(251 days)
The generator is indicated for ablation, resection and coagulation of soft tissue and hemostasis of blood vessels in surgery.
The Gyrus General Purpose Electrosurgical Generator operates only in bipolar mode. It has controls for output waveform type and power. The unit has readouts for set power and waveform. There are two custom 9-way connectors on the front panel for PlasmaCision instruments and PlasmaKinetic bipolar instruments. The foot pedal is connected on the back panel. Accessories included with the generator are the disposable instruments, footswitch and a power cable.
The provided text describes a 510(k) premarket notification for the "Gyrus General Purpose Electrosurgical Generator System." This document is for a medical device and outlines its intended use and comparison to predicate devices, ultimately leading to an FDA determination of substantial equivalence.
However, the provided text does not contain any information regarding acceptance criteria or a specific study that proves the device meets acceptance criteria in the context of performance metrics (sensitivity, specificity, accuracy, etc.) typically associated with AI/software-as-a-medical-device (SaMD).
Instead, this document focuses on regulatory approval based on substantial equivalence to predicate devices. The "performance testing" mentioned is to validate the device's functional performance in line with these predicate devices, not typically a clinical study with detailed statistical outcomes for an AI algorithm.
Therefore, many of the requested items cannot be answered from the provided text.
Here's a breakdown of what can and cannot be answered:
1. A table of acceptance criteria and the reported device performance
- Cannot be answered from the provided text. The document states "Performance testing has been done to validate the performance of the device," but it does not provide specific acceptance criteria (e.g., minimum output power, waveform stability within a tolerance) or the numerical results of such testing. This type of detail is usually found in a separate performance test report, not in the summary document.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Cannot be answered from the provided text. The document does not describe a "test set" in the context of data for an AI algorithm, nor does it mention sample sizes, data provenance, or whether any human data was used for performance evaluation beyond general "performance testing" of the hardware.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Cannot be answered from the provided text. There is no mention of experts establishing ground truth, as this is not a study evaluating an algorithmic output that requires such annotations.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Cannot be answered from the provided text. Not relevant to this type of device submission.
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
- Cannot be answered from the provided text. No MRMC study is mentioned, nor is any AI component.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Cannot be answered from the provided text. This device is an electrosurgical generator, which is hardware, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Cannot be answered from the provided text. Ground truth is not discussed in the context of an algorithmic evaluation. The ground truth for this device's performance would likely be engineering specifications and safety standards.
8. The sample size for the training set
- Cannot be answered from the provided text. There is no "training set" as this is not an AI/ML device.
9. How the ground truth for the training set was established
- Cannot be answered from the provided text. Not applicable.
Summary of what is present:
- Device Name: Gyrus General Purpose Electrosurgical System (Generator & Accessories)
- Intended Use: The generator is indicated for ablation, resection, and coagulation of soft tissue and hemostasis of blood vessels in surgery.
- Comparison Basis: Substantial equivalence to predicate devices: K041285 (Gyrus ENT G3 System), K031085 (Gyrus Superpulse® System), K002906 (Harmonic Scalpel®).
- Regulatory Status: 510(k) clearance, Class II medical device.
- Performance Claim: "Performance testing has been done to validate the performance of the device." (Details of this testing are absent from the provided text).
The provided text is a regulatory clearance document, not a detailed scientific study report on performance metrics for an AI/SaMD product.
§ 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.