(148 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: (1) a sterile, single use, neurological endoscope and (2) a non-sterile, reusable control unit, Image Control Box (ICB).
The Aurora Surgiscope includes the following components:
- Sheath
- Camera
- LED (Light Emitting Diodes)
- Sheath Cable
- Obturator
The Sheath is fabricated from ABS plastic and is cylindrically shaped. It acts as both the insertion portion and instrument channel of the endoscope. Depth markers are located on both sides of the Sheath in 1 cm increments to aid with device insertion. LEDs are embedded into the interior wall of the Sheath that provide illumination of the surgical field. A larger diameter plastic ring, Camera mount (or Fixation ring), is located at the proximal end of the Sheath and may be used with fixation arm(s) to hold/fix the device.
The Camera assembly is rigidly attached to the Camera Mount and positioned to produce a forward view (0° direction) of the surgical site. An optical lens and prism are also incorporated for imaging.
The Surgiscope electronics are connected to the ICB by a flexible shielded Sheath Cable. The cable exits from the rear of the Camera housing and is connected 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 to minimize injury to tissue during insertion. At the proximal end, a plastic handle is used for removal of the Obturator from the Sheath and has an attachment on the handle to secure stereotactic instruments for neuronavigation. A stainless steel tube connects the Obturator tip and handle.
The Image Control Box (ICB) controls the real-time video image that it receives from the camera on the Surgiscope. It also delivers the real-time video to an external Display Monitor and provides isolated power to the Surgiscope LEDs and camera. The ICB is supplied with two cables: an isolated 110V power cable to be connected to an AC electrical outlet and a cable which is to be connected to the Display Monitor in the operating room.
The user interface is a membrane keypad with buttons that can be depressed for image adjustment, such as zoom, contrast, brightness, and orientation. The connections to the Surgiscope, Display Monitor and Power are the side of the ICB as well as the ON/OFF switch.
The provided text is a 510(k) summary for the Aurora Surgiscope System. It describes the device, its intended use, and a comparison to a predicate device to establish substantial equivalence. However, it does not contain information about the acceptance criteria or a study that proves the device meets specific performance criteria through a clinical or non-clinical validation study in the format requested.
The document primarily focuses on:
- Device Description: What the Aurora Surgiscope System is composed of (single-use endoscope, reusable control unit, etc.).
- Indications for Use: Its purpose in endoscopic neurosurgery for visualization, diagnostic, and therapeutic procedures.
- Non-Clinical Testing: A list of conducted or adopted tests for safety and effectiveness (Biocompatibility, Electrical Safety, EMC, Particulate Testing, Sterilization, Packaging/Shelf-life, Design Verification, Software/System V&V).
- Comparison to Predicate Device: A detailed table comparing the subject device to a previously cleared Aurora Surgiscope System (K182211) across various characteristics like indications, materials, endoscope specifications, light source, camera, control unit, and use.
The document uses the predicate device as a basis for demonstrating substantial equivalence, meaning that the new device operates similarly and has similar technological characteristics, and therefore, does not raise new questions of safety or effectiveness. The non-clinical tests listed are typically used to show that the device performs as intended in a controlled environment and meets relevant safety standards, but they are not presented as a "study that proves the device meets acceptance criteria" in terms of clinical performance metrics like sensitivity, specificity, accuracy, or human reader improvement with AI assistance.
Therefore, I cannot populate the requested table or answer most of the specific questions about acceptance criteria, study design (sample size, data provenance, expert ground truth, MRMC study, standalone performance), or training set information, as this information is not present in the provided 510(k) summary.
The only information that can be extracted is:
- Type of Ground Truth Used (for non-clinical testing): Standards-based testing (e.g., ISO, IEC, USP, ASTM) and design verification. This is not clinical ground truth.
- Study Design (implicitly, non-clinical): Design verification and various safety and performance tests. This is not a clinical study to assess performance against a specific clinical acceptance criterion.
To directly answer your request based on the provided text, many fields would be "Not Applicable" or "Information Not Provided."
Here's a table based on the information provided (or the lack thereof):
| Category / Question | Information from Text |
|---|---|
| 1. Acceptance Criteria & Reported Device Performance | Not explicitly stated as clinical acceptance criteria or performance metrics. The document lists non-clinical tests demonstrating safety and effectiveness by meeting engineering and regulatory standards for substantial equivalence to a predicate device. Performance is demonstrated through these non-clinical tests, such as: |
- Biocompatibility per ISO 10993-1
- Electrical Safety & Enclosure Protection per IEC 60601-1 & IEC 60529-1
- Emissions & Immunity per IEC 60601-1-2
- Particulate Testing per USP
- Sterilization per ISO 11135-1 (SAL of 10-6)
- Packaging & Shelf-life per ISTA 2A & ASTM F1980
- Design Verification testing
- Software and System Verification and Validation |
| 2. Sample Size (Test Set) & Data Provenance | Not Applicable / Information Not Provided. This document describes non-clinical testing for substantial equivalence, not a clinical trial with a "test set" of patient data for performance evaluation in the context of diagnostic accuracy. |
| 3. Number of Experts & Qualifications (Ground Truth for Test Set) | Not Applicable / Information Not Provided. No clinical ground truth establishment described. |
| 4. Adjudication Method (Test Set) | Not Applicable / Information Not Provided. No clinical test set described. |
| 5. MRMC Comparative Effectiveness Study & Effect Size (Human Readers w/wo AI) | Not Applicable / No AI component or MRMC study described. The device is a physical endoscope and control system, not an AI/software. |
| 6. Standalone Performance Study (Algorithm only without Human-in-the-loop) | Not Applicable / No AI algorithm described. The "Image acquisition" and "Image processing" refer to the camera and control unit’s standard functions, not a diagnostic algorithm. |
| 7. Type of Ground Truth Used | Primarily Engineering Standards and Design Specifications. For instance, a sterile SAL of 10-6 is a defined standard to meet. The ground truth for biocompatibility is whether the device materials meet the specified ISO standards for various toxicities. |
| 8. Sample Size for Training Set | Not Applicable / No training set for an AI/algorithm described. Testing refers to device verification and validation against specified requirements. |
| 9. How Ground Truth for Training Set was Established | Not Applicable / No training set for an AI/algorithm described. |
In summary, the provided document is a 510(k) summary demonstrating substantial equivalence for a medical device (an endoscope system) based on non-clinical testing and comparison to a predicate, not a clinical study report proving performance against specific clinical acceptance criteria for diagnostic or therapeutic accuracy in the way an AI/software device might be evaluated.
§ 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).