Search Results

The NEUROVENT is indicated for use in ventricular pressure monitoring and cerebrospinal fluid drainage applications. It can be used for the measurement of the intracranial pressure (ICP).

The NEUROVENT IFD-S is indicated for use in ventricular pressure monitoring and cerebrospinal fluid drainage applications. It can be used for the measurement of the intracranial pressure (ICP).

The NEUROVENT IFD-R is indicated for use in ventricular pressure monitoring and cerebrospinal fluid drainage applications. It can be used for the measurement of the intracranial pressure (ICP).

The NEUROVENT-P is indicated for use in parenchymal pressure monitoring and can be used for the measurement of the intracranial pressure (ICP).

The NEUROVENT-PX is indicated for use in parenchymal pressure monitoring and can be used for the measurement of the intracranial pressure (ICP).

The NEUROVENT-P-TEMP is indicated for use in parenchymal pressure monitoring and can be used for the measurement of the intracranial pressure (ICP). Additional measurement of the brain temperature allows the direct measurement of the cerebral tissue temperature.

The NEUROVENT-TEMP is indicated for use in ventricular pressure monitoring and cerebrospinal fluid drainage applications. It can be used for the measurement of the intracranial pressure (ICP). Additional measurement of the brain temperature allows the direct measurement of the cerebral tissue temperature.

The NEUROVENT-TEMP IFD-S is indicated for use in ventricular pressure monitoring and cerebrospinal fluid drainage applications. It can be used for the measurement of the intracranial pressure (ICP). Additional measurement of the brain temperature allows the direct measurement of the cerebral tissue temperature.

The NEUROVENT-TEMP-IFD-R is indicated for use in ventricular pressure monitoring and cerebrospinal fluid drainage applications. It can be used for the measurement of the intracranial pressure (ICP). Additional measurement of the brain temperature allows the direct measurement of the cerebral tissue temperature.

The NEUROVENT-PTO is indicated for use in parenchymal pressure monitoring and can be used for the measurement of the intracranial pressure (ICP). Additional measurement of the brain temperature allows the direct measurement of the cerebral tissue temperature. Additional measurement of the oxygen partial pressure is an adjunct monitor of trends indicating the perfusion status of cerebral tissue local to sensor placement. The measured values are relative within an individual and should not be used as the sole basis for decisions as to diagnosis or therapy.

The NEUROVENT-PTO-2L is indicated for use in parenchymal pressure monitoring and can be used for the measurement of the intracranial pressure (ICP). Additional measurement of the brain temperature allows the direct measurement of the cerebral tissue temperature. Additional measurement of the oxygen partial pressure is an adjunct monitor of trends indicating the perfusion status of cerebral tissue local to sensor placement. The measured values are relative within an individual and should not be used as the sole basis for decisions as to diagnosis or therapy.

The BOLT(-DRILL) KITs are indicated to provide a cranial access for RAUMEDIC neurosurgical precision pressure catheters of the RAUMEDIC NEUROMONITORING-SYSTEM.

The DRILL KITs are indicated to provide a cranial access for RAUMEDIC neurosurgical precision pressure catheters of the RAUMEDIC NEUROMONITORING-SYSTEM.

The Tunneling KITs are indicated to provide a cranial access for catheters of the RAUMEDIC NEUROMONITORING-SYSTEM.

The RAUMEDIC® NEUROMONITORING-SYSTEM consists of several different models of probes and probe catheters capable of performing one or several different functions:

• Models with a dedicated lumen can be used for drainage of cerebrospinal fluid (CSF).
• Models equipped with ICP sensors can determine the level and change in intracranial pressure (ICP).
• Models equipped with temperature thermistors can monitor intracranial temperature.
• Models equipped with fiber optic sensors can monitor partial tissue oxygen pressure (ptiO2).

The RAUMEDIC® NEUROMONITORING-SYSTEM is intended to be used in conjunction with previously cleared RAUMEDIC® EASY logO Monitor (K130529), RAUMEDIC® MPR2 logO DATALOGGER (K171666), RAUMEDIC® NPS3 (K103206) or RAUMEDIC® NPS2 X (Brand name for NPS2 cleared in K103206).

The RAUMEDIC® NEUROMONITORING-SYSTEM includes components needed to facilitate the surgical implantation of NEUROVENT® catheters.

The RAUMEDIC® NEUROMONITORING-SYSTEM can be used in MR environment under specific constraints (MR conditional). Those constraints vary by device type, implantation method (bolting or tunneling), and magnetic field strength (1.5 or 3.0 Tesla).

The provided FDA 510(k) clearance letter for NEUROVENT Devices does not contain the specific details required to describe the acceptance criteria and the study that proves the device meets those criteria, particularly for performance metrics.

The document primarily focuses on:

• Device Identification: Listing all device names, regulation numbers, classification, and product codes.
• Regulatory Equivalence: Stating that the device is substantially equivalent to previously cleared predicate devices based on intended use, indications for use, and technological characteristics.
• Intended Use/Indications for Use: Detailed descriptions of what each NEUROVENT component is used for (e.g., ICP monitoring, CSF drainage, brain temperature, tissue oxygen partial pressure).
• MR Safety Testing: A list of ASTM and ISO/TS standards used to confirm the device's MR conditional status, along with the specific tests performed (magnetically induced displacement force, torque, image artifacts, heating, malfunction for various fields).

Crucially, the document explicitly states: "Based on performance testing and the available information concerning the referenced comparison devices, the RAUMEDIC® NEUROMONITORING-SYSTEM is equivalent in that: - The devices have the same intended use and indication for use. - Performance characteristics are suitable for designated indications for use."

