(205 days)
To detect or image the distribution of radionuclides in the body or in organ, using the following technique(s): Planar imaging, Whole body imaging, Tomographic imaging (SPECT) for non Positron emitter, Positron imaging without coincidence. Could be used with 511 keV photo imaging and photons of smaller energy simultaneously (e.g. 140 keV and 511 keV).
511 keV Collimator for TRIONIX Triad
I am sorry, but the provided text does not contain the detailed information necessary to describe the acceptance criteria, the specific study proving the device meets those criteria, or the various aspects of a clinical study typically associated with device performance (sample sizes, expert qualifications, ground truth establishment, MRMC studies, or standalone performance).
The documents are FDA 510(k) clearance letters and "Indication For Use" forms for a "511 keV Collimator for TRIONIX Triad" (K964438). These documents confirm that the device is substantially equivalent to legally marketed predicate devices and outline its intended uses (e.g., planar imaging, whole body imaging, tomographic imaging for non-positron emitters, positron imaging without coincidence, all for 511 keV energy range).
However, they do not include:
- A table of acceptance criteria and reported device performance: The documents do not list specific performance metrics (e.g., sensitivity, specificity, accuracy, resolution, signal-to-noise ratio) nor any numerical results from tests.
- Details about a study: While a 510(k) submission requires evidence of substantial equivalence, the provided letters do not describe the methodology, results, or specifics of such a study.
- Sample sizes, data provenance, expert details, or ground truth establishment: Information regarding patients, data sources, or the methodology for confirming diagnoses (ground truth) is absent.
- MRMC comparative effectiveness or standalone performance: These types of studies are not mentioned or detailed.
The 510(k) process primarily focuses on demonstrating that a new device is as safe and effective as a legally marketed predicate device, often by showing it has the same technological characteristics and intended use, or by providing valid scientific evidence to demonstrate substantial equivalence for different technological characteristics without raising new questions of safety or effectiveness. It does not typically involve the detailed disclosure of performance criteria and study results in the same way as a full clinical trial publication.
§ 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.