(8 days)
The CSCS-001A is a non-invasive post processing package that can be used to evaluate calcified plaques in the coronary arteries, which may be a risk factor for coronary artery disease. This software can be used to generate both DiCOM reports and hard copy reports for the purpose of monitoring disease state over time.
This device is a non-invasive post processing package that allows the user to process volume sets to evaluate calcified plaque in the coronary arteries. These regions of interest can be selected manually or semi-automatically. Using multiple algorithms this software will calculate the calcium score. The software also provides hard copy reports or adds the data to the DiCOM file to allow tracking of the patient,
The provided document is a 510(k) Pre-market Notification for the Toshiba America Medical Systems, Inc. CSCS-001A Calcium Scoring Package. It outlines the device description, indications for use, and a statement of substantial equivalence to predicate devices. However, it does not contain the detailed information required to answer the specific questions about acceptance criteria and the study proving the device meets them.
Here's a breakdown of what's missing and why it cannot be extracted from the provided text:
- Acceptance Criteria and Reported Device Performance: This information is typically found in a clinical or performance evaluation section, often with specific metrics (e.g., accuracy, sensitivity, specificity, inter-observer variability) and target values. The document only mentions "performance standard" as 21 CFR Subchapter J, Federal Diagnostic X-ray Equipment Standard, which is a general regulatory standard, not specific performance criteria for calcium scoring.
- Sample size and data provenance for test set: The document does not describe any specific test set used for validating the device's performance.
- Number of experts and qualifications for ground truth: No information is provided about experts or ground truth establishment.
- Adjudication method for test set: No test set is described, so no adjudication method is mentioned.
- Multi-reader multi-case (MRMC) comparative effectiveness study: There is no mention of such a study or any effect size related to human reader improvement with AI assistance.
- Standalone performance study: The document focuses on the regulatory submission and substantial equivalence, not on a detailed performance study of the algorithm in a standalone capacity.
- Type of ground truth used: Since no test set or performance study is described, the type of ground truth is not specified.
- Sample size for training set: No training set information is included.
- How ground truth for training set was established: No training set information is included.
Conclusion:
The provided 510(k) summary focuses on demonstrating substantial equivalence to predicate devices and adherence to general regulatory standards. It does not present the detailed clinical or performance study data, acceptance criteria, or ground truth establishment methods that would be necessary to answer your specific questions. These details are typically found in a separate performance study report or a more comprehensive technical document that might be referenced but is not included here.
§ 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.