(52 days)
The Blackrock NeuroPort Biopotential Signal Processing System supports recording, processing and display of biopotential signals from user supplied electrodes. Biopotential signals include: Electrocorticography (ECoG), electroencephalography (EEG), electromyography (EMG), electrocardiography (ECG), electrooculography (EOG) and Evoked Potential (EP).
The Blackrock NeuroPort Biopotential Signal Processing System (System), when connected to customer supplier bio-potential electrodes or the NeuroPort Electrode Array (K042384), supports recording and display of bio-potential signals. Bio-potential signals that can be recorded by the System include:
- Electrooculography (EOG),
- Electrocorticography (ECoG),
- electroencephalography (EEG),
- electromyography (EMG),
- electroencephalography (ECG) and
- evoked potential (EP).
The System is not a monitoring system. No physiologic alarms are provided. The acquisition and display of bio-potential signals is for the interpretation and use of the clinician.
The provided 510(k) summary for the Blackrock NeuroPort Biopotential Signal Processing System does not contain the detailed information typically found in a clinical study report that proves a device meets specific acceptance criteria using a test set. This document is a premarket notification for a medical device to demonstrate substantial equivalence to existing predicate devices.
Instead, it focuses on comparing the new device's technical specifications and intended use with previously cleared (predicate) devices to argue that it raises "no new questions of safety or effectiveness."
Therefore, much of the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness studies is not available in this document.
Here's an attempt to extract and infer information based on the provided text, while making explicitly clear what is not present:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in the sense of predefined performance targets for a clinical study. Instead, it compares the device's technical specifications to those of predicate devices. The implicit acceptance criterion is that the device's performance characteristics are equivalent to or better than the predicate devices, and that it adheres to relevant safety standards.
| Feature | Predicate NeuroPort Instrument (K060523) Performance (Implicit Acceptance Criteria) | Device Under Review Performance |
|---|---|---|
| Intended Use, Indications for Use | Recording, processing and display of biopotential signals (EEG, ECoG, ECG, EMG, EOG, EP) | Equivalent |
| Typical Biopotential Signals Recorded | EEG, ECoG, ECG, EMG, EOG, EP | Equivalent |
| Number of Signal Recording Channels | 96 | Up to 128 (cascadable to 256) |
| Amplifier Input Impedance | 1000 Megohm | 1000 Megohm |
| A/D Conversion | 16 Bit | 16 Bit |
| Sampling Rate | Up to 30,000 Hz | Up to 30,000 Hz |
| CMRR | > 90 dB | > 90 dB |
| Analysis Software | Embedded, commercially available and user defined (e.g., Persyst Insight™, NeuroPlex™, Matlab™, Spike 2™) | Equivalent, same examples |
| Power | 110 VAC | 110 VAC |
| Alarms | No | No |
| Safety Standards Compliance | IEC 60601-1, IEC 60601-1-2, IEC 60601-2-26 | Same |
Note on "Reported Device Performance": The reported performance is essentially a restatement of the technical specifications, demonstrating they match or exceed the predicate devices. There is no independent "study" performance data presented in this 510(k) summary that would provide statistical measures like sensitivity, specificity, accuracy, or other metrics typically seen in diagnostic device studies.
2. Sample size used for the test set and the data provenance
- Not Provided. This document does not describe a "test set" in the context of a clinical study with human or animal subjects, nor does it mention data provenance (country of origin, retrospective/prospective). The assessment appears to be based on direct technical specification comparison and perhaps internal engineering testing (referred to as "system testing" and "software documentation" in Section 4.0).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable/Not Provided. Since there is no "test set" or clinical study described for ground truth establishment, this information is not present.
4. Adjudication method for the test set
- Not Applicable/Not Provided. No adjudication method is mentioned as there's no described test set or expert evaluation process.
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/Not Provided. This device is a signal processing system for acquiring and displaying biopotential signals. It is not an AI-assisted diagnostic tool for human readers, and therefore, an MRMC study comparing human reader performance with and without AI assistance is not relevant to this device description and was not performed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable/Not Provided. The device itself is a hardware and software system for signal acquisition and display. It does not perform automated interpretations or diagnoses requiring a standalone "algorithm only" performance evaluation in the typical sense of AI/ML devices. Its performance is defined by its ability to accurately acquire and condition the biopotential signals. The "software testing" mentioned in Section 6.0 likely refers to verification and validation of the software's functionality within the system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not Applicable/Not Provided. Given the nature of a signal processing system, "ground truth" would typically relate to the accuracy of the signal acquisition and conditioning itself, which is assessed through engineering tests against known input signals, not clinical ground truth like pathology or outcomes data. The document does not specify how the performance metrics (e.g., CMRR, impedance, sampling rate) were verified, but it would logically involve calibrated electronic test equipment.
8. The sample size for the training set
- Not Applicable/Not Provided. This device is not an AI/ML device that requires a "training set" in the context described.
9. How the ground truth for the training set was established
- Not Applicable/Not Provided. As there's no training set, this is not applicable.
Summary of the "Study" (as described in the 510(k) Summary):
The "study" described in this 510(k) summary is not a clinical trial or performance study against predefined clinical acceptance criteria involving human subjects or expert readers. Instead, it is a technical comparison and verification process.
- Purpose: To demonstrate "substantial equivalence" of the Blackrock NeuroPort Biopotential Signal Processing System to legally marketed predicate devices (K042626, K060803, K040113).
- Methodology:
- Comparison of Intended Use/Indications for Use: Showing the new device's intended use is equivalent to or falls within the scope of predicate devices.
- Comparison of Technological Characteristics: A detailed feature-by-feature comparison of specifications (e.g., number of channels, input impedance, A/D conversion, sampling rate, CMRR) between the new device and predicate devices.
- Hardware Modifications Verification: Mention of verifying new interface cables and a passive splitter box through "continuity of the single pathway" and "continuity of the signal pathways."
- Software Testing: Indication that "software testing" was performed for new functionalities like syncing with external EEG instruments and cascading two systems.
- Standards Compliance: Affirmation of compliance with relevant safety standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-26).
- Conclusion: The modifications to the predicate NeuroPort System "raise no new questions of safety or effectiveness," indicating that the device is considered safe and effective based on its equivalence to existing cleared devices.
In essence, this document is a regulatory submission demonstrating technical equivalence rather than a report of a scientific study with clinical performance endpoints.
§ 882.1835 Physiological signal amplifier.
(a)
Identification. A physiological signal amplifier is a general purpose device used to electrically amplify signals derived from various physiological sources (e.g., the electroencephalogram).(b)
Classification. Class II (performance standards).