However, it does NOT provide:

• A table of specific numerical acceptance criteria (e.g., ICP accuracy within X mmHg, temperature accuracy within Y °C, ptiO2 accuracy within Z mmHg).
• The reported device performance metrics against those criteria.
• Details about the "performance testing" beyond the MR safety tests. This implies that the performance characteristics (accuracy, precision, etc., for measuring ICP, temperature, ptiO2) were either derived from the predicate devices, established using bench testing, or considered suitable without presenting detailed clinical performance data in this 510(k) summary. Given the device type, it's highly likely a combination of bench and possibly animal/cadaveric testing, as well as reliance on the long-established performance of similar predicate devices, was used.
• Information about clinical study design. There is no mention of human subject data, test sets, training sets, ground truth establishment, expert adjudication, or MRMC studies. The phrases "anticipated clinical performance" and "does not raise new issues of safety or effectiveness" suggest reliance on the substantial equivalence principle rather than novel clinical trial data.

Therefore, based solely on the provided text, I cannot complete the requested information for acceptance criteria and the study proving the device meets them, beyond the MR safety aspects.

I will indicate "Not provided in the document" for sections where the information is missing.

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

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

• Sample Size for test set: Not provided in the document. The document primarily refers to "performance testing" and "MR safety requirements" being "tested and confirmed" to meet standards, rather than a clinical test set from human subjects.
• Data provenance: Not provided. The MR safety tests are likely laboratory-based.

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/Not provided. The document does not describe a study involving expert-established ground truth for performance evaluation of vital sign monitoring. The evaluation methodology focuses on substantial equivalence and laboratory testing for MR compatibility.

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

• Not applicable/Not provided.

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 device is a monitoring system and a kit for surgical access, not an AI-assisted diagnostic tool for human readers.

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

• Not applicable. The performance evaluation discussed pertains to the physical and functional aspects of the hardware (catheters, sensors, and their compatibility with MR environments), not a standalone algorithm.

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

• For the MR safety testing, the "ground truth" would be established by the specifications and measurement techniques defined in the referenced ASTM and ISO/TS standards.
• For the core physiological measurements (ICP, temp, ptiO2), the "ground truth" would typically refer to the accuracy of the sensors against calibrated reference standards in laboratory or animal models. This specific detail is not provided, but it's implied compliance with recognized industry standards or internal validation that is deemed "suitable for designated indications for use" and "equivalent."

8. The sample size for the training set

• Not applicable. The document does not describe the use of machine learning or AI, and therefore, no "training set."

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

• Not applicable.

Ask a specific question about this device

The B4C System is intended for the monitoring of variation in intracranial pressure in patients with suspected alteration of intracranial pressure (ICP) or change in intracranial compliance, by providing surrogate ICP waveforms and associated parameters (estimated P2/P1 ratio, normalized Time-to-Peak, derived useful ICP pulses and cardiac pulses) for interpretation.

The B4C System is a non-invasive device intended for monitoring of variation in intracranial pressure including patients with suspected alteration of intracranial pressure (ICP) or change in intracranial compliance. It consists of a sensor with Bluetooth wireless module, headband, mobile device software application, receiver, charger, as well as processing and analytical software. The subject of this 510(k) is to introduce an additional sensor, model BcSs-PICNIW-2000, that is compatible with the existing B4C System (K201989). The BcSs-PICNIW-2000 sensor consists of a piezoelectric fixed on a circular base that is supported on a headband placed over the patient's head. The skull pulsation is sensed by the fixed piezoelectric. Users may use either the existing sensor with the B4C System. During monitoring sessions, either sensor continuously transmits the Mobile App via Bluetooth connection and then to the analytical software component, Physio Core, to perform signal processing. The processed information is then sent back to the Mobile App in the form of minute graphs of waveform derived parameters as well as a report with additional waveform information. Like the predicate sensor, the proposed sensor does not measure absolute intracranial pressure values, but continues to produce surrogate waveform morphology, its trend, and associated parameters reflecting changes in ICP. The B4C System and surrogate waveform and associated outputs do not substitute ICP monitoring methods when measurement of the absolute value of ICP is required to make a clinical decision.

The sensor is supported on a headband worn by the patient, such that the sensor is in contact with the scalp and is perpendicularly positioned in the temporoparietal transition, 2 inches (5-6 cm) above the entrance of the external auditory canal on the coronal plane. Slight pressure is applied so that the sensor maintains contact with the scalp throughout the monitoring session. The sensor continuously records and transfers acquired data to the B4C analytical and processing software, and back to the mobile device application or to a compatible multi-parameter monitor that has piezoresistive pressure transducer sensitivities of 5uV/Vex/mmHg or greater and automatic amplitude window adjustment capability via a paired receiver. Data is transferred wirelessly via Bluetooth connection between sensor and mobile application and HTTPS protocol between mobile application and analytics software. The clinician may view the visualized waveform on the mobile device along with real-time waveform, minute graphs, intermediate, or final reports of surrogate waveform and associated parameters including surrogate waveform trend line, average waveform per minute and estimated P2/P1 ratio, normalized time to peak, as well as derived useful ICP pulses and cardiac pulses. Alternatively, with a supplied dongle, a paired patient monitor's inherent software interprets the signal received from the B4C System's sensor and displays a surrogate waveform that allows for viewing the same ICP waveform on the monitor's display. Clinicians review the B4C System outputs to assess patients with suspected intracranial hypertension or changes in intracranial compliance based on the characteristics Percussion (P1), Tidal (P2,), and Dicrotic (P3) peaks of the waveform morphology and associated parameters.

The B4C System is not intended to be a standalone diagnostic tool. The surrogate waveform and associated parameter outputs do not replace a comprehensive clinical evaluation, but only provide an element for preliminary assessment. The clinician is responsible for determining the additional clinical information that may be required to make a diagnosis.

The provided text describes the 510(k) premarket notification for the B4C System, with a new sensor model (BcSs-PICNIW-2000). The focus of this submission is to demonstrate substantial equivalence to the existing B4C System (K201989). The document primarily outlines the comparison between the new sensor and the predicate device, and the non-clinical performance data to support this claim.

Based on the provided text, there is no information regarding acceptance criteria outlined as specific metrics (e.g., sensitivity, specificity, accuracy) for the device's performance in a clinical study setting. The document emphasizes non-clinical performance data to demonstrate a new sensor model is substantially equivalent to a previously cleared device.

