(14 days)
This device is a digital x-ray system configured for use as a diagnostic x-ray angiography system. This x-ray angiography system is used for diagnostic and interventional procedures for cardiac blood vessels, cerebral blood vessels, abdominal blood vessels and lower extremities.
This device is a digital radiography/fluoroscopy system used in a diagnostic angiography configuration. This system is indicated for use in diagnostic and angiographic procedures for blood vessels in the heart, brain, abdomen and lower extremities.
This system is a single system that employs x-rays to obtain fluoroscopy or radiography images of the body. The system is comprised of a computer system, support arms (that contain the tube and solid state detector), x-ray generator and a patient table.
The provided text does not contain information about specific acceptance criteria or a study designed to prove the device meets such criteria. Instead, it details a 510(k) premarket notification for a medical device (INFX-8000H) and its substantial equivalence to a predicate device (Toshiba INFX-8000C).
The information focuses on:
- Device Description and Intended Use: The device is a digital X-ray angiography system for diagnostic and interventional procedures in various blood vessels.
- Technological Characteristics: It employs similar materials and processes to the predicate device.
- Safety and Effectiveness Concerns: Emphasizes adherence to Quality System Regulations (21 CFR § 820), Federal Diagnostic Equipment Standard (21 CFR § 1020), and medical device safety standards (IEC 60601 series).
- Substantial Equivalence: The primary assertion is that the INFX-8000H is substantially equivalent to the Toshiba INFX-8000C (K081621), implying it complies with the same or equivalent standards and has the same intended use.
- FDA Communication: A letter from the FDA confirming the review of the 510(k) and determining substantial equivalence.
Since the document's core is a declaration of substantial equivalence to a predicate device, it typically relies on existing performance data and regulatory compliance of the predicate, rather than presenting a new, dedicated performance study with specific acceptance criteria. The "acceptance criteria" here are implicitly the regulatory and safety standards met by the predicate device and the new device's adherence to those same standards.
Therefore, I cannot populate the requested table or answer questions about sample sizes, expert qualifications, adjudication methods, MRMC studies, or specific ground truth establishment for a performance study, as this information is not present in the provided text.
§ 892.1650 Image-intensified fluoroscopic x-ray system.
(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. 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). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic 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. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.