Search Results

Intended to remove tissue and control bleeding by use of high frequency electrical current. (21 CFR §878.4400).

Semkin Bipolar Forcep

This is a letter about the substantial equivalence of a medical device (Semkin Bipolar Forcep) filed under a 510(k) premarket notification. These documents typically don't include detailed information about acceptance criteria or specific studies that prove the device meets those criteria in the way a clinical trial report or specific performance testing report would. The purpose of a 510(k) is to demonstrate that a device is as safe and effective as a legally marketed predicate device, not necessarily to re-prove its safety and effectiveness from scratch with specific performance metrics and dedicated studies.

Therefore, many of the requested details about acceptance criteria and study particulars cannot be found in the provided text.

Based on the provided document:

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

   • The document does not explicitly state specific quantifiable acceptance criteria (e.g., sensitivity, specificity, accuracy percentages) or the reported performance of the Semkin Bipolar Forcep against such criteria.
   • The basis for acceptance in a 510(k) is "substantial equivalence" to a predicate device. This typically means demonstrating that the new device has the same intended use, technological characteristics, and performs as well as or better than the predicate, or if there are differences, that those differences do not raise new questions of safety or effectiveness. The document implies the device met the requirements for substantial equivalence.

2. Sample size used for the test set and the data provenance:

   • Not mentioned in the document. 510(k) submissions generally rely on existing predicate data, and if new testing is conducted, its details like sample size and provenance are often in supporting documentation not included here.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not mentioned in the document.

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

   • Not mentioned in the document.

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:

   • This document is for a Bipolar Forcep, a surgical instrument. MRMC studies and AI assistance are not relevant to this type of device.

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

   • Not relevant for this type of device.

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

   • Not mentioned in the document. For a bipolar forcep, ground truth would likely relate to its ability to remove tissue and control bleeding, demonstrated through engineering tests or pre-clinical/clinical data if deemed necessary for substantial equivalence.

8. The sample size for the training set:

   • Not mentioned, and generally not applicable in the context of a 510(k) for a basic surgical instrument, which doesn't involve "training sets" in the AI sense.

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

   • Not mentioned, and not applicable for this type of device.

Summary of available information:

The document is a 510(k) clearance letter for the "Semkin Bipolar Forcep," indicating that the FDA determined it is substantially equivalent to a legally marketed predicate device. The intended use is "Intended to remove tissue and control bleeding by use of high frequency electrical current." The acceptance criterion, implicitly met, is "substantial equivalence" to a predicate device, meaning it is as safe and effective. Details on specific performance studies (like clinical trials, test set data, expert reviews, or AI-related metrics) are not provided in this regulatory letter itself, as they would typically be part of the larger 510(k) submission which this letter is a response to.

Ask a specific question about this device