(89 days)
To detect or image the distribution of radionuclides in the body or organ, using the following techinique(s): Planar Imaging, Whole Body Imaging, Positron imaging with out coincidence. Camera range increases to 588 keV.
E.CAM Extra High Energy Collimator
This 510(k) submission for the Siemens E.CAM Extra High Energy Collimator does not contain information regarding objective performance criteria or a study demonstrating the device meets such criteria.
The document primarily focuses on establishing substantial equivalence to legally marketed predicate devices, which is a common pathway for 510(k) clearances. This means the manufacturer is asserting their device is as safe and effective as a device already on the market, rather than needing to prove new safety and effectiveness through extensive clinical trials with pre-defined acceptance criteria.
Here's a breakdown of why the requested information cannot be provided from the given text:
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A table of acceptance criteria and the reported device performance: This information is not present. The submission focuses on product description and comparison to existing devices, not on quantitative performance metrics against pre-defined criteria.
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Sample size used for the test set and the data provenance: No test set is described. The device is a "collimator," an accessory for a nuclear medicine camera, not a diagnostic algorithm or a device that processes patient data in a way that requires specific "test sets" for performance evaluation in the context of this submission. The "study" mentioned in the prompt usually refers to clinical performance studies, which are not detailed here.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as there's no described test set or ground truth establishment process.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for the same reasons as above.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a collimator, not an AI-powered diagnostic tool. MRMC studies are typically for evaluating the impact of AI on human interpretation of medical images.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a hardware component (collimator), not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as there's no described performance evaluation against a "ground truth."
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The sample size for the training set: Not applicable, as this is a hardware component. Training sets are relevant for machine learning algorithms.
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How the ground truth for the training set was established: Not applicable.
In summary, the provided documents indicate a 510(k) clearance based on substantial equivalence, not on a detailed performance study against specific acceptance criteria. The "Summary of Safety and Effectiveness" (K982387) states:
- "The Siemens E.CAM Extra High Energy Collimator is a product which is substantially equivalent to legally marketed devices."
- "The device labeling contains instructions for use. It includes indications for use and cautions. This information assures safe and effective use of the device."
These statements highlight the regulatory strategy chosen by the manufacturer, which relies on demonstrating similarity to already approved devices rather than presenting novel performance data.
§ 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.