(114 days)
MultiCam 3000 eco is intended to detect and obtain Planar and SPECT images of the distribution of a gamma emitting radionuclide in the organs or bone and store the data, when the radionuclide is administered in the body.
The MultiCam 3000 eco consist of the gantry with 3 Gamma Camera detectors, a patient table together with an Acquisition Workstation. The Performance or Quality assurance can be done on the Acquisition Workstation with the integrated quality software or on the connected Processing Workstations. The data will be transferred via the DICOM 3.0 Standard to a Nuclear Medicine Workstations of another Manufacturer, where the patient documentation will be done. The signal processing is done similar to the existing Prism 3000 or the CX 250 but on one high integrated board - LQN - which provides the Detector data via TCP/IP network to the Acquisition Computer. Also in the MultiCam 3000 eco a Nal crystal is used with 49 Photomultiplier. The Field of View is 13" x 7,9". For the system there are 7 different collimators are optional available. The collimator exchange can be done manual. Each collimator has its own collimator switch which disables the dedicated motion over a separate electronic circuitry. The function of the collimator is also checked continuously by this safety circuits. The patient monitor is used for patient positioning. It consists of a color monitor for the display of the patient study during acquisition. Additional on it is a window with numeric information for the gantry motion information and the collimator information. It shows also Warning - and Error - Messages of the gantry. Functional characteristics: Each photomultiplier is precisely digitized with a resolution of 18 bit ADC's. No electronic is anymore needed on the photomultiplier. The output of all 3 detectors are combined in a 1000 Mbit switch and connected over a proprietary TCP/IP network to the Acquisition Computer.
The provided text makes no mention of specific acceptance criteria or a study designed to prove the device meets such criteria. The 510(k) summary focuses on describing the device, comparing it to predicate devices, and stating its intended use and general safety claims.
Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and a detailed study from the given information.
Here's a breakdown of what is and is not present:
What the document does include:
- Intended Use Statement: "MultiCam 3000 eco is intended to detect and obtain Planar - and SPECT Images of the distribution of a gamma emitting radionuclide in the organs or bone and store the data, when the radionuclide is administered in the body. Like all Gamma Cameras with the dedicated radiopharmaceutical it is possible to show functional imaging for diagnostic purpose."
- General Safety and Effectiveness Claims: "The device has been designed, verified and validated complying with applicable safety standards for this type of medical equipment. Bench and clinical data demonstrate that images otandards for this type of comparing to the predicate devices. No adverse effect has been detected. Additionally, a laboratory test has been carried out to validate the electromagnetic compatibility and biocompatibility by a third party organization."
- Substantial Equivalence Claim: "A matrix was made comparing the MultiCam 3000 eco to predicate devices and therefore we concluded that it is substantially equitalent to the legally marketed device."
What the document does not include (and is necessary to answer your request):
- Specific, quantifiable acceptance criteria (e.g., specific image resolution, sensitivity, or diagnostic accuracy thresholds).
- Any details of a study conducted to demonstrate that the device meets these criteria.
- Reported device performance metrics against acceptance criteria.
- Sample sizes for test or training sets.
- Data provenance (country, retrospective/prospective).
- Number and qualifications of experts for ground truth.
- Adjudication methods.
- Information on a multi-reader multi-case (MRMC) comparative effectiveness study.
- Details about standalone algorithm performance.
- The type of ground truth used (e.g., pathology, expert consensus).
- How ground truth for any potential training set was established.
Without specific performance data, quantitative acceptance criteria, and study details, it's impossible to create the table or answer the other highly specific questions about study design and results. The content provided is typical for a 510(k) summary focused on substantial equivalence to predicate devices, rather than a detailed performance study report.
§ 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.