(48 days)
Intended for use by practitioners in a manner identical to similar electrosurgical electrodes of this type presently in commercial distribution. It is intended to provide electrocautery over a large surface.
The Fusion Ball Tip Electrode is a reusable electrode for use in monopolar electrosurgical accessories.
This 510(k) premarket notification for the Fusion Ball Tip Electrode does not contain information about acceptance criteria or a study demonstrating the device meets such criteria in the context of an AI/ML device. The provided text describes a medical device, specifically an electrosurgical electrode, and compares its technological characteristics to a predicate device for the purpose of demonstrating substantial equivalence.
Therefore, the following requested information cannot be extracted or inferred from the provided text:
- A table of acceptance criteria and the reported device performance: Not applicable. The document focuses on technological characteristics for substantial equivalence, not performance metrics against acceptance criteria.
- Sample size used for the test set and the data provenance: Not applicable. No test set for performance evaluation is mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No test set or ground truth establishment is mentioned.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No test set or adjudication is mentioned.
- 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 is not an AI/ML device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML device.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. No ground truth is mentioned.
- The sample size for the training set: Not applicable. No training set is mentioned as this is not an AI/ML device.
- How the ground truth for the training set was established: Not applicable. No training set or ground truth establishment is mentioned.
The document is a traditional 510(k) submission focused on demonstrating substantial equivalence to a legally marketed predicate device based on technological characteristics, indications for use, and material composition, rather than performance against specific acceptance criteria relevant to AI/ML or diagnostic performance.
§ 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.