Therefore, for the purpose of answering your request, I will extract the information related to the non-clinical performance data which serves as the "study" proving the device meets the "acceptance criteria" for substantial equivalence. The acceptance criteria here are implicitly showing that the new sensor performs comparably to the predicate device and meets established safety and performance standards.

Here's the breakdown of the information based on your request, extracted from the provided text:

Acceptance Criteria and Device Performance for New Sensor (BcSs-PICNIW-2000)

The "acceptance criteria" in this context are primarily derived from demonstrating that the new BcSs-PICNIW-2000 sensor, when integrated into the B4C System, maintains comparable performance, safety, and effectiveness to its predicate device (B4C System K201989). This is achieved through non-clinical testing, ensuring the differences do not raise new questions of safety and effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document does not specify a "sample size" in terms of patient data for a clinical test set. The reported "performance data" is non-clinical bench testing and verification/validation.
• Data Provenance: The data provenance for these non-clinical tests is not explicitly stated (e.g., country of origin, retrospective/prospective). However, such testing is typically controlled laboratory or engineering testing.

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

• Not Applicable. As the reported data is non-clinical bench testing and verification/validation, it does not involve human experts establishing "ground truth" for patient data in the way a clinical study would. The "ground truth" for these tests would be defined by engineering specifications and regulatory standards (e.g., IEC standards).

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

• Not Applicable. No human adjudication method is described as the data pertains to non-clinical tests.

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:

• No such study was done or reported. The device is an intracranial pressure monitoring device, and the submission is for a new sensor model. It is not an AI-assisted diagnostic tool that would typically involve a multi-reader multi-case study to assess human reader improvement.

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

• The information provided primarily focuses on the technical validation of the hardware (sensor) and its integration with the existing B4C System software and receiver. Specifically, it mentions "Software Verification and Validation" demonstrating that "all software requirements were appropriately implemented."
• While the device outputs parameters for "interpretation," the assessment here is on the technical functionality and equivalence of the new sensor's output, not a standalone diagnostic algorithm's performance. The device is explicitly stated as not a standalone diagnostic tool, but provides information for clinician interpretation.

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

• Not Applicable in the traditional clinical sense. For the non-clinical bench testing and verification/validation, the "ground truth" refers to established engineering specifications, regulatory standards (e.g., IEC 60601-1), or the known performance of the predicate device against which the new sensor's outputs ("stability, repeatability, and reproducibility of ICP waveform outputs") are compared.

8. The sample size for the training set:

• Not Applicable. The document describes a 510(k) submission for a new sensor model and its non-clinical performance and equivalence to a predicate. It does not refer to an AI/ML algorithm that would require a "training set" in the common sense of machine learning. The B4C System contains "analytical and processing software," but the submission does not detail its development or "training" data.

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

• Not Applicable. See point 8.

Ask a specific question about this device

The ICP Monitor is intended for use as an interface between compatible strain gauge type pressure transducers and standard physiological pressure monitoring systems. The ICP Monitor is also intended for use as an independent pressure monitor for displaying the mean, systolic and diastolic values of a physiologic pressure waveform in the absence of an external patient monitor. The CereLink ICP Extension cable is intended for use as a connecting cable between the ICP input channel of the CereLink ICP Monitor and a CereLink ICP Sensor.

The CereLink ICP Monitor is indicated for use in the ICU or Operating Room (OR) environment for monitoring intracranial pressure (ICP) via a solid-state sensor placed directly in parenchymal tissue or integrated into an external ventricular drainage catheter placed in the ventricle. In addition to monitoring ICP and activating alarms when the intracranial pressure is outside user-set limits, the device performs these functions:

• Displays ICP Waveform
• Displays Mean ICP numeric
• Displays the historic mean pressure as a trend
• Displays trend statistics (Pressure Time Dosage (PTD), time above threshold, boxplot, histogram)
• Stores 14-days' worth of mean ICP values
• Stores 24 hours of pressure waveform
• Can capture and store screen-shots
• Can download various data to a USB device for printing or analysis
• Real-time data streaming of mean ICP and waveform via USB connection
• Connect to external patient monitor

The CereLink ICP Monitor can be transported with the hospital to continuously record data. The monitor includes a 7" color touch screen that is compatible with the use of gloves. The monitor is provided to the user with a CereLink ICP Extension Cable, external power supply, and comes equipped with an internal rechargeable battery. The monitor has one output channel to transfer physiological data to a compatible Patient Monitor, as well as one input channel to receive ICP readings from the implanted CereLink ICP sensor. The implanted sensor is connected to the CereLink ICP Monitor by way of the CereLink ICP Extension Cable; the CereLink ICP Monitor connects to compatible patient monitors through the patient monitor interface cables.

The provided text describes a 510(k) premarket notification for a medical device, the CereLink ICP Monitor and CereLink ICP Extension Cable, which are intended for intracranial pressure monitoring. The document outlines acceptance criteria and performance testing for these devices, particularly focusing on modifications made to the extension cable.

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document refers to "the CereLink Systems" being exposed to the electrical stress setup. It does not provide a specific number for the sample size (e.g., number of devices or test units) used in these tests.
The data provenance is from bench testing as explicitly stated ("Performance Bench Test Results"). This indicates controlled laboratory conditions. There is no mention of country of origin for the data, and the nature of the tests (bench) makes the retrospective/prospective distinction less relevant in the typical clinical study sense. However, the tests are for design verification and validation, implying they were conducted prospectively to assess the new design.

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

Not applicable. This submission pertains to a hardware device (ICP monitor and cable) and its electrical and mechanical performance, not an AI/software device that requires human expert review to establish ground truth for image or diagnostic interpretation. The testing relies on established engineering and medical device standards.

4. Adjudication Method for the Test Set:

Not applicable. As noted above, this is not an AI/software device requiring subjective interpretation or adjudication by experts. The tests are objective performance evaluations against specifications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, an MRMC comparative effectiveness study was not done. The device is a hardware ICP monitor and cable, not an AI-assisted diagnostic tool for human readers.

