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The Gyrus PlasmaCision Laparoscopic Spatula is indicated for resection and Coagulation of son and blood vessels in laparoscopic and general surgical when used with the Gyrus PlasmaKinetic Generator or the Gyrus PlasmaKinetic SuperPulse Generator.

The Gyrus PlasmaCision Laparoscopic Spatula is a bipolar electrosurgical instrument with the capability to cut and coagulate soft tissue and blood vessels in laparoscopic with the saper carbon dioxide gas or air insufflation. The instrument will pass through a 5mm cannula or through an operating laparoscope's working channel of 5mm minimum diameter. The instrument is to be used only with the Gyrus PlasmaKinetic Generator, the Gyrus SuperPulse Generator and associated 5 way connector cable. The device is intended for use in a non-irrigated (dry) environment. The device has the functionality to dissect, resect or vaporise tissue with haemostasis, to coagulate tissue and blood vessels and to blunt (cold) dissect tissue.

The provided 510(k) summary for the Gyrus PlasmaCision Laparoscopic Spatula (K041633) does not contain a specific study with defined acceptance criteria and reported device performance in the format requested.

Instead, the summary acts as a notification to the FDA of the intent to market the device, asserting its substantial equivalence to predicate devices based on intended use and technological characteristics. It mentions that "performance validation" has been done to validate the performance of the device without detailing the specific study design, acceptance criteria, or results for device performance against those criteria.

Therefore, I cannot extract the information required for the table and other detailed questions about a specific study.

Information NOT present in this document:

• A table of acceptance criteria and the reported device performance: The document states that "performance validation" has been performed but does not provide specific acceptance criteria or the reported performance data.
• Sample size used for the test set and the data provenance: Not mentioned.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
• Adjudication method for the test set: Not mentioned.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: Not mentioned.
• If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable for this type of device (it's a surgical instrument, not an AI algorithm).
• The type of ground truth used: Not mentioned.
• The sample size for the training set: Not applicable for this type of device.
• How the ground truth for the training set was established: Not applicable for this type of device.

Key takeaway from the document regarding performance:

The document states, "In addition, performance validation results presented in this 510(k) notification to the FDA confirm the comparison and falls substantially equivalent to predicate devices and is safe and effective in its intended use." This is a general statement of equivalence and safety, not a detailed report of a specific study with concrete acceptance criteria and quantitative performance results.

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