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Use of the CODMAN MICROSENSOR Basic Kit is indicated when direct ICP monitoring is required. The kit is indicated for use in both subdural and intraparenchymal pressure monitoring applications only.

Use of the CODMAN MICROSENSOR Plastic/Metal Skull Bolt Kit is indicated when direct intracranial pressure (ICP) monitoring is required. The kit is indicated for use in both subdural and intraparenchymal pressure monitoring applications.

Use of the Ventricular Catheter Kit is indicated when direct intraventricular pressure monitoring is required. The kit is indicated for use in ICP monitoring and cerebrospinal fluid (CSF) drainage applications.

The Microsensor monitors intracranial pressure (ICP) through either a stand-alone probe, or a probe coupled with an EVD catheter, and is intended to be used in conjunction with the Codman ICP Express (product code 82-6635) neuromonitoring platform products. The ICP Express and Codman Microsensor are intended for use in Intensive Care Units (ICUs). The Microsensor converts the pressure signal to a voltage signal. The monitor provides power to the Microsensor, interprets the voltage signal from the Microsensor, and displays the corresponding pressure measurements taken by the Codman Microsensor during a patient's treatment and during patient transport. There is no change to the Codman ICP Express monitor as a result of the probe modifications described in this submission.

The Codman Microsensor probe contains a small, thin and delicate pressure sensor used to measure the intracranial pressure. The sensing element uses a strain gauge located at the tip of the probe. The sensing element is protected by a titanium housing and is exposed to the environment via a silicone membrane. The sensor is connected via wires to a plastic connector housing, and the wires are snaked through a nylon catheter. The connector housing includes a compensation/calibration passive circuit on a Printed Circuit Board and has an electrical connector to attach the ICP Express monitoring box.

The Codman Microsensor Kits include components needed to facilitate the surgical implantation of the ICP Microsensor. The components that will be included with the proposed Codman Microsensor are currently cleared devices, and are identical to the components currently packaged within the current Codman Microsensor kits (i.e. via this 510k, there are no changes being made to the kit components, only the Microsensor is being updated). Each component and their function are described in the Description section of the Instructions for Use for each kit.

The provided text describes the Codman Microsensor Kits, an intracranial pressure monitoring device, and the studies conducted to demonstrate its substantial equivalence to a predicate device. The information is presented in the context of a 510(k) premarket notification.

Here's an analysis of the acceptance criteria and the studies that prove the device meets them, based on the provided document:

Acceptance Criteria and Reported Device Performance

The document outlines acceptance criteria and performance through a series of bench tests. The relevant information is summarized in "Table 4. Verification and Validation Bench Tests" and implicitly stated through "PASS" results for each test.

Study Details:

1. Sample size used for the test set and the data provenance:

   • The document does not specify the exact sample sizes (number of devices or measurements) used for each individual bench test listed in Table 4.
   • Data Provenance: The studies are described as "Bench Testing" and "Biocompatibility Testing," implying laboratory-controlled experiments rather than human or animal subject data, except for some biocompatibility tests which use animal models. No country of origin for the data is explicitly mentioned, but the submission is to the U.S. FDA, and relevant standards like ASTM and ISO are cited. The studies are prospective in nature, conducted specifically for this submission.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • This question is not applicable as the evaluation relies on physical and chemical measurements against engineering specifications and industry standards, not on expert interpretation of complex clinical data to establish a ground truth. The "ground truth" here is defined by established scientific principles and performance metrics.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • This is not applicable as the studies are bench tests and biocompatibility evaluations, which involve objective measurements and adherence to predetermined standards rather than subjective human interpretation requiring adjudication.

4. 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:

   • No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is an intracranial pressure monitoring transducer, not an AI-assisted diagnostic imaging device that would typically involve human readers or AI algorithms for interpretation.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • This is not applicable. The device is a physical medical device (a pressure transducer), not a software algorithm or AI model.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • The "ground truth" for the performance evaluation is based on engineering specifications, established physical measurement methods, and compliance with recognized industry standards (e.g., ASTM, ISO). For biocompatibility, it's based on biological responses in animal models and in vitro tests (cytotoxicity, sensitization, irritation, pyrogenicity, mutagenicity, implantation, hemolysis) against accepted safety thresholds.

7. The sample size for the training set:

   • This is not applicable as the device is a physical medical device and does not involve AI or machine learning algorithms that require training sets.

8. How the ground truth for the training set was established:

   • This is not applicable for the same reason as point 7.

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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:

1. 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.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not specified.

3. 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.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.

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: Not applicable, as the device does not employ AI.

6. 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.

7. 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.

8. The sample size for the training set: Not applicable, as the device does not employ AI/ML that requires a training set.

9. 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.

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