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The UniCam Evo Software package is indicated for nuclear medicine image post-processing software for scinitigraphic and SPECT imaging. UniCam Evo is indicated for processing and quantification of planar and tomographic bone scintigraphy scans, processing of cerebrovascular scintigraphic scans, processing of planar and tomographic cardiovascular scintigraphic studies, renal dynamic scans, planar and SPECT lung scintigraphy, planar gastrointestinal scintigraphic scans, liver scintigraphy, thyroid scintigraphy and displaying multimodal image fusion between SPECT/CT/MR/PET/ultrasound modalities.

UniCam Evo is a software package for processing planar, whole body, dynamic planar and SPECT nuclear medicine data sets. The UniCam Evo Software is used for digital images capture, pre-processing, saving, post-processing, multiplanar reconstruction, multimodal image fusion, multimodal image registration, 3D rendering, viewing, archiving and transferring between image viewing workstations. The UniCam Evo Software is intended for nuclear medicine specialists, nuclear medicine radiologists, or trained medicine technologists. The operator shall have basic computer operation skills.

The software loads scintigraphic data sets in Dicom 3.0 format from the local database or queries the corresponding dicom data from a PACS archive. The operator may perform analysis on the data, ROI analysis, tomographic reconstruction, organ dependent procedure steps and the software displays the results in form of images, numerical data or curves. The operator may print the results, store as an image or dicom secondary capture. Reconstructed transversal, coronal and sagittal slices can be also stored in Dicom format.

The data to be processed can be transferred via the DICOM 3.0 Standard to another Nuclear Medicine Workstations of another Manufacturer or from a Gamma Camera / SPECT acquisition workstation.

The software runs under standard Windows operating systems, such as XP, 7, 8, 10, 11.

The document provided does not contain a detailed study with specific acceptance criteria and performance metrics for the UniCam Evo Software. Instead, it describes a 510(k) Premarket Notification for the device, which focuses on demonstrating substantial equivalence to legally marketed predicate devices.

Here's what can be inferred and what is not available from the provided text:

No Specific Acceptance Criteria and Device Performance Table:
The document does not include a table of acceptance criteria with reported device performance metrics (e.g., accuracy, sensitivity, specificity values). The verification and validation testing mentioned are to confirm that "product specifications are met" and that "functional testing met for the acceptance of the device," but the specific quantifiable metrics are not detailed.

Inferred Study Type:
The provided text suggests that the study performed was primarily focused on verification and validation (V&V) testing to ensure the software's functionality, design adherence to specifications, and to support the claim of substantial equivalence to predicate devices. It's a general claim about testing rather than a specific clinical performance study.

Information Not Found in the Document:

1. A table of acceptance criteria and the reported device performance: This is not provided. The V&V testing is mentioned generally, stating all tests passed and met acceptance criteria, but no specific performance metrics are quantified.
2. Sample sizes used for the test set and the data provenance: Not mentioned. It states "phantom studies are generated" and "a carefully selected series of studies," but no specific numbers or patient demographics/origin are given.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
4. Adjudication method for the test set: Not mentioned.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance: An MRMC study is not described. The document focuses on the software's inherent functionality and its equivalence to predicate devices, not on human-in-the-loop performance improvement with the AI. The device is described as "Medical image management and processing system" and "nuclear medicine image post-processing software," which typically doesn't involve AI assistance in the direct diagnostic interpretation sense that would necessitate an MRMC study for reader improvement.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The "Nonclinical testing summary" broadly suggests standalone testing of the software's functions (e.g., "results from the current version with the results from reference values wherever possible the phantom studies are generated and the results from the program are validated with the expected values calculated in an independent way"), but specific performance metrics are absent.
7. The type of ground truth used: It mentions using "expected values calculated in an independent way" for phantom studies and "values from the published original reference" for a "carefully selected series of studies." This suggests a combination of simulated/calculated truth (for phantoms) and potentially literature-based/expert consensus/established clinical outcomes (for reference values), but it's not explicitly detailed.
8. The sample size for the training set: Not applicable based on the description of the device as post-processing software rather than a machine learning model that requires a training set. The descriptions focus on the functionality and data handling.
9. How the ground truth for the training set was established: Not applicable, as there's no mention of a machine learning component requiring a training set and corresponding ground truth.

Key Statements Regarding Acceptance and Study:

• Nonclinical testing summary: "Verification and validation testing confirms that product specifications are met which are equivalent in design and technological characteristics as the predicate devices. The testing results support that the functional testing met for the acceptance of the device. The UniCam Evo Software passed all testing and supports the claims of substantial equivalence to the predicate devices."
• Summary of the performed tests: "All performed tests passed and have met the acceptable test criteria. There were no test failures."
• Summary conclusion: "Bench and clinical data demonstrate that processing methods, images and results are equivalent comparing to the predicate devices. No adverse effect has been detected."

In summary, the provided FDA 510(k) clearance letter and summary are a regulatory document demonstrating substantial equivalence. They indicate that internal verification and validation testing was conducted and passed, but they do not provide the detailed public study results and performance metrics that would typically be found in a clinical trial report or a scientific publication. The "acceptance criteria" here are that the software correctly performs its specified post-processing functions and that it is substantially equivalent to existing cleared devices based on functional checks, rather than clinical performance thresholds like sensitivity/specificity for a diagnostic AI.

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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.

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Ask a specific question about this device