(192 days)
The HICP200 is designed for use with any Hummingbird catheter. Together, they comprise a system that is indicated for use in those conditions where continuous monitoring of ICP is required. As dictated by clinical judgment, direct measurement of ICP may be obtained from the subdural, parenchymal, or intraventricular locations.
The HICP200 is a reusable patient/monitor interconnect cable with integrated Control and Catheter-Connect Modules. The principle of operation of the HICP200 and Hummingbird intracranial pressure catheter system is air-coupled pressure transduction.
The HICP200 Catheter-Connect Module houses the pressure transducer and provides a high-reliability pneumatic connection to the Hummingbird ICP catheter. The connector provides for audible and tactile feedback indicating a secure connection. The Intracranial Pressure (ICP) waveform is transduced in the Catheter-Connect Module and the analog signal is transmitted to the patient monitor, according to AAMI BP-22 standard protocol of 5u V/V/mmHg.
The HICP200 Control Module monitors the same ICP signal transmitted to the monitor to control and implement system air priming cycle requirements and user interface audio/visual system status.
The HICP200 is configured with a user-specified connector to interface with the patient monitor.
The provided text describes the HICP200 Patient/Monitor Interconnect Cable and its substantial equivalence to predicate devices, focusing on regulatory affairs and technical specifications rather than a detailed device performance study with specific acceptance criteria and outcome metrics typical for clinical trials or AI/algorithm performance.
Therefore, much of the requested information (items 1, 2, 3, 4, 5, 6, 7, 8, 9) is not explicitly available in the provided document, as it pertains to a 510(k) submission for a Class II medical device, which typically relies on demonstrating substantial equivalence to a legally marketed predicate device through technical and performance testing rather than a comparative effectiveness study or a standalone algorithm performance study with ground truth.
However, I can extract information related to the performance data and testing mentioned:
1. Table of acceptance criteria and the reported device performance:
The document lists standards the device conforms to, which imply certain performance criteria, but does not provide a table with specific pass/fail values or reported device performance metrics against those values. Instead, it states the device "demonstrates conformance" to these standards.
| Acceptance Criteria (Implied by Standards Conformance) | Reported Device Performance |
|---|---|
| AAMI NS 28:1988/(R)2010 Intracranial Pressure Monitoring Devices: | |
| - Absolute accuracy | Conforms to requirements |
| - Accuracy over time | Conforms to requirements |
| - Labeling requirements | Conforms to requirements |
| IEC 60601-1-2:2007 + ISH1:2010 (Electromagnetic compatibility) | Conforms to requirements |
| EN 60601-1-2:2007 + CORR1:2010 (Electromagnetic compatibility) | Conforms to requirements |
| IEC 60601-1:2005 + A1:2012 (Basic safety and essential performance) | Conforms to requirements |
| AAMI/ANSI ES 60601-1:2005/(R)2012 + A1:2012. C1:2009/(R)2012 and A2:2010/(R)2012 (Basic safety and essential performance) | Conforms to requirements |
| EN 60601-1:2006 + A1:2013 (Basic safety and essential performance) | Conforms to requirements |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified for any of the performance tests. The document refers to "extensive design verification and validation testing, including functional and performance testing," but does not quantify the sample sizes for these tests.
- Data Provenance: Not specified. The testing was conducted by the company ("extensive design verification and validation testing") and an "independent laboratory" for IEC 60601 compliance. It is not a clinical study on patients, but rather engineering verification and validation testing of the device itself.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This is not applicable as the document describes device performance testing against engineering specifications and industry standards, not a study involving interpretation of clinical data by experts to establish a ground truth.
4. Adjudication method for the test set:
Not applicable for this type of device performance testing.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This is a cable for an intracranial pressure monitoring system, not an AI/imaging diagnostic device that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. The HICP200 is a hardware component with integrated software, not a standalone algorithm. Its performance is evaluated as part of the overall system functionality.
7. The type of ground truth used:
For the performance data mentioned, the "ground truth" would be the established scientific and engineering principles and the specified parameters within the referenced standards (e.g., AAMI NS 28 for accuracy, IEC 60601 for safety and EMC). The device's measurements and behavior are compared against these known, precise benchmarks.
8. The sample size for the training set:
Not applicable, as this is hardware and embedded system development, not a machine learning model that requires a training set. The software development procedure RD-004 is based on IEC 62304:2006 and FDA software-related guidance documents, implying software validation rather than training data.
9. How the ground truth for the training set was established:
Not applicable, for the same reason as 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).