(53 days)
The NetCo MDTS software is intended to be used in the transportation, storage, and retrieval of digital patient files.
The DICOM storage service class functionality is provided by two applications that execute on the NAD platform. The applications act as proxies for DICOM storage Service Class Provider (SCP) devices and storage Service Class User (SCU) devices on either end of a transportation network connection. The storage SCP proxy is configure-able to emulate another SCP device that is the destination of DICOM data. The file is moved across the transportation network to one or more destination NADs. On the destination NAD is a proxy SCU application that is configured to emulate the original SCU that sent the data. The original DICOM message file is kept intact as it is processed through the originating NAD and transmitted via the pathway.
The provided document is a 510(k) summary for the NetCo Medical Data Transportation Service software. It primarily focuses on regulatory approval, intended use, and comparison to predicate devices, rather than a detailed study proving device performance against acceptance criteria.
As such, the document does not contain the information required to populate the table and answer the specific questions about acceptance criteria and a study proving performance.
The document states:
- Intended Use: "The NetCo MDTS software is intended to be used in the transportation, storage, and retrieval of digital patient files."
- Device Description: It describes the software's functionality in handling DICOM storage service class, acting as proxies for SCP and SCU devices, moving files across a network, and keeping the original DICOM message file intact.
- Comparison of technological characteristics: "The NetCo MDTS software and the predicate product software all employ proprietary software and DICOM file standards to interface with a health care subscriber's network to transmit, store and retrieve medical image data."
However, it does not include:
- A table of acceptance criteria or reported device performance metrics (e.g., speed of transfer, data integrity percentage, error rates for storage/retrieval).
- Details of any specific study conducted to demonstrate the device meets performance criteria, including sample sizes, data provenance, ground truth establishment, expert involvement, or adjudication methods.
- Information on multi-reader multi-case (MRMC) studies or standalone algorithm performance.
- Details on training sets.
Therefore, I cannot fill out the requested table or answer the specific questions based on the provided text. The document is a regulatory submission summary, not a technical performance report.
§ 892.2020 Medical image communications device.
(a)
Identification. A medical image communications device provides electronic transfer of medical image data between medical devices. It may include a physical communications medium, modems, and interfaces. It may provide simple image review software functionality for medical image processing and manipulation, such as grayscale window and level, zoom and pan, user delineated geometric measurements, compression, or user added image annotations. The device does not perform advanced image processing or complex quantitative functions. This does not include electronic transfer of medical image software functions.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 892.9.