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

Not applicable. This is not an algorithm-based device. The "performance" refers to the physical and electrical characteristics of the monitor and cable. The tests described (ICP Drift, Out-of-Range Failure, Electrical Safety, etc.) are essentially "standalone" performance evaluations of the device itself.

7. The Type of Ground Truth Used:

The ground truth for the device's performance is based on engineering specifications and internationally recognized standards (e.g., ISO, IEC). For the specific "Out-of-Range Failure Test," the ground truth for "failure" is when the device enters the out-of-range state, and the "recovery" is when it exits that state within a specified time, which are objective, measurable outcomes in a controlled "electrical stress setup" designed to reproduce these failures.

8. The Sample Size for the Training Set:

Not applicable. This is not a machine learning or AI device that requires a training set.

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

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

Ask a specific question about this device

The B4C System is intended for the monitoring of variation in intracranial pressure in patients with suspected alteration of intracranial pressure (ICP) or change in intracranial compliance, by providing surrogate ICP waveforms and associated parameters (estimated P2/P1 ratio, normalized Time-to-Peak, derived useful ICP pulses and cardiac pulses) for interpretation.

The B4C System is a non-invasive device intended for the monitoring of variation in intracranial pressure, including patients with suspected alteration of intracranial pressure (ICP) or change in intracranial compliance. It consists of a sensor with Bluetooth wireless module, headband, mobile device software application, receiver, external battery pack and charger, as well as processing and analytical software. The sensor contains four strain gauges situated on a metal bar that detects variations in skull deformation through tension and compression of the metal bar in response to changes in intracranial pressure. These resistance measures are converted to a digital signal using a high-resolution ADC (Analog to Digital Converter) in the sensor that is transmitted to software components for viewing, processing and analysis. The proposed device does not measure absolute intracranial pressure values, but produces surrogate waveform morphology, its trend, and associated parameters reflecting changes in ICP. The B4C System and surrogate waveform and associated outputs do not substitute ICP monitoring methods when measurement of the absolute value of ICP is required to make a clinical decision.

Here's a breakdown of the acceptance criteria and the study that proves the B4C System meets them, based on the provided FDA 510(k) summary:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for the B4C System's clinical performance are implicitly derived from the study objectives and the statistical analyses performed. The primary objective was to demonstrate a "consistent correlation" and "reliability and accuracy of the correlation" between the B4C System's surrogate ICP waveform and parameters and those from invasive ICP monitoring.

Detailed Study Information:

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

   • Total enrolled subjects: 123
   • Subjects after device label check: 107
   • Subjects after data quality check: 85 (78 adults, 7 pediatric)
   • Analyzed participants (test set): 78 adults (due to reduced quantity of pediatric subjects, enabling statistically relevant performance only for adults).
   • Total acquisition time analyzed: 4695 minutes (98% adult, 2% pediatric across the broader dataset).
   • Data Provenance: Not explicitly stated, but the mention of "4 centers" suggests a multi-center study. The sponsor is Braincare Desenvolvimento e Inovacao Tecnologica S.A. based in Brazil, suggesting the origin of the data is likely within Brazil or other international sites. The study was described as "combined prospective, multi-center, observational study."

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

   • The document implies that the ground truth was established using "gold standard invasive ICP monitoring methods such as the external ventricular drain or intraparenchymal micro transducers."
   • It does not explicitly state the number of experts or their qualifications for establishing the ground truth from these invasive methods. It relies on the inherent validity of the invasive measurements as the "gold standard."

3. Adjudication method for the test set:

   • No adjudication method (e.g., 2+1, 3+1) is mentioned for the test set ground truth. The ground truth was established directly from invasive ICP devices. This type of data does not typically involve multiple human readers or adjudication in the same way as, for example, image interpretation.

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 explicitly performed or described. This study focused on the technical correlation and agreement between the device's output and invasive ICP measurements. It did not directly assess the impact of the B4C System on human reader performance or diagnostic accuracy.

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

   • The study primarily focused on the standalone performance of the B4C System's ability to produce surrogate ICP waveforms and associated parameters that correlate with invasive ICP measurements. The analysis (Spearman correlation, normalized mutual information, Bland-Altman, Deming regression) evaluates this algorithm-only performance.
   • The device is intended to provide "surrogate ICP waveforms and associated parameters... for interpretation," implying a human-in-the-loop for interpretation, but the study itself is about the accuracy of the device's output compared to ground truth.

6. The type of ground truth used:

   • Objective/Physiological Data: The ground truth was established using "gold standard invasive ICP monitoring methods such as the external ventricular drain or intraparenchymal micro transducers." This represents direct physiological measurement rather than expert consensus on subjective interpretation.

7. The sample size for the training set:

   • The document does not specify a separate training set size. The clinical study described appears to be a validation study (test set) for the pre-existing B4C System, which includes processing and analytical software. Given the description, the models and algorithms within the B4C System would have been developed and trained using other data, but that training data and its size are not disclosed in this 510(k) summary.

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

   • As the training set details are not provided, the method for establishing its ground truth is also not described in this document.

Ask a specific question about this device

The ICP Monitor is intended for use as an interface between compatible strain-gauge type pressure transducers and standard physiological pressure monitoring systems. The ICP Monitor is also intended for use as an independent pressure monitor for displaying the mean, systolic and diastolic values of a physiologic pressure waveform in the absence of an external patient monitor.

The CereLink ICP Monitor is indicated for use in the ICU or OR environment for monitoring intracranial pressure (ICP) via a solid-state sensor placed directly in parenchymal tissue or integrated into an external ventricular drainage catheter placed in the ventricle. In addition to monitoring ICP and activating alarms when the intracranial pressure is outside user-set limits, the device performs these functions:

• Displays ICP Waveform .
• Displays Mean ICP numeric .
• Displays the historic mean pressure as a trend .
• Displays trend statistics (Pressure Time Dosage (PTD) , time above threshold, boxplot, . histogram)
• Stores 14-days' worth of mean ICP values .
• . Stores 24 hours of pressure waveform
• Can capture and store screen-shots 9
• . Can download various data to a USB device for printing or analysis
• Real-time data streaming of mean ICP and waveform via USB connection .
• Connect to external patient monitor .

