(55 days)
Simultaneous cutting and cauterization of soft tissue during surgery.
The Starion Instruments thermal cautery grasper/dissector is a single use, hand-held surgical instrument intended for simultaneously cutting and cauterizing soft tissue during surgery. The Starion Instruments thermal cautery grasper/dissector contains handle controls that allow the surgeon to position the distal jaws of the instrument around the region of tissue to be cut/cauterized. While squeezing the handle, the surgeon depresses a finger switch, which activates a heating element in the jaws. This heat is conducted to the tissue between the jaws to provide cutting/cauterization.
This 510(k) submission (K994019) focuses on demonstrating substantial equivalence of the Starion Instruments Thermal Cautery Grasper/Dissector to a predicate device, rather than proving the device meets specific acceptance criteria through a clinical study. Therefore, most of the requested information regarding study design, sample sizes, expert involvement, and ground truth is not applicable.
The submission is a summary of safety and effectiveness data, as required by 21 CFR 807.92, for a Class II device. The core argument for clearance is based on its substantial equivalence to the Starion Instruments thermal cautery forceps (K990728).
Here's a breakdown of the applicable and non-applicable information based on the provided text:
1. A table of acceptance criteria and the reported device performance
Not applicable. The document does not describe specific numerical acceptance criteria for performance metrics (e.g., cutting speed, tissue damage, sealing strength) nor the results of specific tests against such criteria. The "performance" reported is its substantial equivalence to the predicate device in terms of intended use, target population, energy source, and principles of operation.
2. Sample sized 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 comparing the device against a defined acceptance criterion with a test set. This is a regulatory submission for substantial equivalence.
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. There is no mention of a test set requiring ground truth established by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No test set requiring expert adjudication is described.
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 device is a surgical instrument, not an AI-assisted diagnostic or imaging tool. MRMC studies are irrelevant here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a manual surgical instrument, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The concept of "ground truth" as it pertains to medical device performance studies (especially for diagnostic or AI devices) is not relevant in this substantial equivalence submission for a surgical tool. The "truth" in this context is that the device functions similarly to a legally marketed predicate.
8. The sample size for the training set
Not applicable. There is no mention of a training set as this is not a machine learning or AI-driven device.
9. How the ground truth for the training set was established
Not applicable. As there is no training set, there is no ground truth establishment for one.
§ 886.4115 Thermal cautery unit.
(a)
Identification. A thermal cautery unit is an AC-powered or battery-powered device intended for use during ocular surgery to coagulate tissue or arrest bleeding by heat conducted through a wire tip.(b)
Classification. Class II.