(70 days)
The Volumetric Specimen Imager is a Cabinet x-ray system that is used to provide two and three dimensional digital x-ray images of harvested specimens from various anatomical regions in order to provide rapid verification that the correct tissue has been excised during the biopsy procedure. Doing the verification directly in the same room or nearby enables cases to be completed faster, thus limiting the time the patient needs to be under examination. Specimen radiography can potentially limit the number of patient recalls.
The Clarix Imaging Volumetric Specimen Imager (VSI) is a portable, fully shielded cabinet X-ray system that provides high resolution 2D and 3D radiographic images of surgically excised specimens. The VSI system consists of an image-acquisition device and software for image reconstruction, visualization, and archival. Enabled by optimized imaging geometry and iterative image reconstruction algorithm, VSI provides superior spatial and contrast resolution for visualizing specimens with soft tissues or boney structures. VSI is designed to comply with 21 CFR 1020.40 and DICOM standards.
The provided text is a 510(k) summary for the Clarix Imaging Volumetric Specimen Imager (VSI). It describes the device, its intended use, and a comparison with a predicate device. However, it explicitly states that clinical data was not required to demonstrate substantial equivalence to the predicate device. Therefore, the document does not contain the detailed information requested regarding acceptance criteria and a study proving the device meets those criteria through clinical performance.
The "Non-clinical Performance Data" section lists several tests performed, but these are primarily for electrical safety, electromagnetic compatibility, compliance with regulations and standards (IEC, CFR, DICOM), phantom imaging, and user testing. The "Tissue Verification" listed here would likely refer to non-clinical verification of image quality for tissue, not a clinical study involving human patients or complex diagnostic assessments.
Given the information provided in the 510(k) summary, I cannot fill out the requested table or describe a study that proves the device meets specific acceptance criteria based on clinical performance. The 510(k) pathway for this device relied on demonstrating substantial equivalence to a predicate, not on new clinical performance data to establish specific diagnostic accuracy or efficacy metrics.
Therefore, many of the requested fields about ground truth, expert readers, MRMC studies, and effect sizes cannot be answered from this document. If such a study were performed, its details would be found in a separate clinical study report, not typically summarized in this manner for a 510(k) submission where clinical data was explicitly not required for substantial equivalence.
§ 892.1680 Stationary x-ray system.
(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.