The CereLink ICP Monitor can be transported with the patient within the hospital to continuously record data. The monitor includes a 7" color touch screen that is compatible with the use of gloves. The monitor is provided to the user with an CereLink ICP extension cable, external power supply, and comes equipped with an internal rechargeable battery. The monitor has one output channel to transfer physiological data to a compatible Patient Monitor, as well as one input channel to receive ICP readings from the implanted CereLink ICP sensor (cleared via K173192). The implanted sensor is connected to the CereLink ICP Monitor by way of the CereLink ICP Extension Cable (cleared via K183406); the CereLink ICP Monitor connects to compatible patient monitors through the patient monitor interface cables (cleared via K152670).

Let's break down the information provided to answer your request.

Based on the provided document, the CereLink ICP Monitor is a device that interfaces with pressure transducers and monitors intracranial pressure. The submission to the FDA (K210993) is for modifications to an existing CereLink ICP Monitor (predicate K183406), not for a brand new device. Therefore, the "study" described is primarily focused on demonstrating that the modifications do not negatively impact the device's safety and effectiveness compared to the original, already cleared device.

Here's the breakdown of acceptance criteria and the study that proves the device meets them:

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

Since this is a submission for modifications to an already cleared device, the "acceptance criteria" are implied to be the successful demonstration that the modifications do not introduce new safety or effectiveness concerns and that the device continues to perform as intended and substantially equivalent to its predicate. The document doesn't list specific quantitative acceptance criteria for clinical performance in the way one might expect for a novel diagnostic algorithm. Instead, it focuses on various engineering and design-related tests to confirm the changes are benign or improvements.

2. Sample size used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
4. Adjudication method for the test set
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
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For a device like the CereLink ICP Monitor, which is a physiological measurement and monitoring device, the "test set" and "ground truth" are interpreted differently than for, say, an AI-powered diagnostic imaging tool.

• Test Set/Sample Size: The document refers to various bench tests including "ICP Drift Test," "Common Mode Noise and Leakage Current Power Supply Test," "13 Day Simulated Environment Validation Test," etc. These are engineering validation tests, not clinical studies with patient data in the traditional sense of a "test set." The sample sizes would refer to the number of devices or components tested, but this specific detail is not provided in a summarized form.
• Data Provenance: Not applicable in the context of clinical data for performance validation. The testing seems to be internal engineering verification and validation.
• Experts/Ground Truth/Adjudication Method/MRMC/Standalone Performance: These concepts are largely not applicable here. The CereLink ICP Monitor is not an AI-driven diagnostic device that relies on expert interpretation or establishing a ground truth for diagnostic accuracy (like identifying a lesion on an image). It's a device that measures and displays physiological parameters. The "ground truth" in this context would be the actual physical/electrical properties that the device is designed to measure and the expected behavior under various conditions (e.g., drift, noise, safety limits). The study's focus is on validating the device's performance against these engineering and safety standards, not on its diagnostic accuracy based on expert consensus.

The document explicitly states:

• "No clinical studies were required."
• "Appropriate verification of the subject device was achieved based on the comparison to the predicate device and from the results of the bench, software, electrical safety, and electromagnetic compatibility testing."
• "The CereLink ICP Monitor is a reusable, non-sterile device. There is no expiry date and shelf-life is not applicable for this device."
• "The CereLink ICP Monitor is non-patient contacting. Therefore, biocompatibility is not applicable for this device."
• "No animal studies were required."

This indicates that the "study" primarily consisted of bench testing and engineering verification and validation to confirm that the technical modifications (power supply, internal components, software updates, etc.) did not compromise the device's ability to accurately measure ICP, maintain electrical safety, and function reliably.

8. The sample size for the training set
9. How the ground truth for the training set was established

These questions are not applicable as the CereLink ICP Monitor is not described as an AI/machine learning device that requires a training set. The modifications described are hardware and software updates to an existing physiological monitoring device, not the development of a predictive algorithm using a "training set."

Ask a specific question about this device

Draining and monitoring of CSF flow from the lateral ventricles or lumbar subarachnoid space is indicated in selected patients to:

1. Reduce ICP, e.g., pre-, intra- or postoperative.
2. Monitor CSF chemistry, cytology, and physiology.
3. Provide temporary CSF drainage in patients with infected cerebrospinal fluid shunts.
   Monitoring of ICP is indicated in selected patients with:
4. Severe head injury.
5. Subarachnoid hemorrhage graded III, IV or V preoperatively.
6. Reyes syndrome or similar encephalopathies.
7. Hydrocephalus.
8. Intracranial hemorrhage.
9. Miscellaneous problems when drainage is to be used as a therapeutic maneuver.
   Monitoring can also be used to evaluate the status pre- and postoperatively for space-occupying lesions.

The Exacta External Drainage and Monitoring System (EDMS) is provided as a complete closed system for the drainage and monitoring of cerebrospinal fluid (CSF) flow from the lateral ventricles or the lumbar subarachnoid space. The system is offered in various kit configurations for various clinical applications.
The Exacta EDMS product family is comprised of a single use drainage system, a reusable blue pole clamp and a laser level accessory. The single use drainage assembly is comprised of a patient line, main system stopcock, graduated cylinder and drainage bag. The single use drainage assembly is mounted on the reusable blue pole clamp. The reusable blue pole clamp secures the system to an I.V. pole and includes the system pressure scale and holds an optional laser level accessory. The optional laser level accessory assists the user in leveling the single use drainage system to the patient's Foramen of Monro or lumbar catheter exit site.

This document is a 510(k) summary for the Medtronic Exacta External Drainage and Monitoring System (EDMS). The submission focuses on changes to a laser level accessory and does not involve AI. Therefore, several requested sections, especially those related to AI model evaluation, are not applicable.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria provided are qualitative (e.g., "met the acceptance criteria") rather than quantitative thresholds.

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

The document does not specify the sample size for the test set used in the bench testing. It only states that the testing was performed, but not how many units were tested.

