Search Results

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.

Ask a specific question about this device

The Parenchymal Bolt Pressure Monitoring Kit is indicated for use on patients that require continuous intracranial pressure monitoring.

This device should only be used by a physician or qualified personnel under the direction of a physician.

Care must be taken to ensure compliance with the manufacturer's Directions for Use.

Prescription Use Only (Per 21 CFR 801.109)

Parenchymal Bolt Pressure Monitoring Kit

This document is a 510(k) clearance letter from the FDA for a medical device called the "Parenchymal Bolt Pressure Monitoring Kit." It does not contain information about acceptance criteria, device performance studies, or AI/software validation. Therefore, I cannot extract the requested information.

The document primarily states that the device is substantially equivalent to legally marketed predicate devices and outlines regulatory requirements. It clarifies the device's intended use but does not provide technical specifications or study details.

Ask a specific question about this device

Model 110-4BT: Use by a qualified neurosurgeon for direct measurement of intracranial pressure and temperature in the parenchyma. Model 110-4HMT: Use by a qualified neurosurgeon for direct measurement of intracranial pressure and temperature in the ventricles and cerebrospinal fluid drainage. Intended to be used with an external drainage system as indicated by individual manufacturers.

The Intracranial Pressure-Temperature Monitoring System consists of a catheter and monitor. The catheter is a sterile transducer-tipped pressure monitoring catheter with thermistor and accessory items to be used as a diagnostic tool for rapidly determining and continuously monitoring intracranial pressure and temperature. The Camino catheter has a miniature transducer and thermistor at the distal tip. The pressure transducer is identical to the Camino predicate device. The design eliminates the need for a "fluid-filled system" to carry pressure waves to an external transducer is 4F, fiber optic with a pressure measurement range of -10 to 250 mmHg and a temperature measurement range of 30°C -40°C. The Multi-Parameter Monitor (MPM) is a compact, portable device for use with Camino The MPM measures Intracranial Pressure (ICP). Pressure-Temperature catheters. Intracranial Temperature (ICT) and calculates Cerebral Perfusion Pressure (CPP). The MPM provides a continuous display of the pressure waveform, as well as mean ICP. CPP. temperature or systolic and diastolic values. A continuous record of mean pressure and temperature values over the most recent 24-hour period is stored in memory, and can be displayed on command as a TREND either as the most recent 8 or 24 hour period. An analog output accessory provides a continuous ICP waveform for hard copy documentation or data acquisition. Although the MPM is intended to be a stand alone system, it also conveniently connects to any hospital bedside monitoring system. A builtin rechargeable battery permits monitoring during patient transport. The monitor is equipped with an high ICP alarm. The dimensions are 274 mm x 216 mm x 89 mm and weighs 4.3 Kg.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Camino device:

Acceptance Criteria and Device Performance

Note: The document does not explicitly state "acceptance criteria" as a set of quantified thresholds. The performance data provided is primarily for demonstrating substantial equivalence based on a comparison to a predicate device, rather than meeting predefined, independent performance targets. The implicit acceptance criterion for temperature is that the new device's temperature readings should be very close to those of the predicate device. For pressure, the device uses the same transducer as a predicate, implying inherited performance without new testing.

Study Details

2. Sample Size and Data Provenance

• Test Set Sample Size: 10 animals
• Data Provenance: Not explicitly stated, but "animal studies" suggest it's likely a controlled laboratory or research setting. Given the context of a 1996 submission, it's almost certainly prospective as part of the regulatory submission process.

3. Number of Experts and Qualifications for Ground Truth

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.

Note: The study described is a comparison of two devices' readings, not an assessment by human experts against a "ground truth" established by experts in the typical clinical sense (e.g., radiologists interpreting images). The "ground truth" for the temperature measurement was essentially the reading from the predicate device placed alongside the test device.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. The study involved a direct comparison of physical measurements from two devices, not an interpretive task requiring expert adjudication of results.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• MRMC Study Done: No. This device is a medical monitoring instrument, not an AI or diagnostic imaging tool that would typically involve human readers.

6. Standalone (Algorithm Only) Performance

• Standalone Performance Done: Yes, in essence. The device inherently operates in a standalone manner, providing direct measurements. The study evaluated the device's intrinsic measurement capabilities (temperature) by comparing it to another device. The "algorithm" here is the physical measurement principle and sensor, not an AI algorithm.

7. Type of Ground Truth Used

• Ground Truth Type: "Predicate device comparison." For temperature, the readings from the established predicate device were used as the reference against which the subject device's readings were compared. For pressure, the device uses the identical transducer as a predicate, inferring equivalence.

8. Sample Size for Training Set

• Training Set Sample Size: Not applicable. This device is not an AI/ML model that requires a training set. It's a physical monitoring device.

9. How Ground Truth for Training Set Was Established

• Ground Truth Establishment for Training Set: Not applicable, as there is no training set for this type of device.

Ask a specific question about this device