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The Neurorecovery™, Inc., Neurorecovery™ Comprehensive Intracranial Pressure Evaluation and Relief Kit (NRI CIPER™ Kit) is intended for single patient use for the measurement of intracranial pressures (ICP) and drainage of Cerebral Spinal Fluid (CSF). It is intended for short term management of patients with increased intracranial pressure.

The Neurorecovery" Comprehensive Intracranial Pressure Evaluation and Relief Kit (NRI CIPER™ Kit) is composed of many permanently connected components that incorporate a transducer for connection to an ICP monitoring device. The NRI CIPER™ Kit incorporates components of a cleared intracranial pressure monitoring device, an intracranial pressure transducer, and many components of the Neurorecovery™ Main Valve Assembly. The NRI CIPER™ Kit is designed to be used with the Neurorecovery " Main Valve Assembly. It is provided to the user sterile, non-pyrogenic (fluid path), single use, disposable, and not recommended for reuse of any kind.

The provided text is a 510(k) summary for the Neurorecovery™ Comprehensive Intracranial Pressure Evaluation and Relief Kit (NRI CIPER™ Kit). It describes the device, its intended use, and its substantial equivalence to predicate devices. However, the document does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.

The 510(k) summary primarily focuses on establishing substantial equivalence to legally marketed predicate devices (Medex, Inc. Intracranial Pressure Monitoring Device (K822864) and Medex, Inc. Transtar Intracranial Pressure Transducer (K020780)) based on "indications for use, design, materials, and operational characteristics." It explicitly states: "Neurorecovery™, Inc., believes that differences between devices are minor and raise no new issues of safety or effectiveness."

Therefore, I cannot populate the table or provide answers to the questions regarding performance studies, as this information is not present in the provided text. The document is a regulatory submission for premarket notification, not a clinical study report.

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The Neurorecovery™, Inc., Neurorecovery" Ventricular Catheter & Main Valve Assembly Kit is designed to be used for external monitoring of intracranial pressure (ICP), cerebrospinal fluid (CSF) sampling, and CSF drainage from the lateral ventricles of the human brain. The Main Valve Assembly is designed to facilitate the monitoring, sampling, clearing, and drainage function in an aseptic manner.

The Neurorecovery", Inc., Neurorecovery" Ventricular Catheter & Main Valve Assembly Kit consists of legally marketed ventricular catheter, stylet, trocar, valves, tubing, associated connectors, caps, check-valves, needle-free valve, and stopcocks.

The provided 510(k) summary for the Neurorecovery™ Ventricular Catheter & Main Valve Assembly Kit (K022638) does not contain the detailed study information needed to fully answer all aspects of your request, particularly regarding specific acceptance criteria metrics and a comprehensive study report. This document focuses on demonstrating substantial equivalence to predicate devices rather than providing a full performance study report with quantitative acceptance criteria.

However, based on the provided text, here's what can be extracted and inferred:

Acceptance Criteria and Device Performance

The 510(k) summary states that "Testing submitted in the 510(k) demonstrates that the Neurorecovery™ Ventricular Catheter & Main Valve Assembly Kit complies with specifications for biocompatibility, sterility, and functional performance."

This indicates that acceptance criteria were established for these three general categories. Without the full submission, specific quantitative thresholds for "biocompatibility," "sterility," or "functional performance" are not available in this public summary.

Study Details

Given that this is a 510(k) application for a Class II device, the primary study is a demonstration of substantial equivalence to predicate devices rather than a de novo clinical trial with novel performance metrics. The information provided heavily emphasizes this substantial equivalence.

1. Sample size used for the test set and the data provenance:

• Sample Size: Not specified in the provided summary. Performance testing would likely involve testing of manufactured device units, but the number of units tested is not disclosed.
• Data Provenance: Not specified. Testing would be conducted by the manufacturer or a contracted lab. The summary does not indicate retrospective or prospective clinical data from patients for establishing performance.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• This type of information (experts, ground truth, clinical data) is typically associated with clinical studies or performance studies involving human subjects or real-world data analysis, which are not detailed in this 510(k) summary for this type of device. The stated performance testing relates to material properties and functional operation.

3. Adjudication method for the test set:

• Not applicable as the provided information does not detail a clinical or comparative expert review scenario.

4. 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 MRMC study mentioned. This device (Ventricular Catheter & Main Valve Assembly Kit) is a physical medical device for fluid management and pressure monitoring, not an AI/software device that assists human readers in diagnostic tasks. Therefore, an MRMC study or AI assistance is not relevant to its stated function.

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

• Not applicable. As above, this is a physical medical device, not an algorithm or AI.

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

• For biocompatibility: Ground truth would be defined by established ISO standards (e.g., ISO 10993 series) and corresponding test results (e.g., cytotoxicity, sensitization, irritation tests).
• For sterility: Ground truth would be defined by regulatory standards for sterilization (e.g., ISO 11135 or 11137 for EO or radiation sterilization) and sterility assurance level (SAL).
• For functional performance: Ground truth would be defined by engineering specifications and testing against those specifications (e.g., flow rates, pressure resistance, connection integrity, material strength, valve function).

7. The sample size for the training set:

• Not applicable in the context of this device type and the provided 510(k) summary. "Training set" typically refers to data used to train AI models, which is not relevant here.

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

• Not applicable for the reasons mentioned above.

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