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

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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.

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