(167 days)
The Bovie IDS 300 High Frequency Electrosurgical Generator is a non-sterile reusable multi-purpose electrosurgical generator that is designed to perform monopolar and bipolar functions in the operating arena.
The IDS 300 High Frequency Electrosurgical Generator is a non-sterile, reusable multi-purpose electrosurgical generator for use in the operating arena which features both monopolar and bipolar functions which meet surgical demands for safety, flexibility, and convenience. Functions which the IDS 300 performs includes: monopolar cut; monopolar cut with hemostasis (blend); force coagulation; fulguration; and bipolar.
This document does not contain the information required to complete your request. The provided text is a 510(k) summary for an electrosurgical generator (IDS 300 High Frequency Electrosurgical Generator).
It focuses on establishing substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a detailed study.
Here's what is missing:
- Acceptance Criteria Table and Reported Device Performance: The document states that "Testing which has been performed on the IDS 300 indicates that this device is substantially equivalent in performance and method of operation." However, it does not provide a table of specific quantitative acceptance criteria (e.g., power output accuracy within X%, impedance range Y-Z ohms, etc.) nor does it report the actual measured performance values of the IDS 300 against such criteria.
- Sample Size and Data Provenance for Test Set: No specific test set is described, nor is any sample size, country of origin, or retrospective/prospective nature of data mentioned.
- Number and Qualifications of Experts: No experts are mentioned in relation to establishing ground truth, as the evaluation is based on technical performance comparison, not diagnostic interpretation.
- Adjudication Method: Not applicable, as there's no diagnostic interpretation scenario.
- MRMC Comparative Effectiveness Study: There is no mention of a multi-reader, multi-case study involving human readers or AI assistance.
- Standalone Performance: The testing mentioned is for the device's functional performance, not an algorithm's standalone performance in a diagnostic context.
- Type of Ground Truth: The "ground truth" here is implied to be engineering and safety standards, and performance characteristics for electrosurgical generators, derived from predicate devices, rather than expert consensus, pathology, or outcomes data.
- Training Set Sample Size and Ground Truth: No training set is discussed as this is not an AI/ML device that requires training.
In summary, this document is a regulatory submission demonstrating substantial equivalence for a physical medical device, not a typical study report for a diagnostic algorithm or AI-powered device that would include the requested metrics. The "testing" referred to is likely engineering verification and validation against established standards for electrosurgical generators, ensuring safety and functional equivalence to legally marketed devices.
§ 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.