(27 days)
The Bipolar Coagulation Probe is intended to be passed through an endoscope's working channel to provide hemostasis throughout the gastrointestinal tract.
The proximal end of the Merit Bipolar Coagulation Probe consists of a plug which connects to an electrosurgical generator and a luer flush hub which connects to an irrigation source. The plug comes in one of two configurations: a single or dual bipolar plug. The tubing from the plug encases a Teflon coated wire which is united with the flushing lumen from the luer in a Y connection. A single tube with the coated wire and flushing lumen leads from the Y connection to the distal probe tip. The distal end (tip) consists of uniformly spaced metal electrodes configured in a spiral fashion on the rounded ceramic tip.
Here's a breakdown of the acceptance criteria and the study details based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Test/Description | Reported Device Performance |
|---|---|---|
| Mechanical Performance | Tensile strength | Met predetermined acceptance criteria |
| Flow | Met predetermined acceptance criteria | |
| Leak (integrity) | Met predetermined acceptance criteria | |
| Kink resistance | Met predetermined acceptance criteria | |
| Tip separation | Met predetermined acceptance criteria | |
| Electrical Performance | High frequency leakage | Met predetermined acceptance criteria |
| High frequency dielectric strength | Met predetermined acceptance criteria | |
| Mains frequency dielectric strength | Met predetermined acceptance criteria | |
| Wiring continuity | Met predetermined acceptance criteria | |
| Overall Conclusion | Device safety, effectiveness, and performance compared to predicate | As safe, as effective, and performs as well as or better than the predicate device. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the numerical sample size for each test (e.g., how many devices were subjected to tensile testing, how many flow tests were performed).
The data provenance is internal testing performed by Merit Medical Systems, Inc. The document does not specify country of origin for the data or whether it was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
This information is not provided in the document. The study described is a performance verification of a medical device against pre-determined engineering and safety criteria, not a clinical study involving expert interpretation of data or images.
4. Adjudication Method for the Test Set:
This information is not applicable/provided. The tests described are objective, quantitative measurements (e.g., tensile strength, leak rate) against pre-defined engineering and safety standards. There is no mention of a subjective assessment requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study was not conducted. This document describes the performance testing of a physical medical device (a bipolar coagulation probe), not an AI-powered diagnostic tool that assists human readers. Therefore, the concept of improving human readers with AI assistance is not relevant to this submission.
6. Standalone (Algorithm Only Without Human-in-the-loop Performance) Study:
Not applicable. This document describes the performance testing of a physical medical device. There is no algorithm or AI component involved to have a standalone performance evaluation.
7. Type of Ground Truth Used:
The "ground truth" for this device's performance testing is based on predetermined acceptance criteria derived from engineering specifications, risk analysis, and safety standards for medical devices. These are objective, measurable thresholds for various physical and electrical properties of the device.
8. Sample Size for the Training Set:
Not applicable. This submission describes the verification testing of a physical medical device. There is no "training set" in the context of an AI/ML algorithm.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. As there is no training set, there is no ground truth establishment for it. The acceptance criteria were established through risk analysis for the device.
§ 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).