(30 days)
The BrainPulse is intended for use on a patient's head to non-invasively detect, amplify and capture the skull motion caused by pulsatile flow from the cardiac cycle. The BrainPulse is not in the diagnosis of neurological conditions, diseases, or disorders.
The BrainPulse™ 1100 is a non-invasive device having three basic components that are provided as an entire system and all are non-sterile and reusable: . Headset with detachable cable that is patient contacting and includes: One Photoplethysmograph (PPG) sensor for o detecting the heart rate and timing; One Sound Pressure Level (SPL) sensor for o detecting ambient environment noise; and Six Accelerometer sensors to detect the o acceleration at six selected locations. ● Data Collector, which digitizes the analog signals from the headset . Computer, which incorporates the device Software and space to store the BrainPulse recording data and, . Device Software, which provides the user interface, hardware control software libraries The BrainPulse collects and stores skull motion caused by pulsatile flow from the cardiac cycle. The normal brain structure produces a motion that is driven by and synchronized with the heart rate, and is manifested by slight acceleration of the skull. The device uses piezoelectric-based accelerometer sensors that measure skull motion rather than brain sounds. The typical frequencies that are employed with the BrainPulse are below 20 Hz and mostly below 10 Hz, well below the lower limit of audible sound. The headset senses the motion and the Data Collector digitizes the signal. The computer mainly provides the user interface and stores the data for further processing. Users place the device's headset on patients and setup the user interface to perform a BrainPulse recording. Typically, a recording is about 2-3 minutes long, though users may obtain recordings up to 30 minutes long depending on their applications. Recordings may be obtained at any time.
The provided text describes the BrainPulse 1100 device and modifications to its software, but it does not contain details about specific acceptance criteria or a study proving the device meets those criteria, especially in terms of diagnostic performance or clinical effectiveness.
Here's a breakdown of what can be extracted and what information is missing:
1. Table of Acceptance Criteria and Reported Device Performance:
- Missing from the provided text. The text mentions "The device met all acceptance criteria during verification and validation tests and demonstrated compliance to design inputs," but it does not specify what those acceptance criteria were or present quantitative performance data.
2. Sample size used for the test set and the data provenance:
- Missing from the provided text. The text mentions "Software validation as well as system verification was performed," but does not detail the sample size or the nature of the test set (e.g., number of recordings, patients, data provenance).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Missing from the provided text. There is no mention of expert involvement in establishing ground truth for any testing.
4. Adjudication method for the test set:
- Missing from the provided text. No adjudication method is described.
5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done:
- Missing from the provided text. There is no mention of an MRMC study or any comparison of human readers with or without AI assistance. The device's intended use is to "detect, amplify and capture the skull motion," not to aid human interpretation of images or other data related to neurological conditions.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Partially addressed, though not in terms of clinical performance. The text indicates that "Software validation as well as system verification was performed to show equivalence to the previous software that was cleared in DEN140040." This suggests an evaluation of the algorithm's output in isolation to ensure it matches the previous version, but not in the context of clinical accuracy or standalone diagnostic performance. The device itself is described as collecting and storing data for "further processing," implying it's a data acquisition tool, not a diagnostic algorithm.
7. The type of ground truth used:
- Missing from the provided text for performance evaluation. For the software validation, the implicitly used "ground truth" was likely the expected output of the previous software version, as the goal was to demonstrate equivalence. However, this is not a clinical ground truth like pathology or outcomes data.
8. The sample size for the training set:
- Not applicable / Missing from the provided text. The document describes a device (BrainPulse 1100) and minor software updates, not the development of a machine learning algorithm. Therefore, there's no mention of a training set for an AI model.
9. How the ground truth for the training set was established:
- Not applicable / Missing from the provided text. As above, this document does not describe the development or training of an AI algorithm.
Summary of Device and Changes (from the provided text):
The BrainPulse 1100 is a non-invasive cranial motion measurement device designed to detect, amplify, and capture skull motion caused by pulsatile flow from the cardiac cycle. It consists of a headset with sensors (PPG, SPL, six accelerometers), a data collector, a computer with device software.
The current submission (K170926) is for the same device and model (BrainPulse 1100) that was previously cleared under de novo DEN140040. The only change is to the software user interface. The hardware remains unchanged.
Software Updates:
- Improved user interface with options to add metadata (hospital, patient details).
- Options to view the signal in real-time.
- Options to review the signal after recording.
- Automatic stopping of recording based on specified time and heartbeat intervals.
- Calculation and display of statistics from the signal for evaluation.
Testing Conducted:
- Software validation and system verification were performed to show equivalence to the previous software cleared in DEN140040.
- Risk analysis was conducted on the updated software.
- Overall system verification was performed.
- The software validation had a Level of Concern determined to be moderate (Level B).
- The device "met all acceptance criteria during verification and validation tests and demonstrated compliance to design inputs."
Crucially, the document explicitly states: "The BrainPulse is not indicated to aid in the diagnosis of neurological conditions, diseases, or disorders." This indicates that its purpose is data acquisition, not diagnostic interpretation, which explains the absence of clinical performance metrics typically associated with diagnostic AI.
§ 882.1630 Cranial motion measurement device.
(a)
Identification. A cranial motion measurement device is a prescription device that utilizes accelerometers to measure the motion or acceleration of the skull. These measurements are not to be used for diagnostic purposes.(b)
Classification. Class II (special controls). The special controls for this device are:(1) The technical parameters of the device, hardware and software, must be fully characterized and include the following information:
(i) Hardware specifications must be provided. Additionally, verification and validation testing as well as a hazard analysis must be performed.
(ii) Software must be described in detail in the Software Requirements Specification (SRS) and Software Design Specification (SDS). Additionally, software verification and validation testing as well as a hazard analysis must be performed.
(2) The device parts that contact the patient must be demonstrated to be biocompatible.
(3) The device must be designed and tested for electrical, thermal, and mechanical safety, and electromagnetic compatibility (EMC).
(4) Clinical performance testing must demonstrate the accuracy, precision, stability, and repeatability of measuring cranial motion per the intended use in the intended use environment.
(5) The labeling must include:
(i) The intended use population and the intended use environment.
(ii) Instructions for technicians to convey to patients regarding the collection of cranial acceleration data to ensure device measurement accuracy, precision, stability, and repeatability.
(iii) Information allowing clinicians to understand potential sources of variability in the measurement to help recognize and identify changes in the measurement.