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The DR-XD 3000 is a mobile C-arm system with detachable flat panel detector, which is intended for use in providing medical imaging for general populations including pediatrics. The device provides pulsed fluoroscopic imaging of patients during diagnostic, interventional and surgical procedures and digital radiographic imaging. It is intended for use in procedures such as cholangiography, endoscopic, orthopedic, neurologic, peripheral vascular, critical care, emergency room procedures. This device does not support cardiac procedures and is not intended for use in performing mammography.

The FDR CROSS is mobile X-ray fluoroscopy equipment designed and manufactured by Fujifilm Corporation (FTYO) featuring high mobility arising from small size and light weight. The C-arm cart irradiates X-rays and detects X-rays by the flat panel sensor to perform X-ray fluoroscopy and radiography. A flat panel sensor has higher sensitivity than an image intensifier, which can result in dose reduction. The flat panel sensor is same as FDR D-EVO III Flat Panel Detector System (predicate device) cleared as radiography purpose. (K192932) The system contains the console software (DR-ID 340CL), control cabinet software (DR-ID 3000MC) and X-ray controller software (DR-ID 3000SX). The DR-ID 340CL and DR-ID 3000MC is modified to add fluoroscopic function based on the DR-ID 300CL and DR-ID 1200MC which are used in FDR D-EVO III Flat Panel Detector System cleared as radiography purpose (K192932). The software's Level of Concern is Moderate.

The provided text is a 510(k) Summary for a medical device (FDR CROSS (DR-XD 3000)), primarily focusing on demonstrating substantial equivalence to a predicate device. It details the device's characteristics and indicates what standards and guidance documents were followed for non-clinical performance data.

However, the document does not contain any information about an acceptance criteria table, device performance data against acceptance criteria, sample sizes for test or training sets, data provenance, expert ground truth establishment (number of experts, qualifications, adjudication), MRMC studies, or standalone algorithm performance.

The "SUMMARY OF STUDIES" section states: "Non-clinical Performance Data: The FDR CROSS (DR-XD 3000) conforms to the voluntary standards such as AAMI/ANSI ES60601-1, IEC 60601-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-1-6, IEC 62304, IEC 62366-1, DICOM 3.0, IEC 60601-2-43, IEC 60601-2-54. In addition, the FDA's Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices (issued on August 6, 1999) was followed to describe the detector characteristics, and Radio Frequency Wireless Technology in Medical Devices (issued August 14, 2013) was followed to test. As required by the risk analysis, necessary verification and validation activities were performed including software testing, and the results were satisfactory."

This indicates that the performance evaluation was based on conformance to voluntary standards and internal verification and validation activities, rather than a clinical study involving human readers or AI performance metrics against a clinical ground truth. The device listed (FDR CROSS (DR-XD 3000)) appears to be an X-ray imaging system, not an AI/CADe device that would typically have the kind of acceptance criteria and performance study described in your prompt.

Therefore, for your specific request:

1. A table of acceptance criteria and the reported device performance: Not provided in the document. The performance evaluation focuses on conformance to general medical device standards for X-ray systems.
2. Sample sized used for the test set and the data provenance: Not provided. The studies mentioned are non-clinical (conformance to standards, software testing).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/Not provided. No human expert review to establish ground truth is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable/Not provided.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not done/Not applicable. This device is an imaging system, not an AI assistance tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm-only device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The performance is assessed against engineering and regulatory standards for X-ray devices.
8. The sample size for the training set: Not applicable/Not provided. This device is an X-ray system, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established: Not applicable.

In conclusion, the provided FDA 510(k) summary for the FDR CROSS (DR-XD 3000) does not contain the type of acceptance criteria and study information (e.g., clinical performance metrics, AI-specific studies) you are asking for. The clearance for this device is based on its substantial equivalence to a predicate X-ray system, demonstrated primarily through engineering safety and performance testing against recognized standards.

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