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510(k) Data Aggregation
(333 days)
The Generator GI I provides radiofrequency power to drive EnSeal® electrosurgical instruments that are used during open or laparoscopic general and gynecological surgery to cut and seal vessels and to cut, grasp, and dissect tissue. In addition the generator provides power to drive Harmonic ultrasonic surgical instruments that are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired.
EnSeal® and Harmonic® instruments when used with the Generator G11 have not been shown to be effective for sterilization procedures or tubal coagulation. Do not use these instruments for these procedures.
The Ethicon Endo-Surgery Generator G11 supplies energy to EnSeal® electrosurgical instruments and Harmonic ultrasonic surgical instruments. The generator utilizes a touchscreen display interface and has a receptacle port that accepts either EnSeal® or Harmonic® devices. Connectors (one for Harmonic and one for EnSeal® instruments) are used to enable the generator to power currently cleared surgical instruments.
This document describes the 510(k) submission for the Ethicon Endo-Surgery Generator G11. The submission focuses on demonstrating substantial equivalence to predicate devices through technical characteristics and performance data, rather than specific acceptance criteria for AI performance. Therefore, many of the requested categories are not applicable to this type of device submission.
Here's an analysis based on the provided text, addressing the requested points where possible:
Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria
This 510(k) submission is for a surgical generator, a hardware device, not an AI/software device. Therefore, many of the requested categories related to AI performance, such as sample size for test sets, ground truth establishment, MRMC studies, and training set details, are not applicable to this submission. The performance data provided is focused on demonstrating the generator's ability to power surgical instruments safely and effectively, consistent with its intended use and comparable to predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
Given that this is a hardware device (electrosurgical and ultrasonic generator) and not an AI or software product, the concept of "acceptance criteria" for AI performance metrics (like sensitivity, specificity, AUC) is not relevant. The "performance data" provided refers to engineering and animal model testing to ensure the generator functions as intended and is safe.
| Acceptance Criteria Category (Hypothetical for AI) | Reported Device Performance (as per 510(k) for Generator G11) |
|---|---|
| Generator Functionality | "Bench testing and laboratory evaluations in an animal model were conducted to demonstrate that the Generator G11 performs as intended." (This implies the generator successfully delivered appropriate power, voltage, current, and frequency to EnSeal® electrosurgical and Harmonic® ultrasonic instruments, consistent with their intended use for cutting, sealing, grasping, dissecting tissue, and achieving hemostasis.) |
| Safety | The FDA clearance (K101990) implies that the device met safety requirements, likely demonstrated through electrical safety testing (e.g., against IEC 60601-1), EMC testing, and performance as observed in animal models, showing no unexpected adverse effects related to the generator's operation. |
| Substantial Equivalence | The FDA determined the device is "substantially equivalent" to predicate devices (EnSeal® RF60, EnSeal® Universal, UltraCision Harmonic® Scalpel Generator 300) for its stated indications for use. This means it has similar technological characteristics (despite a broader range of power parameters and a combined functionality) and raises no new questions of safety or effectiveness. |
| User Interface Usability | Implied through the incorporation of a "touchscreen user interface" to "provide the user with information, control, and feedback during use." While not explicitly detailed in terms of usability metrics, it would have been tested to ensure safe and effective operation by users. |
2. Sample Size Used for the Test Set and Data Provenance
- Not Applicable (N/A) for AI/software test sets. The performance data involved "Bench testing and laboratory evaluations in an animal model."
- Sample Size: Not specified in the summary. For bench testing, this would refer to the number of tests performed on the device or its components. For animal models, it would be the number of animals used. This information is typically found in the detailed test reports submitted to the FDA, not in the public summary.
- Data Provenance: The studies were conducted by Ethicon Endo-Surgery, LLC. The specific country of origin for the studies is not stated but is presumably the USA, where Ethicon Endo-Surgery, Inc. is located (Cincinnati, OH). The studies would be prospective in nature, designed specifically to test the G11 generator.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not Applicable (N/A). This device is a surgical generator, not an AI diagnostic tool requiring expert-established ground truth for image interpretation or similar tasks. The "ground truth" for this device would be its ability to generate specified power outputs and enable its associated instruments to perform their intended surgical functions (e.g., cutting, sealing tissue) effectively and safely. This is typically assessed by engineers and veterinary surgeons/pathologists in animal studies.
4. Adjudication Method for the Test Set
- Not Applicable (N/A). Adjudication methods like 2+1 or 3+1 are used for resolving disagreements among human readers/experts when establishing ground truth for AI algorithms. This is not relevant for a surgical generator. Performance would be assessed against engineering specifications and observable surgical outcomes in animal models.
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
- Not Applicable (N/A). This is a hardware device; no AI assistance for human readers is involved.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
- Not Applicable (N/A). This is a hardware device; there is no algorithm or AI component to be tested in a standalone fashion. The generator itself is "standalone" in the sense that its functionality (power generation) can be tested independently of a human operator's skill, but its intended use is always with human-operated surgical instruments.
7. The Type of Ground Truth Used
- Engineering Specifications and Animal Model Outcomes: The "ground truth" for this device's performance would be:
- Engineering Specifications: Successful delivery of specific power, voltage, current, and frequency outputs as designed for the EnSeal® and Harmonic® instruments.
- Animal Model Outcomes: Observable biological effects (e.g., effective vessel sealing, tissue cutting, dissection, hemostasis) consistent with the intended use of the respective instruments when powered by the G11 generator, and comparison to established performance of predicate devices or clinical standards. Pathology might be used to confirm tissue effects.
8. The Sample Size for the Training Set
- Not Applicable (N/A). This device does not have an AI component that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable (N/A). This device does not have an AI component requiring a training set with established ground truth.
Summary of Device and Performance Data:
The Ethicon Endo-Surgery Generator G11 is a hardware device designed to power both electrosurgical (EnSeal®) and ultrasonic (Harmonic®) surgical instruments. Its 510(k) clearance was based on demonstrating "substantial equivalence" to existing predicate devices. Performance data included "Bench testing and laboratory evaluations in an animal model" to show that the generator "performs as intended" by successfully delivering the necessary power to the surgical instruments for their specified indications (cutting, sealing vessels, dissecting tissue, achieving hemostasis). The technological characteristics, such as the ability to power both types of instruments and a touchscreen interface, were detailed, but the core performance validation focused on the output characteristics and biological effects consistent with safe and effective surgical use.
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