(54 days)
The da Vinci E-200 Electrosurgical Generator is intended to deliver high-frequency energy for cutting, coagulation and vessel sealing of tissues in da Vinci robotic procedures, and non-robotic open and laparoscopic procedures.
The da Vinci E-200 is an electrosurgical unit (ESU) designed to provide high-frequency (HF) traditional monopolar, bipolar, and advanced bipolar outputs intended for cutting, coagulation and/or vessel sealing of tissues. The da Vinci E-200 is intended to be used with the IS4000/IS4200 da Vinci surgical systems, and also operate as a standalone electrosurgical generator. When connected to the da Vinci surgical system, the E-200 provides HF output to da Vinci instruments. Control and status messages are passed between the E-200 and the da Vinci system through an Ethernet communication cable. The E-200 is also compatible with open and laparoscopic third-party handheld monopolar and bipolar instruments, fingerswitch equipped instruments (where applicable) and Intuitive provided auxiliary footswitches. The primary function of the E-200 Electrosurgical Generator is to allow a surgeon to deliver HF output to cut, seal, or coagulate tissue during surgery. The user interface includes audible indicator tones, LED indicators on the front of the generator, and status messages provided on its LCD display.
The provided text is a 510(k) Summary for the da Vinci E-200 Electrosurgical Generator. It focuses on demonstrating substantial equivalence to a predicate device through verification and validation activities. However, it does not resemble a study report for an AI/ML device, which would typically include acceptance criteria, specific performance metrics like AUC, sensitivity, specificity, and details about human reader studies or ground truth establishment relevant to AI/ML performance.
The document describes standard medical device testing, such as:
- Design Verification (bench testing): Hardware, EMC, Electrical Safety, Software (including Cybersecurity), System interface, Instrument compatibility, Packaging, and Labeling.
- Design Validation (in-vivo porcine model): Safety and efficacy evaluation, including accessories and compatible systems in a simulated surgical setting.
- Thermal effects testing: Comparing the new monopolar "Low" coagulation mode to a reference device (Valleylab FT-10 Energy Platform).
- Neutral electrode contact quality monitor (CQM) study: Conformance to IEC standards with a specific neutral electrode pad.
- Capacitive coupling behavior evaluation: Comparing to the predicate device.
- Human factors evaluation: Safety and effectiveness in various configurations.
Therefore, I cannot extract the information required for an AI/ML device acceptance criteria and study from this document. The questions posed in your prompt (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance, training set details) are specific to the evaluation of AI/ML algorithms and are not addressed in this 510(k) summary for an electrosurgical generator.
§ 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.