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The RAUMEDIC® -ICP-Monitoring-System ventricular is indicated for use in ventricular pressure monitoring and cerebrospinal fluid drainage applications. Use of the ventricular intracranial pressure monitoring kit with bolt is contra-indicated in children under one year old. The RAUMEDIC® catheters are MR Unsafe.

The RAUMEDIC® -ICP-Monitoring-System ventricular is composed of NEUROVENT® components, spliceable tunneling sleeves, and bolt and drill kits. The device is used for intracranial pressure monitoring and cerebrospinal fluid drainage applications, and is implanted in the ventricle using various methods.

Despite the user's request, the provided document does not contain the detailed information necessary to describe acceptance criteria, device performance, or study details such as sample sizes, ground truth establishment, or multi-reader multi-case studies for a diagnostic AI device.

The document is a 510(k) summary for a medical device called the "RAUMEDIC® -ICP-Monitoring-System ventricular." This device is an intracranial pressure monitoring system, not an AI-powered diagnostic tool. The information provided is typical for a traditional medical device submission, focusing on:

• Device Identification: Name, applicant, contact, date.
• Device Description: Components (NEUROVENT® components, tunneling sleeves, bolt and drill kits).
• Intended Use/Indications for Use: Ventricular pressure monitoring and cerebrospinal fluid drainage, contraindications (children under one year old for the bolt kit), and MR safety status (MR unsafe).
• Substantial Equivalence: Comparison to predicate devices (K103206 and K062584).
• Testing: Mentions biocompatibility studies and performance testing to demonstrate safety and compliance with standards, but does not provide details on specific performance metrics, acceptance criteria, or study methodologies that would be relevant for an AI diagnostic device.
• Regulatory Classification: Class II, product code GWM.

Therefore, I cannot fulfill the request for information on acceptance criteria and study details as they pertain to an AI diagnostic device, because the provided text describes a physical medical device for monitoring and fluid drainage, not an AI software.

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The RAUMEDIC® -ICP-Monitoring-System is indicated for use in parenchymal pressure monitoring. Use of the parenchymal intracranial pressure monitoring kit with bolt is contra-indicated in children under one year old. The RAUMEDIC® precision pressure catheters are MR Unsafe.

The RAUMEDIC® -ICP-Monitoring-System determines safely, quickly and accurately the level and change in intracranial pressure (ICP) by using semi-conductor pressure sensors. The Neurovent® - P and Neurovent® - P - C are indicated for use in parenchymal pressure monitoring. Both types of catheters are implanted in parenchyma via a RAUMEDIC® - Bolt Kit CH5. In addition to the catheter a zero point module NPS2 x is needed. "x" depends on the type of patient monitor available in the hospital - there are 20 different references. To the equipment also belongs an ICP-Temp-Cable and a NPS3 pressure display unit. The difference between the Neurovent® - P and the Neurovent® - P - C is that the housing material in the C-version is ceramic instead of titanium. The RAUMEDIC® -ICP-Monitoring-System is composed of the following elements: Neurovent® - P, Neurovent® P C, RAUMEDIC® - Bolt Kit (CH 5), RAUMEDIC® Drill Kit 4,5 mm (CH 5), ICP-TEMP-Cable, NPS2, NPS3.

The provided document is a 510(k) summary for the RAUMEDIC® -ICP-Monitoring-System, which describes the device, its intended use, and its substantial equivalence to a predicate device. While it mentions device testing, it does not contain a detailed study proving the device meets specific acceptance criteria with performance metrics, sample sizes, ground truth establishment, or multi-reader studies.

Therefore, I cannot provide the requested information in the format of a table of acceptance criteria and reported performance, nor can I detail the specifics of a study that is not present in the document.

However, I can extract what is mentioned about device testing and regulatory acceptance:

Key Takeaways from the Document Regarding Testing and Acceptance:

• Substantial Equivalence: The primary basis for acceptance is substantial equivalence to a legally marketed predicate device (Pressio® ICP MONITORING SYSTEM, K062584). This means the FDA determined the RAUMEDIC® system is as safe and effective as the predicate device.
• Biocompatibility: Studies were conducted per ISO 10993 standard, demonstrating the materials are safe for intended use.
• Performance Testing (Catheters): The two implantable catheters (Neurovent® P and Neurovent® P C) "were subjected to extensive performance testing." The results "showed that the catheter designs are safe for their intended uses." No specific performance metrics, acceptance criteria, or study details are provided.
• Safety Tests (NPS3): The NPS3 unit "underwent numerous safety tests, including testing to IEC 60601-1." No specific safety metrics or acceptance criteria are provided.
• Manufacturing Compliance: The manufacturing process complies with FDA and European Standards for medical devices.

Missing Information:

The document explicitly states that performance characteristics are "suitable for designated indications for use," but does not define these characteristics quantitatively (e.g., accuracy +/- X mmHg, drift rate, etc.) or provide a study demonstrating achievement of these criteria. Therefore, most of the requested points cannot be answered based on the provided text.

Specifically, the document does not include:

1. A table of specific acceptance criteria and detailed reported device performance for clinical accuracy or efficacy.
2. Sample sizes used for a "test set" (clinical data) or data provenance.
3. Information on experts used to establish ground truth or their qualifications.
4. Adjudication methods.
5. Any multi-reader multi-case (MRMC) comparative effectiveness study.
6. Detailed standalone (algorithm-only) performance results.
7. The type of ground truth used (beyond implying the predicate device's established performance).
8. Sample size for a training set (as this is a hardware device, not an AI/ML algorithm in the context of the questions).
9. How ground truth for a training set was established.

This is a typical scope for a 510(k) summary, which often relies on demonstrating equivalence through design, materials, and general performance testing rather than a de novo clinical trial with defined acceptance criteria and statistical power to show performance against those criteria.

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