(78 days)
The Link Technology Non-Stick Bipolar Forceps product is intended to facilitate grasping and manipulation of soft tissue and blood vessels and provide electrocautery in surgical procedures.
The Link Technology Non-Stick Bipolar Forceps electrosurgical tool in the typical tweezers configuration. The forceps are constructed with stainless steel and coated with an electrical insulator. The uninsulated forceps tip is plated with a proprietary metallurgical alloy. The forceps are compatible with standard OEM (original equipment manufacturer) electrosurgical generators and bipolar electrode cables.
The provided text is a 510(k) summary for the Link Technology, Inc. Non-Stick Bipolar Forceps. It primarily focuses on demonstrating substantial equivalence to predicate devices based on material composition and general design, rather than outlining a study with specific acceptance criteria and performance metrics.
Therefore, many of the requested details, such as a table of acceptance criteria, device performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance, are not available in the provided document.
Here's an analysis based on the information that is present:
1. A table of acceptance criteria and the reported device performance
- Not available. The document does not specify quantitative acceptance criteria or provide specific performance metrics for the Link Technology Non-Stick Bipolar Forceps. The claim is one of "substantial equivalence" to predicate devices, particularly regarding "non-stick properties, biocompatibility, and thermal and electrical conductivity" based on material identity or similar design.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not available. No specific test set or data provenance is mentioned. The assessment relies on material equivalence and established biocompatibility standards.
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 available. No mention of experts or ground truth establishment for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not available. No adjudication method 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 / Not available. This device is a surgical instrument (bipolar forceps), not an AI-powered diagnostic or assistive tool. Therefore, 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 / Not available. This device is a physical surgical instrument.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not available in the conventional sense for a diagnostic device. The "ground truth" for this submission revolves around the properties of the materials and the design congruence with legally marketed predicate devices.
- For the "non-stick properties, biocompatibility, and thermal and electrical conductivity," the ground truth is established by the identity of the proprietary metallurgical alloy with that used in a predicate device (Fusion Ball Tip Electrode).
- For biocompatibility, the ground truth is established by chosen materials having an "established history of safe use in similar medical devices, literature research, and biocompatibility studies that meet the standards outlined in ISO 10993-1."
8. The sample size for the training set
- Not applicable / Not available. This is not a machine learning device.
9. How the ground truth for the training set was established
- Not applicable / Not available. This is not a machine learning 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.