(326 days)
The Kogent Disposable Copper Bipolar Forceps are a single use product sold sterile and are intended for use in electrosurgery for coagulation of tissue. The Kogent Disposable Copper Irrigating Bipolar Forceps are a single use product sold sterile and are intended for use in electrosurgery for coagulation and irrigation of tissue. The Kogent Disposable Copper Illuminating Bipolar Forceps are a single use product sold sterile and are intended for use in electrosurgery for coagulation and to supply light for surgical procedures.
These devices are disposable bipolar forceps, designed for single use in general surgical procedures. They require connection with a suitable bipolar cable to the bipolar output of an electrosurgical generator. These forceps are designed to grasp, manipulate, coagulate, irrigate and illuminate, when applicable, selected tissues. The irrigation tube is designed to carry sterile fluid to the tips of the instrument. The illumination style forceps contain illumination fibers on each tine to deliver light to the surgical site. Coagulation is achieved using electrosurgical energy generated by the electrosurgical generator and activated by a footswitch. The forceps are provided sterile by ethylene oxide and in sterile pouches.
I am sorry, but based on the provided text, there is no information about a study that would include acceptance criteria and device performance in the context of an AI/human reader study or clinical trial as you've outlined.
The document is a 510(k) summary for medical devices (Kogent Disposable Copper Forceps, Irrigating, and Illuminating Bipolar Forceps), which focuses on demonstrating substantial equivalence to predicate devices, primarily through bench testing and adherence to recognized standards, rather than clinical efficacy trials involving human readers or AI.
Here's why none of your requested information can be extracted:
- No AI component: The devices described are electrosurgical forceps, not AI-powered diagnostic or assistive tools.
- No human reader component: The evaluation is for physical medical devices and their performance characteristics (e.g., sterilization, biocompatibility, electrical safety, thermal conductivity, non-stick ability), not for human interpretation of data.
- No clinical study: The document explicitly states, "Clinical Testing was not required to prove substantial equivalence." The evaluation is based on bench testing.
Therefore, I cannot provide:
- A table of acceptance criteria and reported device performance related to AI or human interpretation.
- Sample size for a test set in a human-in-the-loop or standalone AI study.
- Number and qualifications of experts for ground truth establishment.
- Adjudication method.
- MRMC study results or effect size for AI assistance.
- Standalone AI performance.
- Type of ground truth (expert consensus, pathology, outcomes data) for AI/diagnostic purposes.
- Training set sample size (as there's no AI model to train).
- How ground truth for a training set was established.
The provided document describes the following performance data and tests for the physical medical device:
- Medical Electrical Equipment Standards: IEC 60601-1 (various editions), IEC 60601-2-2, IEC 60601-1-6.
- Biocompatibility: ISO 10993-5 (In Vitro Cytotoxicity), ISO 10993-10 (Irritation and Skin Sensitization), ISO 10993-11 (Systemic Toxicity).
- Sterilization: ISO 11135 (Ethylene oxide sterilization).
- Shelf Life: ASTM F1980 (Accelerated Aging).
- Bench Testing: Thermal Conductivity, Non-Stick Ability, Average Flow Rate (for irrigating forceps), Average Illumination Output (for illuminating forceps), Average Temperature Rise due to Illumination Output, Thermal Effects on Tissue.
These tests are designed to show that the new forceps are as safe and effective as existing legally marketed predicate devices, not to evaluate an AI or human interpretive performance.
§ 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.