(88 days)
The ETHICON Non-Stick Bipolar Forceps are non-sterile, reusable devices intended to facilitate tissue grasping/manipulation, bipolar point coagulation, and bipolar coagulation while grasping soft tissue, including vessels up to 3mm in diameter in open surgical procedures.
The ETHICON Non-Stick Bipolar forceps are available in various standard sizes and shapes similar to conventional forceps. These forceps can be connected to the bipolar output mode on electrosurgical generators to facilitate bipolar coagulation and bipolar point coagulation. The ETHICON Non-Stick Bipolar Forceps are designed for use with the ETHICON Bipolar Cable (K#960476). The ETHICON Bipolar Cable is used to connect the ETHICON Non-Stick Bipolar Forceps to the generator (ESU).
The device under consideration is the ETHICON Non-Stick Bipolar Forceps.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Device functions as intended for tissue grasping/manipulation, bipolar point coagulation, and bipolar coagulation of soft tissue, including vessels up to 3mm in diameter. | "Preclinical laboratory evaluations (complies with IEC-602-2.2) were performed to ensure that the device functions as intended." |
| Compliance with IEC-602-2.2 (Standard for medical electrical equipment - Part 2-2: Particular requirements for the safety of high frequency surgical equipment). | "complies with IEC-602-2.2" |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated. The document refers to "preclinical laboratory evaluations" but does not detail the number of units tested or specific test cases.
- Data Provenance: The data is from "preclinical laboratory evaluations". The country of origin is not specified, but the submission is to the US FDA, implying data gathered for that regulatory body. It is retrospective in the sense that the evaluations were completed before the 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the document. The study relies on "preclinical laboratory evaluations" and compliance with a technical standard, rather than expert-derived ground truth from a clinical setting.
4. Adjudication method for the test set:
This information is not provided. Given the nature of preclinical laboratory evaluations for a medical device (surgical forceps), adjudication typically involves objective measurements and adherence to test protocols, rather than a human consensus method for subjective interpretation.
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 document describes a traditional medical device (bipolar forceps) and its regulatory submission. It is not an AI/Software as a Medical Device (SaMD) and therefore, an MRMC comparative effectiveness study involving AI assistance would not be relevant or performed.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. As stated above, this is not an AI/SaMD device. Performance evaluation for this device is based on its physical and electrical functionality, not algorithm performance.
7. The type of ground truth used:
The ground truth is based on objective performance specifications and adherence to the technical standard IEC-602-2.2, which sets requirements for the safety and performance of high-frequency surgical equipment. The "ground truth" here is the device's ability to mechanically grasp tissue and effectively perform bipolar coagulation as intended, verified through laboratory testing against established specifications.
8. The sample size for the training set:
Not applicable. This device does not involve a "training set" in the context of machine learning or AI development.
9. How the ground truth for the training set was established:
Not applicable. As stated above, this device does not involve a training set.
§ 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.