(135 days)
The DW-CACTAS is a medical image processing software, combining digital image processing and visualization tools (multiplanar reconstruction (MPR) think, maximum intensity projection(MP) thin/thick, inverted MIP thinkthick, volume rendering technique (VRT), curved planar reformation (CPR)), this software is used for post-processing of coronary CT angiography images.
Medical image processing software (DW- CACTAS) is a network system management and image processing software based on local storage service. The software obtains image data from medical image equipment through image network transmission and storage technology, and stores data in the server. Through the information system management function module and image processing module, medical institution can transmit, store, query, browse, manage and process image data. Combining digital image processing and visualization tools (multiplanar reconstruction (MPR) thin/thick, maximum intensity projection(MIP) thin/thick, inverted MIP thin/thick, volume rendering technique (VRT), curved planar reformation (CPR)), the DW- CACTAS is used for post-processing of coronary CT angiography images. The data transmission of the software follows the HTTP transmission protocol and DICOM network protocol, and supports the DICOM3.0 standard data transmission interface. The medical image storage format is DICOM.
The provided text describes the regulatory clearance for the "Medical image processing software" (DW-CACTAS) but does not contain any information regarding acceptance criteria, reported device performance, or a study to prove the device meets said criteria.
The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device (syngo.CT Coronary Analysis, K173637). The submission primarily relies on non-clinical bench testing and software verification and validation to support its claims.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and reported device performance.
- Sample size used for the test set and data provenance.
- Number of experts and their qualifications for ground truth establishment.
- Adjudication method for the test set.
- MRMC comparative effectiveness study results.
- Standalone performance data (beyond functional software testing).
- Type of ground truth used (as no clinical performance data is presented).
- Sample size for the training set.
- How ground truth for the training set was established.
The document explicitly states:
- "No clinical study is included in this submission." (Page 4)
- "Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards: Bench Testing for the Software Test Report" (Page 4)
- "Non-clinical tests (integration and functional) were conducted for DW- CACTAS during product development. Performance tests were conducted to test the functionality of DW- CACTAS. The modifications described in this Premarket Notification were supported with verification/validation testing. These tests have been performed to test the ability of the included features of the subject device. The results of these tests demonstrate that the subject device performs as intended." (Page 7)
The only performance-related information provided is highly general and relates to functional software testing and adherence to standards:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Implied by regulatory standards & functional testing) | Reported Device Performance |
|---|---|
| Conformance to IEC 62304 (Software life cycle processes) | Device complies with IEC 62304 Edition 1.1 2015-06. |
| Conformance to NEMA PS 3.1 - 3.20 (DICOM Set) | Device complies with NEMA PS 3.1 - 3.20 (06/27/2016). |
| Conformance to ISO 14971 (Risk management) | Device complies with ISO 14971 (2019-12). |
| Conformance to IEC 62366-1 (Usability engineering) | Device complies with IEC 62366-1 Edition 1.1 (2020-06). |
| Functionality of software features | "The function of the software meets the expected functional requirements." |
| DICOM communication protocol | Establishes communication with PACS, obtains medical image data via network, able to transmit, browse, query, and process medical images. |
| Cybersecurity requirements | Conforms to cybersecurity requirements by implementing processes to prevent unauthorized access, modifications, misuse, denial of use, or unauthorized information transfer. |
| Software specifications | "All software specifications have met the acceptance criteria." |
No specific quantitative or qualitative performance metrics (e.g., sensitivity, specificity, accuracy for coronary lesion detection/measurement) related to the device's diagnostic capabilities are provided in this document. The "performance data" section is focused on demonstrating functional compliance and risk management, not clinical efficacy or diagnostic accuracy.
§ 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.