(29 days)
The intended use of the Cyberkinetics Neurotechnology Systems, Inc. NeuroPort System is for temporary (
The NeuroPort System, when connected to the NeuroPort Array Electrode, supports recording and display of local field potentials and extra cellular spikes from the brain. The NeuroPort Array is not modified by this 510(k) submission. The NeuroPort Electrode Array has 100 electrode contacts on a substrate of 4mm. The NeuroPort Electrode array is implanted in the cortex of the brain for less than 30 days. The NeuroPort Electrode Array passes neural activity of the brain cortex to the NeuroPort System through a Patient Cable assembly. The modification described within this 510(k) submission is summarized as: a) the addition of an impedance test switch to the Patient Cable, b) a hardware change to support automated impedance testing of the NeuroPort Electrode Array, and c) a software change to support automated impedance testing of the NeuroPort Electrode Array.
This document describes the 510(k) submission for a modified NeuroPort System, focusing on the addition of an automated impedance test function. It is a modification to an existing device, and the submission primarily addresses the verification and validation of these specific changes.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria or detailed performance metrics. Instead, it indicates that "Testing is completed. No safety or effectiveness concerns remain." for the automated impedance test modification.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Software functions as intended | "Software verification and validation" completed, no safety or effectiveness concerns. |
| Hardware meets design input requirements | "Hardware verification of design output meeting design input requirements" completed, no safety or effectiveness concerns. |
| The modification does not negatively impact the safety or effectiveness of the NeuroPort System | "No new questions of safety or effectiveness are raised." |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not specify a sample size for a test set. The testing performed was related to "Software verification and validation" and "Hardware verification of design output meeting design input requirements" for the impedance test modification. These typically involve internal testing and validation rather than a clinical "test set" in the traditional sense for AI/machine learning. The data provenance is internal to Cyberkinetics, Inc., and is retrospective in the sense that it evaluates the modifications to an existing device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not provided. Given the nature of the modifications (software and hardware changes for an impedance test), the "ground truth" would likely be established through engineering specifications, functional requirements, and direct measurement/testing by qualified engineers and validation specialists within the company.
4. Adjudication Method for the Test Set
This information is not provided because the type of study described does not involve a "test set" requiring expert adjudication in the context of diagnostic or interpretive accuracy.
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 MRMC comparative effectiveness study was mentioned. The device modification is for an automated impedance test, not an AI-assisted diagnostic or interpretive tool intended for human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The device is the NeuroPort System with an automated impedance test. The "algorithm only" performance would be its ability to accurately and reliably perform the impedance test as designed. The document states "Testing included: 1. Software verification and validation, 2. Hardware verification of design output meeting design input requirements." This implies standalone testing of the automated function.
7. The Type of Ground Truth Used
For the software and hardware verification, the ground truth would be based on:
- Design Input Requirements: The original specifications and intended functionality of the impedance test.
- Engineering Specifications: Technical documentation detailing how the impedance test should operate.
- Direct Measurement/Comparison: For hardware, this would involve comparing outputs to known standards or expected values. For software, it would involve executing test cases and verifying expected behavior.
8. The Sample Size for the Training Set
No information is provided about a "training set." The device modification involves an automated impedance test, which does not typically rely on machine learning or AI models that require a training set in the conventional sense. The software and hardware are designed and verified against specifications, not trained on data.
9. How the Ground Truth for the Training Set Was Established
As no training set is mentioned or implied, this information is not applicable.
§ 882.1400 Electroencephalograph.
(a)
Identification. An electroencephalograph is a device used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head.(b)
Classification. Class II (performance standards).