(180 days)
The Electrosurgical Generator (HV-300A, HV-400) is a non-sterile, reusable multi-purpose electrosurgical generator that is designed to perform monopolar and bipolar functions in the operating arena.
The proposed device (HV-400 and HV-300A) is an electrosurgical generator with, monopolar and bipolar, high frequency current isolation outputs. The proposed device is independent equipment, which include generator and accessories. The main components are front panel ( power switch, touchable screen, operation key, indicator, connector for accessories), back panel (volume controller, foot switch interface, power cable outlet and fuse) and inner component (display panel, main board, control board, speaker etc.). The accessories include power cable, III-2 cable and foot switch). The two models of proposed device share appearance, function, accessories, the only difference is the output parameter.
The provided text describes an Electrosurgical Generator (HV-300A, HV-400) and its 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria for a novel AI/software function. Therefore, much of the requested information (e.g., sample size for test/training sets, ground truth methodology, expert qualifications, MRMC study, standalone algorithm performance) is not applicable or not provided in this document.
However, based on the non-clinical tests conducted, we can infer the acceptance criteria for basic safety and essential performance, and the study showing the device meets these criteria.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard Compliance) | Reported Device Performance (Compliance) |
|---|---|
| Basic Safety and Essential Performance: | |
| IEC 60601-1:2005 (Medical electrical equipment Part 1: General requirements for basic safety and essential performance) | The test results demonstrated that the proposed device complies with IEC 60601-1:2005. |
| Electromagnetic Compatibility (EMC): | |
| IEC 60601-1-2:2007 (Medical electrical equipment Part 1-2: General Requirements for Safety - Collateral standard: Electromagnetic compatibility - requirements and tests) | The test results demonstrated that the proposed device complies with IEC 60601-1-2:2007. |
| Safety of High-Frequency Surgical Equipment (Specific Performance): | |
| IEC 60601-2-2:2009 (Medical electrical equipment Part 2-2: Particular requirements for safety of high frequency surgical equipment) | The test results demonstrated that the proposed device complies with IEC 60601-2-2:2009. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not applicable/Not provided. The tests described are non-clinical hardware tests against international standards, not performance evaluations on a data set with a specific sample size of patient data.
- Data Provenance: Not applicable/Not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable/Not provided. Ground truth in the context of diagnostic or AI performance is not relevant for these hardware safety and performance tests. Compliance with standards is typically assessed by engineers and testing bodies.
4. Adjudication method for the test set
- Not applicable/Not provided. This concept is relevant for expert disagreement resolution in diagnostic studies, not for compliance testing of electrosurgical generators to established ISO/IEC standards.
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
- No. This device is an electrosurgical generator, which is a hardware device for surgical procedures, not an AI or diagnostic imaging system that would involve human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- No. This device is a hardware electrosurgical generator. It does not involve a standalone algorithm in the sense of AI or software performance evaluation.
7. The type of ground truth used
- The "ground truth" here is the requirements set forth by the specific international safety and performance standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2). The device's performance was compared directly against these documented technical specifications and limits within the standards.
8. The sample size for the training set
- Not applicable/Not provided. This is not an AI/machine learning device that involves training sets.
9. How the ground truth for the training set was established
- Not applicable/Not provided.
§ 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.