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The RiaspDR software directly controls and acquires general radiographic images of human anatomy (excluding fluoroscopic, angiographic, dental and mammographic applications). The RiaspDR software is designed to work with X-ray images from the Mars1417X detector (K210316).

RIASPDR is Radiographic Imaging Acquisition Software Platform. RIASPDR software directly controls and acquires images from Mars1417X detector(K210316) whose manufacturer is iRay Technology. Furthermore, RIASPDR acquires and processes images. In addition, it complies with DICOM standards and is able to transmit and receive data with the PACS system.

The provided FDA 510(k) clearance letter and supporting documentation for the Shen Zhen Cambridge-hit Digital Radiographic Imaging Acquisition Software - DR (RiasDR) do not contain detailed information about the specific acceptance criteria and the comprehensive study that proves the device meets these criteria.

The document states:

• "Software verification and validation testing were conducted and documentation was provided in this 510(k). Results demonstrated that the predetermined acceptance criteria were met."
• "Software Verification and Validation Testing was performed in accordance with internal requirements, international standards and guidance shown below, the safety and effectiveness of RIASPDR were supported, and the substantial equivalence to the predicate device was demonstrated."
• "Clinical testing: Not applicable."

This indicates that acceptance criteria were defined and met through non-clinical testing, but the specifics of these criteria and the methodology of the study are not included in this extract. The document mainly focuses on comparative equivalence to a predicate device (Econsole1, K152172) and adherence to general software validation guidelines and DICOM standards.

Therefore, I cannot provide a detailed answer to your request based solely on the provided text, as the specific information about the acceptance criteria table, sample sizes, expert involvement, adjudication, MRMC study, standalone performance, and ground truth establishment is not present.

However, I can extract the available information and highlight what is missing based on your request:

Device: Digital Radiographic Imaging Acquisition Software - DR (RiasDR)

Study Type: Non-clinical (Software Verification and Validation Testing)

1. Acceptance Criteria and Reported Device Performance

The document specifies performance deviations for certain measurement functions, which likely serve as a subset of the acceptance criteria. However, a complete table of acceptance criteria and a detailed breakdown of all reported device performance metrics are not provided.

Partial Acceptance Criteria (from "5. Device specification"):

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