(38 days)
This ICP catheter is indicated for use on patients that require continuous intracranial pressure monitoring.
Ventrix™ Subdural Tunneling Pressure Monitoring Kit
This is a 510(k) clearance letter from 1998, which primarily establishes substantial equivalence to a predicate device. It predates the widespread use of AI in medical devices and the standardized reporting metrics for AI device performance that are now common. Therefore, the detailed information about acceptance criteria, specific studies proving AI performance, ground truth establishment for training data, and AI-specific study designs such as MRMC or standalone performance is not present in this document.
The document indicates that the device is a "Ventrix™ Subdural Tunneling Pressure Monitoring Kit" and its indications for use are "for patients that require continuous intracranial pressure monitoring."
Based on the provided text, here's what can be extracted and what cannot:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not provide a table of acceptance criteria or specific device performance metrics in the format usually requested for AI/software-driven devices (e.g., sensitivity, specificity, AUC).
The basis for clearance is "substantial equivalence (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976." This means the device was found to be as safe and effective as a legally marketed predicate device. The performance data would have been focused on demonstrating this equivalence, likely through traditional engineering and clinical validation rather than AI-specific metrics.
2. Sample Size Used for the Test Set and Data Provenance:
This information is not present in the clearance letter. For a 510(k) of this era and type of device (a physical monitoring kit, not an AI algorithm), the "test set" would refer to the clinical studies or engineering tests performed to demonstrate safety and effectiveness for substantial equivalence. Details on these are not included in the clearance letter itself.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not present. For a device like this, ground truth would typically be established through comparison to established clinical methods or other validated devices, rather than expert interpretation of images or other data for an AI algorithm.
4. Adjudication Method for the Test Set:
This information is not present.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:
This information is not present. MRMC studies are specific to evaluating human reader performance, especially with and without AI assistance, and are not relevant to a physical intracranial pressure monitoring device from 1998.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
This information is not present. This device is a "kit" for monitoring pressure, implying a physical device used by clinicians, not a standalone algorithm.
7. The Type of Ground Truth Used:
The document does not explicitly state the type of ground truth used. However, for an intracranial pressure monitoring device, the ground truth would typically involve:
- Direct measurement: Comparing the device's readings to other established methods of intracranial pressure measurement (e.g., direct ventricular catheterization, if applicable and considered the gold standard at the time).
- Clinical outcomes: Demonstrating that the information provided by the device aids in patient management resulting in comparable or improved clinical outcomes.
- Bench testing: Verifying the accuracy and reliability of the pressure readings against known pressure sources.
8. The Sample Size for the Training Set:
This information is not present. The concept of a "training set" is specific to machine learning and AI, which is not what this 1998 device falls under.
9. How the Ground Truth for the Training Set Was Established:
This information is not present for the reasons mentioned above.
In summary, this document is a 510(k) clearance for a physical medical device from 1998. It does not contain the type of detailed performance data or study design information typically associated with AI/software-driven devices or recent regulatory submissions that require such specificity. The clearance is based on substantial equivalence, implying that the device's technology and intended use were comparable to existing devices, and that relevant safety and performance data (which are not detailed here) supported this claim.
§ 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).