(17 days)
General-purpose electrosurgical generator designed to produce radio frequency (RF) current for cutting and coagulation to be delivered to target tissue through an accessory electrode during open and laparoscopic surgical procedures.
The Megadyne MEGA Power Electrosurgical Generator is a microprocessor controlled, isolated output, high frequency generator designed for use in cutting and coagulating 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.
The provided text is a 510(k) summary for an electrosurgical generator, which is a medical device used for cutting and coagulating tissue. As such, the concept of "acceptance criteria" and "device performance" in this context refers to engineering and electrical safety standards rather than clinical performance metrics typically associated with AI/ML-based diagnostic devices (e.g., sensitivity, specificity).
Therefore, the requested information regarding "acceptance criteria" and "study that proves the device meets the acceptance criteria" will be interpreted in the context of electrical safety and performance standards for electrosurgical generators. Other numbered points related to AI/ML device testing (sample size for test set, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance, ground truth type for training, training set sample size, ground truth for training) are not applicable to this type of device and submission.
Acceptance Criteria and Study Proving Device Meets Acceptance Criteria
The acceptance criteria for the Megadyne MEGA Power Electrosurgical Generator are primarily based on conformance to established electrical safety and performance standards for electrosurgical devices. The study proving the device meets these criteria is the testing conducted to demonstrate this conformance.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard Conformance) | Reported Device Performance (Claimed Conformance) |
|---|---|
| AAMI HF 18:2001 (Electrosurgical Devices Safe Current Limits) | Conforms to applicable sections of AAMI HF 18:2001 |
| IEC 60601-1:2003 (Medical electrical equipment - Part 1: General requirements for basic safety and essential performance) | Conforms to applicable sections of IEC 60601-1:2003 |
| IEC 60601-2-2:1998 (Medical electrical equipment - Part 2-2: Particular requirements for the safety of high frequency surgical equipment) | Conforms to applicable sections of IEC 60601-2-2:1998 |
| IEC 60601-1-2:2001 (Medical electrical equipment - Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests) | Conforms to applicable sections of IEC 60601-1-2:2001 |
Note: The submission states that the "operating principle of the proposed device is identical to the predicate device" and that "questions of safety and effectiveness are the same for this device as they are for the other electrosurgical generators on the market." These statements, combined with conformance to recognized consensus standards, serve as the basis for demonstrating substantial equivalence for this device type. Detailed performance specifications (e.g., power output accuracy, leakage current measurements) would typically be found in the full 510(k) submission, not just the summary.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. For this type of electrosurgical generator, a "test set" in the context of clinical data or image analysis for AI/ML is not relevant. The testing involved electrical and functional performance verification against engineering standards directly on the device itself. Data provenance (country of origin, retrospective/prospective) is not applicable to engineering compliance testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable. Ground truth in this context refers to established harmonized standards for electrical safety and performance, not expert consensus on clinical findings. The "experts" would be the engineers and technicians who conducted the specified tests, ensuring the device's adherence to the technical requirements of the standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. Adjudication methods are used to resolve discrepancies in expert interpretations, particularly in clinical data studies. For engineering compliance testing, a pass/fail criterion based on objective measurements against a standard is typically used, not an adjudication process.
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. MRMC studies are associated with diagnostic imaging devices and AI assistance for human readers. This device is an electrosurgical generator, not an AI-enabled diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable. This question relates to the performance of an AI algorithm in isolation. The device concerned is an electrosurgical generator, which does not incorporate AI algorithms in this manner.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this device's acceptance is defined by the objective, measurable criteria specified within the referenced consensus standards (AAMI HF 18:2001, IEC 60601-1:2003, IEC 60601-2-2:1998, and IEC 60601-1-2:2001). This includes parameters like leakage current, power output accuracy, safety mechanisms, electromagnetic compatibility, etc. The device must perform within the limits and specifications set by these engineering standards.
8. The sample size for the training set
- Not Applicable. This question relates to AI/ML model training. This device does not use a training set for an AI/ML model.
9. How the ground truth for the training set was established
- Not Applicable. This question relates to AI/ML model training. This device does not use a training set for an AI/ML model.
§ 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.