(15 days)
Attenuation correction is a method where the emission images acquired during SPECT acquisitions are compensated for attenuation within the patient. The purpose of attenuation correction is to compensate for varying attenuation of gamma rays in the body.
The intended use of the CardioMD-AC Attenuation Correction option is to provide the costumer with means to measure the attenuation of gamma rays within the body of a patient, when using a DDD CardioMD gamma camera system type 9CSY0799 for SPECT studies, and to map the measured attenuation into images that can be used to compensate emission images for the attenuation. The CardioMD-AC includes additional acquisition of data for scatter correction of these images.
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I apologize, but the provided text from the FDA 510(k) letter for the CardioMD-AC device does not contain the detailed information necessary to answer your request regarding acceptance criteria and the study proving the device meets those criteria.
The 510(k) letter is a regulatory document confirming substantial equivalence to a predicate device, allowing the CardioMD-AC to be marketed. It does not typically include:
- A table of acceptance criteria and reported device performance: This type of data would be found within the 510(k) submission itself, not the FDA's decision letter.
- Sample sizes, data provenance, or expert qualifications for test sets.
- Details on adjudication methods.
- Information about MRMC comparative effectiveness studies.
- Results of standalone algorithm performance studies.
- Specifics on ground truth types or how ground truth was established for training and test sets.
- Training set sample sizes.
The letter primarily focuses on:
- Confirming the device name and regulation details.
- Stating the FDA's finding of substantial equivalence.
- Outlining regulatory responsibilities for the manufacturer.
- Providing the "Indications for Use" statement (on page 2 of the provided text, which states the purpose of attenuation correction and its intended use with the CardioMD gamma camera system).
To obtain the information you're looking for, you would typically need to review the full 510(k) marketing submission document, which may be publicly available through the FDA's website, though often in redacted form.
§ 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.