(32 days)
The Valleylab G3000 Electrosurgical Device is a single-use device intended for use in open surgical procedures (such as general, urologic, thoracic, plastic and reconstructive, gynecologic, arthroscopic) where the surgeon desires monopolar radio-frequency electrosurgical energy to cut and/or coagulate tissue. The G3000 Electrosurgical Device is intended for use with the Valleylab ForceTriad™ Electrosurgical Generator and conventional monopolar electrosurgical electrodes, such as blade, needle, ball, LLETZ loop, and arthroscopic electrodes.
The G3000 Electrosurgical Device is a handheld, single-use device designed to deliver monopolar RF electrosurgical energy to a surgical site to cut and/or coagulate tissue. The G3000 Electrosurgical Device is designed for use only with the Valleylab ForceTriad™ Electrosurgical Generator (510(k) application submitted), and has a connector that will only fit into the ForceTriad™ generator. The G3000 connector is a "smart connector" that allows the ForceTriad™ generator to verify the device type. The device body incorporates "soft touch" material to improve the surgeon's grip. The surgeon activates the desired electrosurgical mode from the sterile field by using one of three push buttons on the device. Three electrosurgical modes are available: Cut, Hemostasis with Division, and Coaq. The surqeon can also control the power settings of the electrosurgical generator from the sterile field using a slider control on the device. The G3000 Electrosurqical Device uses conventional electrosurgical electrodes. such as coated and uncoated blade, needle, ball, LLETZ loops, and arthroscopy electrodes, with a 2.4mm (3/32 inch) shaft diameter.
The provided text describes a 510(k) premarket notification for the Valleylab G3000 Electrosurgical Device. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than establishing efficacy through clinical trials with specific acceptance criteria and ground truth. Therefore, much of the requested information, particularly regarding specific performance metrics, sample sizes, expert involvement, and ground truth methodologies, is not detailed in this document.
Here's an analysis of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide a table of quantitative acceptance criteria with corresponding performance metrics. Instead, it states:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Device functions as intended and meets design specifications. | "Performance testing was performed to ensure that the G3000 Electrosurgical Device functions as intended, and meets design specifications." |
| Substantially equivalent to predicate devices. | "Sufficient data were obtained to show that the device is substantially equivalent to the predicate devices..." |
| Meets safety and effectiveness criteria. | "...and meets safety and effectiveness criteria." |
| Specific functional characteristics (e.g., button functionality, grip). | The document describes features like "soft touch" material for grip, "push buttons on the device" for mode selection (Cut, Hemostasis with Division, Coag), and a "slider control on the device" for power settings, implying these functionalities were tested to meet design intent. The G3000 connector is a "smart connector" that allows the ForceTriad™ generator to verify the device type, suggesting testing for compatibility and proper identification. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified. The document globally refers to "Performance testing" and "Sufficient data," but does not quantify the number of devices tested or the amount of data collected.
- Data Provenance: Not specified, but generally, 510(k) performance testing is conducted internally by the manufacturer using laboratory or bench testing. There is no mention of country of origin for data or whether it was retrospective or prospective in a clinical setting. Given it's a device for surgical use, in vivo testing (animal or human) might have been part of "performance testing," but no details are provided.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable to a 510(k) submission for this type of device. The "ground truth" for a device like an electrosurgical device typically revolves around its mechanical, electrical, and functional performance, verified against engineering specifications and industry standards, not against expert consensus on clinical outcomes in the same way an AI diagnostic tool would be.
4. Adjudication Method for the Test Set
Not applicable. As no expert-based ground truth or comparative clinical study is described, there's no mention of an adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. An MRMC study is not mentioned or described. This type of study is relevant for diagnostic devices (especially imaging) where human reader performance is a key metric. The G3000 is an electrosurgical tool, not a diagnostic device.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. The G3000 is a physical electrosurgical device, not an algorithm. Its performance is inherent to its physical and electrical characteristics and its interaction with the electrosurgical generator.
7. Type of Ground Truth Used
The ground truth for this device would primarily be:
- Engineering Specifications: Testing to ensure the device performs according to its design requirements (e.g., button actuation force, electrical insulation, material integrity, connector compatibility).
- Industry Standards: Compliance with relevant electrical safety and performance standards for electrosurgical devices.
- Bench Testing / In Vitro Models: Verification of tissue cutting and coagulation characteristics in controlled experimental settings.
- In Vivo (Animal or Pre-clinical) Testing: Potentially, testing in animal models to confirm functional performance in a biological environment, if required.
The document states "Performance testing was performed to ensure that the G3000 Electrosurgical Device functions as intended, and meets design specifications," indicating the ground truth was tied to these internal design specifications and anticipated function.
8. Sample Size for the Training Set
Not applicable. This device is not an AI model or a system that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set 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.