(48 days)
The ESU-1 Electrosurgical Generator is used to deliver RF energy via an assortment of surgical devices to cut and coagulate different kinds of tissue.
The ESU-1 Electrosurgical Generator is a high frequency isolated generator that utilizes electrical current via an assortment of surgical devices to cut and coagulate different types of tissue. The ESU-1 Electrosurgical Generator features cutting up to 300 watts with 2 cut modes, including "Cut T", a blend mode with 4 levels, 3 coagulation modes and 4 bipolar modes with Auto Bipolar option. "Cut T" mode is a new feature that includes a timing feature which automatically ceases RF activation after a user selectable period of time that can be altered between 0.1 and 3.0 seconds. The RF activation for Cut T mode is initially pre-set at 2 seconds (Note: if the operator changed these settings, the generator will powerup with the mode and setting in which the operator last activated the generator). The generator offers 2 monopolar headpiece outputs, monopolar foot controlled output, bipolar handpiece output, and bipolar foot controlled output. The generator has a return electrode sensing feature allows the user to use either a split or solid return electrode site. The padsensing feature allows the user to use either a split or solid return electrode.
The device consists of a generator and power cord and is packaged with a User's Guide in a cardboard shipping box with protective foam inserts. The main device components are a front panel containing the power button, wattage selection buttons, LED numeric display, alarm and return electrode indicator lights, and connector ports for accessories, a back panel consisting of footswitch ports, volume controls, a power cord outlet and fuse, and internal components (printed circuit boards, speakers, cabling).
The provided FDA 510(k) summary for the ESU-1 Electrosurgical Generator focuses on demonstrating substantial equivalence to a predicate device (Bovie® IDS-310 Electrosurgical Generator) through engineering and performance testing. It does not describe acceptance criteria or a study proving that the device meets those criteria in the context of clinical efficacy or diagnostic accuracy.
This document outlines a regulatory clearance process based on establishing similarity and safety/performance equivalence to a previously cleared device, rather than a de novo clinical study proving a specific performance benefit or diagnostic criterion.
Therefore, many of the requested categories (like sample size for test set, number of experts for ground truth, adjudication method, MRMC study, standalone performance, training set size) are not applicable to the information provided in this 510(k) summary.
Here's an analysis of what is available:
1. Table of Acceptance Criteria and Reported Device Performance (as far as discernible from the document):
| Acceptance Criteria Category | Reported Device Performance (Summary from Document) |
|---|---|
| Safety & Essential Performance (Standards Compliance) | The ESU-1 complies with IEC60601-1 (third edition), IEC60601-2 (electromagnetic compatibility), and IEC60601-2-2 standard for the safety of electrosurgical equipment. |
| Design Specifications | Bench testing was performed to demonstrate that the generator met its design specifications. The results from these tests demonstrate that the technological characteristics and performance criteria of the ESU-1 are adequate for the intended use of the device. |
| Technological Equivalence to Predicate Device | The ESU-1 has the same intended use/indications for use as the Bovie IDS-310. Each device is identical in size, weight, construction, uses high-frequency RF current, offers monopolar and bipolar output modes, offers the same waveforms, output frequencies, and maximum output power for all monopolar modes and for Micro, Standard, and Bovie Bipolar modes. Both have AutoBipolar Feature, same Return Electrode Monitoring System, same chassis, interconnections, internal PCBs, electrical components, and rated duty cycle. The RF output for both generators is identical. |
| New Feature Performance (Cut T mode) | "Cut T" mode includes a timing feature which automatically ceases RF activation after a user selectable period of time (0.1 to 3.0 seconds). Initially pre-set at 2 seconds. This mode replaces the Cut II function on the IDS-310. Specific performance values for Cut T mode are not explicitly stated beyond its functional description. |
2. Sample size used for the test set and the data provenance:
- Not applicable. This summary refers to "bench testing" and "design verification and validation" on the ESU-1 or "devices representative of its design." This is not a clinical study with human subjects, so there is no "test set" in the sense of patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. No expert ground truth typical of diagnostic or clinical performance studies is mentioned. The "ground truth" here is compliance with engineering standards and design specifications.
4. Adjudication method for the test set:
- Not applicable. No expert review or adjudication process for a test set is mentioned.
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 document pertains to an electrosurgical generator, not an AI-assisted diagnostic or therapeutic device that would involve human readers or AI improvement studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is an electrosurgical generator; it does not involve algorithms for standalone performance in the context of diagnostic AI. The software for the ESU-1 was "verified and validated based on its moderate level of concern," which refers to software functionality and safety within the device, not a performant algorithm.
7. The type of ground truth used:
- For the performance testing, the "ground truth" seems to be compliance with engineering design specifications and recognized international safety and performance standards (e.g., IEC 60601 series). It also includes demonstrating functional equivalence to the predicate device.
8. The sample size for the training set:
- Not applicable. This document does not describe the development of a machine learning algorithm with a training set. The "bench testing" would involve testing the physical device and its software's adherence to specifications.
9. How the ground truth for the training set was established:
- Not applicable. As no training set for an AI algorithm is mentioned, this question is not relevant.
§ 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.