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Use of the Integra™ Camino® Flex Ventricular Intracranial Pressure Monitoring Kit is indicated when direct and continuous intraventricular intracranial pressure (ICP) monitoring and cerebrospinal fluid (CSF) drainage are required.

The Integra™ Camino® Flex Ventricular Intracranial Pressure Monitoring Kit functions as an entire system that includes the following: Integra Camino Flex Ventricular Catheter Monitoring Kit (Catheter and Accessories) and Integra Camino Flex Adapter and Extension Cable), in which the Integra Camino Flex Adapter connects to the previously cleared Integra Camino Advanced Monitor (K962928 Integra LifeSciences Corporation) or to Integra Camino ICP Monitor (K121573 Integra LifeSciences Corporation).

The Integra Camino Flex Ventricular Intracranial Pressure Monitoring Kit is indicated when direct and continuous intraventricular intracranial pressure (ICP) monitoring and cerebrospinal fluid (CSF) drainage are required. The device is a single use, disposable product. The device is comprised of a highly flexible catheter with a tensile member, a pressure sensing tip, an electrical connection to a monitor, and a drainage lumen to allow fluid connection to an extraventricular drainage (EVD) device. The device is designed for the tunneling surgical method and the kit includes the necessary accessories for access and implantation of the catheter.

The tip of the Integra Camino Flex Ventricular Catheter is implanted within the anterior horn of the left or right lateral cerebral ventricle. A cylindrical volume with a height of at least 11 mm and a diameter of at least 5 mm are required for catheter implantation.

The Integra Camino Flex Ventricular Catheter in an MR environment is for conditional use in 1.5 Tesla (T) and 3.0 T MR Environments. The conditions for safe use are:

• · Not to exceed a maximum head or whole body averaged specific absorption rate (SAR) of 2 Watts/kg.
• · Not to exceed maximum scan duration of 15 minutes.
• · Circularly coil the externalized portions of the catheter within a 2.5 inch (6.3cm) to 3.5 inch (8.8cm) diameter range and securely tape it over the top of the patient's head.
• · Use only the following coils for MRI procedures:
  • o Transmit Body/Receive Body RF Coils
  • o Transmit Body Coils with any Receive-Only Coil (including receive-only head coils)
• · Do not use transmit head coils for MRI procedures
• · None of the catheter accessories, such as the trocar, stylet, drill stop and hex wrench should be brought into the MR environment. These accessories are only required during catheter placement and not needed in the MR environment.

Here's an analysis of the acceptance criteria and the study proving device performance, based on the provided text:

This submission (K133754) is a labeling modification to add MR safety information for the Integra™ Camino® Flex Ventricular Intracranial Pressure Monitoring Kit. Therefore, the "acceptance criteria" and "device performance" in this context refer to the device's compatibility and safety within an MR environment, not its primary function of ICP monitoring. The core functionality and performance related to ICP monitoring are assumed to be consistent with the predicate device as there are no changes to the product itself.

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document mentions "non-clinical tests" and "Magnetic Resonance testing only to demonstrate MR compatibility for the catheter." It does not specify a sample size for a test set that would typically involve human patients or clinical data. The testing appears to be entirely bench-top or laboratory-based to evaluate MR compatibility. Therefore, questions of country of origin or retrospective/prospective do not apply in the usual sense.

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)

This type of information is not provided in the document. Given that the study is a non-clinical, MR compatibility test for a labeling modification, the "ground truth" would be established by engineering and physics principles of MR safety and device integrity, rather than expert clinical interpretation of images or patient outcomes.

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

Not applicable. No adjudication method is mentioned as this was not a study involving human readers or clinical data requiring adjudication.

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. This study is not an MRMC comparative effectiveness study and does not involve AI assistance or human readers in that capacity.

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

Not applicable. This study is not evaluating an algorithm or AI performance. It is evaluating the physical and electrical compatibility of a medical catheter with an MR environment.

