(52 days)
A Monopolar Cord is intended to be used with a compatible electrosurgical generator and an RF electrode to cut tissue and control bleeding by use of high-frequency electrical current.
The Monopolar Cord, sold as sterile packaged, and ready for use devices, is intended to be used with compatible accessories to cut tissue and control bleeding by use of high-frequency electrical current. The Monopolar Cord is compatible with the monopolar instruments with shrouded 2.5 mm female electrical connections, electrosurgical generator, and patient return electrode. During the operation, the sterile cord should connect to the sterile accessory, and then generator connector end is inserted into the adapter and generator which it receives the high frequency current and delivers the current onto a target tissue for cutting and coagulation in a procedure. These devices can be used in hospitals and are used by trained professionally only.
This is a medical device for electrosurgical cutting and coagulation, not an AI/ML device. Therefore, the questions related to AI/ML specific criteria (sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, ground truth type for test set, training set size, and training set ground truth) are not applicable.
1. Table of acceptance criteria and the reported device performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Visual Inspection (General Mfr Requirement) | PASS |
| Continuity test (General Mfr Requirement) | PASS |
| Drop Test (preconditioning) (IEC 60601-1:2005+ AM1:2012, Clause 15.3.4.1) | PASS |
| Cable pull force from Terminal Pin (IEC 60601-1:2005+ AM1:2012, Clause 8.10.2) | PASS |
| 0.26kg Dynamic Strain Relief | PASS |
| 10 Pound Static Strain Relief | PASS |
| Anchorage Test (IEC 60601-2-2:2017, Clause 201.8.10.4.2) | PASS |
| HF Leakage Current Test (IEC 60601-2-2:2017, Clause 201.8.8.3.102) | PASS |
| High Frequency Dielectric Test (IEC 60601-2-2:2017, Clause 201.8.8.3.103) | PASS |
| Hi-Pot Test (IEC 60601-2-2:2017, Clause 201.8.8.3.104) | PASS |
| Mains Frequency Dielectric Strength Test | PASS |
| Connector pull force (IEC 60601-2-2:2017, Clause 201.15.4.1) | PASS |
| EMC Test (IEC 60601-2-2:2017, Clause 201.17, 202) | PASS |
| Package system performance testing per ASTM D4169 | Met acceptance criteria (functional and remains in sterile barrier after shipping) |
2. Sample size used for the test set and the data provenance: Not applicable. This device is subjected to bench and electrical safety testing, not a clinical 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. Ground truth for a device like this is established through engineering and regulatory standards.
4. Adjudication method (e.g. 2+1, 3+1, none) 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: Not applicable. This is not an AI device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The ground truth is based on established engineering and safety standards (e.g., IEC 60601 series, ASTM D4169) and the functional requirements for an electrosurgical accessory.
8. The sample size for the training set: Not applicable. This is not an AI/ML device that requires a training set. The device development process involves design, prototyping, and testing against pre-defined specifications.
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.