• Data Provenance: The tests were "design verification bench testing," implying they were conducted in a lab setting by the manufacturer, Medtronic, Inc., located in Irvine, California, USA. The data is retrospective in the sense that it was collected as part of the device development and submission process.

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

Not applicable. The testing described is bench testing of physical device characteristics (mechanical, laser performance, electrical safety) against established engineering and safety standards, not against clinical ground truth requiring expert consensus.

4. Adjudication Method for the Test Set

Not applicable. This was bench testing against engineering specifications, not a clinical study requiring expert adjudication of results.

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 submission is for an External Drainage and Monitoring System and its laser level accessory. It is a physical medical device, not an AI-powered diagnostic or assistive tool for human readers.

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

Not applicable. This device is not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the bench testing was defined by engineering specifications and international standards for mechanical strength, beam uniformity, laser accuracy, laser safety (IEC/EN 60825-1:2014), electrical safety (IEC 60601-1:2005 + AMD1:2012), and EMC (IEC 60601-1-2:2014 / EN 60601-1-2:2015).

8. The Sample Size for the Training Set

Not applicable. This device does not use a training set as it is not an AI/machine learning product.

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

Not applicable.

Ask a specific question about this device

Draining CSF and monitoring CSF flow from the lateral ventricles or lumbar subarachnoid space is indicated in selected patients to:

• 1. Reduce intracranial pressure (ICP), e.g. pre-, intra- or postoperative.
• 2. Monitor CSF chemistry, cytology and physiology.
• 3. Provide temporary CSF drainage in patients with infected cerebrospinal fluid shunts.

The monitoring of the intracranial pressure (ICP) is indicated in selected patients with:

• 1. Severe head injury
• 2. Subarachnoid hemorrhage graded III, IV or V preoperatively
• 3. Reye's syndrome or similar encephalopathies
• 4. Hydrocephalus
• 5. Intracranial hemorrhage
• 6. Miscellaneous problems when drainage is to be used as a therapeutic maneuver.

Monitoring can also be used to evaluate the status pre- and postoperative for space-occupying lesions.

The Medtronic External Drainage and Monitoring System EDMS is provided as a complete closed system for the drainage and monitoring of cerebrospinal fluid (CSF) flow from the lateral ventricles or the lumbar subarachnoid space. The system is offered in various kit configurations for various clinical applications. The EDMS Drainage Assembly is supplied pre-assembled, sterile and non-pyrogenic in a double wrap package system. A drainage bag with braided cord is also included with each EDMS kit.
The EDMS and components are intended for single (one time) use only and is not designed or intended to be re-used, re-processed, or re-sterilized. Some of the basic features include the following:

• . a patient line stopcock with latex-free injection site and non-distensible patient connection line:
• a graduated chamber and hanging bracket for I.V. pole suspension; ●
• a drainage bag connection line with two slide clamps and latex-free injection site;
• a removable vented drainage bag with approximate volumetric graduations and drainage port; ●
• pressure scale tape.

The provided text does not describe an AI medical device. It pertains to the Medtronic External Drainage and Monitoring System (EDMS), which is a physical device for draining and monitoring cerebrospinal fluid. Therefore, the questions related to AI device performance metrics, such as ground truth establishment with experts, MRMC studies, or standalone algorithm performance, are not applicable.

However, I can extract information related to the acceptance criteria and the study that proves the device meets those criteria for the Medtronic EDMS.

Acceptance Criteria and Performance for Medtronic External Drainage and Monitoring System (EDMS)

The Medtronic EDMS underwent bench testing to demonstrate its safety and effectiveness, particularly addressing changes made to the disposable drainage bag.

1. Table of Acceptance Criteria and Reported Device Performance:

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

• The text does not specify the exact sample size for each bench test conducted.
• The tests were bench tests (laboratory-based testing of the physical device or its components). Data provenance is internal to the manufacturer's testing facility.

3. 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 study involved bench testing of a physical medical device, not an AI algorithm requiring expert ground truth for image or data interpretation.

4. Adjudication method for the test set:

• This question is not applicable as there was no expert review or adjudication process for bench testing a physical device.

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:

• This question is not applicable as the device is not an AI-assisted diagnostic or interpretive tool.

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

• This question is not applicable as the device is not a standalone algorithm.

7. The type of ground truth used:

• The ground truth for the bench tests was based on engineering specifications and established test methods designed to verify the physical properties and functionality of the device components (e.g., verifying volumetric graduations, absence of leaks, strength of seals).

8. The sample size for the training set:

• This question is not applicable as this is not an AI device that requires a training set.

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

• This question is not applicable as this is not an AI device that requires a training set.

Ask a specific question about this device

Draining and monitoring of CSF flow from the lateral ventricles or lumbar subarachnoid space is indicated in selected patients to:

1. Reduce intracranial pressure (ICP), e.g., pre-, intra- or postoperative;
2. Monitor CSF chemistry, cytology, and physiology;
3. Provide temporary CSF drainage in patients with infected cerebrospinal fluid shunts.
   Monitoring of intracranial pressure (ICP) is indicated in selected patients with:
4. Severe head injury
5. Subarachnoid hemorrhage graded III, IV. or V preoperatively
6. Reyes syndrome or similar encephalopathies
7. Hydrocephalus
8. Intracranial hemorrhage
9. Miscellaneous problems when drainage is to be used as a therapeutic maneuver.
   Monitoring can also be used to evaluate the status pre- and postoperatively for space-occupying lesions.

The Becker External Drainage and Monitoring System (Becker EDMS) provides the physician with a complete closed system for:

1. Draining cerebrospinal fluid (CSF) from the lateral ventricles of the brain or the lumbar subarachnoid space.
2. Monitoring CSF pressure and flow rate from the lateral ventricles of the brain and the lumbar subarachnoid space.
   The Becker EDMS consists of a nondistensible blue or green striped (proximal end) patient connection line, patient line stopcock, mounting panel/main system section, two latex-free injection sites and a removable drainage bag with approximate volumetric graduations and microbial barrier air vent.
   The main system section located on the mounting panel includes:
3. Mounting bracket for height adjustment of system
4. Optional self-adjusting cord with lock for adjustment of system height
5. Main system stopcock with optional transducer attachment location
6. Sliding, graduated, 50 cc drip chamber with drip former and conical bottom, and locking bracket
7. Two drainage line slide clamps for flow monitoring and sampling
8. Drainage bag connection line
9. Needleless Injection Site (Interlink or Smartsite)
10. Instructions for Use
    The system does not contain any latex components.

