(327 days)
The HotDog Return Electrode Mattress is intended to conduct monopolar electrosurgical energy from the target tissue of a patient back to one electrosurgical unit (ESU) or generator in monopolar surgery. The HotDog Return Electrode Mattress is restricted to use with isolated monopolar electrosurgical generators. The Hotdog Return Electrode Mattress is intended for use with adult patients only.
The HotDog Return Electrode Mattress is sold with a Return Electrode Cable, 4m (A136) that enables connection to one electrosurgical generator. The HotDog Return Electrode Mattress completes the circuit required for electrosurgery through Capacitive method. A capacitor is created when two conductive plates are separated by an insulator. The separation of two conductive plates by an insulator creates a capacitor. The insulator prevents current from flowing directly between the two plates, thereby avoiding the resistance which creates heat. With capacitive grounding, current from the active electrode produces a charge on the first conductive plate. This causes an equal (but opposite) charge to form on the second conductive plate. Current produced by the charge on the second plate produces electrical returns to the generator and completes the circuit.
The provided text describes a 510(k) premarket notification for a medical device called the "HotDog Return Electrode Mattress". This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not typically for proving new clinical efficacy through a comparative effectiveness study or complex AI validation study.
Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria and a study proving a device meets these criteria, especially concerning AI/software performance or human-in-the-loop studies.
Specifically, the document states:
- Clinical Data: "Not required" (Page 5). This directly indicates that clinical studies, which would typically involve human subjects and the types of performance metrics you're asking about, were not part of this submission for substantial equivalence.
- The device is an electrosurgical accessory (a return electrode mattress), not a diagnostic AI device requiring complex performance metrics like sensitivity, specificity, or AUC, nor is it subject to MRMC studies.
- The "study" mentioned is "Designed bench and functional use testing in a porcine model as recommended by the FDA guidance Premarket Notification 510(k) Submission for Electrosurgical Devices for General Surgery to support substantial equivalence to the Predicate." This suggests engineering and safety testing, not a clinical performance validation against ground truth established by experts.
In summary, the provided text does not contain any of the information requested in your prompt's numbered points because the device and the nature of the 510(k) submission do not require such studies or data.
§ 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.