(170 days)
The LICOX Brain Oxygen Monitoring System measures intracranial oxygen and temperature and is intended as an adjunct monitor of trends of these parameters, indicating the perfusion status of cerebral tissue local to sensor placement. LICOX System values are relative within an individual, and should not be used as the sole basis for decisions as to diagnosis or therapy. It is intended to provide data additional to that obtained by current clinical practice in cases where hypoxia or ischemia are a concern.
The LICOX® IT2 Complete Brain Tunneling Probe Kit is intended for use with the LICOX Brain Oxygen Monitoring System. The LICOX Brain Oxygen Monitoring System measures intracranial oxygen and temperature.
The provided 510(k) summary for the LICOX® IT2 Complete Brain Tunneling Probe Kit does not contain detailed information about specific acceptance criteria or a study proving that the device meets those criteria. Instead, it describes a substantial equivalence submission based on an existing predicate device (K040235) and states that no material changes were made to the components.
The main claims in the document relate to safety testing for MR compatibility and compliance with manufacturing standards, rather than performance according to specific functional acceptance criteria.
Here's an analysis based on the information provided, highlighting the absence of the requested details:
Acceptance Criteria and Device Performance Study
The 510(k) submission for K053244, concerning the LICOX® IT2 Complete Brain Tunneling Probe Kit, primarily relies on substantial equivalence to a previously cleared device (K040235). The document explicitly states: "No material changes were made to the LICOX® IT2 Complete Brain Tunneling Probe Kit components therefore no new Biocompatibility studies were necessary." and "The LICOX® IT2 Complete Brain Tunneling Probe Kit is substantially equivalent to the unmodified LICOX® IT2 Complete Brain Tunneling Probe Kit. The labeling revision does not affect the intended use or the fundamental scientific technology of the device."
This type of submission typically means that detailed performance studies against new acceptance criteria are not required because the device's fundamental function and performance characteristics are considered identical to the predicate. Therefore, the document does not report specific quantitative acceptance criteria or a study designed to demonstrate the device's performance against such criteria for its primary function (measuring intracranial oxygen and temperature).
The only "testing" mentioned is related to safety for MR compatibility.
Detailed Breakdown of Available Information:
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Table of Acceptance Criteria and Reported Device Performance: This information is not provided in the submitted text. The document asserts substantial equivalence without outlining specific performance metrics, acceptance thresholds, or reported values for the primary function of measuring intracranial oxygen and temperature.
Acceptance Criterion Reported Device Performance (Not specified) (Not specified) -
Sample size used for the test set and the data provenance: This information is not provided. As no new performance study was conducted, there is no test set or related data provenance mentioned for the core function of the device.
- For the MRJ testing (Radio Frequency Induced Heating, Magnetically Induced Displacement Force and Torque), the sample size of devices tested is not specified, nor is the data provenance. These were likely internal engineering tests.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not provided. There was no clinical test set for which ground truth would need to be established by experts for performance evaluation.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set: This information is not provided, as no clinical test set was used for performance evaluation.
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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: This information is not applicable and not provided. The LICOX® IT2 Complete Brain Tunneling Probe Kit is a medical device for measuring physiological parameters (intracranial oxygen and temperature), not an AI diagnostic tool that assists human readers.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: This information is not applicable and not provided. The device is a measurement probe and system, not an algorithm. Its performance is measured directly through its physical and electronic capabilities, not through an algorithm's standalone performance.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): This information is not provided, as no new performance study with a test set requiring ground truth was conducted for the device's primary function. For MRJ testing, "ground truth" typically relates to physical measurements and established safety limits.
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The sample size for the training set: This information is not applicable and not provided. The device does not employ an AI or machine learning model requiring a training set.
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How the ground truth for the training set was established: This information is not applicable and not provided, as there is no training set for this device.
Summary of Device Evaluation in the Document:
The provided 510(k) submission primarily focuses on demonstrating that the LICOX® IT2 Complete Brain Tunneling Probe Kit, as modified (in terms of labeling and possibly minor manufacturing aspects), remains substantially equivalent to its predicate device (K040235). The key points of the submission are:
- No material changes were made to the components, thus no new biocompatibility studies were needed.
- Safety assessment for MR compatibility was performed, and the device components were deemed "MR Conditional" as per Draft ASTM F 2503-05. This test involved evaluating Radio Frequency Induced Heating, Magnetically Induced Displacement Force, and Torque. The results of these tests serve as the "performance" for the MR compatibility aspect.
- The manufacturing process complies with FDA and European standards.
In essence, the "study" for this 510(k) was an declaration of substantial equivalence, supported by MR safety testing, rather than a new performance study against specific acceptance criteria for measuring brain oxygen and temperature.
§ 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).