(81 days)
The Siemens/CPS E.CAM LSO 311 PET/SPECT System is intended to be utilized by appropriately trained health care professionals to image and measure the distribution of injected single photon radiopharmaceuticals and positron emitting radiopharmaceuticals in humans for use in the determination of various metabolic and physiologic functions within the human body and in the diagnosis of certain disease conditions in various organs, tissues and other anatomical structures.
The E.CAM LSO 311 PET/SPECT system is a dual detector head nuclear camera having the purpose of performing a full range of nuclear medicine procedures, including:
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- static, dynamic, whole body, and gated planar single photon procedures;
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- dynamic, whole body, and gated single photon emission computed tomography (SPECT) procedures; and
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- static, dynamic, whole body, and gated coincidence positron emission tomography (PET) procedures.
The E.CAM LSO 311 system comprises the following components: gantry and patient table mechanical components, computer system (hardware and software), and dual detector heads. Additional features of the system include attenuation correction capabilities and the ability to upgrade existing Siemens E.CAM cameras in the field to the E.CAM LSO 31 l configuration.
The provided text does not contain acceptance criteria for device performance or a study demonstrating the device meets such criteria.
Instead, this document is a 510(k) Summary of Safety and Effectiveness for the E.CAM LSO 311 PET/SPECT System. Its primary purpose is to demonstrate substantial equivalence to previously marketed devices, not to present specific performance metrics against pre-defined acceptance criteria.
The document discusses the device's capabilities and its comparison to predicate devices, but lacks the detailed performance data, sample sizes, ground truth establishment, or expert involvement that would be present in a study designed to prove acceptance criteria.
Therefore, I cannot provide a table of acceptance criteria and reported device performance from this document, nor can I answer the specific questions about sample sizes, ground truth, expert qualifications, or MRMC studies.
The closest information provided is about the device's intended use and general capabilities:
- Intended Use: "to image and measure the distribution of injected single photon radiopharmaceuticals and positron emitting radiopharmaceuticals in humans for use in the determination of various metabolic and physiologic functions within the human body and in the diagnosis of certain disease conditions in various organs, tissues and other anatomical structures."
- Capabilities: "performing static, dynamic, whole body and gated planar single photon imaging procedures, as well as single photon emission computed Tomography (SPECT) procedures and positron emission tomography (PET) procedures utilizing a new combination LSO and NaI(TI) crystal detector system developed by CPS." and "optimizes the clinical usability of coincidence detection imaging, by enhancing the trues count rate and sensitivity performance of the camera, while still retaining optimum single photon capabilities."
These are statements of overall functionality and improved performance relative to older technologies, but they are not quantifiable acceptance criteria with corresponding performance results.
§ 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.