(132 days)
The Ethicon Megadyne® Electrosurgical Generator is intended as a general-purpose electrosurgical generator designed to produce radio frequency (RF) current for cutting and coagulation to target tissue through an accessory electrode during open and laparoscopic surgical procedures.
The Ethicon Megadyne Electrosurgical Generator is a microprocessor controlled, isolated output, high frequency generator designed for use in cutting and coagulation of tissue. The generator has the ability to perform both monopolar cutting and coagulation and bipolar coagulation of tissue in a wide range of surgical applications.
This document is a 510(k) premarket notification for an electrosurgical generator. It does not pertain to an AI/ML powered device, therefore, the requested information regarding acceptance criteria, study design for AI/ML performance, sample sizes for training/test sets, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, and ground truth type is not applicable.
The document discusses the substantial equivalence of the Ethicon Megadyne Electrosurgical Generator to a predicate device (Mega Power Electrosurgical Generator). The acceptance criteria and the study proving the device meets these criteria are described in terms of safety and performance bench testing, rather than AI/ML performance metrics.
Here's a breakdown of the relevant information provided, adapted to the context of this traditional medical device:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't present a formal table of "acceptance criteria" and "reported device performance" in the way one would for an AI/ML model with metrics like sensitivity/specificity. Instead, it describes compliance with recognized electrical safety and electromagnetic compatibility standards and comparative bench testing.
| Acceptance Criteria (Bench Testing Focus) | Reported Device Performance (Summary) |
|---|---|
| Electrical Safety: Compliance with IEC 60601-1 and IEC 60601-2-2. | Testing was completed in compliance with IEC standard 60601-1 and IEC 60601-2-2. |
| Electromagnetic Compatibility (EMC): Compliance with IEC 60601-1-2. | Testing was completed in compliance with IEC 60601-1-2. |
| Capacitive Coupling Safety: Compliance with IEC 60601-2-18. | IEC 60601-2-18 was also completed for capacitive coupling. |
| Thermal Effects on Tissue: No significant difference in thermal effect compared to the predicate device across all generator modes, power settings (minimum, default, maximum). | Ex-vivo harvested animal tissue (skeletal muscle, liver, and kidney) was used. Testing was performed in triplicate at minimum, default and maximum power settings. "Based on testing results, the thermal effect is not significantly different from what is measured from the predicate device." |
| Software Verification and Validation: Compliance with FDA guidance on software for medical devices (Major level of concern). | Software validation and verification was completed following FDA's "General Principles of Software Validation" and "Guidance for the Content of Premarket Submission for Software Contained in Medical Devices." The recommended documentation for a software with a Major level of concern is provided. |
| Biocompatibility: No direct or indirect patient-contacting components. | The device does not have any direct or indirect patient contacting components, hence biocompatibility testing was not required. |
| Sterilization/Shelf-Life: Device shipped non-sterile. | The device is packaged and shipped non-sterile. |
| Design Validation: Overall acceptability of device setup and use for intended users. | The design validation testing demonstrated the overall acceptability of the subject device setup and use for its intended users. |
2. Sample Size Used for the Test Set and the Data Provenance:
- Sample Size: For the thermal effects on tissue, testing was performed in triplicate at minimum, default and maximum power settings for each tissue type (skeletal muscle, liver, kidney) and each generator mode. The exact number of tissue samples is not explicitly stated beyond "triplicate" per condition.
- Data Provenance: The thermal effects testing used ex-vivo harvested animal tissue (skeletal muscle, liver, and kidney). The country of origin is not specified, but it's presumed to be associated with the manufacturer's testing facilities. The nature of the study is bench testing rather than retrospective or prospective clinical data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
- Not Applicable in the traditional AI/ML sense. For this device, "ground truth" for thermal effects would be the measurable thermal change on the tissue. The measurement was done through "image analysis using open source image processing software." It does not involve human expert consensus or labeling of images for diagnostic purposes. The expertise would lie in the design and execution of the bench tests and the interpretation of the physical measurements, not in expert clinical review for ground truth.
4. Adjudication Method for the Test Set:
- Not Applicable. As this is not an AI/ML diagnostic device with expert annotation, there is no need for an adjudication method for labeling a test set. The data comes from physical measurements in a controlled bench setting.
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. This is not an AI/ML diagnostic device that assists human readers. Therefore, an MRMC study is irrelevant to this submission.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not Applicable. This is an electrosurgical generator, a hardware device, not a standalone AI/ML algorithm. Its performance is evaluated through bench testing of its physical output and safety features.
7. The Type of Ground Truth Used:
- For thermal effects on tissue, the "ground truth" was established by direct measurement of thermal damage through image analysis of ex-vivo animal tissue, compared to the performance of the predicate device.
- For electrical safety, EMC, and software validation, the ground truth is compliance with relevant recognized consensus standards (IEC standards) and FDA guidance documents.
8. The Sample Size for the Training Set:
- Not Applicable. This device does not use an AI/ML algorithm that requires a training set. The "training" in this context refers to engineering design and development, not machine learning.
9. How the Ground Truth for the Training Set was Established:
- Not Applicable. No training set or associated ground truth for machine learning was established 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.