(15 days)
The Silhouette FC is intended for use in generating radiographic images of human anatomy in all general purpose diagnostic procedures. This device is not intended for mammographic applications.
The Silhouette FC consists of a radiographic table, a overhead suspension, high frequency generator and power tube distribution unit, wall stand, dual focal spot x-ray tube and operator's console.
This 510(k) pertains to the Silhouette FC Diagnostic X-Ray System. The provided text does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria in the context of device performance metrics (e.g., sensitivity, specificity, accuracy).
Instead, the document focuses on:
- Device Description: A general description of the physical components of the Silhouette FC (radiographic table, overhead suspension, generator, wall stand, x-ray tube, console).
- Intended Use: "generating radiographic images of human anatomy in all general purpose diagnostic procedures. This device is not intended for mammographic applications."
- Conformance to Standards: The device will conform to specific sections of 21CFR 1020.30 and 1020.31, and UL 2601-1 (which includes IEC 601-1 and UL 187), and also meets IEC 601-1-2 for EMC. This is related to electrical and radiological safety, not diagnostic performance.
- Substantial Equivalence: The primary conclusion is that GE considers the Silhouette FC to be "equivalent with other marketed devices with the same indications for use and meeting similar standards." The FDA's letter confirms substantial equivalence to legally marketed predicate devices.
Therefore, I cannot populate the requested table or answer the detailed questions about studies, sample sizes, ground truth, or expert involvement, as this information is not present in the provided text.
This type of 510(k) submission, especially from 1999, typically relies on demonstrating that the new device has the same intended use and technological characteristics as an existing, legally marketed predicate device, and that any differences do not raise new questions of safety or effectiveness. It does not typically require extensive clinical performance studies with acceptance criteria as would be expected for a novel diagnostic algorithm or a device with a new clinical claim.
§ 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.