(287 days)
KLS Martin Bipolar Scissors are intended for dissecting, cutting and bipolar coagulation of tissue during general surgical procedures.
KLS Martin Bipolar Instruments with Handles and Exchangeable Electrodes are intended for grasping, dissecting, cutting and bipolar coagulation of tissue during general, gynecology and laparoscopic surgical procedures.
KLS Martin marLap Bipolar Coagulation instruments are intended for grasping, dissecting, cutting and bipolar coagulation of tissue during general, gynecology and laparoscopic surgical procedures.
KLS Martin Bipolar Forceps/Non-Stick are design to grasp, manipulate and coagulate selected tissue.
KLS Martin Electrosurgical Instruments have not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures and should not be used for these procedures
KLS Martin Electrosurgical cables are intended for use in electrosurgical procedures to provide transmission of electrical power from the bipolar electrosurgical generator to a bipolar instrument.
The KLS Martin Electrosurgical Instruments are surgical instruments that allow the surgeon to cauterize and coagulate tissue by passing a electrical current that is provided by a electrosurgical generator. The instruments are insulated to isolate the user from the current. The KLS Martin Electrosurgical Instruments are manufactured in a variety of shapes and sizes to allow the operating surgeon choices for optimum efficiency.
The provided text is a 510(k) summary for the KLS Martin Electrosurgical Instruments. This document asserts substantial equivalence to predicate devices rather than providing a study that establishes performance against specific acceptance criteria. This type of submission relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device, often by showing identical or very similar technological characteristics and intended use, rather than conducting a de novo clinical trial with defined acceptance criteria and performance metrics.
Therefore, the requested information regarding acceptance criteria and a study proving the device meets them, including details like sample size, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, training set details, and ground truth establishment, is not present in this 510(k) summary.
Here's why and what can be inferred:
- No Acceptance Criteria or Performance Study: The document explicitly states, "The KLS Martin Electrosurgical Instruments are identical in design, manufacturing, material and operation to the Claris Non-Stick Bipolar Forceps (K051429), BiTech Bipolar Scissors (K042077), POWERGRIP Bipolar Coagulation Forceps (K033177), Bissinger Cables (K981919) and Bissinger Detachable Bipolar Coagulation Forceps (K970968)."
- This is the core of a substantial equivalence claim. It means the manufacturer is asserting that since the device is identical or substantially similar to previously cleared devices, it inherently meets the same performance and safety standards as those predicates. There is no new performance data presented because the performance is assumed to be equivalent to the predicates.
- No AI Component: The device is an electrosurgical instrument (physical surgical tools). There is no mention of any AI or software component in the device's functionality. Therefore, questions related to AI performance, human-AI collaboration, sample sizes for AI training/testing, or ground truth for AI algorithms are not applicable to this submission.
In summary, based on the provided text, a table of acceptance criteria and a study proving the device meets these criteria cannot be generated because the 510(k) submission model used here is based on substantial equivalence to predicate devices, not on a new performance study with explicit acceptance criteria.
§ 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.