(305 days)
The Duoblade is intended for general electrosurgical applications, including cutting and coagulation, and (Models: DB1SEP, DB1SEP-H, DB1SEP-T, DB1SEP-TH) for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system.
The Electrosurgical Cutting and Coagulation Device and Accessories (Model: Duoblade) is a single-use, monopolar RF device. It is designed to be used with the qualified Generator as part of the Surgery System. It can be operated with the integrated hand switch or a qualified Footswitch. The Duoblade consists of a single blade and telescoping shaft that can be configured in both standard and extended length. The finger grip also incorporates a suction lumen for the evacuation of smoke and fluids.
The models of of Duoblade are identified according to with/without a suction function (removing smoke).
- Suction function (Removing smoke): DB1SEP, DB1SEP-H, DB1SEP-T, DB1SEP-TH
- No Suction function (No removing smoke): DB1SP, DB1SP-H, DB1SP-T, DB1SP-TH
The provided document is a 510(k) summary for the Duoblade electrosurgical device. It is a submission for regulatory clearance and focuses on demonstrating substantial equivalence to a predicate device, not on proving device performance against specific acceptance criteria for an AI/ML algorithm.
Therefore, the document does not contain the information requested regarding acceptance criteria and the study proving the device meets those criteria for an AI/ML product. The questions asked are typically relevant for AI/ML device clearances where performance metrics like sensitivity, specificity, AUC, etc., are established and validated through specific study designs.
The Duoblade is an electrosurgical cutting and coagulation device, which is a physical medical device, not an AI/ML algorithm. The "Performance Test - Thermal effects on tissue" described in section 12 is a physical performance test, not a study evaluating an algorithm's performance.
In summary, none of the requested information (acceptance criteria table, sample sizes for test/training sets, data provenance, expert qualifications, adjudication methods, MRMC study, standalone performance, ground truth types, etc.) can be extracted from this document because it pertains to a different type of medical device lacking an AI/ML component.
§ 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.