(269 days)
The Neuroblade System is a neuroendoscopy system indicated for the illumination and visualization of intracranial tissue and fluids, controlled aspiration of tissue and or fluid, powered cutting of soft tissue, and coagulation of tissue under direct visualization during surgery of the ventricular system or cerebrum.
The Neuroblade System is comprised of three components: Neuroblade, Neuropad and Cart. The Neuroblade is a hand-held, sterile neuroendoscope with lighting and camera at its distal end. The camera images are displayed on the Neuropad via a connecting cable that extends from the proximal end of the Neuroblade. It has integrated irrigation and aspiration functions. The distal bipolar electrode allows the application of RF energy from a third-party radiofrequency (RF) generator for coagulation of bleeding vessels in the neuro space. A cutting window on the side of distal end is for the removal of blood clots. The Neuroblade System, like other neuroendoscopes, is advanced into the brain through a burr hole created in the patient's skull. The tip of the Neuroblade is advanced under visualization via the illuminated camera image transmitted from the distal tip of the Neuroblade to the Neuropad. The Neuroblade has irrigation and vacuum tubing (2.0 m) that allows for connection to a third party saline infusion bag and a vacuum waste bucket, respectively. The waste bucket is connected to a vacuum regulator which is attached to the hospital's vacuum system. The bipolar electrode is incorporated into the distal tip of the Neuroblade and has a bipolar plug (20 cm) on the proximal end that allows for connection to a third-party bipolar cord. The proximal end of that bipolar cord connects to the RF Generator. An RF Generator and bipolar cord are common accessories in the operating room. The Neuroblade has a working channel that will facilitate the introduction of flexible endoscopic surgical devices (≤1.7 mm outer diameter) into the surgical site. That same working channel will also facilitate irrigation of the target site and is the channel that supports the aspiration of fluid and tissues. The Neuropad can be installed onto the Cart and adjusted by the user for height and tilt. The Neuropad allows the user to input patient data, control some aspects of the image, and record the case.
I am sorry, but the provided text does not contain the specific acceptance criteria for the device, nor the detailed results of a study that proves the device meets those criteria in a format that would allow me to populate the requested table directly. The document primarily describes the device, compares it to predicate devices, and lists various tests performed (biocompatibility, electrical safety, bench testing, an animal study, etc.) with a "Pass" result, but without specifying the quantitative or qualitative acceptance criteria for each of those tests or linking them to a comprehensive performance evaluation in the way requested.
Specifically, the document lacks:
- A table of acceptance criteria and reported device performance: While tests are listed, the specific criteria for "Pass" are not detailed, nor are numerical or descriptive performance metrics provided for each criterion.
- Sample size used for the test set and data provenance: A general animal study is mentioned, but specific sample sizes for particular performance tests are not given.
- Number of experts used to establish ground truth and their qualifications: Not explicitly stated for any specific test.
- Adjudication method: Not discussed.
- MRMC comparative effectiveness study: No mention of such a study or effect sizes of human reader improvement with AI. The device is a neuroendoscopy system, not an AI-assisted diagnostic tool.
- Standalone performance: The tests are generally standalone device performance evaluations, but the specific metrics are not provided as requested.
- Type of ground truth: For the animal study, necropsy and histopathology were used for confirmation, but for other tests, "ground truth" in the requested sense is not clearly defined.
- Sample size for the training set: Not applicable as this is not an AI/ML device with a separate training set.
- How ground truth for the training set was established: Not applicable.
The document mainly focuses on proving substantial equivalence to predicate devices through various engineering and safety tests, rather than presenting a clinical performance study with detailed acceptance criteria and results.
§ 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).