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510(k) Data Aggregation
(60 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 human 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.
This document is a 510(k) premarket notification for the da Vinci E-200 Electrosurgical Generator, indicating that it is a medical device approval document and not a study on AI-assisted human reading, or a diagnostic AI device. Therefore, many of the requested criteria related to AI studies (e.g., sample size for test/training sets, ground truth establishment, expert adjudication, MRMC studies, standalone performance) are not applicable to this submission.
The document primarily focuses on demonstrating the substantial equivalence of the da Vinci E-200 Electrosurgical Generator to existing predicate devices through bench testing, in-vivo/ex-vivo models, and human factors evaluation, rather than evaluating an AI algorithm's performance in a diagnostic context.
However, I can extract and present the available information regarding the device's performance and acceptance criteria based on the provided text.
1. Table of Acceptance Criteria and Reported Device Performance
Since this is an electrosurgical generator rather than a diagnostic AI device, the "acceptance criteria" are related to its functional performance, safety, and equivalence to predicate devices, rather than typical diagnostic performance metrics (e.g., sensitivity, specificity, AUC). The document outlines various tests conducted to demonstrate the device meets its design requirements and is safe and effective.
| Category of Testing | Acceptance Criteria (Implied by Test Name) | Reported Device Performance (Summary from Document) |
|---|---|---|
| Design Verification | Device meets hardware, EMC, electrical safety, software (including cybersecurity), system interface, instrument compatibility, packaging, and labeling requirements. | "The subject device, E-200 Electrosurgical Generator, was subjected to series of tests to evaluate performance and to demonstrate that the design outputs meet the design input requirements." |
| Design Validation (In-vivo porcine model) | Safety and efficacy of the E-200 generator, its accessories, and its interaction with intended robotic and third-party instruments/accessories in a simulated surgical setting. Device fulfills user needs and intended use is met. | "Design validation demonstrated that the design outputs fulfill the user needs and that the intended use have been met." |
| Thermal Effects Testing | Comparable thermal effects on tissue to the predicate ForceTRIAD generator (K110268). | "The E-200 generator was found to have acceptable thermal effects when compared to the ForceTRIAD generator." |
| Neutral Electrode Contact Quality Monitor (CQM) Study | Conformance to IEC standards for the CQM system. Validation of the use of Covidien E7507 neutral electrode. | "The study validated the use of the Covidien E7507 neutral electrode (commercially available product) with the E-200 generator for CQM functionality." |
| Vessel Sealing Bench Testing (E-200 vs. E-100) | HF output characteristics are substantially equivalent to the predicate E-100 device (K191280) with no differences expected to change vessel sealing performance. | "The test demonstrated that the HF output characteristics of the two generators are substantially equivalent and that there are no differences which would be expected to result in a change in the vessel sealing performance." |
| Capacitive Coupling Evaluation | No significant increase in unintended capacitively coupled energy delivery compared to the predicate Covidien ForceTriad generator. | "This validation demonstrated that the E-200 generator had no significant increase in unintended capacitively coupled energy delivery when compared to the predicate Covidien ForceTriad generator." |
| Human Factors Evaluation (Usability Validation Study) | Safe and effective use of the E-200 generator and associated accessories by intended users in the intended use environment. | "The usability validation study demonstrated that the E-200 electrosurgical generator could be used safely and effectively by the intended users in the intended use environment." |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document does not specify a numerical sample size for individual tests like "Design Verification" (bench testing), "Thermal Effects Testing," or "CQM Study." For the in-vivo validation, it mentions a "porcine model," but no specific number of animals or cases. Similarly, "vessel sealing bench testing" and "capacitive coupling evaluation" do not specify sample sizes.
- Data Provenance: The studies appear to be prospective bench tests and animal model studies conducted by the manufacturer, Intuitive Surgical, Inc. The document does not mention the country of origin for the data beyond implying it was conducted as part of the FDA submission process.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
This concept is not applicable to this type of device submission. Ground truth in this context refers to the physical and electrical performance of an electrosurgical unit, verified through established engineering and medical device testing standards, rather than expert interpretation of medical images or data. Performance is measured against physical specifications and validated against in-vivo/ex-vivo results.
4. Adjudication Method for the Test Set
This concept is not applicable. Adjudication typically refers to resolving disagreements among human readers or labelers in diagnostic AI studies. The performance validation of an electrosurgical generator involves objective measurements and functional tests, not human interpretation that requires adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI assistance on human reader performance in diagnostic tasks, which is not the purpose of this submission for an electrosurgical generator.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable in the context of AI algorithm performance. The "standalone" operation mentioned in the document refers to the E-200 Electrosurgical Generator operating independently of the da Vinci robotic system, as a traditional ESU. It's a device operating standalone, not an AI algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is established by:
- Design Input Requirements/Specifications: The device's performance is validated against its pre-defined engineering and functional requirements.
- Industry and IEC Standards: Conformance to relevant electrical safety and performance standards.
- Predicate Device Performance: Demonstrating comparable performance to legally marketed predicate devices (Covidien ForceTRIAD and Intuitive E-100) through direct comparative testing (e.g., thermal effects, HF output characteristics, capacitive coupling).
- In-vivo/Ex-vivo Models: Actual physiological effects in tissue (e.g., cutting, coagulation, vessel sealing effectiveness) observed in animal (porcine) models and ex-vivo settings.
- User Needs/Safe and Effective Use: Confirmed through human factors evaluation with intended users.
8. The Sample Size for the Training Set
Not applicable. This submission is for an electrosurgical generator, not an AI model, so there is no "training set."
9. How the Ground Truth for the Training Set was Established
Not applicable. As there is no AI model or training set, the concept of establishing ground truth for it does not apply.
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