(23 days)
The Soniquence Reusable Bipolar Cable is intended to transfer power from an RF Generator to Bipolar Electrodes.
The subject device, Soniquence Reusable Bipolar Cable is a bipolar accessory designed to transfer the electrosurgical power to the Bipolar electrode. It is connected to a High Frequency Generator via the male end and the female end termination connects to the standard Bipolar instrument. The cable is made of Silicone material and Polypropylene H1500 which is flexible and autoclavable. The length of the cable is 3 meters, and it is provided non-sterile.
The provided document is a 510(k) summary for the Soniquence Reusable Bipolar Cable, which is an electrosurgical accessory. It declares substantial equivalence to a predicate device and details non-clinical testing. However, it does not contain the specific information requested about acceptance criteria for device performance, a study proving the device meets these criteria, or any data related to diagnostic accuracy, sample sizes, expert involvement, or ground truth for AI models. The device in question is a cable, not an AI/ML-driven diagnostic tool.
Therefore, most of the requested information cannot be extracted from this document.
Here's an attempt to answer the questions based on the available information:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in the context of specific performance metrics for the device. Instead, it describes compliance with recognized electrical and sterilization standards.
| Acceptance Criteria (Implied by standard compliance) | Reported Device Performance |
|---|---|
| Compliance with IEC 60601-2-2:2017 | Successfully performed |
| Compliance with ISO 17665-1:2006 | Successfully performed |
2. Sample sized used for the test set and the data provenance
Not applicable. The document describes non-clinical engineering and sterilization testing, not a diagnostic test set with patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is not a study involving expert-established ground truth for a diagnostic test.
4. Adjudication method for the test set
Not applicable.
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
No. This document does not pertain to AI/ML devices or MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No. This document does not pertain to AI/ML algorithms.
7. The type of ground truth used
Not applicable. The tests performed are compliance tests against established engineering and sterilization standards, not diagnostic performance with a "ground truth" in the clinical sense.
8. The sample size for the training set
Not applicable. This is not an AI/ML device, so there is no training set mentioned.
9. How the ground truth for the training set was established
Not applicable.
§ 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.