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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.

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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.

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