(307 days)
The Pressio® Ventricular Intracranial Pressure Monitoring Kit with Tunneling, Model PSO-VT, is indicated for use in intraventricular pressure monitoring and cerebrospinal fluid drainage applications.
The Pressio® Intracranial Parenchymal Pressure Monitoring Kit with Tunneling, Model PSO-PT, is indicated for use in subdural or parenchymal pressure monitoring.
The Pressio® Intracranial Parenchymal Pressure Monitoring Kit with Bolt, Model PSO-PB, is indicated for use in parenchymal pressure monitoring.
The Pressio® ICP Monitoring System (PSO-3000) is an electromedical device designed for the monitoring of a patient's intracranial pressure (ICP) via a catheter implanted in the parenchyma (PSO-PB or PSO-PT) or in the ventricles (PSO-VT). The Pressio® ICP Monitoring System is sold as a kit containing a Pressio® ICP Monitor (PSO-3000), a Power Supply Cable (PSO-AC) and the Catheter Extension Cable (PSO-EC20).
The Pressio® ICP Monitor can be connected to a patient monitor via a compatible monitor connection cable (PSO-MCxx). This permits medical staff to display intracranial pressure curves on the patient monitor. This connection is not necessary for Pressio™ Intracranial Pressure Monitor functioning. The calibration of patient monitor is performed via a host monitor calibration key on Pressio™ Intracranial Pressure Monitor.
The Pressio® ICP Monitoring System is composed of the following:
- Pressio® ICP Monitor (PSO-3000)
- Pressio® ICP Catheters: there are three available types of implantable . catheters:
- Catheter implanted in ventricles via tunnelling (PSO-VT) .
- Catheter implanted in parenchyma via tunnelling (PSO-PT) .
- Catheter implanted in parenchyma via a bolt (PSO-PB) .
- . Pressio® Serial Transmitter Model (PSO-TX00)
- . Pressio® Intracranial Pressure Interface Control Unit (PSO-IN00)
- Catheter Extension Cable (PSO-EC20) .
- Monitor Connexion Cable (PSO-MCxx): "xx" depends on the type of . patient monitor available in the hospital, it exists 9 different references
- Power Supply Cable (PSO-AC) .
- Pressio® Pole Clamp (PSO-CL) .
- . Pressio® Disposable Hand Drill (PSO-DR)
The provided text does not contain acceptance criteria for a device, nor does it describe a study proving the device meets specific performance criteria.
Instead, this document is a 510(k) summary for the Pressio® ICP Monitoring system, submitted to the FDA in 2007 for premarket notification. It primarily focuses on demonstrating substantial equivalence to predicate devices and detailing general safety and performance testing.
Here's a breakdown of why the requested information cannot be extracted from the provided text:
- No Acceptance Criteria: The document mentions "extensive performance testing" and compliance with standards like ISO 10993, IEC 60601-1, and UL 2601, but it does not specify any quantitative or qualitative acceptance criteria (e.g., accuracy, precision, drift limits for ICP measurements).
- No Specific Study Details: While "extensive performance testing" is mentioned, no specific study design, methodology, or results (beyond general statements of safety and suitability) are provided. There's no information about sample sizes for test sets, data provenance, ground truth establishment, or expert involvement.
- No mention of AI/ML components: The device described is an "electromedical device designed for the monitoring of a patient's intracranial pressure (ICP) via a catheter." There is no indication of any Artificial Intelligence or Machine Learning (AI/ML) components in its design or function. Therefore, questions related to AI-specific studies (e.g., MRMC studies, standalone performance, training sets) are not applicable.
Summary of what can be extracted related to testing:
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A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not specified in the document.
- Reported Device Performance: The document generally states that "Results of the testing showed that the catheter designs are safe for their intended uses" and that the system components "underwent numerous safety tests, including testing to IEC 60601-1 and UL 2601." It also mentions "Biocompatibility studies were conducted per ISO 10993 standard and have demonstrated that the materials used... are safe for its intended use." No quantitative performance data (e.g., accuracy, reliability) is provided.
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Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not specified.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable, as no specific clinical or diagnostic test set with ground truth established by experts is described. Testing appears to be primarily engineering performance and safety focused.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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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: Not applicable, as the device does not employ AI.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable, as the device does not employ an algorithm in this context.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the context of diagnostic performance. The ground truth for functional tests would likely be established by a reference standard or validated measurement device for parameters like pressure, temperature, etc., which is not detailed here.
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The sample size for the training set: Not applicable, as the device does not employ AI/ML that requires a training set.
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How the ground truth for the training set was established: Not applicable, as the device does not employ AI/ML.
In conclusion, the provided 510(k) summary gives an overview of the device and its general testing for safety and substantial equivalence but lacks the specific details regarding acceptance criteria and performance study outcomes that would be required to answer your questions comprehensively.
§ 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).