(94 days)
The Olympus ESG-400 electrosurgical unit is intended for cutting and coagulation of tissue in open, laparoscopic and endoscopic surgery in conjunction with electrosurgical accessories and ancillary equipment.
The ESG-400 is a reusable, non-sterile electrosurgical generator that features different mono- and bipolar cutting and coagulation modes. The maximum output power is 320 W. On the front side it features a touch screen display that displays the connection status of accessories and peripherals connected to the electrosurgical generator. It is also used to show and modify the output settings (e.g. mode, output power, effect) as well as to control other functions (e.g. save settings). In addition the ESG-400 has a bipolar socket, two monopolar sockets, a neutral electrode socket, and a universal socket to connect applicators with instrument recognition. The power switch turns the generator on and off. Two contact quality indicators (one for split and one for non-split electrodes) are green illuminated if neutral electrodes are correctly connected. Three additional push buttons allow recalling a previously saved setting (Select Procedure), to assign the footswitches to specific output sockets (Footswitch), and to control several other functions (Menu), e.g. select language, touch tone control, output volume, or brightness. On the rear panel the volume control, a ventilation hole, the equipotential bonding point, the AC power socket, and two footswitch sockets can be found. Furthermore, for the connection of peripheral equipment 26-pin plugs respectively 14-pin plugs can be connected to the LINK-IN or to the LINK-OUT socket. On the bottom panel, a docking socket is featured. In future it might be used to connect the ESG-400 directly to upcoming devices.
The provided text describes an electrosurgical unit (ESG-400), not an AI/ML device, and therefore the concepts of acceptance criteria, test sets, ground truth, and human reader studies (MRMC) as typically applied to AI/ML device submissions are not directly addressed. The submission focuses on demonstrating substantial equivalence to predicate electrosurgical devices through compliance with established safety standards and bench testing.
However, I can extract information related to the device's performance and the types of tests conducted to support its safety and effectiveness, based on the provided document. I will interpret "acceptance criteria" as the demonstration of substantial equivalence to predicate devices, primarily through adherence to recognized consensus standards and comparative bench testing of output characteristics.
Here's an attempt to answer your questions based on the provided text, while acknowledging the limitations due to the nature of the device:
1. A table of acceptance criteria and the reported device performance
For a traditional medical device like an electrosurgical unit, "acceptance criteria" are typically defined by compliance with recognized standards and demonstrated equivalence in performance characteristics to legally marketed predicate devices. The document implies:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Compliance with recognized consensus standards (e.g., IEC 60601 series, IEC 62304, IEC 62366, ISO 14971) | "The design of the ESG-400 complies with the following recognized consensus standards:" (lists standards) |
| Safety and Efficacy comparable to predicate devices | "The data show that the differences between the subject ESG-400 and the predicate devices do not affect the safety and efficacy..." |
| Output characteristics, application modes, max output power, and handling do not change safety/effectiveness or create new risks compared to predicates | "There are differences in the output characteristics and the quantity of the application modes, the maximum output power, or the handling, but they do not change the safety and effectiveness or result in new potential risks." |
| Bench test performance comparable to predicate devices | "...bench tests of the subject ESG-400 and the predicate devices VIO 300 D and XUES-41 were performed and demonstrate substantial equivalence." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify a "sample size" in the context of a data test set for an AI/ML model. The testing described is primarily bench testing to compare performance characteristics of the ESG-400 against predicate devices. This typically involves a single device or a small set of devices undergoing various electrical and functional tests.
- Sample Size: Not applicable in the AI/ML sense. It refers to a limited number of physical units for bench testing.
- Data Provenance: The testing was conducted by or on behalf of Olympus Winter & Ibe (Germany) and Olympus America Inc. (USA). The data would originate from these tests. It is retrospective in the sense that the testing was completed before the submission.
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)
This is not applicable as the device is an electrosurgical unit, not an AI/ML model for which ground truth is established by human experts. The "ground truth" for an ESU's performance is determined by adherence to engineering specifications and international safety standards benchmarked against predicate devices and their established safe and effective performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is a concept used in AI/ML model validation involving disagreement resolution among human readers. For an ESU, performance is measured objectively through physical tests (e.g., power output, safety features).
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. An MRMC study is designed to evaluate the impact of an AI system on human diagnosticians' performance. The ESG-400 is an electrosurgical generator, not a diagnostic AI tool that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This concept is not directly applicable. The "standalone performance" of the ESG-400 is its intrinsic performance as measured by its output characteristics (e.g., power, mode settings) during bench testing, independent of direct interaction with a human operator during a clinical procedure. The device is designed to be operated by a human, but its core functional performance can be assessed independently. The document states "bench tests... were performed and demonstrate substantial equivalence," which can be considered analogous to standalone performance assessment.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for an electrosurgical unit's safety and effectiveness is established through:
- Compliance with recognized industry standards: IEC 60601 series, IEC 62304, IEC 62366, ISO 14971. These standards define acceptable performance, safety limits, and testing methodologies.
- Performance data from legally marketed predicate devices: The ESG-400's performance (e.g., output power, mode characteristics) is compared to that of the Erbe VIO ESU and Olympus XUES-41, which are already deemed safe and effective.
- Bench test data: Objective measurements of the device's electrical output and functional operation.
8. The sample size for the training set
Not applicable. The ESG-400 is a hardware device, not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of 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.