(156 days)
The Aurora Surgiscope System is intended for use in endoscopic neurosurgery and pure neuroendoscopy (i.e. ventriculoscopy) for visualization, diagnostic and/or therapeutic procedures such as ventriculostomies, biopsies and removal of cysts, tumors and other obstructions.
The Aurora Surgiscope System consists of two components: A sterile, single use, neurological endoscope called the Aurora Surgiscope and a non-sterile, reusable control unit called the Image Control Box (ICB).
The Aurora Surgiscope includes the following parts:
- Sheath
- Camera
- LED (Light Emitting Diodes)
- Sheath Cable
- Obturator
The Sheath is fabricated from plastic and shaped like a hollow cylinder. It acts as both the insertion portion and instrument channel of the endoscope. LEDs are embedded into the Sheath's distal end for illumination. The Sheath's proximal end incorporates a larger diameter plastic ring with a fixation tab. The Camera is rigidly attached to the plastic ring and positioned to produce a forward view of the surgical site. The Sheath's electronics are connected to the ICB by a flexible shielded cable. The cable exits from the rear of the Camera housing and connects to the ICB during system set-up. The Obturator is pre-loaded into the Sheath. Its distal tip is fabricated from clear plastic and is conical shaped. It has a plastic handle at the proximal end to facilitate removal. A cannulated steel post connects the Obturator tip and handle.
The Image Control Box is supplied with two cables; one for power and the other for connection to a 3rd party external HD Monitor. The ICB delivers power to the LEDs and Camera, transfers the video image to the HD Monitor, and allows a user to turn knobs that digitally adjust image quality and orientation.
I am sorry, but the provided text focuses on the FDA clearance document (K182211) for the Aurora Surgiscope System. This document details the device description, indications for use, comparison to predicate devices, and a summary of non-clinical testing conducted to establish substantial equivalence.
However, the document does not contain the specific information required to answer your questions regarding acceptance criteria, the detailed study design (sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance), or training set information.
The document states that "The following testing was conducted to demonstrate the safe and effective use of the Aurora Surgiscope System and its' substantial equivalence to the primary predicate," and then lists several types of non-clinical testing such as:
- Biocompatibility Testing
- Electrical Safety and Enclosure Protection
- Emissions and Immunity
- Particulate testing
- Sterilization
- Packaging and Shelf-life
- Simulated use testing
- Design verification testing
- Software and System Verification and Validation
While these tests demonstrate performance against certain standards, the document does not specify acceptance criteria in a quantifiable manner (e.g., specific metrics and thresholds for accuracy, sensitivity, specificity, resolution) that would typically be found in a clinical study report for an AI/CADe device. It also does not describe a "study that proves the device meets the acceptance criteria" in the context of an algorithm's diagnostic performance for the criteria you've outlined.
Therefore, I cannot populate the table or answer the specific questions about the study design with the information provided.
§ 882.1480 Neurological endoscope.
(a)
Identification. A neurological endoscope is an instrument with a light source used to view the inside of the ventricles of the brain.(b)
Classification. Class II (performance standards).