Here's an analysis of the acceptance criteria and supporting study for the Becker External Drainage and Monitoring System, based on the provided FDA 510(k) summary:

This device is not an AI/ML device, so many of the requested fields are not applicable.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample size for each specific bench test. However, the testing was conducted as part of the design verification process for a modified component (the disposable drainage bag) within the Becker EDMS. The data provenance is from bench testing, which is a controlled laboratory environment, not derived from human patients or specific geographical regions.

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

This information is not applicable as the studies were bench tests evaluating physical properties and functional performance against engineering specifications, not clinical outcomes requiring expert interpretation of medical data.

4. Adjudication Method for the Test Set

This information is not applicable as the studies were bench tests against predetermined engineering specifications, not studies involving subjective interpretation of data that would require an adjudication method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The device is a physical medical device, not an AI-assisted diagnostic or therapeutic tool for which such studies are typically performed.

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

This information is not applicable. This is a physical medical device, not an algorithm or software.

7. The Type of Ground Truth Used

The "ground truth" for the bench tests was based on engineering specifications and design requirements for the physical properties and functional performance of the modified drainage bag.

8. The Sample Size for the Training Set

This information is not applicable. As this is a physical medical device and not an AI/ML system, there is no "training set."

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

This information is not applicable. There is no training set for this type of device.

Summary of the Study Proving Device Meets Acceptance Criteria:

The device is the "Becker External Drainage and Monitoring System" (Becker EDMS), with specific modifications to its disposable drainage bag component. The study proving the device meets acceptance criteria was a series of "Performance Data - Bench" tests.

The modifications to the disposable bag primarily involved changes in its design (approximate volume capacity of 600ml with approximate volumetric markings in 50mL increments, an inlet port, an outlet port, and a hydrophobic/anti-microbial vent).

The performance testing was conducted in accordance with a risk assessment of these changes, which determined that dimensional verification and design verification testing of the bag were necessary. The specific tests performed included:

• Visual and Dimensional Inspection: To ensure the printed graduations met volumetric capacity.
• Leakage of Drainage Bag: To confirm the bag could withstand inversion without leaking.
• Flow Initiation Pressure: To record the pressure at which fluid flow begins.
• Drainage Bag Seal Weld: To ensure the bag's seals were intact and leak-free.
• Tensile Strength of Drainage Bag Inlet Port: To evaluate the durability of the connection point.

The results of all these bench tests showed that the Becker EDMS device met the specified acceptance criteria for each test. Based on these successful results, the manufacturer concluded that the changes introduced by the modified disposable bag do not raise new questions of safety and effectiveness, thus supporting the substantial equivalence to the predicate device (Medtronic PS Medical Becker External Drainage and Monitoring System, K984053).

No animal or clinical testing was deemed necessary for these specific modifications, as the determination of substantial equivalence was based solely on the design verification bench testing.

Ask a specific question about this device

The BcSs-PICNI-2000 Sensor is intended for the monitoring of variation in intracranial pressure in patients with suspected alteration of intracranial pressure (ICP) or change in brain compliance, by providing ICP waveforms for interpretation.

The BcSs-PICNI-2000 Sensor ("the Braincare Sensor") is a non-invasive device intended for the monitoring of variation in intracranial pressure, including patients with suspected alteration of intracranial pressure (ICP) or change in brain compliance. It consists of a sensor, headband, and adapter cable. The sensor contains four strain gauges situated on a metal bar that detects variations in skull deformation through tension and compression of the metal bar in response to changes in intracranial pressure. The proposed device does not measure absolute intracranial pressure values, but produces waveform morphology and its trend reflecting changes in ICP. The BcSs-PICNI-2000 Sensor and waveform output do not substitute ICP monitoring methods when measurement of the absolute value of ICP is required to make a clinical decision.

The sensor component is supported on a plastic headband worn by the patient, such that the sensor is in contact with the scalp and is perpendicularly positioned in the temporoparietal transition, 2 inches (5-6 cm) above the entrance of the external auditory canal on the coronal plane. Slight pressure is applied so that the sensor pin maintains contact with the scalp throughout the monitoring session. The sensor continuously records and transfers acquired signals through an adapter cable to a compatible multi-parameter monitor that has piezoresistive pressure transducer sensitivities of 5uV/Vex/mmHg or greater and automatic amplitude window adjustment capability. The multi-parameter monitor's inherent software interprets the signal received from the BcSs-PICNI-2000 Sensor and displays a waveform that allows for assessment of suspected intracranial hypertension or changes in brain compliance based on the characteristic Percussion (P1), Tidal (P2), and Dicrotic (P3) peaks of the ICP waveform morphology.

The BcSs-PICNI-2000 Sensor is not intended to be a standalone diagnostic tool. The waveform output does not replace a comprehensive clinical evaluation, but only provides an element for preliminary assessment. The clinician is responsible for determining the additional clinical information that may be required to make a diagnosis.

Here's an analysis of the acceptance criteria and the studies performed for the BcSs-PICNI-2000 Sensor, based on the provided document:

Acceptance Criteria and Device Performance

The document doesn't explicitly state a table of "acceptance criteria" with specific thresholds for performance metrics. Instead, it details various tests and their "Pass" or "Results" that demonstrate the device meets expected performance and safety standards, largely by showing substantial equivalence or demonstrating proper functioning. The "Results" column in the table below is derived from the Table 3 Summary of Non-Clinical Performance Data and the Study Outcomes sections of the clinical studies.

Ask a specific question about this device

The ICP Monitor is intended for use as an interface between compatible strain gauge type pressure transducers and standard physiological pressure monitoring systems. The ICP Monitor is also intended for use as an independent pressure monitor for displaying the mean, systolic and diastolic values of a physiologic pressure waveform in the absence of an external patient monitor.

