Search Results

Ask a specific question about this device

Ask a specific question about this device

Indicated for coagulation of tissue
These devices are intended for use by qualified medical personnel trained in the use of electrosurgery.

Not Found

This document is a 510(k) clearance letter from the FDA for a family of electrosurgical electrodes. It confirms that the device is "substantially equivalent" to predicate devices already on the market, subject to general controls.

However, this document does not contain the detailed information necessary to describe the acceptance criteria and the study that proves the device meets those criteria.

Here's why and what information is missing:

• Acceptance Criteria and Reported Device Performance: This letter states that the device is "substantially equivalent" to existing devices. It does not provide specific performance metrics (e.g., accuracy, precision, impedance, coagulation depth) or a table of acceptance criteria that the device was tested against.
• Study Details (Sample Size, Data Provenance, Ground Truth, etc.): The letter itself is part of the regulatory approval process, not the study report itself. It references an underlying 510(k) submission (K992045) which would contain the study data. None of the following are present in this document:
  • Sample size for the test set or training set.
  • Data provenance (country of origin, retrospective/prospective).
  • Number or qualifications of experts.
  • Adjudication method.
  • Information on MRMC comparative effectiveness studies or standalone algorithm studies.
  • Type of ground truth used.
  • How ground truth for the training set was established.

Conclusion:

Based only on the provided document, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance.
3. Details about expert involvement.
4. Adjudication method.
5. MRMC study information.
6. Standalone study information.
7. Type of ground truth.
8. Training set details.
9. Ground truth establishment for the training set.

This document is a high-level regulatory clearance and does not delve into the detailed technical and clinical study aspects of the device's validation. You would need to consult the actual 510(k) submission (K992045) for that information, which is typically much more extensive.

Ask a specific question about this device

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:

1. 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.
2. Sample size used for the test set and the data provenance: Not applicable. No test set for performance evaluation is mentioned.
3. 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.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No test set or adjudication is mentioned.
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. This is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. No ground truth is mentioned.
8. The sample size for the training set: Not applicable. No training set is mentioned as this is not an AI/ML device.
9. 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.

Ask a specific question about this device