" |
2. Sample size used for the test set and data provenance:
The provided document does not specify the sample size used for any test set or the data provenance (e.g., country of origin, retrospective or prospective) for a performance study. The 510(k) focuses on demonstrating substantial equivalence through a comparison of technological characteristics, safety, and intended use to predicate devices, rather than presenting a detailed clinical performance study with test sets.
3. Number of experts used to establish the ground truth for the test set and qualifications of those experts:
The document does not mention any ground truth establishment process, the number of experts involved, or their qualifications. As no specific performance study is detailed, the information regarding ground truth is absent.
4. Adjudication method for the test set:
Since no specific performance study or test set is described, there is no mention of an adjudication method.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:
The document does not indicate that a multi-reader multi-case (MRMC) comparative effectiveness study was performed. The focus is on the device's standalone capabilities and its equivalence to other legally marketed devices, not on its assistive impact on human readers in a comparative setting.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
The 510(k) summary does not explicitly state that a standalone (algorithm-only) performance study was conducted with quantitative results. While it describes the algorithm's capabilities ("detects findings along the vessel wall by a single click algorithm" and "calculates lumen and vessels contours"), it does not provide metrics of its performance purely in an automated fashion. The device is described as an "interactive tool," implying human involvement in its intended use.
7. The type of ground truth used:
The document does not specify the type of ground truth used as no explicit performance study with ground truth is detailed.
8. The sample size for the training set:
The document does not provide any information regarding the sample size for a training set. As this is a 510(k) summary focused on substantial equivalence rather than a detailed technical report of algorithm development, such information is typically not included.
9. How the ground truth for the training set was established:
The document does not describe how the ground truth for a training set was established, as no training set or its associated ground truth process is mentioned.
§ 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.