(42 days)
Electrosurgical coagulation, dissection, and grasping of tissue during the performance of laparoscopic and general surgical procedures.
The device is a Class II medical device. The Everest Bipolar MACRO, MICRO & MOLLY Forceps and Gyrus Bipolar MACRO, MICRO & MOLLY Forceps is a modification to the predicate device cleared under K904993. The Everest Bipolar MACRO, MICRO & MOLLY Forceps and Gyrus Bipolar MACRO, MICRO & MOLLY Forceps is identical in construction (with the exception of shaft length) and in component materials when compared to the predicate device. The forceps jaws are electrically isolated from each other enabling one jaw to act as a return electrode, eliminating the need for a return pad. The modification has not altered the fundamental technology of the predicate device cleared under K90493. The intended use, Electrosurgical Coagulation, Grasping and Dissection, during surgical procedures is similar to the predicate devices cleared under K904993. The energy source, Bipolar Electrosurgical Energy, is the same energy type as used for the predicate devices.
The provided text is a 510(k) summary for the Everest Bipolar MACRO, MICRO & MOLLY Forceps and Gyrus Bipolar MACRO, MICRO & MOLLY Forceps. This document asserts substantial equivalence to a predicate device and does not involve a study to prove acceptance criteria in the manner you've described for AI/CADe devices.
The device is an electrosurgical instrument, not a diagnostic AI/CADe device. Therefore, the questions related to clinical study design, AI performance metrics, ground truth, and expert evaluation are not applicable to this 510(k) submission.
The core of this 510(k) submission is that the new device is "identical in construction (with the exception of shaft length) and in component materials" to a predicate device (K904993). The modification has not altered the fundamental technology or intended use.
Therefore, many of the requested fields cannot be filled. I will answer the applicable parts based on the type of device and submission.
1. A table of acceptance criteria and the reported device performance
For this type of device, acceptance criteria are typically met by demonstrating substantial equivalence to a predicate device through engineering design, material equivalence, and stated intended use. Performance in terms of accuracy metrics (sensitivity, specificity, etc.) as you would find for an AI/CADe system is not applicable here.
| Acceptance Criteria (Implied for medical device equivalence) | Reported Device Performance (as per 510(k) summary) |
|---|---|
| Material Equivalence: Identical component materials to predicate device. | The device is identical in component materials when compared to the predicate device. |
| Construction Equivalence: Identical construction to predicate device (allowing for minor, non-fundamental modifications). | The device is identical in construction (with the exception of shaft length) when compared to the predicate device. The modification has not altered the fundamental technology of the predicate device. |
| Intended Use Equivalence: Similar intended use to predicate device. | The intended use, Electrosurgical Coagulation, Grasping and Dissection, during surgical procedures is similar to the predicate devices. |
| Energy Source Equivalence: Same energy type as predicate device. | The energy source, Bipolar Electrosurgical Energy, is the same energy type as used for the predicate devices. |
| Safety and Effectiveness: No new issues of safety and effectiveness are raised by the modifications. | Gyrus Medical Inc. believes that no new issues of safety and effectiveness are raised and that the submitted device is substantially equivalent. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This is not a study assessing performance against a test set. This is a submission demonstrating substantial equivalence to a previously cleared device based on design and material comparisons.
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. No ground truth was established by experts for a test set in the context of an AI/CADe device study.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.
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/CADe device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/CADe device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. For this type of electrosurgical instrument, "ground truth" typically refers to established engineering standards, biocompatibility testing (if new materials were introduced, which was not the case here), and functional testing to ensure the device performs its intended mechanical and electrical actions safely. These aspects are handled via internal testing and compliance with recognized standards, not clinical ground truth establishment as in diagnostic studies.
8. The sample size for the training set
Not applicable. This is not an AI/CADe device.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/CADe device.
§ 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.