(29 days)
The LICOX® CC1.G2 is a brain oxygen catheter-microprobe intended for use with the LICOX Brain Oxygen Monitoring System. 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® CC1.G2 is a brain oxygen catheter-microprobe intended for use with the LICOX Brain Oxygen Monitoring System. The LICOX Brain Oxygen Monitoring System measures intracranial oxygen and temperature. The probe is used in conjunction with the LICOX® CMP Monitor and it's associated accessories and cables.
The provided 510(k) Premarket Notification for the LICOX® CC1.G2 Brain Oxygen Catheter-MicroProbe primarily focuses on establishing substantial equivalence to a predicate device (LICOX® CC1.SB). Therefore, the study described is a comparison to the predicate device, rather than an independent performance study against specific acceptance criteria for a novel device.
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (from predicate LICOX® CC1.SB) | Reported Device Performance (LICOX® CC1.G2) |
|---|---|---|
| In Vitro Accuracy, pO₂ | ±2.0mmHg (0-20 mm Hg) | |
| ±10% (21 mm Hg-50 mm Hg) | ||
| ±12% > 51 mm Hg | Identical to the LICOX® CC1.SB |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a separate "test set" in the context of a clinical trial or algorithm validation. Instead, the performance of the LICOX® CC1.G2 was evaluated relative to the predicate device, LICOX® CC1.SB, through "extensive oxygen pressure measurement accuracy testing".
- Sample Size: Not specified. The document states "Results of the testing showed that the catheter design met all accuracy specifications." This implies internal testing, likely on multiple units of the device.
- Data Provenance: Not explicitly stated, but implicitly from in vitro testing conducted by the manufacturer, Integra NeuroSciences. The data is thus retrospective in terms of being generated during product development and testing, not from real-world patient data for this specific comparison.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable. The ground truth for the in vitro accuracy testing would be established by the reference standards used in the laboratory setting (e.g., gas mixtures with known oxygen concentrations, calibrated measurement equipment), not by human experts.
4. Adjudication Method for the Test Set
Not applicable, as the evaluation was based on in vitro measurement against established accuracy specifications, not on human interpretation or consensus.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size.
No. This document describes a medical device, not an AI algorithm requiring human-in-the-loop performance evaluation. The comparison is between two physical devices and their technical specifications.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done.
Not applicable. This is a physical medical device (catheter) that measures physiological parameters.
7. The Type of Ground Truth Used
The ground truth for the "oxygen pressure measurement accuracy testing" was established through reference standards in an in vitro laboratory setting. This would involve controlled environments where the actual pO2 can be precisely known and compared to the device's reading.
8. The Sample Size for the Training Set
Not applicable. This device does not involve a "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
Not applicable.
§ 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).