(55 days)
The ERBE ESU Model VIO dV with Accessories is intended to deliver High Frequency (HF) electrical current for the cutting and/or coagulation of tissue.
The ERBE ESU Model VIO dV with Accessories is an ElectroSurgical Unit that generates High Frequency (HF) electrical current to cut and/or coagulate tissue. It is a stand-alone generator. The ESU has five clearly defined Cutting and Coagulation Modes with different electrical waveforms and electrical parameters, which are programmed with defined Effect levels. Each Effect level corresponds to a specific voltage. The Modes provide the physician flexibility in interventional applications. Thus the Unit may be used for a broad array of surgical applications. The ESU user interface consists primarily of a touchscreen surrounded by a small number of physical controls, such as a power switch and connection points for the instruments and accessories with which the generator is compatible. Various hand instruments and neutral electrodes from ERBE and different manufacturers may be attached to and operated by the generator. The standard Accessories for the ESU consist of reusable Footswitches as well as Monopolar and Bipolar Cables.
The provided document describes a Special 510(k) for an updated electrosurgical unit (ESU), the ERBE ESU Model VIO dV with Accessories. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive clinical trials with specific acceptance criteria and performance metrics for an AI algorithm.
Therefore, many of the requested elements regarding acceptance criteria for device performance, sample sizes for test and training sets, expert involvement, and ground truth establishment are not applicable to this type of device submission. The focus here is on design control, verification, and validation against recognized consensus standards, and demonstrating that the modifications do not raise new questions of safety or effectiveness.
Here's a breakdown of the available information:
1. A table of acceptance criteria and the reported device performance
- Not applicable in the context of a 510(k) for an ESU based on substantial equivalence. The submission focuses on demonstrating that the modified device's performance, as verified through design controls and testing to recognized consensus standards, is equivalent to the predicate device. Specific numerical "acceptance criteria" and "reported device performance" in terms of clinical accuracy metrics (like sensitivity, specificity, F1-score for AI) are not provided nor typically required for this type of medical device.
- The document states: "The ERBE ESU Model VIO dV with Accessories was tested to FDA's "Recognized Consensus Standards"." This implies adherence to established engineering and safety standards relevant to ESUs, which serve as the "acceptance criteria" for the device's technical functionality and safety.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable. This information is relevant for studies involving data-driven algorithms (like AI/ML) where test sets are used to evaluate model performance on unseen data. This document describes a hardware device (electrosurgical unit), not a data-driven algorithm requiring a test set in that sense. Testing would involve engineering verification and validation on physical units to ensure compliance with standards.
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 the context of expert consensus is typically used for AI/ML performance evaluation. For an ESU, the "truth" is its ability to safely and effectively cut and coagulate tissue as specified by engineering standards, verified through testing, not through expert-labeled data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. Adjudication methods are used in studies where multiple human readers or algorithms produce outputs that need to be resolved to establish a definitive ground truth. This is not relevant to the verification and validation of an ESU's hardware and software against engineering 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
- Not applicable. MRMC studies are used to evaluate the impact of AI assistance on human reader performance, typically in diagnostic imaging. This device is an electrosurgical unit, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This question pertains to the performance of an AI algorithm independently. The device described is a medical instrument (ESU) that operates under human control, not an autonomous AI algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not applicable in the AI/ML context. For this device, the "ground truth" for verification and validation would be adherence to recognized consensus standards for electrical safety, electromagnetic compatibility, performance characteristics (e.g., power output, voltage curves for different modes), and functional specifications. This is established through objective measurements and compliance with regulatory standards.
8. The sample size for the training set
- Not applicable. This information is relevant for machine learning algorithms. The ESU is a hardware device with programmed functionalities, not a system that is "trained" on a dataset in the AI sense.
9. How the ground truth for the training set was established
- Not applicable. As above, the concept of a "training set" and "ground truth" for it is not relevant to this ESU's design and approval process.
Summary of Device Acceptance / Study Information from the Document:
- Acceptance Criteria Basis: The primary "acceptance criteria" for this Special 510(k) submission are based on demonstrating substantial equivalence to the predicate device (ERBE ESU Model VIO 300 D) and compliance with FDA's "Recognized Consensus Standards."
- Study Proving Acceptance: The study conducted was a design control process involving:
- Design and development planning: (Page 3)
- Design input: (Page 3)
- Design review: (Page 3)
- Design verification/design output: (Page 3)
- Design validation: (Page 3)
- Design transfer: (Page 3)
- Design change control: (Page 3)
- Specific evidence of meeting acceptance criteria:
- "The ERBE ESU Model VIO dV with Accessories has been verified or validated in design control." (Page 3)
- "The ERBE ESU Model VIO dV with Accessories was tested to FDA's "Recognized Consensus Standards"." (Page 3)
- The conclusion explicitly states: "The ERBE ESU Model VIO dV with Accessories has the same intended use, principles of operation and technological characteristics as the predicate device... The subject device has been verified or validated in design control. In conclusion, there are no issues with the subject device that would raise additional safety or efficacy issues, when compared to the predicate devices." (Page 3)
- Nature of Testing: The document indicates that animal or clinical performance testing was not considered necessary (Page 3), reinforcing that the acceptance was based on engineering verification, validation, and standard compliance, demonstrating equivalence to a lawfully marketed predicate device.
In essence, the "study" for this device was its robust design and development process, including verification and validation activities conducted according to established procedures and adherence to recognized consensus standards, which collectively demonstrated its safety and effectiveness as being substantially equivalent to the predicate 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.