(108 days)
The Gyrus PlasmaKinetic Superpulse System is intended for use for ablation, removal, resection and coagulation of soft tissue and where associated hemostasis is required in open, endoscopic and laparoscopic surgical procedures.
The Gyrus PlasmaKinetic Superpulse System Generator Description: is an Electrosuraical device with a bipolar mode of operation: The generator has controls for output waveform type and power. The unit has readouts for set power and waveform. The two physically identical connectors on the front panel support PlasmaKinetic, PlasmaKinetic Superpulse (RHS only) and 4mm bipolar instruments. The foot pedal is connected on the back panel. Accessories included with the generator are the electrodes, connector cable, footswitch and a power cable.
The provided text is a 510(k) Premarket Notification for the Gyrus PlasmaKinetic Superpulse Generator System & Accessories. This document is a regulatory submission to the FDA demonstrating substantial equivalence to a legally marketed predicate device, not a study report detailing performance against specific acceptance criteria. Therefore, the document does not contain the information required to populate the table of acceptance criteria and reported device performance or other detailed study information.
The submission focuses on comparing the new device to predicate devices (Gyrus Inc PlasmaKinetic Generator (K003060), Gyrus Medical Ltd PlasmaKinetic Endourology Generator (K003569), and Gyrus Medical Ltd Endourology Axipolar Resectoscope Electrode (K001270)) and validating its performance generally. It states: "The comparison and validation results presented in this 510(k) notification to the FDA show that the device is substantially equivalent to predicate devices and is safe and effective in its intended use." However, it does not specify what those validation results are in terms of quantifiable acceptance criteria and performance metrics.
Specifically, the following information is not present in the provided text:
- A table of acceptance criteria and the reported device performance: This document confirms that "performance testing has been done to validate the performance of the device," but it does not detail the specific acceptance criteria for that testing or the quantitative results achieved.
- Sample size used for the test set and the data provenance: No information about sample sizes or the origin of any test data (country, retrospective/prospective) is provided.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no expert-derived ground truth for a test set is mentioned.
- Adjudication method for the test set: Not applicable, as no test set requiring adjudication is described.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: The document describes a "comparison to predicate devices" but not an MRMC study or any human reader performance evaluation.
- If a standalone performance (algorithm only without human-in-the-loop performance) was done: This is a medical device (electrosurgical generator), not an AI algorithm; therefore, standalone algorithm performance is not applicable.
- The type of ground truth used: No mention of specific ground truth (e.g., pathology, outcomes data) for any performance evaluation.
- The sample size for the training set: Not applicable, as this is not an AI/ML device with a training set.
- How the ground truth for the training set was established: Not applicable.
In conclusion, the provided 510(k) summary asserts the device's substantial equivalence to predicate devices and states that performance testing was conducted, but it does not disclose the detailed acceptance criteria or the specific results of those performance tests.
§ 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.