(127 days)
The Integra Licox PtO₂ monitor measures oxygen partial pressure (PtO2) and temperature in brain tissue and these parameters are used together as an aid in the determination of the perfusion status of cerebral tissue local to sensor placement. Monitor values are relative within an individual, and should not be used as the sole basis for determining a 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 Integra® Licox® PtO2 monitor instrument is a diagnostic tool for continuously monitoring oxygen partial pressure (PtO2) in - brain tissue. Minimally invasive probes are implanted directly into the brain tissue and are connected to the Licox monitor.
The Integra Licox PtO2 Monitor displays both PtO2 and temperature in numeric format. The monitor will store PtO2 trend data from the most recent 5 days. The user can elect to extract the trend data stored on the monitor to an external memory device or stream the data to a compatible PC via the USB output. The device also provides analog output for display on compatible bedside monitors.
The provided text describes the Integra® Licox® PtO2 Monitor, an intracranial pressure monitoring device. It outlines the device's intended use, technological characteristics, and non-clinical testing performed to establish its safety and effectiveness.
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The submission mentions "pre-defined performance and safety specifications" and that testing confirmed "all Design Inputs (requirements and specifications) have been met." However, it does not provide a specific table of acceptance criteria with numerical targets or thresholds for performance metrics like accuracy, alarm sensitivity, or trending precision. Instead, it lists the types of tests conducted:
| Acceptance Criteria Category | Reported Device Performance (as stated in the document) |
|---|---|
| PtO2 Accuracy | "The Integra Licox PtO2 monitor was tested in accordance with the relevant test plans/reports... Testing was performed to ensure that the device met pre-defined performance and safety specifications." |
| Temperature Accuracy | "The Integra Licox PtO2 monitor was tested in accordance with the relevant test plans/reports... Testing was performed to ensure that the device met pre-defined performance and safety specifications." |
| Alarm Setting, Accuracy, Volume | "The Integra Licox PtO2 monitor was tested in accordance with the relevant test plans/reports... Testing was performed to ensure that the device met pre-defined performance and safety specifications." |
| Trend Functionality | "The Integra Licox PtO2 monitor was tested in accordance with the relevant test plans/reports... Testing was performed to ensure that the device met pre-defined performance and safety specifications." |
| Data Export Functionality (bedside monitor, external storage) | "The Integra Licox PtO2 monitor was tested in accordance with the relevant test plans/reports... Testing was performed to ensure that the device met pre-defined performance and safety specifications." |
| Fault Testing | "The Integra Licox PtO2 monitor was tested in accordance with the relevant test plans/reports... Testing was performed to ensure that the device met pre-defined performance and safety specifications." |
| Electromagnetic Compatibility (EMC) | "The Integra Licox PtO2 monitor was tested in accordance with the relevant test plans/reports... Testing was performed to ensure that the device met pre-defined performance and safety specifications." |
| Electrical Safety | "The Integra Licox PtO2 monitor was tested in accordance with the relevant test plans/reports... Testing was performed to ensure that the device met pre-defined performance and safety specifications." |
| Environmental Testing | "The Integra Licox PtO2 monitor was tested in accordance with the relevant test plans/reports... Testing was performed to ensure that the device met pre-defined performance and safety specifications." |
| Cleaning Testing | "The Integra Licox PtO2 monitor was tested in accordance with the relevant test plans/reports... Testing was performed to ensure that the device met pre-defined performance and safety specifications." |
Important Note: The document explicitly states that "All necessary testing has been completed... and the test results support the conclusion that all Design Inputs (requirements and specifications) have been met." However, it does not provide the specific numerical acceptance criteria or the quantitative results of these tests.
2. Sample Size Used for the Test Set and the Data Provenance
The document mentions "production equivalent units" were used for testing. However, it does not specify the sample size for the test set.
Regarding data provenance, the document describes non-clinical testing performed on the device itself (e.g., accuracy, alarms, functionality). This is not data derived from patient studies or human subjects. Therefore, information about country of origin of data or retrospective/prospective nature is not applicable here as it relates to device performance testing, not clinical data collection.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not applicable to the type of testing described in the document. The device performance tests (accuracy, alarms, etc.) typically rely on calibrated instruments and established engineering standards to determine "ground truth," not expert human adjudication of diagnostic outcomes.
4. Adjudication Method for the Test Set
This information is not applicable to the non-clinical device performance testing described. Adjudication methods are relevant for studies involving human interpretation or clinical outcomes.
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
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or reported in this 510(k) summary. The device is a monitor providing physiological parameters, not an AI-assisted diagnostic tool for image interpretation or similar tasks requiring human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
The device itself is a standalone monitor, meaning it directly measures and displays PtO2 and temperature values. The testing described (PtO2 Accuracy, Temperature Accuracy, Alarm setting, etc.) assesses the performance of this standalone device/algorithm without human-in-the-loop performance. However, this is distinct from AI-driven algorithms where "standalone" usually implies the algorithm makes a decision independently. In this context, the device is the "algorithm" for measurement and display.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical tests like PtO2 Accuracy and Temperature Accuracy, the ground truth would have been established using calibrated reference standards or laboratory measurements that are known to be highly accurate. For other functional tests (alarms, trending, data export), the ground truth is defined by the device's functional specifications and expected behavior.
8. The Sample Size for the Training Set
This information is not applicable as the Integra® Licox® PtO2 Monitor is a measurement device, not an AI/machine learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as the device does not use a training set in the context of machine learning.
§ 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).