(69 days)
This device is intended to be used in the diagnosis of circulatory vascular system. / This device is operated and used by Physicians and X-ray technologist. As mentioned at "Intended Use" in this clearance letter, the intended use of the MH-400 is the same as that of predecessor device MH-31A (K903372).
Not Found
This is an FDA 510(k) clearance letter for the Shimadzu Medical Systems Lateral Angiographic C-arm Support MH-400. This type of letter generally communicates the FDA's decision regarding substantial equivalence to a predicate device and does not typically contain detailed information about acceptance criteria or specific study results that prove a device meets those criteria, especially for a non-AI/software device like an angiographic C-arm support system.
Based on the provided text, I cannot extract the information required in your request for the following reasons:
- Device Type: The device in question, the "Lateral Angiographic C-arm Support MH-400," is a physical medical device (an accessory for an angiographic x-ray system), not an AI/software-driven diagnostic tool. Therefore, the concepts of "acceptance criteria" and "study that proves the device meets the acceptance criteria" as they relate to AI algorithms (e.g., performance metrics like sensitivity, specificity, F1-score) are not applicable in this context.
- Document Content: This regulatory clearance letter details the administrative aspects of FDA clearance (e.g., substantial equivalence, regulatory class, general controls) and lists the intended use. It does not contain the technical specifications, performance data, clinical study details, or ground truth establishment relevant to an AI-driven device.
Therefore, I cannot populate the table or answer the specific questions about sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details. These elements are typically found in a 510(k) submission's performance data sections, not in the clearance letter itself.
§ 892.1600 Angiographic x-ray system.
(a)
Identification. An angiographic x-ray system is a device intended for radiologic visualization of the heart, blood vessels, or lymphatic system during or after injection of a contrast medium. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.