(98 days)
The Dornier Bipolar Cable is indicated to be used with a compatible electrosurgical generator and an HF electrode for endoscopic treatment in urological applications: Cutting, ablation, resection, vaporization and coagulation with HF current.
The Dornier Bipolar Cable is a sterile, single use, disposable device that allows connection of an electrosurgical generator to an HF electrosurgical resection and vaporization electrode. The outer body of the Dornier Bipolar Cables are constructed of a medical grade thermoplastic elastomer. The cable consists of a double wire zip cord with one plug end which has four (4) banana and one (1) straight pin, style of connector that is then attached to the generator. The other end is separated and has two (2) overmolded connectors, one male pin on a wire and one female pin on a wire which are compatible with the HF Electrode.
The provided text describes the 510(k) summary for the Dornier Bipolar Cable. This is a submission for a medical device that does not involve Artificial Intelligence (AI). The submission focuses on demonstrating substantial equivalence to a predicate device through conventional engineering and safety testing.
Therefore, many of the requested categories related to AI performance, such as sample sizes for test and training sets, expert consensus, adjudication methods, and MRMC studies, are not applicable to this document.
Here's the information that can be extracted or deduced from the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Sterility | Found to be acceptable |
| Packaging | Found to be acceptable |
| Biocompatibility | Found to be acceptable |
| Electrical Safety Testing (IEC 60601-1-2:2014) | Limited to Radiated Emissions (EN 55011), Radiated and Conducted Immunity (EN 61000-4-3 and EN 61000-4-6). Found to be acceptable. |
| Electrical Safety Testing (ANSI/AAMI/IEC 60601-2-2: 2009) | ACTIVE ACCESSORY HF leakage, ACTIVE ACCESSORY HF dielectric strength, ACTIVE ACCESSORY mains frequency dielectric strength. Found to be acceptable. |
| Dimensional Tests | Found to be acceptable |
| Connector grip test | Found to be acceptable |
| Continuity test | Found to be acceptable |
| Cable insulation HF and Mains Dielectric Strength test | Found to be acceptable |
| Cable tensile strength tests | Found to be acceptable |
| Activation recognition and operation | Found to be acceptable |
| Insulation Resistance | Found to be acceptable |
| Endurance Test | Found to be acceptable |
| Connector pull force | Found to be acceptable |
| Surface temperature measurement test | Found to be acceptable |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable as the device is a physical electrosurgical cable and its evaluation did not involve a "test set" in the context of an AI algorithm or data analysis study. The testing performed was engineering and safety validation. The provenance of test data for physical components is not usually detailed in this manner for 510(k) submissions.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable. "Ground truth" in this context typically refers to the confirmed diagnostic or clinical reality for evaluating an AI model. For a physical medical device, the "ground truth" is established through adherence to engineering standards and validated test methods by qualified engineers and technicians, not through expert consensus on medical images or diagnoses.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable as there was no test set requiring expert adjudication in the context of an AI system.
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
This information is not applicable as the device is a physical electrosurgical cable and does not involve AI assistance for human readers or direct comparative effectiveness in that manner.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable as there is no algorithm or AI component in this device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is based on meeting established engineering standards and validated test methods for its physical and electrical properties. This is typically determined by physical measurements, electrical tests, and adherence to regulatory standards (e.g., IEC 60601 series).
8. The sample size for the training set
This information is not applicable as there is no AI component or training set for this device.
9. How the ground truth for the training set was established
This information is not applicable as there is no AI component or training set for this 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).