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

The ground truth used for this study is based on engineering and physics principles related to Magnetic Resonance (MR) safety and compatibility standards. This would involve measurements of induced heating, image artifact assessment, and force/torque assessments as per relevant MR safety standards (e.g., ASTM F2503). The document broadly states "Testing confirmed that the Integra 'Camino' Flex Ventricular Intracranial Pressure Monitoring Catheter is safe and effective for use in an MR environment under conditions specified in the product labeling."

8. The sample size for the training set

Not applicable. This study does not involve machine learning algorithms or a training set.

9. How the ground truth for the training set was established

Not applicable. This study does not involve machine learning algorithms or a training set.

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The LiquoGuard CSF system is indicated for the external drainage of cerebrospinal fluid (CSF). It connects to any drainage catheter (not part of the product) which is usually inserted by the doctor into the lateral or third ventricle of the brain or lumbar subarachnoid space in selected patients to reduce intracranial pressure. The LiquoGuard CSF system controls CSF pressure using pressure sensors and a pump, thus taking the role of the conventional CSF dripping chamber and collection bag (predicate devices). The LiquoGuard CSF system also monitors intracranial pressure up to 75 mmHg and cerebrospinal fluid flow during CSF drainage, and provides many alarm functions not offered by the passive dripping chamber systems.

The LiquoGuard CSF System consists of a pump and a corresponding tube set with pressure sensors. The dynamic range of this system is from -15mmHg to +75 mmHg. The tube set is inserted into the pump, connected to the intrathecal drainage catheter (not part of the product) via Luer-Lock and the LiquoGuard CSF System device via cable connector. The device then continuously measures the pressure inside the tube and operates a tube pump whenever the actual pressure is higher than a preselected target pressure. Thus the LiquoGuard CSF System combines CSF drainage and intracranial pressure (ICP) monitoring with integrated alarm and documentation/data logging functions, improving safety, simplifying the handling and enhancing patient mobility (by its battery back-up).

Acceptance Criteria and Device Performance for LiquoGuard CSF System (K121248)

The provided document describes the Moller Medical LiquoGuard CSF System, which is indicated for external drainage and monitoring of cerebrospinal fluid (CSF). The acceptance criteria for this device are established through a combination of bench tests and a comparative clinical study against predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the successful completion of the bench tests and the demonstration of equivalence in adverse event rates during the clinical study. No specific numerical thresholds for acceptance were explicitly stated beyond "all tests passed according to the predetermined pass/fail criteria."

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size (Clinical Study): 413 patient records.
• Data Provenance: The records were collected from "several hospitals," indicating a multi-center study. The clinical study combines "similar, independent studies," suggesting a retrospective collection and aggregation of existing patient data rather than a new prospective study exclusively for this submission. The country of origin of the data is not explicitly stated in the provided text.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

The document does not specify the number or qualifications of experts used to establish ground truth for the clinical study. The clinical study compares "adverse events" between the LiquoGuard and predicate devices, implying that these events were recorded as part of standard clinical practice.

4. Adjudication Method for the Test Set

The document does not specify an adjudication method (e.g., 2+1, 3+1, none) for the clinical study's adverse event data. It mentions identifying and comparing rates of incidence, which suggests a quantitative analysis of pre-recorded data rather than a consensus-based adjudication process for individual cases.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. The study focused on comparing adverse event rates between the device and predicate devices in a clinical setting, not on assessing human reader performance with or without AI assistance.

6. Standalone (Algorithm Only) Performance

The device is not an AI-driven diagnostic algorithm. It is a medical device that combines hardware (pump, sensors) and software for CSF drainage and monitoring. Therefore, a standalone (algorithm only) performance study as typically understood for AI/CAD devices was not performed. Its performance is assessed through the comprehensive bench tests and clinical comparison.

7. Type of Ground Truth Used for the Test Set

The ground truth for the "test set" (clinical study) was based on clinical outcomes data, specifically "adverse events" recorded in patient records resulting from CSF drainage using either the LiquoGuard or predicate drip chambers.

