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The Camino Slim-Line™ Intracranial Monitoring System has been designed for use by a qualified neurosurgeon in the direct monitoring of intracranial pressure in both sub-dural and intraparenchymal applications.

The Camino Slim-Line™ system consists of a single-use 1.3mm diameter parenchymal and sub-dural catheter for the real-time measurement of intracran pressure (ICP) and an in-line cable monitor for the display of measured pressure. The Camino Slim-Line™ monitor can be connected to an external patient monitoring system to relay ICP measurements. ICP is monitored directly by a solid state sensor mounted on the side of the Camino Slim-Line™ ICP catheter 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 Camino Slim-Line™ monitor uses a small LCD display to show the measured ICP continuously in real time, both in digital form and as a real-time trace. The monitor can relay this measured information to an external patient monitoring system. In parenchymal applications, the Camino Slim-Line™ ICP catheter is used with an ing single-use Camino cranial access port or bolt, and an existing C ence procedure kit for cranial access. For Sub-dural applie eTM ICP catheter may be used with an existing tunneling trocar and convenience procedure kit for cranial access.

The provided document (K042728) describes the Camino Slim-Line™ Intracranial Pressure Monitoring System. It mainly focuses on demonstrating substantial equivalence to predicate devices rather than presenting a detailed study with specific acceptance criteria and performance metrics for a novel technology.

However, based on the information provided, we can infer the acceptance criteria and the type of study rather than a detailed performance report. The document states: "In vitro testing shows that the device meets similar performance specifications for the predicate devices." This implies that the acceptance criteria are largely derived from the performance specifications of the predicate devices.

Reconstructed Information based on the provided text:

Acceptance Criteria and Study Details for Camino Slim-Line™ Intracranial Pressure Monitoring System

The regulatory submission for the Camino Slim-Line™ system centered on demonstrating substantial equivalence to existing legally marketed devices. This means that the "acceptance criteria" were primarily focused on showing that the new device performs similarly in terms of its core functionality (intracranial pressure measurement) as its predecessors and does not raise new safety or effectiveness concerns.

The study that "proves" the device meets these criteria is the in vitro testing mentioned, which aimed to show comparable performance to the predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: Not specified in the provided document. The term "in vitro testing" suggests laboratory-based testing, which would involve a certain number of devices or scenarios.
• Data Provenance: The "in vitro testing" was conducted by Novus Monitoring Ltd, the submitter, as part of their R&D and regulatory submission process. The country of origin for the data is likely United Kingdom, where Novus Monitoring Ltd is based. The testing would be prospective in nature, as it was conducted specifically to support the regulatory submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

• This type of information is generally not relevant for an in vitro performance assessment of a physical measurement device like an ICP monitor. Ground truth for in vitro testing typically relies on calibrated reference standards or highly accurate laboratory equipment, not human expert consensus for interpretation.
• The document mentions the intended user is a "qualified neurosurgeon," but this relates to clinical use, not the establishment of ground truth for device performance testing itself.

4. Adjudication Method for the Test Set

• Not applicable. Adjudication methods (like 2+1, 3+1) are used when human interpretation of data (e.g., images) forms the ground truth, particularly in studies involving diagnostic aids. For an in vitro test of an ICP monitor, measurement against a reference standard is the method, not adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic imaging devices where human readers interpret medical images, and the AI's assistance is evaluated against human performance. The Camino Slim-Line™ is a direct measurement device, not an imaging device that requires human interpretation in the same way.

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

• Yes, effectively, a standalone performance assessment was done. The "in vitro testing" described would be a standalone evaluation of the device's ability to accurately measure ICP against known reference pressures or conditions, without a human user actively interpreting or modifying the device's output. The device itself (sensor and monitor) forms the "algorithm only" in this context of a direct measurement device.

7. The Type of Ground Truth Used

• The ground truth for the "in vitro testing" would be established using calibrated reference standards or highly precise laboratory equipment capable of generating and measuring known pressures under controlled conditions. This ensures the accuracy, linearity, and stability of the ICP monitor's readings. It is not based on expert consensus, pathology, or outcomes data, which are more relevant for diagnostic or clinical efficacy studies.

8. The Sample Size for the Training Set

• Not applicable. This device is a direct measurement hardware system, not an AI/ML-based diagnostic algorithm that requires a "training set" in the conventional sense of machine learning. The device is pre-calibrated in the factory, meaning its internal settings and performance characteristics are established through manufacturing processes and engineering calibration, not through training on a dataset.

9. How the Ground Truth for the Training Set was Established

• Not applicable. As explained above, there is no "training set" for this type of device. The accuracy and calibration are established through engineering design, factory calibration procedures, and quality control checks against physical reference standards.

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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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