(51 days)
The NeuroSensor® Cerebral Blood Flow and Intracranial Pressure Monitoring System is intended for use by a qualified clinician in monitoring cerebral blood flow in patients at risk of cerebral ischemia, and for the direct monitoring of intracranial pressure in intraparenchymal applications.
Each NeuroSensor® system consists of a single-use probe and introducer for the continuous real-time measurement of Cerebral Blood Flow (CBF) and Intracranial Pressure (ICP), and a monitor for the display and storage of these measured parameters and the computation and display of derived parameters. The NeuroSensor® monitor can be connected to a hospital bedside monitor for display of ICP. The NeuroSensor® monitor can accept Systemic Arterial Pressure (SAP) data from a hospital bedside monitor, and can use this data and the measured CBF and ICP to compute Cerebral Perfusion Pressure (CPP) and Cerebrovascular Resistance (CVR).
The provided document is a 510(k) summary for the Integra NeuroSciences NeuroSensor® Cerebral Blood Flow and Intracranial Pressure Monitoring System. It describes a MODIFIED device that is substantially equivalent to a previously cleared device (K013930). This type of submission focuses on demonstrating that the modifications do not alter the fundamental scientific technology or intended use, rather than conducting new clinical studies to prove the device meets acceptance criteria from scratch.
Therefore, the document does NOT contain information about acceptance criteria, a study proving the device meets those criteria, sample sizes for test or training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance.
The document primarily compares the modified device to the original device, stating that most parameters are "Identical to the original NeuroSensor® System." It mentions "extensive performance testing" for safety but does not provide details of the testing or specific acceptance criteria.
Based on the provided text, I cannot answer the requested questions as the information is not present in a 510(k) summary for a modified device.
Here is what CAN be extracted (and why other parts cannot):
- Acceptance Criteria & Reported Performance: Not explicitly stated for performance metrics. The document focuses on showing the modified device is identical in specifications to the predicate device.
- Sample Size (Test Set) & Data Provenance: Not applicable/not provided. This is not a new clinical study.
- Number of Experts & Qualifications / Adjudication: Not applicable/not provided. No ground truth establishment activity is described for a new clinical study.
- MRMC Comparative Effectiveness Study: No, this is not an AI/software device undergoing such a study.
- Standalone Performance: No, this is a hardware medical device, not a standalone algorithm.
- Type of Ground Truth: Not applicable/not provided.
- Sample Size (Training Set): Not applicable/not provided.
- How Ground Truth for Training Set Established: Not applicable/not provided.
The document contains the following relevant information for its purpose (demonstrating substantial equivalence):
- Device Name: NeuroSensor® Cerebral Blood Flow and Intracranial Pressure Monitoring System
- Indication for Use: Monitoring cerebral blood flow in patients at risk of cerebral ischemia, and direct monitoring of intracranial pressure in intraparenchymal applications.
- Measured Parameters: Cerebral Blood Flow and Intracranial Pressure.
- Operating Principle: Laser Doppler for blood flow, MEMS strain gauge pressure sensor for ICP.
- System Specifications (Cerebral Blood Flow):
- Range: 0 to 300 ml/100g/min
- Resolution: 1ml/100g/min
- (These are specifications of the device, not acceptance criteria for a study proving its performance.)
- Safety: "Biocompatibility studies were conducted per FDA G95-1 and ISO 10993 and have demonstrated that the materials used to manufacture the NeuroSensor® probe are safe for their intended use. In addition, the NeuroSensor® System was subjected to extensive performance testing. Results of the testing showed that the probe design was technically sound and the product safe for its intended use."
In summary, this document is a regulatory submission demonstrating substantial equivalence of a modified medical device, not a clinical study report proving performance against detailed acceptance criteria.
§ 882.1620 Intracranial pressure monitoring device.
(a)
Identification. An intracranial pressure monitoring device is a device used for short-term monitoring and recording of intracranial pressures and pressure trends. The device includes the transducer, monitor, and interconnecting hardware.(b)
Classification. Class II (performance standards).