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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

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.

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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.

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The NeuroSensor™ System is intended for use by a qualified neurosurgeon in monitoring cerebral blood flow in patients at risk of cerebral ischemia, and for the direct monitoring of intracranial pressure in both sub-dural and intraparenchymal applications.

The NeuroSensor™ system consists of a single-use combined 2mm diameter 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. CBF is measured using Laser Doppler flowmetry and provides real-time measurements of local blood flow in the brain. In the NeuroSensor™ system, low power laser light at 780nm is transmitted down a central fiber to the tip of the probe and illuminates the cerebral tissue. The laser light is scattered by the moving red blood cells and is collected by an array of collecting fibers at the tip of the probe. The reflected light is measured and the resulting signal processed to produce a measure of the perfusion or flux of blood in the local tissue sample volume. The flow measurement is converted into absolute units of ml/min/100g using an algorithm determined by a comparison between measurements made using the combined Laser Doppler probe and the reference method of Quantitative Autoradiography. ICP is monitored directly by a solid state sensor mounted on the side of the NeuroSensor™ probe close to its tip. The sensor is precalibrated in the factory with probe identification and calibration values stored within each probe and there is no requirement for the user to calibrate the probe before use. The NeuroSensor™ monitor uses a color LCD display to show the two measured variables CBF and ICP continuously in real time, both in digital form and as a realtime trace. The monitor can accept measured arterial pressure from an external patient monitor, and can use this data and the measured CBF and ICP to derive cerebral perfusion pressure (CPP) and cerebrovascular resistance (CVR). Data is stored by the monitor and can be displayed as a trend graph over a period of 15 minutes, or 1,2,8 or 24 hours. Completing the system is a single-use cranial access port featuring a titanium alloy bolt, and a convenience procedure kit for cranial access.

The provided text is a 510(k) summary for the NeuroSensor™ system, which measures cerebral blood flow (CBF) and intracranial pressure (ICP). This document does not contain a study that proves the device meets specific acceptance criteria with reported device performance metrics. Instead, it states that "In vitro testing shows that the device meets similar performance specifications as those for the predicate devices."

Therefore, I cannot provide a table of acceptance criteria and reported device performance from the provided text, nor can I answer questions about sample sizes, ground truth establishment, or specific study designs (like MRMC) as this information is not present.

However, I can extract information related to the device and its claimed equivalence:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: The document implies that the acceptance criteria are "similar performance specifications as those for the predicate devices." However, the exact quantitative specifications for either the predicate devices or the NeuroSensor™ system are not provided within this text.
• Reported Device Performance: The text states, "In vitro testing shows that the device meets similar performance specifications as those for the predicate devices." No specific performance values (e.g., accuracy, precision, bias) are reported for either CBF or ICP measurements.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• The document mentions "In vitro testing," but it does not provide details on the sample size used, whether the data was retrospective or prospective, or the country of origin of the 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):

• This information is not provided in the document.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• This information is not provided in the document.

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:

• The device is a monitoring system (hardware and software for physiological measurements), not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable to this device and no such study is mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• The document implies that the device's performance was evaluated in "in vitro testing." This would typically be a standalone performance evaluation of the device's measurement capabilities. The text states:
  • "CBF is measured using Laser Doppler flowmetry... The flow measurement is converted into absolute units of ml/min/100g using an algorithm determined by a comparison between measurements made using the combined Laser Doppler probe and the reference method of Quantitative Autoradiography."
  • "ICP is monitored directly by a solid state sensor... The sensor is precalibrated in the factory with probe identification and calibration values stored within each probe..."
• These descriptions suggest a standalone evaluation was performed for the measurement algorithms and sensors, but specific study details are not provided.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• For Cerebral Blood Flow (CBF) measurement, the ground truth mentioned for algorithm determination is the "reference method of Quantitative Autoradiography."
• For Intracranial Pressure (ICP) measurement, the ground truth is established through "precalibrated" sensors in the factory.

8. The sample size for the training set:

• This information is not provided. The document mentions an "algorithm determined by a comparison" for CBF, implying some form of training or calibration data was used, but the sample size is not stated.

9. How the ground truth for the training set was established:

• For the CBF measurement algorithm, the ground truth was established by "a comparison between measurements made using the combined Laser Doppler probe and the reference method of Quantitative Autoradiography."
• For ICP, the sensors are "precalibrated in the factory," indicating that the factory calibration process itself establishes the ground truth for the sensor's accuracy.

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