(27 days)
The Duoblade Plus SE (Models: DB1EP, DB1EP-T, DB1EP-H, DB1EP-TH), and Duoblade Prime (Models: DB1P, DB1P-T, DB1P-H, DB1P-TH) are intended for general electrosurgical applications, including cutting and coagulation. These models are designed without shaft extension functionalities. The Model: DB1EP, DB1EP -T, DB1EP-H, DB1EP-TH are compatible with the smoke evacuation system, 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 Plus SE, Duoblade Prime) is a single-use, monopolar RF device designed to be used with a qualified Generator as part of the Surgery System. It uses high-frequency energy (RF Monopolar Energy) to generate heat for tissue cutting and coagulation. It can be operated using the integrated hand switch or a qualified Footswitch. The device's design simplifies functionality by excluding shaft extension features. The models of Duoblade Plus SE and Duoblade Prime are identified according to with/without a suction function (removing smoke), and a swivel function.
- Suction & swivel function (Duoblade Plus SE): DB1EP, DB1EP-T, DB1EP-H, DB1EP-TH
- No Suction & swivel function (Duoblade Prime): DB1P, DB1P-T, DB1P-H, DB1P-TH
The scope of the submission only includes the addition of model without functions, such as swivel function, shaft extension function and appearance change for marketing purpose.
The provided FDA 510(k) clearance letter and summary are for an electrosurgical device (Duoblade Plus SE, Duoblade Prime), not an AI/software device that would involve a test set, ground truth experts, or MRMC studies. The document primarily focuses on demonstrating substantial equivalence to a predicate device through comparison of features, materials, and established non-clinical tests relevant to electrosurgical devices (e.g., biocompatibility, sterility, electrical safety, thermal effects on tissue).
Therefore, I cannot extract the information required by your prompt regarding acceptance criteria, test set details, ground truth establishment, or human reader effectiveness studies, as these concepts are not applicable to the type of device described in this 510(k) submission.
The document states:
- "No clinical studies were considered for this submission." This directly indicates that there was no human-in-the-loop performance study, nor any evaluation of "how human readers improve with AI vs without AI assistance" because there's no AI component.
- "The thermal effects of a subject device are the same as the predicate device." This highlights that the performance demonstration relies on equivalence to a previously cleared device, not on new independent performance metrics against a defined acceptance criterion of the type you've outlined. The non-clinical test mentioned ("Thermal effects on tissue") is a comparative study against a positive control device, not a test with a specific quantitative acceptance criterion for the new device on its own.
In summary, because this 510(k) submission is for a physical electrosurgical device and not an AI/software product, the requested information about acceptance criteria for AI performance, test sets, ground truth experts, and MRMC studies is not present in the provided text.
§ 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.