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The intended use of the Tecno reusable bipolar electrosurgical forceps is to grasp and coagulate (control bleeding) by use of high-frequency electrical current. The forceps can be used multiple (come of have been AAMI performance tested after 20 exposures to steam sterilization. The areas of specialty that the Tecno electrosurgical bipolar forceps will be used is: neurosurgical, opthalmic, plastic and reconstructive surgical procedures.

Indications for use are hemorrhaging of compromised tissue and subsequent need to coagulate during invasive surgical procedures.

REUSABLE BIPOLAR ELECTROSURGICAL FORCEPS

This 510(k) clearance letter from the FDA for "Reusable Bipolar Electrosurgical Forceps" does not contain the detailed information necessary to complete most of the requested fields regarding acceptance criteria and a study proving the device meets those criteria.

The letter primarily confirms that the device is substantially equivalent to a predicate device and allows it to be marketed. It refers to "AAMI performance tested after 20 exposures to steam sterilization" but provides no specifics on the acceptance criteria, the performance metrics, or the study details.

Here's a breakdown of what can and cannot be answered based solely on the provided text:

1. A table of acceptance criteria and the reported device performance

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size (Test Set): Not specified.
• Data Provenance: Not specified. The document is a regulatory clearance, not a study report.

3. 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. This device is a surgical instrument, not an diagnostic imaging or AI device requiring expert-established ground truth for its performance evaluation in the context of this regulatory letter. Its performance would likely be evaluated against engineering specifications and functional tests.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable for this type of device and the information provided.

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 a surgical instrument, not an AI-powered diagnostic tool, so an MRMC study related to AI assistance would not be relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable. This is a manual surgical instrument, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Not explicitly stated. For a reusable surgical instrument, "ground truth" for performance would typically involve:
  • Engineering specifications/Standards: Compliance with AAMI standards for electrosurgical devices and sterilization.
  • Functional testing: E.g., ability to grasp, effectively coagulate, maintain insulation integrity, and withstand sterilization cycles without degradation.
  • Biocompatibility: Assuring materials are safe for patient contact.
• The document only alludes to "AAMI performance tested after 20 exposures to steam sterilization," suggesting compliance with applicable standards.

8. The sample size for the training set

• Not applicable. This is not an AI/ML device requiring a training set.

9. How the ground truth for the training set was established

• Not applicable.

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