(146 days)
NeuroSpect QUAD is intended to detect and obtain planar and SPECT images of the distribution of a gamma emitting radionuclide administered in the body.
Gamma Camera NeuroSpect QUAD Gamma Camera Emission Computed Tomography System. The NeuroSpect QUAD nuclear imaging system had four (4) rectangular field of view detector heads.
The provided text is a 510(k) summary for the NeuroSpect QUAD Gamma Camera. Rather than detailing acceptance criteria and a study proving device performance against those criteria, this document primarily asserts substantial equivalence to a predicate device.
Therefore, the requested information regarding acceptance criteria, device performance tables, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set details cannot be extracted from the provided text.
Explanation:
The 510(k) summary focuses on demonstrating that the NeuroSpect QUAD Gamma Camera is "substantially equivalent" to an existing, legally marketed predicate device (the Picker Prism 3000). For devices in this category, the primary requirement is to show that the new device is as safe and effective as the predicate device. This is often achieved through comparison of features, intended use, and adherence to safety standards, rather than conducting new clinical trials with specific performance acceptance criteria.
The document explicitly states:
- "This 510(k) Premarket Notification has been prepared to demonstrate that the NeuroSpect QUAD Gamma Camera... is substantially equivalent to the Picker Prism 3000..."
- "The intended use of the two devices is identical."
- "The NeuroSpect QUAD has been deemed safe and effective and is certified to the same electrical safety standards as the predicate device by a third party organization prior to use on patients."
- "a matrix was constructed comparing the features and intended use of the NeuroSpect QUAD with the predicate device."
- "We conclude that the NeuroSpect QUAD is substantially equivalent to the predicate device and that no new safety or effectiveness concerns are raised."
These statements indicate a comparison-based approach rather than a performance-based study against predefined acceptance criteria.
§ 892.1200 Emission computed tomography system.
(a)
Identification. An emission computed tomography system is a device intended to detect the location and distribution of gamma ray- and positron-emitting radionuclides in the body and produce cross-sectional images through computer reconstruction of the data. This generic type of device may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories.(b)
Classification. Class II.