(66 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.
The NeuroSensor® Cerebral Blood Flow and Intracranial Pressure Monitoring System consists of a single-use parenchymal probe for the real-time measurement of cerebral blood flow (CBF) and intracranial pressure (ICP) and a monitor for the display and storage of these measured variables and the computation and display of derived variables.
The provided document describes a 510(k) premarket notification for the "NeuroSensor Cerebral Blood Flow and Intracranial Pressure Monitoring System". This document focuses on the substantial equivalence of the modified device to a previously cleared device (K050720) and outlines the system's functionalities and compliance with various FDA and AAMI guidelines and standards for medical device software and safety.
However, the document does NOT contain information regarding:
- Specific acceptance criteria (e.g., target accuracy, sensitivity, specificity values).
- Any study that provides performance data against such acceptance criteria.
- Details on sample sizes for test sets, data provenance, number/qualifications of experts, or adjudication methods for ground truth establishment.
- Any multi-reader multi-case (MRMC) comparative effectiveness study or standalone algorithm performance.
- The type of ground truth used for performance claims.
- Training set sample size or how ground truth was established for a training set.
The document primarily focuses on verification and validation (V&V) testing of the system's operations and software to confirm that the product's functional specifications met the defined requirements. It states that "The result of software testing indicates the System Requirements Specifications and System Functional Specifications have been fully met and that the NeuroSensor System is safe for use...". This is a statement of successful system verification, not a clinical performance validation against specific disease detection or measurement accuracy targets.
Therefore, I cannot populate the requested table or address most of the questions because the necessary clinical performance data and study details are not present in the provided text.
Based on the provided text, here's what can be stated:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the document. (No quantitative performance metrics like accuracy, sensitivity, specificity, or specific measurement tolerances are provided.) | The software testing indicates that "System Requirements Specifications and System Functional Specifications have been fully met" and that the "NeuroSensor System is safe for use as a cerebral blood flow and intracranial pressure monitoring system". |
2. Sample size used for the test set and the data provenance
- Sample size for test set: Not specified. The document mentions "system testing" and "software testing" but provides no details on the number of cases or patients involved in assessing performance.
- Data provenance: Not specified (e.g., country of origin, retrospective or prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable/Not specified. The document describes system and software testing, not clinical performance validation against expert-established ground truth for disease or condition assessment.
4. Adjudication method for the test set
- Not applicable/Not specified.
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. This device is a monitoring system that measures physiological parameters. It is not an AI-assisted diagnostic tool that would typically involve human readers interpreting images or data for a diagnostic task. Therefore, an MRMC study comparing human reader performance with and without AI assistance is not relevant to this device's function as described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The document implies that the system's functionality (data integrity, display, storage, mechanical/electrical functionality, instructional content) was tested, which could be considered a form of standalone system testing. However, this is not a "standalone algorithm performance" in the context of diagnostic AI where an algorithm makes a decision independently. It's validation of the device's operational capabilities.
7. The type of ground truth used
- Not specified in terms of clinical ground truth (e.g., pathology, outcomes data). The "ground truth" for the testing described appears to be the "System Requirements Specifications and System Functional Specifications" themselves, meaning the system was tested to ensure it performed according to its design specifications (e.g., displaying data correctly, storing data, mechanical function).
8. The sample size for the training set
- Not applicable/Not specified. This device is a physiological monitoring system, not a machine learning model that requires a training set in the conventional sense of AI development for diagnostic tasks.
9. How the ground truth for the training set was established
- Not applicable/Not specified, as this device does not appear to use a training set in the context of machine learning.
§ 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).