(248 days)
The Energy generator intended for use in the operating room for general procedures where ESU cutting and coagulation is required. The Energy generator is equipped with monopolar and bipolar outputs.
The Energy 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. The three models ES300, ES200 and ES100 have the same hardware. They have different software on the control board and has different electrosurgical power limit.
This is an electrosurgical generator, not an AI/ML powered device, so many of the requested fields are not applicable.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| Electrical Safety (IEC 60601-1) | Compliant |
| Electromagnetic Compatibility (IEC 60601-1-2) | Compliant |
| Performance (IEC 60601-2-2) | Compliant |
| System Performance | Compliant |
| Thermal Effects (FDA Guidance for Electrosurgical Devices) | Compliant |
| Software Validation (FDA Guidance for Software in Medical Devices) | Compliant |
2. Sample Size Used for the Test Set and Data Provenance:
Not applicable. This is not an AI/ML powered device that uses a "test set" in the context of data analysis. The testing involved hardware and software validation against established medical device standards.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable. Ground truth, in the context of data for AI/ML, is not relevant for this device. Compliance was assessed against engineering and performance standards by qualified testing personnel and regulatory bodies.
4. Adjudication Method for the Test Set:
Not applicable. There was no "test set" for adjudication as it's understood in AI/ML studies. Compliance was determined by meeting predefined standards and test protocols.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No. This type of study is typically conducted for diagnostic AI tools involving human interpretation of data. This device is an electrosurgical generator, and such a study is not relevant to its function.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Not applicable. This is a hardware device with embedded software. It does not operate as a standalone algorithm in the sense of AI/ML. Its performance is evaluated through its physical and electrical outputs.
7. The Type of Ground Truth Used:
Ground truth for this device is established by:
- Engineering and Performance Standards: International Electrotechnical Commission (IEC) standards (IEC 60601-1, IEC 60601-2-2, IEC 60601-1-2) set the objective criteria for electrical safety, electromagnetic compatibility, and specific electrosurgical device performance.
- FDA Guidance: FDA guidance documents for electrosurgical devices provide criteria for aspects like thermal effects.
- Software Validation Principles: Ground truth for software validation involves adherence to established software engineering principles and documentation requirements outlined in FDA guidance.
8. The Sample Size for the Training Set:
Not applicable. This is not an AI/ML device that requires a training set of data.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. As there is no training set of data, no ground truth needs to be established for it.
§ 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.