(237 days)
Bipolar Coagulation Forceps have been designed to be used with endoscopes to cauterize and coagulate or to perform hemostasis using high-frequency current within the digestive tract.
The Bipolar Coagulation Forceps described in this submission are a sterile, single use devices compatible with the working channel of endoscope. The device is used with endoscopes to cauterize and coagulate or to perform hemostasis using high-frequency current within the digestive tract.
Bipolar Coagulation Forceps consists of Handle part, plug, sheath and forceps part.
The acceptance criteria and study proving device performance are not present in the provided text. The document is a 510(k) summary for the Bipolar Coagulation Forceps, asserting substantial equivalence to a predicate device (Coagrasper™).
The document mentions that "The Bipolar Coagulation Forceps meets all design specifications and medical device standards for electrosurgical safety (IEC 60601), biocompatibility (ISO 10993) and sterility (ISO 11135)." and "The non-clinical performance meets the design specification and shows substantial equivalence to the predicated device." However, concrete acceptance criteria and detailed performance data, sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies are not provided.
Specifically, the following information requested in the prompt is not available in the provided text:
- Acceptance Criteria Table and Reported Performance: No such table is present. The document generally states compliance with standards but provides no specific metrics or thresholds.
- Sample Size for Test Set and Data Provenance: No test set or sample size is mentioned.
- Number of Experts and Qualifications for Ground Truth: No experts or ground truth establishment method for a test set are described.
- Adjudication Method: Not applicable as no human-read test set is described.
- Multi-reader Multi-case (MRMC) Comparative Effectiveness Study: The document explicitly states "No Clinical test is included in this submission," indicating that no human-in-the-loop study was performed.
- Standalone Performance: While "non-clinical performance meets the design specification" is stated, no specific standalone performance metrics or the study details are provided.
- Type of Ground Truth Used: Not applicable as no clinical test or human-read evaluation is detailed.
- Sample Size for Training Set: No training set is mentioned as this is a medical device, not an AI/ML model being trained on data.
- How Ground Truth for Training Set was Established: Not applicable.
The document primarily focuses on demonstrating substantial equivalence through a comparison of technological characteristics with a predicate device and adherence to general medical device standards. It lists biocompatibility tests conducted for the proposed device due to differences in materials compared to the predicate, but these are not for establishing a "ground truth" in the context of an AI/ML or diagnostic device clinical study.
In summary, the provided document does not contain the detailed study information or acceptance criteria requested, as it is a 510(k) summary focused on substantial equivalence rather than a detailed performance study report.
§ 876.4300 Endoscopic electrosurgical unit and accessories.
(a)
Identification. An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator.(b)
Classification. Class II (performance standards).