(8 days)
The PlaqueView (SurePlaque) tool kit application software package is intended to assist trained physicians in the stratification of patients identified to have coronary disease (CAD). This software post processes images obtained using a multidetector Aquilion CT. The package provides tools for the measurement and visualization (color coded maps) of coronary arteries.
The CSPV-001A is an image analysis software package, that will be applied to the Toshiba TSX-101A (Aquilion) CT scanner, that allows the user to process acquired image data. The package allows visualization of the data in image map formats. Additionally, the package allows the display of numeric data via the image analysis software that is integral to the package. The software is post processing and does not control the x-ray features of the system.
The provided text describes a 510(k) submission for "PlaqueView (a.k.a. SurePlaque) CSPV-0001A," an image analysis software package for Toshiba Aquilion CT scanners. However, the document does not contain any information regarding acceptance criteria, performance studies, sample sizes, ground truth establishment, or expert involvement for device validation.
The document focuses on the regulatory aspects of the device, its intended use, technological characteristics, safety and effectiveness concerns (addressed by compliance with Quality System Regulations and IEC-60601 standards), and its substantial equivalence to predicate devices (General Electric Perfusion CT 2 [K0041267] and Siemens Perfusion CT [K990426]).
Therefore, based solely on the provided text, I cannot fill out the requested table or answer the specific questions about acceptance criteria and study details. The document states: "Both this and the prodicate devices are used as post-processing software applied to images collected by the parent CT Scanner." and "This package and the predicate devices are all post-processing and provide the same features of visualization and numeric data." This suggests that the substantial equivalence argument relies on the software performing similarly to existing cleared devices in terms of visualization and data presentation, rather than presenting a new clinical performance study with specific acceptance criteria.
Summary of what can be derived from the text (and what cannot):
1. A table of acceptance criteria and the reported device performance:
- Cannot be provided. The document does not define specific acceptance criteria or report performance metrics (e.g., accuracy, sensitivity, specificity).
2. Sample sized used for the test set and the data provenance:
- Cannot be provided. No information on specific test sets, sample sizes, or data provenance is mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Cannot be provided. No mention of experts or ground truth establishment for a test set.
4. Adjudication method for the test set:
- Cannot be provided. No information on adjudication methods is present.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done:
- Cannot be provided. No MRMC study is described. The submission focuses on substantial equivalence to predicate devices based on shared technological characteristics and intended use.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Cannot be provided. No standalone performance study is described.
7. The type of ground truth used:
- Cannot be provided. No ground truth information is provided for any dataset.
8. The sample size for the training set:
- Cannot be provided. No mention of a training set or its size.
9. How the ground truth for the training set was established:
- Cannot be provided. No information on ground truth establishment for a training set.
In conclusion, the provided 510(k) summary focuses on the regulatory pathway of substantial equivalence rather than presenting a detailed performance study with quantifiable acceptance criteria.
§ 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.