(28 days)
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. The proximal end of the Sheath also incorporates a Tab, which serves as the location for fixation arm to hold the device.
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 working channel.
- The camera captures videos of the surgical field.
- The focus knob allows the user to adjust the focus of the camera to obtain the desired image quality.
To facilitate insertion of the Sheath into the surgical site, an Obturator is provided with the device. During device insertion, the Obturator is fully inserted into the Sheath, and the entire AURORA Surgiscope is advanced to the desired surgical location. The distal end of the Obturator is conical in shape to minimize tissue damage during device insertion. In addition, the proximal handle of the Obturator is designed to accommodate various stereotactic instruments for neuronavigation, which can further aid in device placement. The Obturator is removed after insertion.
The ICB is a non-sterile device that provides three main functions in the AURORA Surgiscope System:
- To power the LEDs and camera of the AURORA Surgiscope.
- To relay the video feed captured by the AURORA Surgiscope camera to a connected Medical Grade Surgical Monitor for real-time image visualization.
- To allow the user to make adjustments to the displayed video feed (e.g., contrast, brightness), and to vary the light output of the LEDs.
The user interface is a membrane keypad with buttons located on the ICB that can be depressed for image adjustment, such as zoom, contrast, and brightness. The connection ports to the AURORA Surgiscope, Medical Grade Surgical Display Monitor, and Power are located on the side of the ICB, along with the ON/OFF switch.
The provided FDA 510(k) clearance letter for the AURORA Surgiscope System (K250752) does not contain the detailed information necessary to fully answer all the questions regarding acceptance criteria and the study that proves the device meets them.
The document primarily focuses on demonstrating substantial equivalence to a predicate device (K201840) based on technological characteristics and functional requirements. It explicitly states that "No clinical test/studies were required or performed as all conducted performance tests appropriately support a determination of substantial equivalence compared with the predicate device (K201840)."
Therefore, for many of the requested points, the answer will be that the information is not available in the provided text.
Here's a breakdown of what can and cannot be answered based on the input:
1. A table of acceptance criteria and the reported device performance
The document mentions "functional requirements" and "performance tests" but does not detail specific acceptance criteria or quantitative performance results. It only states that the device meets these requirements after sterilization, environmental, and transit conditioning, and equivalent to a 1-year shelf-life.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Functional requirements after 2X EO sterilization | Device meets functional requirements |
| Functional requirements after environmental and transit conditioning | Device meets functional requirements |
| Functional requirements after equivalent of 1-year claimed shelf-life | Device meets functional requirements |
| Obturator handle strength (improved connection) | Met (due to design modification with two bridge features) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size for test set: Not specified. The document states "non-clinical testing was performed" but does not detail the number of units tested.
- Data provenance: Not specified. The nature of the testing (functional performance, sterilization effects) suggests it would be laboratory testing rather than patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable / Not specified. Since no clinical studies were performed, there was no need for expert review of clinical data to establish ground truth. The "ground truth" here would be the successful function of the device in engineering tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Not specified. No clinical data was being adjudicated.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No. The document explicitly states: "No clinical test/studies were required or performed". This device is a surgical endoscope, not an AI-assisted diagnostic tool, so an MRMC study comparing human readers with and without AI assistance is not relevant to its clearance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical medical device (endoscope), not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the non-clinical performance tests mentioned, the "ground truth" would be the engineering specifications and functional integrity of the device. This is typically verified through direct measurement, visual inspection, and functional tests (e.g., image quality assessment, illumination intensity, camera function, mechanical integrity) against predefined specifications. It is not based on clinical "ground truth" like pathology or expert consensus.
8. The sample size for the training set
- Not applicable. This notice does not describe an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. No training set was involved for this device.
§ 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).