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The Omega Medical Imaging, Inc. CS-Series systems are intended for use in radiographic/fluoroscopic applications including cardiac, vascular, general radiographic/fluoroscopic diagnostic, and interventional x-ray imaging.

The Omega Medical Imaging, Inc. CS-Series systems are comprised of an x-ray source/image receptor positioning device in a permanently floor mounted C-Arm configuration with options of either an elevating only or elevating/tilt patient table. The system may also be configure with a ceiling suspended "C" for bi-plane operation. The positioning of the source/receptor is achieved by motorized motions controlled by the operator. The imaging is achieved by way of an image intensifier/CCD camera with digital image processing.

The provided text is a 510(k) summary for the Omega Medical Imaging, Inc. CS-Series radiographic/fluoroscopy system. It does not contain information about acceptance criteria or a study proving the device meets those criteria, as an acceptance criteria table and performance data are not typically included in a 510(k) summary for devices of this nature (angiographic X-ray systems).

A 510(k) submission primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing detailed performance studies with acceptance criteria in the same way a new, high-risk device might. The document confirms that the device complies with relevant safety and performance standards (e.g., 21 CFR 1020.30, 21 CFR 1020.31, 21 CFR 1020.32, and various IEC and UL standards).

Therefore, I cannot provide the requested information from the given text.

Here's why each specific point cannot be answered:

1. A table of acceptance criteria and the reported device performance: This information is not present in the 510(k) summary. The document states compliance with general safety and performance standards, but no specific acceptance criteria (e.g., for image quality, diagnostic accuracy) are listed, nor is performance data against such criteria.
2. Sample size used for the test set and the data provenance: Not applicable. No clinical or performance test set data (e.g., patient cases) is mentioned for proving diagnostic or clinical performance. The "testing" primarily refers to compliance with safety regulations and electrical standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. As there is no mention of a test set requiring ground truth, no experts for this purpose are stated.
4. Adjudication method for the test set: Not applicable. No test set requiring adjudication is mentioned.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No. MRMC studies are typically for evaluating diagnostic accuracy using human readers, often comparing AI-assisted vs. unassisted performance. This 510(k) summary is for an X-ray system, not an AI diagnostic algorithm, and therefore such a study is not part of this document.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: No. This device is an X-ray system, not a standalone algorithm. Its function is to acquire images, not to interpret them autonomously.
7. The type of ground truth used: Not applicable. Given the nature of the device and the content of the 510(k) summary, no ground truth (e.g., pathology, outcomes data) for diagnostic performance is discussed.
8. The sample size for the training set: Not applicable. This device is an X-ray system, not a machine learning algorithm that requires a training set. The software/firmware mentioned is for controlling mechanical subsystems and is obtained from certified suppliers, not developed by Omega Medical Imaging, Inc. for diagnostic purposes.
9. How the ground truth for the training set was established: Not applicable, as there is no training set mentioned for this device.

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