8. Sample Size for the Training Set

The document does not explicitly mention a "training set" as would be typical for machine learning models. The device's development and validation relied on engineering principles, bench testing, and a clinical comparison to existing devices. Therefore, a specific sample size for a "training set" in the context of an AI/ML model is not applicable from the provided information.

9. How the Ground Truth for the Training Set Was Established

As there is no explicit mention of a training set in the context of machine learning, the question of how its ground truth was established is not directly applicable. The device's functionality is based on established fluid dynamics, pressure sensing, and pump control mechanisms. Its design and performance would have been refined through iterative engineering development and testing against specifications derived from medical requirements and predicate device functions.

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Use of the Integra™ Camino® Flex Ventricular Intracranial Pressure Monitoring Kit with Integra™ Camino® Flex Adapter is indicated when direct and continuous intraventricular intracranial pressure (ICP) monitoring and cerebrospinal fluid (CSF) drainage are required.

The Integra™ Camino® Flex Ventricular Intracranial Pressure Monitoring Kit with Integra™ Camino® Flex Adapter functions as an entire system that includes the following: Integra Camino Flex Ventricular Catheter Monitoring Kit (Catheter and Accessories) and Integra Camino Flex Adapter (Adapter and Extension Cable), in which the Integra Camino Flex Adapter connects to the previously cleared Camino Advanced Monitor (510(k) K962928 Integra LifeSciences Corporation).

The Integra Camino Flex Ventricular Intracranial Pressure Monitoring Kit with Integra Camino Flex Adapter is indicated when direct and continuous intraventricular intracranial pressure (ICP) monitoring and cerebrospinal fluid (CSF) drainage are required. The device is a single use, disposable product. The device is comprised of a highly flexible catheter with a tensile member, a pressure sensing tip, an electrical connection to a monitor, and a drainage lumen to allow fluid connection to an extraventricular drainage (EVD) device. The device is designed for the tunneling surgical method and the kit includes the necessary accessories for access and implantation of the catheter. The following Accessories are referenced in 510(k) K904883: Drill, Drill Stop, Set Screw, Hex Wrench, Trocar, Trocar Sheath, Suture Loops, and Male Luer Cap.

The tip of the Integra Camino Flex Ventricular Catheter is implanted within the anterior horn of the left or right lateral cerebral ventricle. A cylindrical volume with a height of at least 11 mm and a diameter of at least 5 mm are required for catheter implantation.

The Integra Camino Flex Adapter performs the functions of receiving the transducer signal from the Integra Camino Flex Ventricular Intracranial Pressure Monitoring Kit catheter, amplifying the signal, and transmitting the signal to the Camino® Advanced Monitor. The Integra Camino Flex Adapter converts the signals produced by the Integra Camino Flex Ventricular Intracranial Pressure Monitoring Kit catheter sensor. This signal is sent to the Adapter by means of the extension cable to the Camino® Advanced Monitor.

The Integra™ Camino® Flex Ventricular Intracranial Pressure Monitoring Kit with Integra™ Camino® Flex Adapter is a medical device. The provided text describes the device and its intended use but does not contain information about acceptance criteria or a study proving its performance against such criteria. The document is a 510(k) summary for regulatory clearance, focusing on substantial equivalence to predicate devices, sterilization, and general device description.

Therefore, I cannot provide the requested table, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case study information, standalone performance, or training set details from the provided text. This information would typically be found in a detailed validation or clinical study report, which is not present here.

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The use of a Hummingbird HUMV-500 or HUMV-500MR by a qualified neurosurgeon is indicated when direct measurement of intracranial pressure is clinically important, when the patient may require CSF drainage in the course of their care, when data from one or more parameters may be deemed useful in providing optimum patient management and, in the case of the Hummingbird-500MR, when an MRI may be indicated.

