Search Results

The Aurora Surgiscope System is intended for use in neurosurgery and 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: (1) a sterile, single use, sheath with integrated illumination LEDs and camera, with an obturator, and (2) a non-sterile, reusable control unit, Image Control Box (ICB).

The sheath is intended to provide access to the surgical site by acting as the insertable portion of the device, as well as the instrument channel to accommodate other surgical tools. Depth markers are present along the length of the sheath for user reference.

At the proximal end of the sheath is the imager, which comprises the following components: LEDs (light emitting diodes), camera (and optical components), and focus knob.

• The LEDs provide illumination to the surgical field by directing light down the sheath, along . the instrument channel.
• The camera captures video image of the surgical field. ●

The proximal end of the sheath also contains a tab, which may be used to manually hold the device. To facilitate insertion of the surgical site, an obturator is provided with the device. During insertion, the obturator is fully inserted into the sheath, and the entire unit is advanced to the desired location. The distal end of the obturator is conical in shape to minimize tissue damage. In addition, the proximal handle of the obturator is designed to accommodate various stereotactic instruments for neuronavigation. Once inserted, the obturator is removed. Two sterile, single use accessories optional for use are provided with the Aurora Surgiscope System: an Irrigation Device and 12 French Suction Device.

The ICB is a non-sterile device that provides three main functions in the Aurora Surgiscope System:

• To power the Surgiscope LEDs and camera
• . To relay the video feed captured by the Surgiscope camera to a display monitor for real-time image visualization
• . To allow the user to make adjustments to the displayed video feed (e.g., contrast, brightness), as well as vary the LED light output.

The user interface is a membrane keypad with buttons located on the ICB that can be depressed for image adjustment, such as zoom, contrast, brightness, and orientation. The ICB is supplied with two cables: A power cable for connection to an AC wall outlet, and a display cable for connection to a high definition surgical monitor.

The provided FDA 510(k) clearance letter and summary for the Aurora Surgiscope System do not contain information typically found in a clinical study report or performance evaluation for an AI/software device. The document focuses on demonstrating substantial equivalence to a predicate device, which means proving that the new device is as safe and effective as a legally marketed device, rather than rigorously quantifying performance against defined acceptance criteria in a study setting.

Specifically, the document does not include:

• A table of acceptance criteria and reported device performance related to a diagnostic or AI function.
• Sample sizes for test sets or data provenance for AI model validation.
• Details about expert readers, ground truth establishment, or adjudication methods for AI performance.
• Information on multi-reader multi-case (MRMC) comparative effectiveness studies.
• Standalone algorithm performance data.
• Training set details for an AI model.

The "testing" mentioned in the document pertains to traditional medical device testing for hardware, biocompatibility, electrical safety, and mechanical aspects. While it states "Software verification and validation testing" was conducted and "documentation provided as recommended by the FDA Guidance Content of Premarket Submissions for Device Software Functions," it does not provide any specific performance metrics or acceptance criteria for software functionality that would typically be associated with an AI/ML-driven device's diagnostic performance. The "Image Control Box" software mentioned focuses on image adjustment and display, not diagnostic interpretation.

Therefore, based solely on the provided text, it is not possible to describe the acceptance criteria and the study proving the device meets those criteria from an AI/ML perspective. The device, as described, appears to be a neurological endoscope system for visualization, diagnostic, and therapeutic procedures, with software for image display and adjustment, not an AI-powered diagnostic tool.

If this were an AI-powered device, the information requested would be crucial for its evaluation. Without it, I cannot fulfill the request for AI-related performance criteria.

Ask a specific question about this device

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.

Ask a specific question about this device