(94 days)
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A 0-50 digital display power setting indicator provides the operator a parallax free reading of the power setting (+/- 5watts, full scale @ 100 ohms).
A bar graph display output current monitor provides the operator a relative measure of the output current amplitude and to denote the presence of output energy during activation.
The handswitch is powered by an independent low voltage (7 Vdc) isolated power supply.
Audio and Visual monitors are in accord with IEC 601-1-2 and ANSI HF-18 guidelines.
RF and Low Frequency leakages are well within IEC 601-1-2 and ANSI HF-18 safety guide lines for isolated (body floating) bipolar coagulators.
The provided text is a 510K summary for the BERGEN 610 Coagulator, specifically stating its substantial equivalence to existing approved devices for safety and effectiveness. However, it does not contain any information about a study proving the device meets acceptance criteria in the way that would typically be described for a diagnostic or AI-powered medical device.
The information provided describes the device's technical specifications and compliance with broad safety guidelines, rather than performance metrics from a clinical study. Therefore, I cannot extract the requested information as it is not present in the provided document.
Here's a breakdown of why each point cannot be addressed:
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A table of acceptance criteria and the reported device performance: The document only lists technical specifications (e.g., "0-50 digital display power setting indicator provides the operator a parallax free reading of the power setting (+/- 5watts, full scale @ 100 ohms)") and safety compliance (e.g., "Audio and Visual monitors are in accord with IEC 601-1-2 and ANSI HF-18 guidelines"). It does not define explicit "acceptance criteria" for a study or report device performance against such criteria in the context of diagnostic accuracy, sensitivity, specificity, or similar metrics that would be relevant for a study evaluating performance.
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Sample size used for the test set and the data provenance: No test set is mentioned, nor any study involving data.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No test set or ground truth establishment process is described.
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Adjudication method for the test set: Not applicable, as no test set is mentioned.
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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 coagulator, not an AI-powered diagnostic tool, and no MRMC study is mentioned.
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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 medical device (coagulator) and not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): No ground truth is described, as no study evaluating diagnostic or predictive performance is present.
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The sample size for the training set: Not applicable, as this device is a hardware coagulator and does not involve AI training.
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How the ground truth for the training set was established: Not applicable, as this device is a hardware coagulator and does not involve AI training.
In summary, the provided 510K document is a declaration of substantial equivalence for a physical medical device (coagulator) based on its technical specifications and compliance with general safety standards. It does not describe a clinical performance study using test sets, ground truth, or expert evaluations in the manner requested for diagnostic or AI-driven devices.
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.