The MPS catheter has three lumens, a drainage lumen, a thermocouple lumen and an air column lumen. An MPS catheter has a thin-wall tube termed the cage attached to its distal end. The cage holds the pressure-sensing bladder and provides the inlet holes through which CSF enters the catheter. The Continuous Pressure model eliminates the affect of clogged intet holes on the ICP reading by inserting a partition into the cage that separates cage into two compartments, an upper compartment for the sensing bladder and a lower compartment for CSF inflow. A transfer tube passing through the bladder compartment conveys CSF from the inflow compartment to the drainage lumen of the catheter. The manifold of the approved device has two probe ports. The diameter of one of the ports has been increased to allow the passage of either a flow or dialysis probe. The distal body of the manifold has been extended 1 cm to both accommodate the diameter change and improve the distal end profile for insertion into the brain. The thermocouple of the MRI Conditional catheters has been placed in a removable probe. The probe is removed prior to an MRI and replaced after. The temperature probe is placed in a polyimide tube that has been inserted into a dedicated lumen in the catheter.

This document pertains to a 510(k) premarket notification for a medical device, specifically the InnerSpace Hummingbird HUMV-500 and HUMV-500MR, which are intracranial pressure monitoring devices. It is a submission to the FDA for market clearance and does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the way typically found for AI/ML performance evaluation.

The document describes modifications to existing predicate devices and ensures the safety and effectiveness of the new models through comparison to predicate devices and testing related to MRI compatibility and physical properties. It does not involve a study with acceptance criteria in the context of diagnostic or classification performance metrics (e.g., sensitivity, specificity, AUC) that would be applicable to AI/ML devices.

Therefore, many of the requested fields cannot be populated as they are related to performance studies of AI/ML algorithms, which are not present in this regulatory submission.

Here is an attempt to address the request based only on the provided text, while acknowledging the limitations for AI/ML related questions:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly define "acceptance criteria" in terms of performance metrics like sensitivity, specificity, or accuracy for a diagnostic device. Instead, the submission focuses on substantial equivalence to predicate devices. The "performance" reported relates to physical characteristics and compatibility.

• MPS 8.1 Fr: 3.46 x $10^{-3}$ Sq. in. (Camino Large 2: 1.96 x $10^{-3}$ Sq. in.)
• MPS 9.0 Fr: 4.91 x $10^{-3}$ Sq. in. (Camino Large 1: 2.37 x $10^{-3}$ Sq. in.)
  (MPS catheters have a larger drainage lumen due to polyurethane construction allowing thinner walls, compared to predicate silicone catheters.)

Manifold Port Diameters:

• Modified Device Port 1: .056" (Same as Approved device Port 1)
• Modified Device Port 2: .063" (Larger than Approved device Port 2: .056")
  (Port 2 enlarged to accommodate larger flow/dialysis probes.) |
  | Material Strength | Catheter body made of polyurethane, which is "stronger than silicone." |
  | Continuous Pressure | New "Continuous Pressure" model has a modified cage design with a partition to isolate the sensing bladder from pressure changes due to clogged inlet holes, eliminating the need to stop CSF drainage for true ICP reading. |
  | MRI Compatibility | Hummingbird HUMV-500MR:
• Thermocouple placed in a removable probe to be removed prior to MRI.
• Bolted component (HUMV-500MR) found to be "MR Conditional" as defined by ASTM F2503 using 1.5T and 3.0T MR systems.
  (Catheter and manifold are plastic and MRI safe without the probe.) |
  | Indications for Use | Substantially equivalent to predicate devices, used for direct measurement of intracranial pressure, CSF drainage, and relevant parameter monitoring, with additional indication for MRI compatibility for the -MR model. |

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. This document describes physical device characteristics and MRI compatibility testing, not performance on a "test set" of diagnostic data. The MRI testing for the bolt (ASTM F2503) would have involved specific test methods and conditions but not a "sample size" in the context of data points for AI/ML evaluation.

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. This is not an AI/ML device requiring expert ground truth for a diagnostic test set.

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

Not applicable. This is not an AI/ML device evaluation.

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. This is not an AI-assisted diagnostic device.

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

Not applicable. This is a physical medical device, not an algorithm.

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

Not applicable. Ground truth, in the context of AI/ML, refers to definitively correct labels for data. For this device, "ground truth" would be the physical properties measured against engineering specifications or established standards (e.g., ASTM F2503 for MRI compatibility).

