(244 days)
The Plasmacision and Plasmablend Electrodes are indicated for Bipolar electrosurgical resection and coagulation of soft tissue and blood vessels in laparoscopic or general surgical procedures.
The Gyrus PlasmaCision and PlasmaBlend electrodes are bipolar electrosurgical instruments with the capability to cut and coagulate soft tissue and blood vessels in laparoscopic surgery under carbon dioxide gas or air insufflation. The instrument will pass through a 5mm cannula or through an operating laparoscope working channel of 5mm or larger diameter. The PlasmaCision and PlasmaBlend electrodes may also be used in general surgical procedures. The instruments are to be used only with the Gyrus General Surgery RF Workstation. Activation of the instruments is achieved via footswitch control. The Instruments are available with and without aspiration (suction) / irrigation lines. On such equipped instruments, this provides additional functionality to the device by increasing its range of capabilities within the procedure. The suction / irrigation capable versions incorporate a lumen / Y connector and male connector with polymeric tubing for adaptation to suction / irrigation systems. The instruments are, like other Gyrus bipolar electrosurgical instruments, available in a number of different shaft lengths and diameters, chosen by the surgeon to be most appropriate for the procedure to be undertaken. The instruments have a multipole arrangement at the patient interface. The instruments consist of three individually isolated conductors that act as the tissue effectors. A PlasmaBlend output is a blended cut and coagulation output that is delivered to the L09 instrument. The ratio of cut to coagulation of this output is selectable by the user and this allows the user to select the amount of haemostasis created during cutting. This output is controlled by the Gyrus General Surgery RF Workstation.
The provided text is a 510(k) Premarket Notification for the Gyrus PlasmaCision and PlasmaBlend electrodes. This document focuses on demonstrating substantial equivalence to predicate devices, rather than detailing a specific clinical study with acceptance criteria and device performance metrics in the way a diagnostic AI device would.
Therefore, the requested information elements related to a study proving acceptance criteria (like specific performance metrics, sample size, ground truth establishment, expert qualifications, and MRMC studies) are not present in the provided document. The document describes the device, its intended use, and compares it to predicate devices, stating that "performance testing has been done to validate the performance of the device." However, it does not provide the details of this performance testing, including specific acceptance criteria or quantitative results.
Here's an attempt to address the request based only on the provided text, highlighting what is missing:
1. Table of acceptance criteria and the reported device performance
The provided document does not contain a table of specific acceptance criteria (e.g., sensitivity, specificity, accuracy targets) or quantitative reported device performance metrics for the Gyrus PlasmaCision and PlasmaBlend electrodes. The document focuses on demonstrating substantial equivalence to predicate devices. It generically states that "performance testing has been done to validate the performance of the device."
2. Sample size used for the test set and the data provenance
The document does not specify a test set sample size or data provenance (e.g., country of origin, retrospective/prospective). This type of detail is typical for studies assessing the performance of diagnostic or prognostic devices, which is not the primary focus of this 510(k) for an electrosurgical accessory.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not describe the use of experts to establish a "ground truth" for a test set. This concept is typically relevant for diagnostic imaging or AI-based devices where expert consensus or pathology is used as a reference standard. For an electrosurgical device, performance validation would likely involve engineering tests, bench testing, and potentially animal or cadaver studies, rather than expert interpretation of a clinical test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided as the document does not describe a clinical test set requiring adjudication.
5. 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
An MRMC study is not applicable to this device. The Gyrus PlasmaCision and PlasmaBlend electrodes are electrosurgical instruments, not AI-assisted diagnostic tools. Therefore, there are no "human readers" or "AI assistance" in the context of this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This concept is not applicable to this device. The Gyrus PlasmaCision and PlasmaBlend electrodes are physical surgical instruments and do not involve an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The document does not specify a "ground truth" in the context of a diagnostic or prognostic study. Performance validation for an electrosurgical device would typically involve demonstrating its ability to safely and effectively cut and coagulate tissue, which is often assessed through engineering specifications, bench testing, and potentially in vivo models for tissue effects.
8. The sample size for the training set
The document does not mention a training set. This concept is specific to machine learning and AI algorithms, which are not involved in this electrosurgical device.
9. How the ground truth for the training set was established
Not applicable, as no training set is mentioned for this device.
§ 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.