(115 days)
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
| Acceptance Criteria (Implicit for Substantial Equivalence) | Reported Device Performance (Non-Clinical) |
|---|---|
| Biocompatibility: Device materials are safe for patient contact. | The BcSs-PICNIW-2000 is comprised of the same materials as the predicate device sensor. A biological risk assessment was provided in lieu of repeating testing. (Implies acceptance based on predicate's known safety) |
| Electrical Safety: Device meets electrical safety standards. | IEC 60601-1 / ANSI AAMI ES 60601-1: Pass |
| Electromagnetic Compatibility (EMC): Device operates without interference and is not susceptible to interference. | IEC 60601-1-2: Pass |
| AAMI TIR69: Testing not required based on risk assessment (Implies acceptance based on risk assessment, indicating no new EMC concerns). | |
| Disinfection: Device can be reprocessed safely and effectively. | The BcSs-PICNIW-2000 is intended to be reprocessed according to the same methods as the predicate device sensor. Reprocessing validation was not required. (Implies acceptance based on predicate's established reprocessing methods). |
| Monitor Compatibility: New sensor works with existing monitor/receiver. | There are no changes to the predicate device receiver and wireless communication protocol. Monitor compatibility testing was not repeated. (Implies acceptance as existing compatibility is maintained). |
| Stability and Reproducibility: Device provides stable and consistent ICP waveform outputs. | Demonstration of stability, repeatability, and reproducibility: Pass (This is the most direct "performance" metric mentioned for the new sensor's output comparable to the predicate's wired sensor). |
| Software Verification and Validation: Software meets all requirements. | Demonstrate that all software requirements were appropriately implemented in the software. Pass. (Implies acceptance that the minor software updates do not negatively impact functionality, aligning with existing system software performance). |
| Overall substantial equivalence: Differences do not raise new questions of safety or effectiveness. | The document concludes: "Based on results of the performance testing and substantial equivalence comparison, the B4C System maintains the same intended use as the predicate device and the information presented is sufficient to determine that the subject device is substantially equivalent to the predicate device." (Overall acceptance). |
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.
§ 882.1620 Intracranial pressure monitoring device.
(a)
Identification. An intracranial pressure monitoring device is a device used for short-term monitoring and recording of intracranial pressures and pressure trends. The device includes the transducer, monitor, and interconnecting hardware.(b)
Classification. Class II (performance standards).