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510(k) Data Aggregation
(60 days)
da Vinci E-200 Electrosurgical Generator
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 Electrosurgical Generator 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 Electrosurgical Generator is intended to be used with the da Vinci Xi, and da Vinci 5 surgical systems, and also operate as a standalone electrosurgical generator. When connected to 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 out, 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.
This document focuses on the da Vinci E-200 Electrosurgical Generator, which is an electrosurgical unit (ESU). The information provided is a 510(k) summary, which inherently focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed de novo study with strict acceptance criteria and performance metrics for a novel technology.
Therefore, the requested information elements related to standalone performance, MRMC studies, specific acceptance criteria values, sample sizes for test and training sets, and expert details for ground truth establishment are not explicitly described in the provided text in the manner typically found for AI/ML device studies. The document describes a traditional medical device (electrosurgical generator) and its safety and efficacy testing, not an AI/ML diagnostic or predictive system.
Here's an analysis based on the provided text, addressing the points where information is available or inferable:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not provide a table with specific numerical acceptance criteria and corresponding reported device performance values. Instead, it states that "Verfication and validation activities were successfully completed that the subject device performs as intended and is substantially equivalent to its predicate."
The "acceptance criteria" are implied by the successful completion of the following testing types:
| Test Type | Implied Acceptance Criteria / Performance Demonstrated |
|---|---|
| Design Verification (Bench Testing) | Functional design outputs were met. Specifically: Software requirements (including cybersecurity) were met.EMC (Electromagnetic Compatibility) and Electrical Safety requirements were met.System interface requirements were met.Instrument compatibility requirements were met.Packaging and Labeling requirements were met. |
| Design Validation (Simulated Clinical Use) | Product specifications continued to meet the users' needs and intended use in a simulated clinical environment. (Performed with a porcine model, implying demonstration of cutting, coagulation, and vessel sealing efficacy and safety in tissue.) |
| Human Factor Evaluation | The device was determined to be safe and effective for its intended uses by the intended users in the intended use environment. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: Not explicitly stated. For bench testing, this would refer to the number of test cases or iterations. For simulated clinical use, it refers to the number of porcine models or procedures performed.
- Data Provenance:
- Bench Testing: Likely internal laboratory testing at Intuitive Surgical.
- Simulated Clinical Use: Performed with a porcine model, indicating animal tissue (non-human, in vivo or ex vivo animal studies).
- Retrospective or Prospective: These tests are inherently prospective, as they are conducted specifically for the submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
This concept of "ground truth" established by experts, as typically applied to image-based AI diagnostics, is not directly applicable here. The device is an electrosurgical generator, and its performance (e.g., cutting efficacy, coagulation, vessel sealing) is assessed through objective measurements (bench testing) and direct observation/clinical evaluation (simulated clinical use).
For the Human Factor Evaluation, experts (likely human factors engineers and potentially medical professionals) would assess usability and safety, but they are evaluating the device's interaction with users, not establishing a "ground truth" for a diagnostic output.
4. Adjudication Method for the Test Set:
Not applicable in the context of electrosurgical generator testing as described. Adjudication methods (like 2+1 or 3+1) are typically used to resolve disagreements among multiple expert readers establishing ground truth for diagnostic decisions, which is not the primary output of this device.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:
No, an MRMC comparative effectiveness study is not mentioned. Such studies are generally performed for diagnostic devices, especially those incorporating AI, to compare human performance with and without AI assistance. This device is a surgical tool, not a diagnostic one.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study was Done:
The "standalone" performance for this device refers to its ability to function as an electrosurgical generator without being integrated into a da Vinci robotic system. The device description explicitly states: "The da Vinci E-200 Electrosurgical Generator... also operate as a standalone electrosurgical generator." The testing described (bench testing, simulated clinical use, human factor evaluation) would have covered this standalone operation, ensuring its basic electrosurgical functions (cutting, coagulation, sealing) are performed as intended. However, "standalone" in the context of an algorithm's diagnostic performance (without human interpretation) is not relevant here.
7. The Type of Ground Truth Used:
- Bench Testing: Engineering specifications, electrical safety standards, EMC standards, software requirements, measured physical parameters (e.g., power output, frequency).
- Simulated Clinical Use (Porcine Model): Direct observation of tissue effects (e.g., cut quality, coagulation adequacy, seal strength) by qualified personnel, possibly confirmed by gross and/or histopathological examination. Performance against a "gold standard" of expected surgical outcomes for electrosurgery.
- Human Factor Evaluation: Usability metrics, error rates, user feedback, adherence to human factors engineering principles.
8. The Sample Size for the Training Set:
Not applicable. This is not an AI/ML device that requires a training set of data. The "training set" concept is relevant for machine learning algorithms, which "learn" from data. This device is a traditional electrosurgical generator engineered to specific design parameters.
9. How the Ground Truth for the Training Set Was Established:
Not applicable for the same reason as point 8.
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(54 days)
da Vinci E-200 Electrosurgical Generator
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.
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(60 days)
da Vinci E-200 Electrosurgical Generator
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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