(345 days)
The AURORA Evacuator +Coag is a powered instrument with a handpiece intended for removal of soft tissue and fluids, and coagulation of tissue under direct visualization may include laparoscopic, pelviscopic, pelviscopic, endoscopic, percutaneous, and open. Applications include those when access to the surgical site is limited, such as neurosurgical.
The AURORA Evacuator +Coag device is provided sterile, for single use only. It is a disposable, handheld, battery powered instrument that combines the ability to remove fluids and soft tissue, apply bipolar energy for the coagulation of tissue, and apply irrigation directly to clear the surgical site during minimally invasive surgical procedures. It consists of a wand and handle with connection ports for a bipolar electrode cable, vacuum source (for aspiration) and irrigation line. At the distal tip of the wand, a side aspiration window with an internally rotating whisk is provided to break up and aspirate soft tissue and fluids. The battery and motor that powers the whisk is contained in the device handle. Bipolar electrodes are located at the distal tip of the wand and can be activated to coagulate tissue when connected to an electrosurgical generator. When desired, an irrigation line may be connected to the handle and saline can be delivered to clear the surgical field as a procedural aid. Bipolar electrosurgical generator/cables, vacuum source, and irrigation source are not provided with the device. Prior to use, the device is to be connected to electrosurgical generator, external vacuum source (i.e. operating room suction) and irrigation source (i.e. drip). A green power indicator light is located on the top portion of the handle to show that power is available to the device. A suction control vent for the user to control vacuum pressure and a button for activating the whisk are located conveniently on the handle.
This document is a 510(k) Premarket Notification from the FDA regarding the AURORA Evacuator +Coag device. It describes the device, its intended use, and a comparison to predicate devices, and a summary of non-clinical testing. However, it does not contain information related to software or AI/ML components. Therefore, I cannot provide an answer based on the prompt's request for acceptance criteria and studies related to a device's AI/ML performance.
The document lacks the following information which are critical to answer your request:
- Acceptance criteria for AI/ML performance: The document details acceptance criteria for the physical device's performance (e.g., biocompatibility, electrical safety, sterilization, in-vitro verification, ex-vivo tissue studies), but not for any AI/ML components.
- Study that proves the device meets acceptance criteria for AI/ML: No studies related to AI/ML performance are mentioned.
- Sample size used for the test set and data provenance (AI/ML): Not applicable as no AI/ML component is discussed.
- Number of experts used to establish ground truth (AI/ML): Not applicable.
- Adjudication method (AI/ML): Not applicable.
- Multi-reader multi-case (MRMC) comparative effectiveness study (AI/ML): Not applicable.
- Standalone (algorithm only) performance study (AI/ML): Not applicable.
- Type of ground truth used (AI/ML): Not applicable.
- Sample size for the training set (AI/ML): Not applicable.
- How the ground truth for the training set was established (AI/ML): Not applicable.
Therefore, no table of acceptance criteria and reported device performance for an AI/ML component can be created from this document. The document focuses on regulatory approval for the physical medical device and its electrosurgical, aspiration, and irrigation functionalities.
§ 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.