(90 days)
The Lung Nodule Assessment and Comparison Option is intended for use as a diagnostic patient-imaging tool. It is intended to provide quantitative information about "physician- 1 wou nTEO" identified" lung nodules that are identified on high-resolution computed tomography images of the lung.
The Lung Nodule Assessment and Comparison Option is used in a workstation (Mx View) of a Computed Tomography X-Ray System intended to produce crosssectional images of the lungs by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles
Not Found
The provided text is a 510(k) premarket notification for the "Lung Nodule Assessment and Comparison Option" device. It outlines the device's intended use and substantial equivalence to predicate devices but does not contain information about acceptance criteria, a specific study proving it meets acceptance criteria, or detailed performance metrics.
Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them, as this information is not present in the provided document.
The document primarily focuses on:
- Submitter and Device Name information.
- Intended Use Statement: To provide quantitative information about physician-identified lung nodules on high-resolution CT images.
- Predicate Device Comparison: Stating substantial equivalence to "Image Processing Function on the Select CT/SP" and "Mx8000IDT" based on similar standards and intended uses.
- Safety and Effectiveness Statements: General adherence to FDA GMPs and voluntary standards.
- FDA Clearance Letter: Confirming the 510(k) clearance and classification.
Missing Information:
All of the requested information regarding specific acceptance criteria, study details (sample size, data provenance, expert details, adjudication, MRMC or standalone performance, ground truth types for test and training sets, and training set size and ground truth establishment) is absent from this document.
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.