The CereLink ICP Extension Cable is intended for use as a connecting cable between the ICP input channel of the CereLink ICP Monitor and a CereLink ICP Sensor.

The CereLink ICP Monitor is intended for use in the ICU or OR environment for monitoring intracranial pressure (ICP) via a solid state sensor placed directly in parenchymal tissue or integrated into an external ventricular drainage catheter placed in the ventricle. In addition to monitoring ICP and activating alarms when the intracranial pressure is outside user-set limits, the device performs these functions:

• Displays mean pressure values
• Displays the pressure waveform
• Displays the historic mean pressure as a trend
• Displays trend statistics (Area Under the Curve (AUC), time above threshold, boxplot, histogram)
• Stores 14-days' worth of mean ICP values
• Stores 24 hours of pressure waveform
• Can capture and store screen-shots
• Can download various data to a USB device for printing or analysis

The CereLink ICP Monitor can be transported with the patient within the hospital to continuously record data. The monitor includes a 7" color touch screen that is compatible with the use of gloves. The monitor is sold with an external power supply, and comes equipped with an internal rechargeable battery. The monitor has one output channel to transfer physiological data to a compatible Patient Monitor, as well as one input channel to receive ICP readings from the implanted ICP sensor. The implanted sensor is connected to the CereLink ICP Monitor by way of the CereLink ICP Extension Cable (code 82-6845).

The CereLink ICP Monitor and CereLink ICP Extension Cable are intended to be used in conjunction with Codman's other neuromonitoring devices: the CereLink ICP Sensor Kits (codes 82-6850, 82-6851, 82-6852, and 82-6854 cleared via K173192) and the patient monitor interface cables (codes 82-6880, 82-6881, and 82-6882 cleared via K152670). The CereLink ICP Sensor converts the patients intracranial pressure to a voltage signal. The monitor provides power to the sensor, interprets the voltage signal from the sensor, and displays the corresponding pressure measurements taken by the sensor during a patient's treatment and during patient transport. There is no change to the currently marketed CereLink ICP Sensor Kits or the patient monitor interface cables as a result of the monitor modifications described in this submission.

The CereLink ICP Monitor is an intracranial pressure monitoring system. The acceptance criteria and the study proving the device meets these criteria are detailed below.

1. Table of Acceptance Criteria and Reported Device Performance

The document describes various performance benchmarks the CereLink ICP Monitor was tested against. The "Reported device performance" uniformly indicates that all tests passed, demonstrating "substantial equivalence of the proposed device" or that the results were "All results passed."

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

The document does not explicitly state the specific sample sizes for each test set in the bench testing section beyond noting that for "Device Reliability and Mean Time Between Failure Calculation," no samples were required for execution of this test (analysis was based on materials and components).

For other bench tests, phrases like "All results passed" or "Testing was performed on final finished devices" imply that a sufficient number of devices were tested to validate the claims, but the exact count is not specified. The studies were likely internal verification and validation tests performed by the manufacturer on production-equivalent devices.

The provenance of this data is internal to Integra LifeSciences Corp. and is presented as part of their 510(k) submission. Therefore, it is retrospective in the sense that it was conducted prior to submission for regulatory clearance. There is no information regarding the country of origin of the data provided beyond the manufacturer's location (Mansfield, MA, USA).

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

N/A. This information is typically relevant for studies involving subjective interpretation (e.g., medical imaging diagnostics). For the CereLink ICP Monitor, the performance criteria are objective (e.g., electrical specifications, mechanical integrity, software functionality, physical measurements). The "Summative Usability Testing" involved clinicians, implying professional users, but it does not specify their number or qualifications, nor was their input used to establish "ground truth" in the diagnostic sense, but rather to assess usability and effectiveness of operation.

4. Adjudication Method for the Test Set

N/A. As the testing primarily involved objective performance metrics (electrical, mechanical, software functionality), an adjudication method (like 2+1 or 3+1 often used in clinical trials for diagnostic agreement) was not applicable. Test results were likely pass/fail based on predetermined quantitative criteria.

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

No MRMC comparative effectiveness study was mentioned or conducted. The device is an objective monitoring device, not a diagnostic tool requiring human interpretation with or without AI assistance. The submission focuses on demonstrating substantial equivalence to a predicate device through objective performance testing.

6. Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance)

The device's core function is to monitor and display ICP. Its performance is inherently standalone in the sense that its measurements are objective and do not require human interpretation to generate the primary output (ICP values, waveforms, trends). The "algorithm" here refers to the internal processing of the sensor's voltage signal to display pressure measurements. The various "Bench Testing" and "Software Testing" categories evaluate this standalone performance. For example, "Electrical Performance Testing" and "System Validation Testing" directly assess how accurately the device measures and displays pressure from a sensor or simulator without human intervention affecting the measurement generation itself.

7. Type of Ground Truth Used

The ground truth for the performance tests was based on known physical or electrical standards and predefined functional requirements. For example:

• Pressure Accuracy: Likely tested against calibrated pressure simulators or reference devices with known pressure outputs. The acceptance criteria for input pressure accuracy are given as "+/- 0.5 mmHg over the range -50 to 50 mmHg and +/- 1% over the range 50 to 150 mmHg."
• Electrical Specifications: Tested against known voltage and current standards, expected battery life, and data storage capacity.
• Mechanical Integrity: Tested against engineering specifications for durability, drop resistance, and ingress protection.
• Software Functionality: Tested against software requirements specifications to ensure features operate as intended.

8. Sample Size for the Training Set

The document does not describe a "training set" in the context of machine learning. The CereLink ICP Monitor is an objective measurement device, not an AI/ML-driven diagnostic or predictive algorithm that typically requires large training datasets. Its functionality is based on established engineering principles and signal processing.

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

N/A. As there is no "training set" in the machine learning sense, the method for establishing its ground truth is not applicable. The device's operation is deterministic based on its hardware and firmware design.

Ask a specific question about this device