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI/ML algorithm that undergoes a "training set."

9. How the ground truth for the training set was established

Not applicable.

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The Camino® SPM-1 Intracranial Pressure Monitor is indicated for use when direct measurement of intracranial pressure (ICP) is clinically important.

The SPM-1 is an intracranial pressure monitor which features continuous mean Intracranial Pressure (ICP) display, high ICP alarm, and bedside monitor capabilities. The SPM-1 is a modified MPM-1 ICP monitor. It contains the same circuit boards as the MPM-1 but with fewer components, based on the scaled down features (no waveform display, temperature monitoring or ability to calculate CPP). The SPM-1 is supplied with a PAC-2 Pre-Amp Cable, and a PMIO-SPM Patient Monitor Cable. Non-sterile adapter cables (REF ICP-XX) are used to interface the PMIO-SPM cable to specific bedside monitors. These non-sterile cables come in many configurations, which facilitate data transfer between the PMIO-SPM cable and a specific brand of external bedside monitor. The following Camino® 110-4 Series ICP catheters are intended to be used with the SPM-1: 110-4B (Ventricular Bolt Pressure Monitoring Kit), 110-4G (Post Craniotomy Subdural Pressure Monitoring Kit), 110-4HM (Micro Ventricular Bolt Pressure Monitoring Kit), and 110-4L (Intracranial Pressure Monitoring Catheter with Licox® IMC Bolt Fitting). The use of temperature catheters is not recommended with the SPM-1.

The Camino® SPM-1 Intracranial Pressure Monitor, based on the provided 510(k) summary, does not detail specific acceptance criteria or a dedicated study proving its performance against such criteria in the way a modern AI/ML device submission would. Instead, the submission relies on demonstrating substantial equivalence to a predicate device (Camino® Multi-Parameter Pressure Monitor, K962928) and general safety testing.

Here's a breakdown of the requested information based on the available text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state quantitative acceptance criteria or detailed performance metrics for the SPM-1. The primary claim for performance is its substantial equivalence to the predicate device, implying it performs equivalently.

2. Sample Size Used for the Test Set and Data Provenance:

The document does not describe a clinical "test set" with a specific sample size for performance evaluation in the context of analytical or clinical accuracy. The testing mentioned appears to be primarily engineering verification and validation testing for safety and functionality. No information is provided regarding data provenance (e.g., country of origin, retrospective/prospective).

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts:

Not applicable. The device is a physical Intracranial Pressure (ICP) monitor. Its "ground truth" would be the actual ICP measurements, which are obtained directly by the device, not by expert consensus on images or other diagnostic data.

4. Adjudication Method for the Test Set:

Not applicable. As noted above, there's no "test set" requiring adjudication of ground truth by multiple experts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:

Not applicable. The Camino® SPM-1 is a hardware device for measuring ICP, not an AI-assisted diagnostic tool or an algorithm that human readers would use to improve their interpretations. Therefore, an MRMC study and AI assistance effect size are not relevant to this device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Not applicable. This is a standalone medical device in the sense that it measures ICP directly. It's not an algorithm that functions without human interaction for its primary purpose of measurement, but it also doesn't involve "human-in-the-loop performance" in the context of AI interpretation. Its performance is inherent in its measurement capabilities.

7. The Type of Ground Truth Used:

The ground truth for an Intracranial Pressure Monitor is direct measurement of intracranial pressure. This is a physiological measurement, not an expert consensus, pathology, or outcomes data in the usual diagnostic sense. The accuracy of the device's measurement would be compared against a known standard or another highly accurate measurement method (e.g., in a laboratory setting). While not explicitly stated, general performance testing for such a device would involve calibration and accuracy checks against pressure standards.

8. The Sample Size for the Training Set:

Not applicable. The Camino® SPM-1 is an electromechanical device, not a machine learning or AI model. Therefore, it does not have a "training set" in the computational sense.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as there is no training set for this type of device.

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