(20 days)
The ERBE VIO ESU with Accessories is intended to deliver high frequency (HF) electrical current for the cutting and/or coagulation of tissue.
The ERBE VIO ESU with Accessories is an electrosurgical system that uses high frequency (HF) electrical current waveforms to cut and/or coagulate tissue. There were no modifications to the Accessories from the previously cleared 510(k) K023886; therefore, they are not included with this submission.
Unit (Model VIO 300 D)
General Description. The ESU has a color monitor display that provides the user with an on-screen tutorial as well as setting and operational information. The unit has various cutting and coagulation modes with defined effect levels to provide the physician flexibility in interventional applications (i.e., its ability to generate HF current). The system has automatic start and stop features. The equipment is programmable and various accessories (e.g., footswitches, hand instruments, etc.) as well as modes may be assigned to perform specific functions. When activated, the device has an audio and visual error system (i.e., malfunctions or user errors are detected with medical personnel being alerted visually and/or by sound with, in some cases, no energy being delivered). Upon activation, the energy delivered (in watts) from the ESU to the tissue is displayed on the display screen. Also, the unit can be used in association with an ERBE compatible Argon Plasma Coagulator (APC). The unit is supplied non-sterile and is reusable.
Note: VIO stands for Variable Cut and Coagulation.
This document is a 510(k) premarket notification for an electrosurgical generator (ESU) system. It details modifications made to the ERBE VIO ESU (Model VIO 300 D) compared to its predicate device (K023886). The primary focus of the submission is to demonstrate substantial equivalence, rather than present a study with explicit acceptance criteria and device performance metrics in the way a clinical trial for a diagnostic algorithm would.
Therefore, many of the requested elements for describing acceptance criteria and a study proving those criteria are not directly applicable or present in this regulatory submission. However, I will extract and infer information where possible based on the provided text.
Here's an attempt to answer your questions based on the provided input:
- A table of acceptance criteria and the reported device performance
The document does not present a table of quantitative acceptance criteria typical for a diagnostic or AI device study (e.g., sensitivity, specificity thresholds). Instead, the acceptance criteria are implicitly met by demonstrating "substantial equivalence" to the predicate device, specifically regarding safety and efficacy. The performance is described in terms of features, modes, power output, and protective circuits being "the same" or "unaffected."
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety and Efficacy (not adversely affected by modifications) | "These modifications do not affect the safety or efficacy of the VIO 300 D ESU." (Monopolar Modes) |
| "The addition of these modes does not affect the safety or efficacy of the modified ESU." (Bipolar Modes) | |
| Consistency with Predicate (Protective Circuits, Intended Use) | "The modified ESU (ERBE VIO 300 D ESU) has the same protective circuits and intended use as the predicate ESU..." |
| "The ERBE VIO ESU (Model VIO 300 D) has the same intended use, principles of operation, and technological characteristics as the predicate ESU..." | |
| Equivalence in Monopolar Modes (Cut/Coagulation, Power, Voltage) | "The modified ESU has the same cut and coagulation modes, Effect levels, power maximums (wattages) and voltage maximums." The ENDO CUT program "1" has the same settings as the predicate. ENDO CUT program "Q" has modified default settings but "control/regulation... was improved." |
| Equivalence in Bipolar Modes (Cut/Coagulation, Power, Voltage) | "The modified ESU has the same cut and coagulation modes, Effect levels, power maximums (wattages) and voltage maximums." Note: Two additional modes were added, but confirmed not to affect safety/efficacy. |
| Equivalence in BiClamp, APC, Argon-Assisted Modes | "The modified ESU has the same cut and coagulation modes, Effect levels, power maximums (wattages) and voltage maximums specific to BiClamp, APC, and Argon-Assisted Modes." Note: Hardware modification (capacitor) to reduce NMS effect was added. |
| All modifications verified/validated in design control | "All the unit modifications have been verified or validated in design control." |
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This document describes an engineering and regulatory comparison to a predicate device, not a clinical study involving a "test set" of patient data or samples. The "test set" would primarily refer to the modified ESU hardware and software features themselves. There is no mention of patient data. The device is manufactured by ERBE Elektromedizin GmbH in Germany. -
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 to this type of submission. There are references to "feedback from the physicians" which led to the addition of bipolar modes and "field experience of the predicate Mode" which led to improvement in the ENDO CUT Q mode. However, these are general feedback mechanisms, not the establishment of ground truth by a specific number of qualified experts for a predefined test set. -
Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No "test set" in the context of clinical or diagnostic performance with an adjudication method is described. -
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 device is an electrosurgical generator, not an AI-assisted diagnostic tool. -
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm, but a medical device (hardware and software) that a human operates. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the modifications, the "ground truth" for safety and efficacy is based on design control verification and validation activities and the established safety and efficacy of the predicate device. For the reduction of neuromuscular stimulation (NMS), the "ground truth" is that NMS is a known issue with high-frequency electrical current generators, and adding a capacitor lowers the susceptibility of patients to NMS. This relies on engineering principles and potentially prior clinical evidence/understanding of NMS. The specific "type" of clinical ground truth (e.g., pathology, outcomes) in a study sense is not detailed. -
The sample size for the training set
Not applicable. This is not a machine learning or AI device that requires a training set. -
How the ground truth for the training set was established
Not applicable.
§ 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.